-
HutchMed Anticipates Milestone Payment as Takeda Launches Fruzaqla in Japan for CRC
•
China-based HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) is poised to receive a milestone payment from its partner Takeda (TYO: 4502), following the successful pricing approval and launch of Fruzaqla (fruquintinib) 1mg/5mg capsules in Japan. The drug is indicated for patients with previously treated metastatic colorectal cancer (CRC). Fruzaqla’s Approval…
-
First Patient Dosed in Abbisko’s Phase II Trial of ABSK061 and ABSK043 in FGFR2/3 Altered Tumors
•
Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced the first patient dosing in an open, multi-center Phase II study. The study is designed to assess the safety and efficacy of its investigational drugs ABSK061 combined with ABSK043, with or without chemotherapy, in patients with metastatic or unresectable solid…
-
Bayer’s Nubeqa Files for FDA Approval in mHSPC
•
German pharmaceutical company Bayer AG (ETR: BAYN) has announced that the US Food and Drug Administration (FDA) has accepted its supplemental new drug application (sNDA) for Nubeqa (darolutamide) for review. Bayer is seeking approval for its androgen receptor inhibitor (ARi) in combination with androgen deprivation therapy (ADT) for the treatment…
-
China Grants Marketing Approval for MSD’s Welireg for von Hippel-Lindau Disease Tumors
•
China’s National Medical Products Administration has issued marketing approval for Merck, Sharp & Dohme’s (MSD; NYSE: MRK) oral drug Welireg (belzutifan) as a therapy for von Hippel-Lindau (VHL) disease-related renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastoma, and pancreatic neuroendocrine tumor (pNET) that do not require immediate surgical intervention.…
-
Easton Pharmaceutical Secures NMPA Approval for Generic Jakavi and Urocit-K
•
Chengdu-based Easton Pharmaceutical Co., Ltd (SHA: 688513) has announced that it has received separate marketing approvals from the National Medical Products Administration (NMPA) for its generic versions of Incyte Corporation’s Jakavi(ruxolitinib) and Missionpharma’s Urocit-K(potassium citrate), marking a significant milestone for the company. Approval of Generic JakaviJakavi, a JAK inhibitor, is…
-
Innorna’s mRNA Drug IN015 Earns Orphan Drug Designation for PFIC Treatment
•
Shenzhen-based Innorna Co., Ltd, a leading platform company specializing in mRNA technology and LNP (lipid nanoparticle) delivery technology, has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its investigational mRNA drug, IN015. The designation is for the treatment of progressive…
-
Jiangsu Hengrui Receives NMPA Approval for HRS-6208 Solid Tumor Clinical Study
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its investigational drug HRS-6208 as a monotherapy for solid tumors. HRS-6208: A Selective Small Molecule InhibitorThe drug, a selective small molecule inhibitor with…
-
InxMed’s Ifebemtinib Earns Breakthrough Therapy Designation for NSCLC Treatment in China
•
China-based InxMed (Nanjing) Co., Ltd has announced that the Center for Drug Evaluation of the National Medical Products Administration (NMPA) has granted a Breakthrough Therapy Designation (BTD) to its innovative small-molecule ifebemtinib (IN10018). The designation is for the use of ifebemtinib, a focal adhesion kinase (FAK) inhibitor, in combination with…
-
Hua Medicine and Bayer AG Terminate Co-promotion Agreement for HuaTangNing
•
China-based Hua Medicine (HKG: 2552) has announced the termination of its co-promotion agreement with German pharmaceutical giant Bayer AG (ETR: BAYN) regarding HuaTangNing (dorzagliatin tablets, HMS5552), effective January 1, 2025. The agreement, which began in August 2020, focused on the promotion and distribution of the drug in China. Dorzagliatin’s Impact…
-
Sino Biopharmaceutical Submits NDA for Anlotinib and Penpulimab Combo in HCC to NMPA
•
China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced the submission of a New Drug Application (NDA) to the National Medical Products Administration (NMPA) for its combination therapy of anlotinib and penpulimab in first-line advanced hepatocellular carcinoma (HCC). Phase III Study Data Supports NDA FilingThe filing is supported by data from…
-
Innovent Biologics’ IBI354 Earns Breakthrough Therapy Designation for Ovarian Cancer Treatment
•
The Center for Drug Evaluation (CDE) website has indicated that China-based Innovent Biologics, Inc. (HKG: 1801) is set to obtain breakthrough therapy designation (BTD) for its antibody drug conjugate (ADC) IBI354, which targets HER2, for the treatment of platinum-resistant ovarian cancer. Phase I/II Clinical Study ResultsThe Phase I/II clinical study…
-
CDE Includes Double-Crane’s Hydroxocobalamine and Sanofi Genzyme’s Fitusiran in Rare Disease Care Plan
•
China’s Center for Drug Evaluation (CDE) has announced the inclusion of China Resources Double-Crane Pharmaceutical Co., Ltd’s (SHA: 600062) hydroxocobalamine and Sanofi (NASDAQ: SNY) Genzyme’s fitusiran in its patient-centered rare disease drug development pilot program, known as the Care Plan. Hydroxocobalamine for Metabolic Disorders in Children with MMAHydroxocobalamine, also referred…
-
Apeiron Therapeutics Initiates Phase Ia/B Study for GTA182 in Solid Tumors with MTAP Deficiency
•
Apeiron Therapeutics, a biomarker-driven cancer therapy developer with operations in Shanghai, China, and San Francisco, US, has announced the enrollment of the first patient in the Phase Ia/B study for its investigational drug GTA182. The dosage escalation study aims to assess the safety, efficacy, and pharmacokinetics of the small molecule…
-
NMPA Approves Alpha Biopharma’s Zorifertinib for First-Line NSCLC Treatment with CNS Metastases
•
The National Medical Products Administration (NMPA) has granted approval to China-based Alpha Biopharma’s zorifertinib, commercially known as Zorifer, for the treatment of first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation and central nervous…
-
Pfizer’s Hympavzi Receives European Commission Approval for Hemophilia A and B
•
US pharmaceutical major Pfizer Inc. (NYSE: PFE) has announced that the European Commission (EC) has granted approval for its drug Hympavzi (marstacimab-hncq) for the routine prophylaxis of bleeding episodes in patients aged 12 years and older weighing at least 35 kg with severe hemophilia A (congenital factor VIII [FVIII] deficiency,…
-
Guangdong Zhongsheng Pharmaceutical’s RAY1225 Shows Positive Results in Phase II Study
•
Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a China-based pharmaceutical company, has announced positive top-line results from Part A of a Phase II clinical study for its Category 1 innovative polypeptide drug candidate, RAY1225. The drug demonstrated significant superiority over placebo in achieving weight loss targets and alleviating multiple cardiovascular…
-
US FDA Grants ODD to Ractigen’s siRNA Therapy RAG-21 for ALS Treatment
•
China-based small activating RNA (saRNA) drug developer, Ractigen Therapeutics, has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its drug candidate RAG-21. This FUS gene-targeted siRNA therapy is indicated for the treatment of amyotrophic lateral sclerosis (ALS), an incurable and…
-
UCB’s Bimzelx Receives US FDA Approval for Moderate to Severe Hidradenitis Suppurativa
•
Belgium-based biopharmaceutical company UCB (FRA: UNC) has announced that the US Food and Drug Administration (FDA) has granted another indication approval for its drug Bimzelx (bimekizumab), an interleukin 17A (IL-17A) and IL-17F targeted antibody. The FDA has approved Bimzelx for the treatment of adults with moderate to severe hidradenitis suppurativa…
-
GSK’s Linerixibat Demonstrates Efficacy in Phase III GLISTEN Study for Cholestatic Pruritus
•
UK-based pharmaceutical giant GlaxoSmithKline (GSK; NYSE: GSK) has announced positive headline results from the Phase III GLISTEN study, which assessed the efficacy of its ileal bile acid transporter (IBAT) inhibitor, linerixibat, in treating cholestatic pruritus (relentless itch) associated with primary biliary cholangitis (PBC). Study Design and Primary Endpoint AchievementThe GLISTEN…
-
Astellas Pharma’s Izervay sNDA for Geographic Atrophy Receives FDA Complete Response Letter
•
Japan-based Astellas Pharma Inc. (TYO: 4568) has announced that its supplemental New Drug Application (sNDA) for Izervay (avacincaptad pegol), indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), has received a Complete Response Letter (CRL) from the US FDA. The CRL addresses a statistical matter…
-
MSD Announces Positive Topline Results from Phase III Subcutaneous Keytruda Trial
•
US-based Merck, Sharp & Dohme Inc., (MSD, NYSE: MRK) has released positive topline results from the pivotal Phase III MK-3475A-D77 trial. The study aimed to assess the noninferiority of subcutaneous administration of PD-1 inhibitor Keytruda (pembrolizumab) combined with berahyaluronidase alfa, a hyaluronidase variant developed by Alteogen Inc., in comparison to…
-
Brii Biosciences’ Elebsiran Shows Promising Results in Phase II ENSURE Study for Chronic HBV
•
China-based Brii Biosciences Ltd (HKG: 2137) has published the latest data from its ongoing Phase II ENSURE study for elebsiran (BRII-835, VIR-2218), an investigational small interfering ribonucleic acid (siRNA) therapy for chronic hepatitis B virus (HBV) infection. Phase II ENSURE Study Design and Initial FindingsThe active-controlled and randomized Phase II…
-
Epigenic Therapeutics Receives Approval for EPI-003 Clinical Study in New Zealand
•
Shanghai-based Epigenic Therapeutics, a biotechnology company specializing in the development of novel gene modulation therapies, has announced that it has received approval from the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) and The Health and Disability Ethics Committees (HDEC) to conduct a clinical study for its investigational drug,…
-
UCB and Biogen’s Dapirolizumab Pegol Shows Promise in Phase III SLE Study
•
Partners UCB (FRA: UNC) and Biogen Inc. (NASDAQ: BIIB) have announced positive results from a Phase III study of their co-developed drug candidate, dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L agent, when combined with the standard-of-care (SOC) in patients with moderate-to-severe systemic lupus erythematosus (SLE). The findings, which indicate a…
-
Betta Pharmaceuticals’ MCLA-129 Approved for Clinical Trial in Advanced Solid Tumors
•
China’s Betta Pharmaceuticals (SHE: 300558) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug candidate, MCLA-129. The upcoming trial will evaluate the biologic product as a potential treatment for advanced solid tumors, including wild-type colorectal cancer, liver cancer,…
-
Shanghai Junshi Biosciences Enters Licensing Agreement for Dual-Targeted Fusion Proteins
•
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a China-based biopharmaceutical company, has announced a licensing agreement with an undisclosed company due to commercial sensitivity and trade secret considerations. Exclusive Licensing Rights for Greater ChinaAccording to the agreement, Junshi Bio will secure exclusive licensing rights and sublicensing rights to…
-
Biogen and Samsung Bioepis Win EC Approval for Opuviz Biosimilar in Europe
•
US-based Biogen Inc. (NASDAQ: BIIB) and South Korea’s Samsung Bioepis Co., Ltd. have jointly announced that they have received marketing approval from the European Commission (EC) for their Opuviz 40 mg/mL solution for injection in a vial. This biosimilar product, a version of Bayer/Regeneron’s Eylea (aflibercept), is now approved for…
-
Rona Therapeutics’ RN0191 Showcases Positive Phase I Results at AHA Scientific Sessions
•
Shanghai-based nucleic acid drug developer Rona Therapeutics has announced the presentation of positive Phase I results for its investigational drug, RN0191, at the American Heart Association’s (AHA) Annual Scientific Sessions in Chicago, IL. The study’s findings highlight the potential of RN0191 in managing lipid levels and offer promising news for…
-
Eli Lilly’s Tirzepatide Meets Primary Endpoints in Phase III SUMMIT Heart Failure Study
•
Eli Lilly and Company (NYSE: LLY), a leading US pharmaceutical corporation, has announced positive results from the Phase III SUMMIT study assessing the effects of tirzepatide in heart failure. The study successfully met both primary endpoints, marking a significant advancement in the treatment of heart failure. Study Outcomes and EfficacyTirzepatide,…
-
AstraZeneca’s Tagrisso Receives Positive CHMP Opinion for EGFR-Mutated NSCLC
•
AstraZeneca (AZ, NASDAQ: AZN), a leading UK pharmaceutical company, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued positive opinions for its drug Tagrisso (osimertinib). The EGFR-tyrosine kinase inhibitor (EGFR-TKI) is now recommended for approval to treat adult patients…
-
Everest Medicines’ Nefecon Receives Full Approval from South Korea’s MFDS for IgAN Treatment
•
China-based Everest Medicines (HKG: 1952) has announced that it has received full approval from the Ministry of Food and Drug Safety (MFDS) in South Korea for its Nefecon (targeted-release budesonide) for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) who have a urine protein excretion of ≥1.0 g/day…
-
Eli Lilly’s Muvalaplin Demonstrates Potent Lp(a) Reduction in Phase II Study
•
Eli Lilly & Co. (NYSE: LLY), a leading US pharmaceutical company, has announced positive results from a Phase II study for its investigational drug, muvalaplin, a selective lipoprotein(a) [Lp(a)] inhibitor. The study successfully met its primary endpoint, showing a significant reduction in elevated Lp(a) levels in adults, a genetic risk…
-
Sunshine Guojian Pharmaceutical’s SSGJ-608 Files for NMPA Approval in Plaque Psoriasis
•
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, (SHA: 688336) a subsidiary of 3SBio Inc. (HKG: 1530), has announced that the National Medical Products Administration (NMPA) has accepted its market filing for the drug candidate SSGJ-608 for review. The company is seeking regulatory approval for the anti-IL-17A monoclonal antibody to treat moderate…
-
Huahui Health’s Libevitug Earns FDA Breakthrough Designation for Chronic Hepatitis Delta Virus
•
Beijing-based biotech company Huahui Health, specializing in viral hepatitis, hepatology, and oncology, has announced that it has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for its libevitug (HH-003), an anti-PreS1 human monoclonal antibody (mAb), for the treatment of patients with chronic hepatitis delta virus…
-
Huadong Medicine’s DR10624 Receives NMPA Approval for MAFLD and MASH Clinical Trials
•
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with clinical trials for its protein drug DR10624 in metabolic related fatty liver disease (MAFLD) and metabolic associated steatohepatitis (MASH). DR10624’s Mechanism and Pre-Clinical PerformanceDR10624 is a…
-
Huadong Medicine’s HDM1005 Receives FDA Approval for MASH Clinical Study
•
Huadong Medicine Co., Ltd (SHE: 000963), a China-based pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its Category 1 chemical drug, HDM1005, in metabolic associated steatohepatitis (MASH). This development marks a significant step forward for…
-
TenNor Therapeutics’ Rifasutenizol Shows High Eradication Rate in H. pylori Phase III Study
•
China-based TenNor Therapeutics has announced positive results from its Phase III clinical study for rifasutenizol (TNP-2198) in treating Helicobacter pylori (H. pylori) infection. The study successfully met its primary endpoints, showing significant advantages of the rifasutenizol regimen over the bismuth-containing quadruple therapy (BQT), which is the current standard of care.…
-
Beijing Wantai Receives NMPA Clearance for Nine-Valent HPV Vaccine Targeting Male Population
•
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392), a leading Chinese pharmaceutical company, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its nine-valent human papillomavirus (HPV) vaccine (Escherichia coli), specifically designed for the male population. Global Impact and Vaccine RelevanceGlobally, approximately…
-
Hasten Biopharmaceutical Initiates Phase III Clinical Trial for Lerodalcibep in China
•
China-based Hasten Biopharmaceutical Co., Ltd, a comprehensive biopharmaceutical company co-established by CBC Group, has announced the first subject dosing in its Phase III clinical study for lerodalcibep, a third-generation PCSK9 inhibitor. The drug was in-licensed from US firm LIB Therapeutics Inc. in September of the previous year. Study Design and…
-
CanSino Biologics Initiates Phase I Clinical Trial for Freeze-Dried Hib Conjugate Vaccine
•
China-based biopharmaceutical company CanSino Biologics (HKG: 6185) has announced the commencement of a Phase I clinical study for its freeze-dried Haemophilus influenzae type b (Hib) conjugate vaccine, marking a significant step in the development of this important pediatric vaccine. The study has begun with the enrollment of the first subject,…
-
EMA’s CHMP Recommends Approval for MSD’s Keytruda Combo in Mesothelioma Treatment
•
Merck, Sharp & Dohme Inc., (MSD; NYSE: MRK), a leading US pharmaceutical company, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of its PD-1 inhibitor, Keytruda (pembrolizumab), in combination with pemetrexed plus…
-
EMA’s CHMP Recommends Approval for BMS’s Opdivo/Yervoy Combo in mCRC
•
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Bristol-Myers Squibb’s (BMS, NYSE: BMY) anti-PD-1 drug Opdivo (nivolumab) in combination with the anti-CTLA-4 biologic Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch…
-
Sandoz Receives EC Approval for Biosimilar to Eylea for Retinal Diseases
•
Switzerland-based pharmaceutical company Sandoz (SWX: SDZ) has announced that it has received marketing approval from the European Commission (EC) for its biosimilar of Bayer/Regeneron’s (ETR: BAYN / NASDAQ: REGN) Eylea (aflibercept). The product is now available in the form of a 2 mg vial kit and pre-filled syringe for intravitreal…
-
Sanofi’s Dupixent sBLA for Chronic Spontaneous Urticaria Accepted by FDA for Review
•
French pharmaceutical giant Sanofi has announced that the US Food and Drug Administration (FDA) has accepted for review the supplemental biologics license application (sBLA) for Dupixent (dupilumab). The application seeks to expand the monoclonal antibody’s (mAb) indication to treat adults and pediatric patients aged 12 years and older with chronic…
-
Novo Nordisk Launches Semaglutide for Weight Management in China
•
Denmark-based healthcare giant Novo Nordisk A/S (NYSE: NVO) has announced the official market launch of semaglutide in China for long-term weight management. Globally, Novo Nordisk markets the glucagon-like peptide-1 receptor agonist (GLP-1RA) under the trade name Wegovy for weight loss, expanding access to this treatment for individuals seeking to manage…
-
Sichuan Kelun-Biotech Secures NMPA Approval for Two Antibody Drug Conjugates
•
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a leading biopharmaceutical company based in China, has announced receiving separate Investigational New Drug (IND) approvals from the National Medical Products Administration (NMPA) for its antibody drug conjugates (ADCs), SKB535 and SKB571, which target solid tumors. This development marks a significant milestone in…
-
Exegenesis Bio’s Gene Therapy EXG110 Earns Orphan Drug Status for Fabry Disease
•
Exegenesis Bio, a leading provider of epigenetics experimental and analytical services headquartered in Hangzhou, has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its proprietary gene therapy, EXG110, which is indicated for the treatment of Fabry disease. This designation highlights…
-
Janssen-Cilag’s Lazcluze-Rybrevant Combo Receives Positive EMA Opinion for NSCLC Treatment
•
Janssen-Cilag International NV, a subsidiary of the US pharmaceutical giant Johnson & Johnson (J&J; NYSE: JNJ), has announced that it has received positive opinions from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) regarding the combination of Lazcluze (lazertinib) and Rybrevant (amivantamab-vmjw). This combination therapy…
-
Shanghai Junshi Biosciences’ Toripalimab Wins UK Approval for Nasopharyngeal and Oesophageal Cancers
•
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has announced that it has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its PD-1 inhibitor, toripalimab, marketed as Loqtorzi. This approval allows the use of toripalimab in…
-
Ascentage Pharma Submits Application for Lisaftoclax, a Novel Oral Bcl-2 Inhibitor
•
Ascentage Pharma (HKG: 6855) has announced that its proprietary oral Bcl-2 selective inhibitor, Lisaftoclax (APG-2575), has submitted its market application, which has been officially accepted by regulatory authorities. The formulation is being produced in collaboration with Xuantai Pharmaceutical. This innovative treatment targets patients suffering from refractory or relapsed chronic lymphocytic…
-
BlissBio Secures NMPA Approval for BB-1712, Pioneering ADC Therapy
•
BlissBio announced that its Investigational New Drug (IND) application for the innovative antibody-drug conjugate (ADC) BB-1712 has been approved by the National Medical Products Administration (NMPA) of China. BB-1712, a B7-H3 targeted ADC utilizing Eribulin as its cytotoxic agent, has been developed for the treatment of multiple solid tumors, signifying…
-
GSK’s Blenrep Shows Survival Benefit in Phase III Multiple Myeloma Study
•
UK-based pharmaceutical company GSK plc (NYSE: GSK) has reported positive results from a Phase III trial for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) as a second-line or later treatment for relapsed or refractory multiple myeloma (RRMM). The DREAMM-7 head-to-head study demonstrated that GSK’s BCMA-targeted antibody drug…
-
Janssen-Cilag’s Nipocalimab Shows Promise in Phase II Study for Sjögren’s Disease
•
Janssen-Cilag International NV, a subsidiary of Johnson & Johnson (J&J, NYSE: JNJ), has unveiled the latest analysis results from the Phase II DAHLIAS study for nipocalimab, an investigational FcRn blocker, in adult patients with moderate-to-severe Sjögren’s disease (SjD). The study has shown that the drug significantly improved key measures of…
-
Sanofi’s Sarclisa Receives CHMP Recommendation for Newly Diagnosed Multiple Myeloma
•
French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with…
-
Jiangsu Hengrui Receives NMPA Approval for SHR-2173 Clinical Trial in ITP
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its investigational biologic product, SHR-2173, in patients with primary immune thrombocytopenia (ITP). This development marks a significant step forward in expanding treatment options…
-
Eisai and Biogen’s Lecanemab Receives Positive CHMP Opinion for Early Alzheimer’s Treatment
•
Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have jointly announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of lecanemab, an amyloid-beta (Aβ) monoclonal antibody, for the treatment of adult patients…
-
Sino Biopharmaceutical’s TQB3002 Receives FDA Clearance for Phase I Study
•
Sino Biopharmaceutical Ltd (HKG: 1177), a leading China-based pharmaceutical company, has announced that it has received clearance from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study for its TQB3002. This is an in-house developed fourth-generation epidermal growth factor receptor (EGFR) inhibitor, marking a significant…
-
Mabwell Bioscience Receives NMPA Approval for 9MW2821 Clinical Trials
•
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate clinical studies for its antibody drug conjugate (ADC), 9MW2821. This drug targets Nectin-4 and will be evaluated in combination with programmed-death 1 (PD-1)…
-
WuXi Biologics Expands Sterile Filling Capabilities in Germany with New Line
•
China’s Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has announced plans to establish a new sterile filling line for prefilled syringes (PFS) at its facility in Leverkusen, Germany. This move is set to enhance the company’s drug product (DP) capabilities in the region, optimizing the facility’s…
-
Jiangxi Jemincare’s JMX-2002 Liposome Injection Gets NMPA Clinical Clearance
•
Jiangxi Jemincare Group, a China-based pharmaceutical company, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its JMX-2002 liposome injection. This innovative drug, known for its high efficiency and safety, is now set to commence clinical studies focusing on solid tumors, including non-small…
-
Lion TCR Gains NMPA Approval for mRNA TCR-T Therapy GZL-016 in HCC
•
Singapore-based clinical-stage biotechnology company Lion TCR, supported by Chinese investors, has secured tacit clinical approval from the National Medical Products Administration (NMPA) for its innovative therapy GZL-016. This approval marks a significant milestone in the development of mRNA T-cell receptor engineered T-cells (TCR-T) therapy aimed at treating hepatitis B virus-associated…
-
Eli Lilly’s Tirzepatide Shows Sustained Weight Loss in 176-Week Study
•
US pharmaceutical giant Eli Lilly and Company (NYSE: LLY) has released 176-week follow-up data from its Phase III SURMOUNT-1 study for tirzepatide, marking the longest completed study to date for the dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist. This data provides significant insights into the drug’s…
-
ImmuneOnco Initiates Phase II Study for IMM27M in ER+ Advanced Breast Cancer
•
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541), a leading biopharmaceutical company specializing in immuno-oncology, has announced the commencement of a Phase II clinical study for its investigational drug, IMM27M, targeting estrogen receptor positive (ER+) advanced breast cancer following endocrine therapy failure or recurrence. This announcement coincides with the enrollment of…
-
Huadong Medicine’s Biosimilar SaiLeXin Receives First National Prescription in China
•
China-based pharmaceutical company Huadong Medicine Co., Ltd (SHE: 000963) has announced a significant milestone with the issuance of the first national prescription for its biosimilar drug, SaiLeXin, at the Peking University People’s Hospital. This marks a new chapter in the treatment of autoimmune diseases in China, offering patients an alternative…
-
Novartis’ Pluvicto Accepted for Review by China’s NMPA for Prostate Cancer Treatment
•
The Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) has accepted a marketing approval filing from Swiss pharmaceutical giant Novartis (NYSE: NVS) for its radioligand therapy (RLT), Pluvicto (177Lu vipivotide tetraxetan). This acceptance marks a significant step towards making this innovative treatment available to patients in…
-
Daiichi Sankyo and AstraZeneca File BLA for Datopotamab Deruxtecan in NSCLC
•
Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN), partners in the development of innovative oncology treatments, have jointly announced the submission of a Biologic License Application (BLA) to the US Food and Drug Administration (FDA) for their co-developed TROP-2-targeted antibody drug conjugate (ADC), datopotamab deruxtecan (Dato-DXd). This application seeks…
-
CSPC Pharmaceutical Gains NMPA Approval for Clinical Trial of mRNA Vaccine SYS6026
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its therapeutic bivalent mRNA vaccine, SYS6026. This vaccine is indicated for the treatment of precancerous lesions caused by human papillomavirus (HPV) types 16 or 18. Vaccine…
-
Gan & Lee’s GZR18 Shows Significant Weight Loss in Phase IIb Study at ObesityWeek 2024
•
Gan & Lee Pharmaceuticals (SHA: 603087), a China-based pharmaceutical company, has announced the oral presentation of results from the Phase IIb study for its glucagon-like peptide-1 (GLP-1) receptor agonist, GZR18, at ObesityWeek 2024. The drug is administered once per week and targets the obese or overweight Chinese population. Study Design…
-
J&J’s Nipocalimab Receives FDA Breakthrough Therapy Designation for Sjögren’s Disease
•
US-based pharmaceutical giant Johnson & Johnson (J&J, NYSE: JNJ) has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its investigational drug nipocalimab. The designation is for the treatment of moderate-to-severe Sjögren’s disease (SjD), a chronic autoantibody disease with a high…
-
Zai Lab and argenx Receive NMPA Approval for Vygart Hytrulo in Chronic Inflammatory Demyelinating Polyneuropathy
•
China-based biotech Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) and its US partner argenx SE (NASDAQ: ARGX) have announced the receipt of supplementary Biologic License Application (sBLA) approval from the National Medical Products Administration (NMPA) for Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). This approval allows Vygart Hytrulo to be…
-
Cutia Therapeutics’ CU-10201 Receives NMPA Approval for Acne Vulgaris Treatment
•
Cutia Therapeutics (HKG: 2487), a developer of dermatology therapies, has announced that its CU-10201, a 4% minocycline foam agent for external use, has received market approval from the National Medical Products Administration (NMPA) in China. The approval is for the treatment of non-nodular moderate to severe acne vulgaris in individuals…
-
BeyondSpring Presents Positive Phase II Data for Plinabulin Combination Therapy in NSCLC at SITC
•
BeyondSpring Inc. (NASDAQ: BYSI), a US-based biotech company, has announced the presentation of the latest results from the Phase II KeyPelms-004 study at the 39th Society for Immunotherapy of Cancer’s (SITC) Annual Meeting. The study evaluated the efficacy and safety of plinabulin combined with pembrolizumab plus docetaxel in patients with…
-
Abbisko Therapeutics’ Pimicotinib Meets Primary Endpoint in Phase III MANEUVER Study for TGCT
•
hanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has revealed positive top-line results from the pivotal Phase III MANEUVER study for its drug candidate ABSK021 (pimicotinib) in tendon sheath giant cell tumor (TGCT). The study, designed to assess the efficacy and safety of pimicotinib in TGCT patients suitable for systemic…
-
ETERN Therapeutics’ ETS-006 Receives FDA Orphan Drug Designation for Pleural Mesothelioma
•
ETERN Therapeutics, a Shanghai-based developer of small-molecule anti-tumor drugs, has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its compound ETS-006. The designation is for the treatment of pleural mesothelioma (PM), a rare and aggressive form of cancer. Development and…
-
Frontera Therapeutics Receives FDA Approval for Phase II Study of FT-003 in nAMD
•
Frontera Therapeutics, Inc., a Sino-US biopharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase II clinical study for its investigational drug FT-003. This recombinant adeno-associated virus (rAAV) gene therapy is designed for the treatment of neovascular age-related macular…
-
Alteogen Secures Exclusive Licensing Deal with Daiichi Sankyo for Subcutaneous Enhertu
•
Alteogen Inc. (KOSDAQ: 196170), a South Korea-based biotechnology company, has announced an exclusive licensing agreement with Japan-headquartered Daiichi Sankyo (TYO: 4568). This strategic partnership grants Daiichi Sankyo worldwide rights to utilize Alteogen’s ALT-B4, a novel hyaluronidase based on Hybrozyme Technology, in the development and commercialization of a subcutaneous version of…
-
AstraZeneca’s Tezspire Meets Phase III Co-Primary Endpoints in CRSwNP Study
•
AstraZeneca Inc., (AZ, NASDAQ: AZN), a leading UK pharmaceutical company, has announced positive high-level results from the Phase III WAYPOINT study for Tezspire (tezepelumab) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The drug, a thymic stromal lymphopoietin (TSLP)-targeted monoclonal antibody (mAb) co-developed with US firm Amgen (NASDAQ: AMGN),…
-
Jiangsu Kanion Pharmaceutical Gets FDA Approval to Test KYS202004A for Psoriasis
•
Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557), a Chinese pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its pipeline candidate, KYS202004A, in the treatment of psoriasis. KYS202004A: A Dual-Targeted Fusion Protein for PsoriasisKYS202004A is an…
-
J&J Submits Regulatory Filings for Darzalex Faspro and Subcutaneous Daratumumab
•
Johnson & Johnson (J&J, NYSE: JNJ) has announced the submission of regulatory filings for its therapies Darzalex Faspro (daratumumab and hyaluronidase-fihj) to the US Food and Drug Administration (FDA) and for the subcutaneous (SC) formulation of Darzalex (daratumumab) to the European Medicine Agency (EMA). The company is seeking new indication…
-
Jiangsu Hengrui Medicine Receives NMPA Clearance for Multiple Clinical Trials of Oncology Drugs
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a Chinese pharmaceutical company, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for a suite of drugs including HRS-2189, HRS-5041, HRS-1358, HRS-8080, SHR-8068, adebrelimab, and HRS-6209. The company is set to initiate an open, multi-center Phase…
-
Alphamab Oncology Presents JSKN033 Phase I/II Study Results at SITC 2024
•
Alphamab Oncology (HKG: 9966), a China-based biopharmaceutical company, has announced the presentation of the latest results from the Phase I/II study of its investigational drug JSKN033 at the 2024 Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2024). The study focuses on patients with HER2-expressing advanced or metastatic…
-
Sino Biopharmaceutical Ltd Receives NMPA Approval for KRAS G12C Inhibitor Garsorasib
•
Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company in China, has announced that it has received conditional marketing approval from the National Medical Products Administration (NMPA) for garsorasib (D-1553), a KRAS G12C inhibitor co-developed with InventisBio (Shanghai) Co., Ltd. The drug is indicated for the treatment of patients with…
-
Daiichi Sankyo and Alteogen Sign $300 Million Deal to Develop Subcutaneous Enhertu
•
Daiichi Sankyo (TYO: 4568), a leading Japanese pharmaceutical company, has entered into a potentially $300 million agreement with South Korean biotechnology firm Alteogen to develop a subcutaneous injection version of its cancer drug Enhertu, which is also in collaboration with AstraZeneca. This innovative step aims to enhance patient accessibility and…
-
Dizal Pharmaceutical Submits NDA to FDA for Sunvozertinib as NSCLC Therapy
•
Dizal Pharmaceutical Co., Ltd (SHA: 688192), a Chinese pharmaceutical company, has announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for sunvozertinib, a targeted therapy for lung cancer. The company is seeking approval for the treatment of locally advanced or metastatic non-small…
-
Ascletis Pharma’s ASC47 Showcases Promising Weight Loss Results in Phase I Clinical Trial
•
Ascletis Pharma Inc. (HKG: 1672), a China-based pharmaceutical company, has announced positive results from a Phase I clinical study for its drug candidate ASC47 in Australia. This in-house developed therapy is designed to facilitate weight loss without the loss of muscle mass, offering a potential new option for obesity management.…
-
Sichuan Biokin Pharmaceutical Gets FDA Approval for Phase I Study of BL-M17D1 in Solid Tumors
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study for its in-house developed bispecific antibody drug conjugate (ADC), BL-M17D1, in patients with advanced solid tumors. BL-M17D1’s…
-
Sichuan Huiyu Pharmaceutical’s HYP-6589 Receives NMPA Approval for Solid Tumor Clinical Trial
•
Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug, HYP-6589, which targets advanced solid tumors. HYP-6589’s Mechanism of ActionHYP-6589 is an in-house developed SOS1 small molecule…
-
Ascentage Pharma’s Lisaftoclax and AceLink Therapeutics’ AL01211 Receive FDA Designations
•
The Center for Drug Evaluation (CDE) website has indicated that China-based Ascentage Pharma’s (HKG: 6855) lisaftoclax (APG-2575) and AceLink Therapeutics(Suzhou)’s AL01211 are on track to receive priority review and breakthrough therapy designation (BTD) statuses respectively from the US Food and Drug Administration (FDA). Lisaftoclax, an oral BCL-2 inhibitor, is indicated…
-
AskBio’s AB-1003 Receives Rare Pediatric Disease and Orphan Drug Designations from FDA
•
Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned subsidiary of Bayer AG (ETR: BAYN), has announced that it has received both rare pediatric disease designation (RPDD) and orphan-drug designation (ODD) from the US Food and Drug Administration (FDA) for its investigational gene therapy, AB-1003 (LION-101). The therapy targets limb-girdle muscular dystrophy…
-
CDE Releases Technical Guidelines for Pilot Registration and Phased Manufacturing of ADCs
•
The Center for Drug Evaluation (CDE) has issued the “Technical Requirements for Pilot Registration and Application of Phased Manufacturing of Antibody Drug Conjugates (ADC).” This document complements the “Pilot Work Plan for Phased Manufacturing of Biological Products” released last month and aims to guide the pilot work of phased manufacturing…
-
Belief BioMed’s BBM-D101 Receives FDA Orphan Drug and Pediatric Rare Disease Designations for DMD
•
Belief BioMed has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) and Pediatric Rare Disease Designation (RPDD) for its gene therapy drug, BBM-D101 injection, indicated for the treatment of Duchenne muscular dystrophy (DMD). BBM-D101: A Pioneering rAAV Gene Therapy for Duchenne Muscular DystrophyBBM-D101…
-
HutchMed to Present Updated Data from Solvleplenib ESLIM-01 Phase III Trial at ASH and ESMO Congress 2024
•
China-based HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced plans to present new and updated data from the sovleplenib ESLIM-01 Phase III trial, along with several investigator-initiated studies of compounds discovered by HutchMed, at the American Society of Hematology (ASH) Annual Meeting and the European Society for Medical Oncology…
-
Pfizer’s Talzenna (talazoparib) Approved by China’s NMPA for mCRPC Treatment
•
The National Medical Products Administration (NMPA) website has indicated that Pfizer’s (NYSE: PFE) marketing filing for Talzenna (talazoparib) has been approved, clearing the way for the poly ADP-ribose polymerase (PARP) inhibitor to treat metastatic castration-resistant prostate cancer (mCRPC) in China. Talazoparib’s Global Approvals and IndicationsTalazoparib received approval in the US…
-
Shouyao Holdings Adjusts Development Strategy for SY-1530, Halts Monotherapy Clinical Trials
•
Beijing-based Shouyao Holdings (Beijing) Co., Ltd (SHA: 688197) has announced a strategic adjustment regarding its drug candidate SY-1530. The company has decided to proactively terminate the clinical development of the BTK inhibitor as a monotherapy for recurrent/refractory mantle cell lymphoma (MCL) and other B-cell derived non-Hodgkin lymphoma (B-NHL). Despite this,…
-
Nanjing Leads Biolabs Secures FDA Orphan Drug Designation for LBL-034 in Multiple Myeloma Treatment
•
Nanjing Leads Biolabs Co., Ltd, a China-based biopharmaceutical company, has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its Category 1 drug LBL-034, which is intended for the treatment of multiple myeloma (MM). LBL-034: A Novel Bispecific Antibody Targeting GPRC5D…
-
Sanofi’s Dupixent Gains EMA Approval for Eosinophilic Esophagitis in Children
•
French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that it has received marketing approval from the European Medicines Agency (EMA) for its drug Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children aged one to 11 years who weigh at least 15 kg. The approval covers patients who are inadequately…
-
China’s NHC Announces Initiative to Boost Gerontology Medical Services
•
The National Health Commission (NHC) has issued a notification aimed at enhancing gerontology medical service capabilities, outlining specific work requirements. These include the construction of geriatric medicine departments, development of geriatric medical talent teams, standardization of geriatric medical diagnosis and treatment services, and enrichment of service models. Improving Geriatric Medicine…
-
Amgen’s Tavneos Receives NMPA Approval for ANCA-Associated Vasculitis Treatment in China
•
US biotechnology company Amgen (NASDAQ: AMGN) has announced that it has received market approval in China for its drug Tavneos (avacopan). The National Medical Products Administration (NMPA) has approved Tavneos for use as adjuvant therapy in adults with severe and active anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis, specifically granulomatous polyangitis…
-
CARSgen Therapeutics Presents Latest CAR-T Data at ASH Annual Meeting
•
CARSgen Therapeutics Holdings Ltd (HKG: 2171), a China-based specialist in chimeric antigen receptor (CAR)-T cell therapies, has announced the presentation of the latest data for its CAR-T therapies, CT053 (zevorcabtagene autoleucel; zevor-cel), CT071, and CT0590, at the 66th American Society of Hematology (ASH) annual meeting. CT053 Phase II Study Subgroup…
-
Changchun High & New Technology Industries Receives NMPA Approval for Long-Acting Somatropin
•
Changchun High & New Technology Industries (Group) Inc., (SHE: 000661), a leading China-based company, has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its polyethylene glycol recombinant human somatropin, a long-acting somatropin, for the treatment of idiopathic short stature (ISS). Understanding Idiopathic…
-
Huadong Medicine Co., Ltd Receives NMPA Approval for Stelara Biosimilar SaiLeXin
•
Huadong Medicine Co., Ltd (SHE: 000963), a China-based pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) auto-immune disease drug Stelara (ustekinumab), named SaiLeXin. This development marks a significant step forward…
-
Ascentage Pharma to Present Olverembatinib and Lisaftoclax Clinical Data at ASH Annual Meeting
•
China-based Ascentage Pharma (HKG: 6855) has announced that it will present the results of multiple clinical studies for its olverembatinib (HQP1351) and three clinical studies for its lisaftoclax (APG-2575) at the 66th American Society of Hematology (ASH) annual meeting. These presentations highlight the company’s commitment to advancing treatments for various…
-
CStone Pharmaceuticals Presents CS5001 Clinical Data at the ASH Annual Meeting
•
China-based CStone Pharmaceuticals (HKG: 2616) has announced the presentation of the latest clinical data on CS5001, an anti-ROR1 antibody drug conjugate (ADC) for lymphoma, at the 66th American Society of Hematology (ASH) Annual Meeting. CS5001 is a leading asset in CStone’s Pipeline 2.0 and has shown significant promise in treating…
-
Roche to Showcase 40+ Abstracts on Blood Disorders at ASH Annual Meeting
•
Swiss pharmaceutical giant Roche (SWX: ROG) has announced plans to present over 40 abstracts across nine blood disorders at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. The presentations will feature data on approved medicines Polivy (polatuzumab vedotin), Lunsumio (mosunetuzumab), and Columvi (glofitamab), including long-term follow-up and…
-
China Medical System’s Opzelura Approved in Hong Kong for Non-segmental Vitiligo Treatment
•
China Medical System Holdings (CMS; HKG: 0867) has announced that the market filing for its Opzelura (ruxolitinib) cream has been approved in Hong Kong. This topical Janus kinase (JAK) inhibitor is now approved for use as a local treatment for non-segmental vitiligo in patients aged 12 years and above, expanding…
-
Legend Biotech to Showcase CARTITUDE-4 Trial Data on Carvykti at ASH Annual Meeting
•
China-based Legend Biotech Corporation (NASDAQ: LEGN) is set to present new data on minimal residual disease (MRD) negativity rates from the Phase III CARTITUDE-4 trial at the 66th Annual American Society of Hematology (ASH) Annual Meeting in San Diego. The data will compare Carvykti (ciltacabtagene autoleucel; cilta-cel) treatment with the…
-
Asieris Pharmaceuticals Receives NMPA Approval for Hexvix (APL-1706) in Bladder Cancer Diagnosis
•
China-based urogenital cancer specialist Asieris Pharmaceuticals (SHA: 688176) has announced that the National Medical Products Administration (NMPA) has approved a marketing filing for its product Hexvix (APL-1706), which is used in the diagnosis and management of bladder cancer. Product Approval and ImpactThe approval of Hexvix by the NMPA marks a…
-
Frontier Biotechnologies Inc. Gets NMPA Approval for Phase II Study of Albuvirtide as HIV Therapy
•
Nanjing-based Frontier Biotechnologies Inc. (SHA: 688221) has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study for its version of albuvirtide, marking a significant step forward for China’s first domestically developed innovative HIV therapy. The study will evaluate albuvirtide as a maintenance…
-
Windtree Therapeutics Secures Hong Kong Patent for Istaroxime Heart Failure Treatment
•
US biotechnology company Windtree Therapeutics, Inc. (NASDAQ: WINT) has announced the receipt of a patent approval in Hong Kong for its drug istaroxime. The patent, titled “Istaroxime-containing intravenous formulation for the treatment of heart failure (AHF),” covers formulations comprising istaroxime and methods of use, either alone or in combination with…
-
BMS’s Opdivo Secures NMPA Approval for Urothelial Carcinoma Treatment
•
Bristol Myers Squibb (BMS; NYSE: BMY) has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its anti-PD-1 drug Opdivo (nivolumab) in combination with cisplatin and gemcitabine. This approval is for a first-line treatment of unresectable or metastatic urothelial carcinoma (UC). The Opdivo/chemo…
-
HuidaGene Receives FDA Clinical Clearance for HG202 in Neovascular AMD Treatment
•
China-based HuidaGene (Shanghai) Biotechnology Co., Ltd has announced receiving clinical clearance from the US Food and Drug Administration (FDA) for its drug candidate HG202, an innovative treatment for neovascular age-related macular degeneration (nAMD). BRIGHT Study to Assess Safety and Tolerability of HG202The upcoming BRIGHT study, an open-label, multicenter dosage escalation…
-
Isap Biotech Secures FDA IND Approval for iSAP-0909 for Bladder Cancer Imaging
•
Beijing-based biotech firm Isap Biotech has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its injectable agent, iSAP-0909. The agent will be assessed for its use in the auxiliary diagnosis and intraoperative localization of non-muscle invasive bladder cancer (NMIBC).…
-
China Grand Pharmaceutical Completes Phase III Clinical Study for Post-Cataract Surgery Treatment
•
China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced the successful completion of a Phase III clinical study for its investigational drug, GPN00833, used for inflammation and pain management following cataract surgery in China, meeting all clinical endpoints. GPN00833: A Nanosuspension Eye Drop for Inflammation and PainGPN00833…
-
Innorna Co., Ltd Receives FDA Rare Pediatric Disease Designation for mRNA Drug IN015
•
Shenzhen-based Innorna Co., Ltd has announced that it has received Rare Pediatric Disease Designation (RPDD) from the US Food and Drug Administration (FDA) for its proprietary mRNA drug, IN015, developed for the treatment of progressive familial intrahepatic cholestasis (PFIC). Understanding PFIC and the Impact of IN015Progressive familial intrahepatic cholestasis (PFIC)…
-
Teva Pharmaceutical Reports Positive Phase III Results for TEV-‘749 in Schizophrenia Trial
•
Israel-based Teva Pharmaceutical Industries Ltd (NYSE: TEVA) has released new positive data on social functioning and quality of life from the Phase III Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS) trial. The study assesses the efficacy of TEV-‘749 in adult patients diagnosed with schizophrenia. SOLARIS Study Design and TEV-‘749’s EfficacyThe SOLARIS…
-
Novo Nordisk’s Semaglutide Meets Primary Endpoints in ESSENCE Phase III Study for MASH
•
Denmark-based pharmaceutical company Novo Nordisk (NYSE: NVO; CPH: Novo-B) has announced that part 1 of the Phase III ESSENCE study, a pivotal 240-week, double-blinded trial involving 1,200 adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis, has successfully reached its primary endpoints. The trial evaluated the efficacy…
-
Jiuzhitang Co., Ltd Announces Clinical Clearance for Volagidemab in Type 1 Diabetes
•
China-based traditional Chinese medicine (TCM) giant Jiuzhitang Co., Ltd (SHE: 000989) has announced that volagidemab (REMD-477), a Category 1 drug developed by Beijing CoSci-REMD Bio Med-Tech Co, Ltd (CoSci-REMD Bio), a subsidiary of U.S. biotech REMD Biotherapeutics Inc., has received clearance for clinical study in type 1 diabetes in China.…
-
Shenzhen Chipscreen Biosciences Receives NMPA Approval for Chiauranib Clinical Study
•
China-based biopharmaceutical company Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its category 1 innovative drug, chiauranib. The study will evaluate chiauranib in combination with a programmed-death (PD)-(ligand) 1 monoclonal antibody and chemotherapy as a…
-
Novartis’ Trispecific Antibody PIT565 Secures NMPA Approval for Clinical Trial
•
Swiss pharmaceutical giant Novartis (NYSE: NVS) has received acceptance for its clinical trial application for the investigational drug PIT565 from the China National Medical Products Administration (NMPA). PIT565 is a potential “first-in-class” trispecific antibody targeting CD3, CD19, and CD2, which Novartis is developing to treat B-cell malignancies. Preclinical research results…
-
Shenzhen Chipscreen Biosciences’ Tivozanib Secures NMPA Approval for ES-SCLC Phase III Trial
•
Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) has announced that the National Medical Products Administration (NMPA) has approved its New Drug Application (NDA) for Tivozanib in combination with PD-(L)1 monoclonal antibodies and chemotherapy as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). Tivozanib, a novel multi-target inhibitor developed…
-
Humanwell Healthcare Receives NMPA Approval for Compound Sodium Lactate Ringer’s Injection
•
Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has received approval from the National Medical Products Administration (NMPA) for the registration of its compound sodium lactate Ringer’s injection. The product, classified as a Class 3 chemical drug, has been granted marketing approval and is considered to have passed consistency evaluation. The…
-
CARsgen Therapeutics’ Suspended CAR-T Therapies Get FDA Green Light to Resume
•
The US Food and Drug Administration (FDA) has removed the suspension on clinical studies for three chimeric antigen receptor (CAR)-T therapies developed by CARsgen Therapeutics Holdings Ltd (HKG: 2171), according to the company’s statement to the Hong Kong Stock Exchange. The therapies include CT053 (zevorcabtagene autoleucel), a BCMA-targeted CAR-T therapy…
-
AIM Vaccine Submits Market Filing for 13-Valent Pneumococcal Conjugate Vaccine in China
•
China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced the submission of a market filing for its in-house developed 13-valent pneumococcal conjugate vaccine to the National Medical Products Administration (NMPA). Streptococcus pneumoniae disease is a high-priority target for vaccine prevention efforts. The 13-valent pneumococcal conjugate vaccine is designed for infants…
-
Eisai and Biogen Complete BLA Submission for Alzheimer’s Drug Leqembi to FDA
•
Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have jointly announced the completion of a rolling submission of a Biologics License Application (BLA) for their co-developed Alzheimer’s disease drug Leqembi (lecanemab) to the U.S. Food and Drug Administration (FDA). The submission seeks approval for Leqembi as a subcutaneous…
-
Tasly Pharmaceuticals Gets FDA Approval for Acute Ischemic Stroke Cell Therapy Clinical Study
•
China-based Tasly Pharmaceuticals (SHA: 600535) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its investigational therapy, NR-20201. This allogeneic adipose-derived mesenchymal stem cell therapy is in development for the treatment of acute ischemic stroke. Preclinical study results…
-
Zhejiang Huahai Pharmaceutical Gets New Zealand Approval for Asthma Bispecific Antibody Trial
•
Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced receiving clinical trial approval in New Zealand for its HB0056, a bispecific antibody (BsAb) targeting thymic stromal lymphopoietin (TSLP) and interleukin-11 (IL-11), clearing the way for the drug to enter Phase I clinical studies for asthma treatment. HB0056 is the world’s…
-
Youcare Pharmaceutical Group Gets NMPA Approval for YKYY015 Phase I Study
•
China-based Youcare Pharmaceutical Group (SHA: 688658) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its investigational drug YKYY015, targeting primary hypercholesterolemia or mixed hyperlipidemia characterized by elevated LDL-C levels. YKYY015, an siRNA drug, is distinctive for…
-
Innovent Biologics Reports Q3 2024 Sales Exceeding RMB 2.3 Billion, Up 40% YOY
•
China-based Innovent Biologics Inc., (HKG: 1801) has announced product sales exceeding RMB 2.3 billion (USD 323 million) for the third quarter of 2024, marking a 40% year-on-year (YOY) increase. The company’s competitive edge in China is attributed to its product indication expansion, extensive coverage on the National Reimbursement Drug List,…
-
CStone Pharmaceuticals’ Sugemalimab Wins UK Approval for NSCLC Treatment
•
China-based CStone Pharmaceuticals (HKG: 2616) has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for sugemalimab, in combination with platinum-based chemotherapy, as a first-line treatment for adult patients with metastatic non-small cell lung cancer (NSCLC) without EGFR-sensitive mutations or ALK, ROS1, RET genomic alterations. This…
-
AbbVie’s Allergan Aesthetics Launches Juvéderm VOLUX in China
•
Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), has announced the official market launch of its Juvéderm VOLUX dermal filler product in China. Juvéderm VOLUX is a hyaluronic acid-based product specifically designed for contouring the lower jaw area. It is used for injection onto the facial periosteum to enhance the…
-
Sichuan Kelun-Biotech’s Sacituzumab Tirumotecan Files for New Indication with China’s NMPA
•
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that the National Medical Products Administration (NMPA) in China has accepted for review another indication approval filing for its sacituzumab tirumotecan (SKB264/MK-2870). The new indication is for the treatment of locally advanced or metastatic EGFR mutant non-small cell lung cancer (NSCLC)…
-
Akeso Biopharma Initiates Phase III Clinical Trial for PD-1/VEGF Bispecific Antibody Combination
•
China-based Akeso Biopharma (HKG: 9926) has announced the enrollment of the first patient in a randomized, controlled, multicenter Phase III clinical study (AK117-302), assessing the combination of the innovative PD-1/VEGF bispecific antibody ivonescimab and its next-generation CD47 monoclonal antibody ligufalimab (AK117) against pembrolizumab for the first-line treatment of PD-L1 positive…
-
Shanghai Henlius and Organon Submit Biosimilar Application for Denosumab to FDA
•
Shanghai Henlius Biotech Inc. (HKG: 2696) and its US partner Organon (NYSE: OGN) have jointly announced that the Biologic License Application (BLA) for HLX14, an investigational biosimilar of Amgen’s (NASDAQ: AMGN) Prolia/Xgeva (denosumab), has been accepted for review by the US Food and Drug Administration (FDA). Denosumab, a recombinant anti-RANKL…
-
AIM Vaccine Secures NMPA Approval for mRNA Vaccine Targeting RSV
•
AIM Vaccine Co., Ltd (HKG: 6660), based in China, has received clinical trial approval from the National Medical Products Administration (NMPA) for its mRNA vaccine targeting respiratory syncytial virus (RSV). RSV is a leading cause of mortality in infants under one year old and significantly contributes to respiratory infections and…
-
Novartis Secures FDA Accelerated Approval for Scemblix in Newly Diagnosed CML Patients
•
Swiss pharmaceutical giant Novartis (NYSE: NVS) announced that its drug Scemblix (asciminib) has received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). This accelerated approval is supported by the…
-
Yantai Dongcheng Pharma Secures FDA Fast-Track Designation for 177Lu-LNC1004 in Thyroid Cancer
•
China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced that it has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its investigational therapy, 177Lu-LNC1004, in patients with metastatic iodine-131 refractory differentiated thyroid cancer who have previously undergone treatment with at least one tyrosine kinase…
-
Sunshine Guojian Pharmaceutical Secures NMPA Approval for Clinical Trials of SSGJ-626 in Lupus Indications
•
China-based Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd (SHA: 688336) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its monoclonal antibody, SSGJ-626. This BDCA2-targeted mAb will now enter trials for systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE), indications that have…
-
Zai Lab Reports Positive Phase III Results for KarXT, Showcasing Efficacy in Psychiatric Conditions
•
China-based biotech Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced encouraging topline results from its Phase III multi-center trial evaluating the safety and efficacy of KarXT (xanomeline and trospium chloride) within China. In line with prior global studies, this registrational bridging trial successfully met its primary endpoint, showing a…
-
Sun-Novo Pharmaceuticals Gets Green Light for CAR-T Therapy Clinical Trial in Lupus Treatment
•
Beijing Sun-Novo Pharmaceutical Research Co., Ltd. (SHA: 688621) has secured approval from China’s National Medical Products Administration (NMPA) to initiate clinical trials for ZM001, a CD19-targeted chimeric antigen receptor (CAR)-T therapy, in the treatment of systemic lupus erythematosus (SLE). The therapy, co-developed with Beijing-based gene therapy specialist Immunochina Pharmaceuticals, is…
-
Innovent Biologics’ Picankibart Shows 64.6% Skin Clearance in Phase II Psoriasis Study
•
China-based Innovent Biologics, Inc. (HKG: 1801) has announced encouraging results from the multi-center, open Phase II study of its picankibart, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection. The study focused on psoriasis patients with a poor response to prior biologic treatments, primarily IL-17 antibodies. After 16 weeks of treatment…
-
Livzon Pharmaceutical’s Leuprorelin Acetate Microspheres Passes China’s GQCE
•
China’s Livzon Pharmaceutical Group Inc., (HKG: 1513, SHE: 000513) has announced that its leuprorelin acetate microspheres for injection have successfully passed the generic quality consistency evaluation (GQCE) in China. Leuprolide, a gonadotropin-releasing hormone (GnRH) receptor agonist, is utilized in the treatment of prostate cancer and endometriosis. Originally developed by Japan’s…
-
Xi’an Xintong Pharma’s Pradefavir Wins NMPA Nod for Chronic Hepatitis B Treatment
•
The National Medical Products Administration (NMPA) has granted market approval for pradefavir, a Category 1 drug developed by Xi’an Xintong Pharmaceutical Research Co., Ltd., for the treatment of adult chronic hepatitis B virus (HBV) infection under the trade name XinShuMu. Pradefavir, a nucleoside liver-targeting drug, functions by inhibiting HBV DNA…
-
Eli Lilly’s Mounjaro Approved in Hong Kong for Obesity and Type 2 Diabetes Treatment
•
Eli Lilly & Co. (NYSE: LLY) has received market approval from Hong Kong’s Department of Health for its Mounjaro (tirzepatide) in KwikPen presentation, marking a significant step in the treatment of weight management and type 2 diabetes. Mounjaro is indicated for adults with obesity (BMI of 30 kg/m^2 or greater)…
-
Clover Biopharmaceuticals Reports Strong Phase I Results for RSV Vaccine SCB-1019
•
China-based Clover Biopharmaceuticals Ltd. (HKG: 2197) has announced encouraging additional immunogenicity and safety data from its Phase I trial of SCB-1019, a non-adjuvanted bivalent RSV prefusion-stabilized F (PreF)-Trimer subunit vaccine candidate. The trial assessed SCB-1019 against GSK (NYSE: GSK)’s AS01E-adjuvanted RSV vaccine, Arexvy, in elderly subjects. In the ongoing Phase…
-
Merck and Moderna Launch Phase III Study for Individualized Neoantigen Therapy in Lung Cancer
•
US pharmaceutical companies Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) and Moderna Inc. (NASDAQ: MRNA) have initiated the Phase III INTerpath-009 study to evaluate V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab). The study will focus on patients with resectable Stage…
-
Merck’s Keytruda Gains Two Additional EU Indications for Gynecologic Cancer Treatment
•
Merck, Sharp & Dohme Inc., known as MSD (NYSE: MRK), has received two additional indication approvals from the European Union for its immunotherapy drug Keytruda (pembrolizumab), increasing the total number of approved uses in the region to 30. The PD-1 inhibitor is now approved for use in combination with carboplatin…
-
Jiangsu Hengrui Medicine Advances Clinical Trials for Cancer Therapies with NMPA Clearance
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received clinical clearance from China’s National Medical Products Administration (NMPA) for a suite of cancer treatments, including HRS-4642 (adebrelimab), SHR-1826, SHR-8068, and a bevacizumab biosimilar. The company is set to initiate a multi-center, open Phase Ib/II study to evaluate the safety, tolerability,…
-
AstraZeneca’s Fasenra Approved by EU for Eosinophilic Granulomatosis Treatment
•
UK pharmaceutical giant AstraZeneca Inc. (NASDAQ: AZN) has received marketing approval from the European Commission for its drug Fasenra (benralizumab) as an additional treatment for adult patients suffering from relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The approval follows the successful outcomes of the MANDARA Phase III trial, marking…
-
AbbVie Inks $1.4 Billion Deal to Acquire Alzheimer’s Drug Developer Aliada Therapeutics
•
US pharmaceutical company AbbVie (NYSE: ABBV) has entered into a definitive agreement to acquire all outstanding equity of Aliada Therapeutics, Inc., a fellow US firm, for $1.4 billion in cash. The acquisition includes ALIA-1758, an anti-pyroglutamate amyloid beta (3pE-Aβ) antibody in development for the treatment of Alzheimer’s disease (AD). Aliada’s…
-
CSPC Pharmaceutical’s SYS6020 Receives NMPA Approval for Myasthenia Gravis Clinical Trial
•
CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its SYS6020. This investigational treatment is a BCMA-targeted chimeric antigen receptor (CAR)-T cell therapy intended for myasthenia gravis (MG). Notably,…
-
Eli Lilly’s Ebglyss Shows Positive Results in Phase III Study for Atopic Dermatitis Patients Previously Treated with Dupilumab
•
Eli Lilly & Co. (NYSE: LLY), a leading U.S. pharmaceutical company, has announced the results of the Phase III Adapt study for its interleukin-13 (IL-13) inhibitor, Ebglyss (lebrikizumab). The study demonstrated that Ebglyss improved skin conditions, including on the hands and face, and reduced itch in patients with moderate-to-severe atopic…
-
Biogen’s Felzartamab Demonstrates Promising Results in Phase II Study for IgA Nephropathy
•
Biogen Inc. (NASDAQ: BIIB), a prominent biopharmaceutical company based in the U.S., has announced comprehensive results from the Phase II IGNAZ study for felzartamab in the treatment of IgA nephropathy. The findings were showcased at Kidney Week 2024, the annual meeting of the American Society of Nephrology. The study demonstrated…
-
Humanwell Healthcare Receives NMPA Approval for Chemically Synthesized Semaglutide Clinical Trial
•
Humanwell Healthcare (Group) Co., Ltd (SHA: 600079), a leading healthcare company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 2.2 chemically synthesized semaglutide injection, intended for the treatment of type 2 diabetes. Semaglutide, a glucagon-like peptide-1…
-
RiboX Therapeutics’ Circular RNA Therapy RXRG001 Gets FDA Green Light for Dry Mouth Clinical Trial
•
RiboX Therapeutics, a Shanghai-based developer of circular RNA (circRNA) therapies, has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate the Phase I/IIa clinical study SPRINX-1 for its candidate RXRG001. This study will evaluate the efficacy and safety of RXRG001 in patients suffering…
-
AstraZeneca’s Zoladex Receives NMPA Approval for Higher Dosage Form in Breast Cancer Treatment
•
AstraZeneca Inc., (AZ, NASDAQ: AZN), a UK-based pharmaceutical giant, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its Zoladex (goserelin sustain-released implant) 10.8mg. This new dosage form is intended for use in premenopausal and perimenopausal women with breast cancer who can be…
-
MicuRx Pharmaceuticals’ Antibiotic MRX-5 Completes Successful Phase I Clinical Trial in Australia
•
MicuRx Pharmaceuticals Inc. (SHA: 688373), a Sino-US pharmaceutical company, has announced the successful completion of a Phase I clinical study for its in-house developed antibiotic, MRX-5, in Australia. This new benzodiazole antibiotic is designed to treat infections caused by Mycobacterium, with a particular focus on non-tuberculosis Mycobacterium (NTM). The Phase…
-
Chinese ADCs from Escugen, Hansoh, and MediLink Therapeutics Eye Breakthrough Designations in China
•
The Center for Drug Evaluation of the National Medical Products Administration (NMPA) has indicated on its website that three antibody drug conjugates (ADCs) from Chinese pharmaceutical companies are on track to receive breakthrough therapy designations (BTDs) in China. These include Shanghai Escugen’s ESG401, Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692)’s…
-
LaNova Medicines Regains Rights to Claudin 18.2 Targeting ADC LM-302 from BMS
•
LaNova Medicines Ltd, a Shanghai-based developer of cancer therapies, has announced the reclamation of control over LM-302, an antibody drug conjugate (ADC) targeting Claudin 18.2, from US pharmaceutical giant Bristol-Myers Squibb (BMS; NYSE: BMY). LaNova had previously signed an agreement with Turning Point Therapeutics, Inc. (TPTX.US) in May 2022 to…
-
Zhuhai Beihai Biotech’s Beizary Receives FDA Clearance for Multiple Cancer Indications
•
Zhuhai Beihai Biotech Co., Ltd has announced that it has received marketing clearance from the US Food and Drug Administration (FDA) for its in-house developed drug, Beizary, a modified version of docetaxel, which is indicated for the treatment of various cancers including breast cancer, non-small cell lung cancer, head and…
-
BeiGene’s PD-1 Inhibitor Tevimbra Scores First US Prescription, Offers More Affordable Option
•
BeiGene Ltd, a leading China-based biotechnology company (NASDAQ: BGNE; HKG: 6160; SHA: 688235), has announced the first prescription of its programmed death-1 (PD-1) inhibitor, Tevimbra (tislelizumab), in the United States. This marks a significant milestone for the company as it expands its global reach. Tislelizumab received approval in the US…
-
RemeGen’s Telitacicept Receives Priority Review Status from China’s CDE for gMG Treatment
•
RemeGen (HKG: 9995), a China-based pharmaceutical company, has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted another market filing for its drug telitacicept with priority review status. The filing seeks approval for the treatment of generalized myasthenia gravis (gMG), a serious…
-
RemeGen’s Taitaxipu Receives CDE Acceptance for New Indication Application in China
•
RemeGen Co., Ltd. (HKG: 9995, SHA: 688331) has announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted a new indication application for its Claudin18.2-targeted antibody, Taitaxipu (Telitacicept), in combination with tislelizumab and chemotherapy as a first-line treatment for advanced gastric cancer. This…
-
Chongqing Zhifei Biological’s Influenza Vaccine Application Accepted by China’s Drug Evaluation Center
•
On October 24, 2024, the Center for Drug Evaluation of the National Medical Products Administration indicated that the influenza virus split vaccine marketing application from Chongqing Zhifei Biological Products Co., Ltd. (SHE: 300122)’s wholly-owned subsidiary, Zhifei Longkoma, has been accepted, with the acceptance number CXSS2400114. Currently, Chongqing Zhifei Biological has…
-
BMS Launches Cardiac Myosin Inhibitor Camzyos in China for Obstructive Hypertrophic Cardiomyopathy
•
Bristol-Myers Squibb (BMS; NYSE: BMY) has announced the official market launch of its cardiac myosin inhibitor Camzyos (mavacamten) in China. The drug is indicated for the treatment of patients with obstructive hypertrophic cardiomyopathy (HCM) graded II to III under the New York Heart Association (NYHA) functional classification, aiming to improve…
-
Everest Medicines’ Velsipity Approved for Use in Select Hospitals in China’s Greater Bay Area
•
Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that it has received approval in the Greater Bay Area (GBA) for its drug Velsipity (etrasimod) to be used in Foshan Fosun Chancheng Hospital and the First Affiliated Hospital of Sun Yat-sen University. These medical institutions are part of the…
-
Daiichi Sankyo’s Pexidartinib Poised for Priority Review in China for TGCT Treatment
•
The official website of the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) has indicated that Daiichi Sankyo (TYO: 4568)’s pexidartinib (PLX3397) is on track to receive priority review status for the treatment of symptomatic giant cell tumor of the tendon sheath (TGCT) in adult patients…
-
Asieris Pharmaceuticals Gets FDA Green Light for USP1 Inhibitor APL-2302 in Advanced Solid Tumors
•
Asieris Pharmaceuticals (SHA: 688176), a China-based specialist in urogenital cancer treatments, has announced that it has received clinical clearance from the U.S. Food and Drug Administration (FDA) for its in-house developed ubiquitin specific peptidase 1 (USP1) inhibitor, APL-2302, for the treatment of advanced solid tumors. Preclinical studies have indicated that…
-
Henlius Biotech Commences Global Phase III Trial for Serplulimab in First-Line Metastatic Colorectal Cancer
•
Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced the dosing of the first patient in a global, multi-center Phase III study for its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab, HLX10). The study combines serplulimab with bevacizumab and chemotherapy for the first-line treatment of…
-
ImmuneOnco Biopharmaceuticals Initiates Phase Ib Study for Dual-Target Therapy in Systemic Lupus Erythematosus
•
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541), a Chinese biopharmaceutical company, has announced the first patient in (FPI) for a Phase Ib clinical study of its dual-target macromolecular drug amulirafusp alfa (IMM0306) in the treatment of moderate to severe systemic lupus erythematosus (SLE). This marks a significant advancement in the…
-
Sanofi’s Dupixent Demonstrates Positive Results in Phase III Study for Chronic Urticaria
•
Sanofi (NASDAQ: SNY), the French pharmaceutical giant, has announced the presentation of new data from the Phase III LIBERTY-CUPID Study C for its drug Dupixent (dupilumab) in the treatment of chronic spontaneous urticaria (CSU) at the American College of Allergy, Asthma and Immunology (ACAAI) 2024 annual meeting. The LIBERTY-CUPID Study…
-
Eli Lilly’s Alzheimer’s Drug Kisunla Secures Marketing Approval in Great Britain
•
Eli Lilly & Co. (NYSE: LLY) has announced that it has received marketing approval in Great Britain for Kisunla (donanemab), an Alzheimer’s disease (AD) treatment. Kisunla is an intravenous infusion administered every four weeks to eligible adults with mild cognitive impairment and mild dementia due to AD. Eligibility is restricted…
-
Gan & Lee Pharmaceuticals Initiates Phase I Clinical Trial for Biosimilar Secukinumab
•
Gan & Lee Pharmaceuticals (SHA: 603087), a Chinese pharmaceutical company, has announced the commencement of a Phase I clinical study for GLR1023, a biosimilar candidate to Novartis’ Cosentyx (secukinumab). The company has recently dosed the first patient in the trial, which is focused on evaluating the safety and efficacy of…
-
Lundbeck’s Vyepti Migraine Treatment Available at Sun Yat-sen Memorial Hospital Through Greater Bay Area Policy
•
Vyepti (eptinezumab), a migraine treatment developed by Denmark-based biopharmaceutical company H. Lundbeck A/S (OTCMKTS: HLBBF), has been introduced at Sun Yat-sen Memorial Hospital, Sun Yat-sen University, facilitated by the “Hong Kong-Macau Drug and Device Access” policy. This policy, part of the broader Greater Bay Area initiative, enables patients to access…
-
Lee’s Pharmaceutical’s Subsidiary Reports Positive Results from Phase III Myopia Treatment Study
•
Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), a China-based pharmaceutical company, through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced positive top-line results from the Phase III China CHAMP study for NVK002, an atropine external use eye solution designed to address myopia progression. The Phase III study, a randomized, double-blinded,…
-
LINDIS Biotech’s Catumaxomab Receives Positive Opinion from EMA’s COMP for Malignant Ascites Treatment
•
LINDIS Biotech GmbH, a German biotechnology company, has announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has issued positive opinions regarding Korjuny (catumaxomab). The trifunctional anti-CD3 x anti-EpCAM antibody (trAb) is recommended for the intraperitoneal treatment of malignant ascites (MA) in adults with…
-
Grifols Partners with BARDA to Develop Treatment for Sulfur Mustard Ocular Injury
•
Grifols (BME: GRF; NASDAQ: GRFS), a Spanish biopharmaceutical company, has announced a partnership with the Biomedical Advanced Research and Development Authority (BARDA) to test investigational ocular surface immunoglobulin (OSIG) eye drops for their potential to treat ocular damage resulting from sulfur mustard exposure. BARDA, which is part of the Administration…
-
Walvax Biotechnology’s Weuphoria Vaccine Approved in Oman for Pediatric Pneumococcal Infections
•
Walvax Biotechnology Co., Ltd (SHE: 300142), a Chinese biopharmaceutical company, has announced that it has received market approval in the Sultanate of Oman for its vaccine Weuphoria, a 13-valent pneumococcal polysaccharide conjugate vaccine (PCV-13). This approval marks a significant step for the company as it expands the reach of its…
-
LENZ Therapeutics’ Presbyopia Therapy LNZ100 Accepted for FDA Review
•
LENZ Therapeutics, Inc. (NASDAQ: LENZ), a US-based biopharmaceutical company, has announced that the US Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for LNZ100 (aceclidine), a therapy for presbyopia. The FDA has set an action date of August 8, 2025, for the application. LNZ100…
-
AstraZeneca’s Wainzua Earns CHMP Nod for hATTR-PN Treatment in the EU
•
UK pharmaceutical juggernaut AstraZeneca (AZ, NASDAQ: AZN) has announced that Wainzua (eplontersen), an RNA-targeted therapy co-developed with US-based Ionis Pharmaceuticals (NASDAQ: IONS), has received a positive recommendation for approval from the Committee for Medicinal Products for Human Use (CHMP) within the European Union (EU). The treatment is intended for adults…
-
Novo Nordisk’s Semaglutide Shows 14% Reduction in Cardiovascular Events in Landmark SOUL Trial
•
Copenhagen-based healthcare giant Novo Nordisk (NYSE: NVO) has declared the primary outcomes of the SOUL cardiovascular outcomes trial, showcasing that its oral glucagon-like peptide-1 (GLP-1) analogue, semaglutide, successfully reduced major adverse cardiovascular events (MACE) by 14%. The SOUL trial, a global, multi-center, randomized, double-blinded, and parallel-controlled study, enrolled 9,650 individuals…
-
AstraZeneca’s Saphnelo Approved for Use in Guangdong Under ‘Hong Kong-Macau Drug Access’ Policy
•
AstraZeneca (AZ, NASDAQ: AZN), a leading UK pharmaceutical company, has announced that its drug Saphnelo (anifrolumab) has been approved by the Guangdong Medical Products Administration (MPA) bureau to be included in medical institutions as part of the “Hong Kong-Macau Drug and Device Access” policy. This policy, within the Greater Bay…
-
BeiGene’s Tevimbra Receives CHMP Recommendation for Expanded Use in G/GEJ and ESCC Cancers in EU
•
BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading China-based biotechnology company, has received notification that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended an extension of authorization for its programmed death-1 (PD-1) inhibitor Tevimbra (tislelizumab). The expanded authorization covers…
-
Olymvax Bio Receives NMPA Approval for Clinical Study of Trivalent Influenza Vaccine
•
Olymvax Biopharmaceuticals Inc. (SHA: 688319), a leading vaccine specialist headquartered in Chengdu, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its trivalent influenza virus split vaccine (MDCK cells). This vaccine is designed for the prevention of influenza caused…
-
Guangzhou Releases First Batch of Innovative Drugs and Medical Devices List, Featuring Local Companies
•
The Guangzhou Municipal Industry and Information Technology Bureau has unveiled the first batch of innovative drugs and medical devices included in the city’s list, with 24 products making the shortlist. This initiative is aimed at promoting local innovation and development within the pharmaceutical and medical device sectors. Among the notable…
-
Sino Biopharmaceutical’s Anlotinib Receives Ninth Indication Approval from China’s CDE for Soft-Tissue Sarcoma
•
Sino Biopharmaceutical Ltd (HKG: 1177), a leading pharmaceutical company in China, has announced that it has received another indication approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its oral multi-target kinase inhibitor, anlotinib. The request is for anlotinib to be used in…
-
Johnson & Johnson’s Akeega Approved in China as First Dual Action Tablet for mCRPC
•
Johnson & Johnson (J&J, NYSE: JNJ), a leading US pharmaceutical company, has announced that China’s National Medical Products Administration (NMPA) has granted indication approval for Akeega (niraparib and abiraterone acetate), to be taken with prednisone or prednisolone, for the treatment of adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2…
-
Everest Medicines’ Nefecon Approved in Taiwan for Primary IgAN Treatment
•
Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that it has received market approval from the Taiwan Food and Drug Administration for its targeted-release budesonide, Nefecon, for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. This approval allows for the use…
-
BeiGene’s Tevimbra Approved in China for NSCLC Patients as Neoadjuvant and Adjuvant Therapy
•
BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading China-based biotechnology company, has announced that it has received market approval in China for its programmed death-1 (PD-1) inhibitor Tevimbra (tislelizumab). The National Medical Products Administration (NMPA) has granted approval for tislelizumab in combination with platinum-containing chemotherapy as both neoadjuvant…
-
Novo Nordisk’s Alhemo Receives CHMP Recommendation for Haemophilia Prophylaxis in Europe
•
Novo Nordisk (NYSE: NVO), a Danish pharmaceutical company, has been notified that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Alhemo (concizumab). This would make Alhemo the first once-daily subcutaneous prophylactic treatment for individuals aged 12 years or…
-
Novartis’s Kisqali Receives Positive CHMP Opinion for Early Breast Cancer Treatment in the EU
•
Novartis (NYSE: NVS), the Swiss pharmaceutical giant, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending the approval of Kisqali (ribociclib), a CDK4/6 inhibitor, for the adjuvant treatment of adults with hormone receptor-positive/human epidermal growth…
-
Kanghong Pharmaceutical’s NASH Drug KH629 Approved for Clinical Trials in China
•
Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its Category 1 chemical drug KH629, which is intended for the treatment of adult non-alcoholic steatohepatitis (NASH). This development follows the…
-
Huadong Medicine Gets Green Light for HPK1 PROTAC Drug HDM2006 in Advanced Solid Tumors
•
Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct a study for its Category 1 chemical drug HDM2006, which targets advanced solid tumors. This development marks a significant step for Huadong as it…
-
Astellas Pharma’s Vyloy Receives FDA Approval for Gastric Cancer Treatment in CLDN18.2 Positive Tumors
•
Astellas Pharma Inc. (TYO: 4503), a Japanese pharmaceutical company, has announced that it has received market approval from the US Food and Drug Administration (FDA) for its drug Vyloy (zolbetuximab-clzb). The approval is for use in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally…
-
Gilead Sciences to Withdraw Accelerated Approval of Trodelvy in Urothelial Carcinoma
•
Gilead Sciences Inc., (NASDAQ: GILD), a leading US-based biopharmaceutical company, has announced its intention to voluntarily withdraw the accelerated approval of its antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who have been previously treated with platinum-based chemotherapy…
-
Jiangsu Hengrui Medicine Initiates Phase III Clinical Trial for SHR-A1904 in Gastric Cancer
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has filed for a Phase III clinical study of its Claudin18.2-targeted antibody drug conjugate (ADC) SHR-A1904 on Clinicaltrials.gov. The study aims to enroll 524 patients with second-line recurrent or metastatic gastric cancer and is anticipated to…
-
Jacobio Pharma’s G12C Inhibitor Gecirasib Earns Orphan Drug Designation in Europe for Pancreatic Cancer
•
Jacobio Pharma (HKG: 1167), a China-based biopharmaceutical company, has announced that it has received Orphan Drug Designation (ODD) from the European Medicine Agency (EMA) for its KRAS G12C inhibitor, glecirasib, for the treatment of pancreatic cancer. This designation follows previous awards for glecirasib, including ODD in the US and Breakthrough…
-
MicroPort NeuroTech’s NUMEN Silk Receives FDA Approval for Embolization Treatment
•
MicroPort NeuroTech Limited (HKG: 2172), a Chinese medical device company, has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its product NUMEN Silk, a spring coil embolization system that marks its first international approval. This milestone follows the initial approval of the…
-
Astellas Pharma’s Vyloy Receives FDA Approval for CLDN18.2 Positive Gastric Cancer Treatment
•
Astellas Pharma (TYO: 4503) has announced that the U.S. Food and Drug Administration (FDA) has granted approval for its Claudin18.2 (CLDN18.2) targeting antibody Vyloy (zolbetuximab) in combination with a fluoropyrimidine- and platinum-based chemotherapy regimen for the first-line treatment of adult patients with locally advanced unresectable or metastatic, HER2-negative gastric or…
-
Westgene Biopharma’s Pioneering mRNA Vaccine for EBV-Related Tumors Clears IND Hurdle in China
•
Westgene Biopharma has received approval from the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) in China for its new drug research application (IND) for “WGc-043 Injection.” The approval, dated August 6, 2024, grants Westgene Biopharma the green light to initiate Phase I clinical trials. “WGc-043…
-
Kanghong Pharmaceutical’s NASH Drug KH629 Receives Clinical Trial Implicit Approval in China
•
On October 18th, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China announced that Kanghong Pharmaceutical (SHE: 002773)’s Class 1 new drug, KH629 tablets, has been granted implicit approval for clinical trials for the treatment of adult non-alcoholic steatohepatitis (NASH).…
-
Akeso Biopharma Launches Phase Ib/II Trial for Cadonilimab and AK112 in Pancreatic Cancer
•
On October 17, ClinicalTrials.gov reported that Akeso Biopharma (HKG: 9926) has initiated a Phase Ib/II clinical study to evaluate the combination of Cadonilimab (CTLA-4/PD-1 dual antibody) and AK112 (Envafolimab, a PD-1/VEGF dual antibody) with chemotherapy as a first-line treatment for pancreatic cancer. The primary endpoints of the study include safety,…
-
FDA Extends Review of Amgen’s Lumakras for KRAS G12C mCRC Treatment to January 2025
•
On October 18, FirstWord reported that the U.S. FDA has extended the review period for Amgen (NASDAQ: AMGN)’s KRAS G12C inhibitor Lumakras (sotorasib) in combination with the anti-EGFR monoclonal antibody panitumumab for second-line treatment of KRAS G12C-mutated metastatic colorectal cancer (mCRC) by three months, pushing the decision date to January…
-
Shenzhen Chipscreen Advances CS231295 for Cancer Treatment as IND Accepted by NMPA
•
On October 17, Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced that its innovative Class 1 national drug candidate, CS231295, for cancer treatment has received acceptance for its clinical trial application (IND) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China (Acceptance Numbers:…
-
AstraZeneca Files for Market Approval of Tremelimumab in China for Hepatocellular Carcinoma
•
The Center for Drug Evaluation (CDE) has indicated on its website that AstraZeneca (NASDAQ: AZN), a leading UK pharmaceutical company, has submitted a market filing for tremelimumab, which is likely intended for the treatment of hepatocellular carcinoma (HCC) in combination with durvalumab. This move suggests a strategic expansion in AstraZeneca’s…
-
Changshan Biochemical Pharmaceutical Wins Marketing Approval for Enoxaparin in Niger
•
Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255), a Chinese pharmaceutical company, has announced that it has received marketing approval for its enoxaparin in Niger. This development marks an important step for Changshan Bio as it expands the international reach of its pharmaceutical products. Changshan Bio’s enoxaparin is a…
-
Huahai Pharmaceutical Gets FDA Nod for Generic Empagliflozin and Metformin ANDA
•
Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a prominent Chinese pharmaceutical company, has announced the receipt of Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its generic version of Boehringer Ingelheim’s (BI) empagliflozin and metformin combination therapy. This therapy was originally approved in…
-
Laekna Advances Obesity Treatment Candidate LAE102 with Subcutaneous Dosing in Phase I Study
•
Laekna, a Sino-US biotech firm, has announced the commencement of a subcutaneous dosing cohort within its Phase I single ascending dose (SAD) study for the monoclonal antibody drug candidate LAE102, which is under investigation for the treatment of obesity. The study, which is randomized, double-blinded, and placebo-controlled, aims to evaluate…
-
Antengene’s Xpovio Secures Expanded Access in South Korea for Multiple Myeloma Treatment
•
Antengene Corp., Ltd (HKG: 6996), a China-based biopharmaceutical company, has announced that it has received an additional supplementary New Drug Application (sNDA) approval from the National Health Insurance Service (NHIS) of South Korea for its drug Xpovio (selinexor). This marks Xpovio as the world’s first and only FDA-approved oral XPO1…
-
AbbVie’s Vyalev Wins FDA Approval as First Subcutaneous Levodopa Therapy for Advanced Parkinson’s
•
AbbVie (NYSE: ABBV), a leading pharmaceutical company based in the US, has received approval from the US Food and Drug Administration (FDA) for its drug Vyalev (ABBV-951, foscarbidopa and foslevodopa). Vyalev is indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). This approval positions Vyalev…
-
Chongqing Zhifei Biological’s EC Injection Receives Market Approval in Indonesia
•
Chongqing Zhifei Biological Co., Ltd (SHE: 300122), a leading biopharmaceutical company based in China, has announced that it has received market approval in Indonesia for its in-house developed Category 1 drug, the recombinant Mycobacterium tuberculosis fusion protein (EC) injection. This development marks an important milestone for the company as it…
-
Kintor Pharmaceutical Initiates Phase II/III Trial for KX-826 Tincture 1.0% in Treating Male Androgenetic Alopecia
•
Kintor Pharmaceutical Ltd (HKG: 9939), a biopharmaceutical company based in China, has announced the commencement of patient enrollment in a pivotal Phase II/III study for its KX-826 tincture 1.0%. The study aims to evaluate the efficacy and safety of the treatment in adult males with androgenetic alopecia (AGA) in China.…
-
Innovent Biologics’ Picankibart Achieves Positive Results in Phase II UC Study
•
Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that its Phase II clinical trial for picankibart, an anti-IL-23p19 antibody injection, has successfully met its primary endpoint in Chinese patients with moderately to severely active ulcerative colitis (UC). The multi-center, randomized, double-blinded, placebo-controlled study (NCT05377580)…
-
Johnson & Johnson’s Nipocalimab Shows Promise in Treating Adolescent Myasthenia Gravis in Phase II/III Trial
•
Johnson & Johnson (J&J, NYSE: JNJ), a US pharmaceutical giant, has reported encouraging outcomes from its Phase II/III clinical trial, Vibrance-MG, which evaluated the efficacy of nipocalimab in treating adolescents with generalized myasthenia gravis (gMG) who tested positive for anti-AChR antibodies. The study successfully achieved its primary and secondary endpoints,…
-
Alphamab Oncology and CSPC Pharma’s KN026 Phase III Trial for Breast Cancer Gets NMPA Approval
•
Alphamab Oncology (HKG: 9966) and CSPC Pharma (HKG: 1093) have jointly announced that their Phase III clinical study application for the combination of HER2 bispecific antibody KN026 and nab-paclitaxel HB1801 (Study Protocol Number: KN026-004) has received approval from the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) for neoadjuvant…
-
Shanghai Junshi Biosciences’ Toripalimab Wins Marketing Approvals in India and Hong Kong for Nasopharyngeal Carcinoma
•
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biotech company based in China, has announced that it has received marketing approvals in India and Hong Kong for its drug toripalimab, used for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The drug will be marketed under…
-
Jiangsu Hengrui Resubmits Application for Camrelizumab Combo in HCC to FDA
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company based in China, has announced a new attempt at a market filing with the US Food and Drug Administration (FDA) for its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab, in combination with the small-molecule targeted cancer therapy apatinib, as…
-
Innovec Pharma’s IVB103 Gene Therapy for nAMD Receives Clinical Trial Approval from China’s CDE
•
Beijing Innovec Pharmaceutical Technology Co., Ltd., a leading gene therapy company based in China, has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) for its IVB103 treatment for neovascular (wet) age-related macular degeneration (nAMD). This follows a clinical trial approval for the same…
-
Aficamten Market Filing Accepted by China’s CDE for Hypertrophic Cardiomyopathy Treatment
•
Ji Xing Pharmaceuticals (Jixing) and Cytokinetics Inc (CYTK, NASDAQ: CYTK) have achieved a significant milestone with the acceptance of their market filing for aficamten by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. Aficamten, a next-generation cardiac myosin inhibitor, is under development for…
-
Jiangsu Hengrui’s Hetrombopag Olamine Receives NMPA Review for Severe Aplastic Anemia Indication
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review another indication approval filing for its drug candidate, hetrombopag olamine. This new indication is for the use of hetrombopag olamine in combination with…
-
Hinova Pharmaceuticals Gets NMPA Green Light for HP568 Clinical Study in Breast Cancer
•
Hinova Pharmaceuticals Inc. (SHA: 688302), a biotech firm based in Chengdu, has announced that it has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its drug candidate HP568. This new drug is intended for the treatment of estrogen receptor (ER) positive, human epidermal…
-
Huadong Medicine Gets NMPA Green Light for BCMA-Targeted ADC HDM2027 Phase I/IIa Study
•
Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to initiate a Phase I/IIa study for its drug candidate HDM2027 (HDP-101). This antibody drug conjugate (ADC), co-developed with Heidelberg Pharma, targets the B cell maturation…
-
Leqembi, Alzheimer’s Drug by Eisai and Biogen, Now Covered by Qihuibao Insurance in China
•
Leqembi (lecanemab), an Alzheimer’s disease treatment co-developed by Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB), has been included in the coverage scope of “Qihuibao,” a commercial supplementary health insurance program in Zibo city, Shandong province, China. The drug received approval in China in January of this year…
-
Changchun High & New Technology Industries Receives FDA Tacit Approval for GenSci122 Clinical Study
•
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661), a leading biopharmaceutical company, has announced that it has received tacit approval from the US Food and Drug Administration (FDA) to commence a clinical study for its drug candidate, GenSci122, in patients with advanced solid tumors. GenSci122 is a small…
-
Jiangsu Hengrui’s HR19042 Earns Breakthrough Designation for Autoimmune Hepatitis Treatment in China
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) for its modified drug HR19042, which targets active autoimmune hepatitis (AIH). AIH is a rare liver disease that, if untreated,…
-
Eli Lilly’s Mirikizumab Shows Statistically Significant Improvement in Crohn’s Disease VIVID-1 Study
•
Eli Lilly & Co. (NYSE: LLY), a leading pharmaceutical company in the U.S., has published the results of the VIVID-1 study, demonstrating the efficacy of mirikizumab in patients with moderately to severely active Crohn’s disease. The study showed that mirikizumab achieved nominally statistically significant improvements across all histological and histological…
-
Humanwell Healthcare Secures NMPA Approval for Clinical Trial of HW211026 to Treat Actinic Keratosis
•
Humanwell Healthcare (Group) Co., Ltd (SHA: 600079), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate HW211026. This Category 1 chemical drug is designed to treat actinic keratosis, a skin condition caused by prolonged sun…
-
United Laboratories’ TUL12101 Eye Drops Enter Phase IIa Clinical Trial for Dry Eye Syndrome
•
United Laboratories International Holdings Ltd (HKG: 3933), a Hong Kong-based pharmaceutical company, has announced the enrollment of the first subject in the Phase IIa clinical study for its Category 1 drug, TUL12101 eye drops, in China. This development marks a significant step forward in the clinical evaluation of the drug.…
-
3D Medicines’ Envafolimab Earns NMPA Breakthrough Designation for TMB-H Solid Tumors
•
3D Medicines (HKG: 1244), a biopharmaceutical company based in China, has announced that its envafolimab has been granted Breakthrough Therapy Designation (BTD) by China’s National Medical Products Administration (NMPA) for an additional indication. The PD-L1 monoclonal antibody (mAb) is now indicated for the treatment of unresectable or metastatic solid tumors…
-
Roche’s Vabysmo Receives NMPA Approval for Macular Edema Treatments in China
•
Roche (SWX: ROG), the Swiss pharmaceutical giant, has announced the receipt of another marketing approval from the National Medical Products Administration (NMPA) for its ophthalmology bispecific antibody (BsAb) Vabysmo (faricimab). The new indication is for macular edema secondary to central retinal vein occlusion (CRVO) or hemi-retinal vein occlusion (HRVO). Vabysmo,…
-
Intas Pharmaceuticals Receives FDA Approval for Biosimilar Stelara, Expanding Treatment Options for Autoimmune Diseases
•
Intas Pharmaceuticals Ltd, an Indian pharmaceutical company and partner of China’s Shanghai Henlius Biotech Inc. (HKG: 2696), has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its ustekinumab-srlf. This biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) auto-immune disease drug Stelara…
-
RemeGen’s Disitamab Vedotin Receives Priority Review for New Indication in Breast Cancer by China’s NMPA
•
RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted another indication approval filing for its drug candidate disitamab vedotin (RC48). The antibody-drug conjugate (ADC) has been granted priority review status. This…
-
AstraZeneca and Daiichi Sankyo’s Enhertu Receives Fourth Indication Approval in China
•
AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568)’s co-developed antibody drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), has received conditional approval from China’s National Medical Products Administration (NMPA) for the treatment of adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors exhibit activating HER2 (ERBB2)…
-
BMS’s Dual Immunotherapy Achieves Global First Approval for MSI-H/dMMR CRC in China
•
On October 14, 2024, Bristol-Myers Squibb (BMS, NYSE: BMY) announced that the National Medical Products Administration (NMPA) of China has approved a new indication for its dual immune combination therapy, Opdivo (nivolumab) and Yervoy (ipilimumab), for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or deficient…
-
Sichuan Biokin Pharmaceutical Gets FDA Approval for CD33-Targeting ADC in Acute Myeloid Leukemia
•
Sichuan Biokin Pharmaceutical Co., Ltd, a Chinese pharmaceutical company listed on the Shanghai Stock Exchange as (SHA: 688506), has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study for its antibody-drug conjugate (ADC), BL-M11D1. This therapy targets CD33…
-
BrightGene’s BGM0504 Shows Promise in Phase II Obesity Study Without Diabetes
•
BrightGene Bio-Medical Technology Co., Ltd (SHA: 688166), a Chinese biopharmaceutical company, has announced positive results from the Phase II clinical study (CTR20233198) for its investigational drug BGM0504. This dual agonist targets GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulin stimulating polypeptide) receptors and is being studied for the treatment of…
-
Dizal Pharmaceutical’s Sunvozertinib Earns Breakthrough Designation for NSCLC from China’s NMPA
•
Dizal Pharmaceutical Co., Ltd (SHA: 688192), a biopharmaceutical company based in China, has announced that it has received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib. This designation is in relation to the drug’s potential use as…
-
Reforgene Medicine’s Gene Editing Therapy RM-101 Clears IND Hurdle for Usher Syndrome Treatment
•
Reforgene Medicine, a pioneer in gene editing therapy based in Guangzhou, has secured Investigational New Drug (IND) approval from China’s National Medical Products Administration (NMPA) for its flagship candidate, RM-101. This AAV-based gene editing drug is aimed at treating Usher syndrome, a genetic condition that leads to significant vision impairment…
-
Jiangsu Hengrui’s RGL-193 Receives NMPA Greenlight for Parkinson’s Disease Clinical Study
•
Jiangsu Hengrui Medicine Co., Ltd, a leading pharmaceutical company based in China and listed as (SHA: 600276), has received approval from the National Medical Products Administration (NMPA) for its Category 1 drug, RGL-193. This marks a significant step forward as the drug advances into clinical studies focused on Parkinson’s disease…
-
Novartis’s Brolucizumab Accepted for Review by China’s CDE for Potential DME Treatment
•
The Center for Drug Evaluation (CDE) has indicated that Novartis (NYSE: NVS), the Swiss pharmaceutical giant, has had its second market filing for brolucizumab accepted for review. The filing is anticipated to be for the treatment of visual impairment resulting from macular edema associated with diabetes (DME). Brolucizumab, recognized as…
-
Pfizer’s Talzenna Combo Shows Improved Survival in mCRPC Patients, According to TALAPRO-2 Study
•
Pfizer Inc. (NYSE: PFE) has announced positive topline results regarding overall survival (OS) in the Phase III TALAPRO-2 study for Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, when combined with Xtandi (enzalutamide), an androgen receptor pathway inhibitor (ARPI). This combination is used for the treatment of patients with…
-
CSPC Pharma Initiates Phase III Trial for JMT101 in First-Line EGFR-Positive NSCLC Treatment
•
CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has initiated a Phase III clinical study for its Category 1 drug JMT101. This study combines JMT101 with osimertinib (Tagrisso) and compares it against osimertinib alone in the first-line treatment of locally advanced or metastatic epidermal growth…
-
KangaBio’s KGX101 Receives NMPA Approval for Clinical Trial in China
•
KangaBio, a biopharmaceutical company based in Shanghai, has announced that its investigational new drug (IND) application for KGX101 has received clinical trial approval from the China National Medical Products Administration (NMPA). This Class 1 new drug, an IL-12 Fc fusion protein injection, is expected to be used for the treatment…
-
Johnson & Johnson’s KLK2-CD3 Bispecific Antibody JNJ-78278343 Advances in Prostate Cancer Clinical Trials
•
JNJ-78278343, a KLK2-CD3 bispecific antibody, is currently in Phase I clinical trials globally. According to data released by Johnson & Johnson (J&J, NYSE: JNJ), this drug targets kallikrein-related peptidase 2 (KLK2), an antigen highly expressed in prostate cancer, and binds to CD3 on T cells to activate them, inducing an…
-
Merck KGaA’s Pergoveris Treatment Expands Access to Advanced Reproductive Care in Greater Bay Area
•
Merck KGaA (MRK, NYSE: MRK) , a leading science and technology company based in Germany, has announced the availability of its ovulation-stimulating treatment Pergoveris in the Guangdong–Hong Kong–Macao Greater Bay Area. The treatment, which combines recombinant human follicle stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH), has been approved…
-
Junshi Biosciences’ Ongericimab Wins NMPA Nod for Hypercholesterolemia Treatment
•
Junshi Biosciences (HKG: 1877; SHA: 688180), a leading biopharmaceutical company in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its PCSK9 monoclonal antibody, ongericimab (JS002). This therapy is now approved for use in combination with statins or statins plus ezetimibe for…
-
Juventas Cell Therapy’s CAR-T Therapy Clears for SLE-ITP Study in China
•
The China Center for Drug Evaluation (CDE) has given the green light for a study on inaticabtagene autoleucel (CNCT 19), a chimeric antigen receptor (CAR)-T cell therapy developed by Juventas Cell Therapy Ltd, a Chinese firm. This therapy is now approved for research in refractory systemic lupus erythematosus-associated immune thrombocytopenia…
-
Immupeutics Medicine Secures NMPA Approval for Personalized Liver Cancer Immunotherapy IPM001
•
Immupeutics Medicine, a pioneer in tumor immunotherapy based in Beijing, has announced that it has received clinical approval from the National Medical Products Administration (NMPA) for its proprietary therapy, IPM001. This marks a significant step forward in the field of cancer treatment in China. IPM001 is a groundbreaking multi-antigen targeted…
-
Pfizer’s Hympavzi Secures FDA Nod, Offering Novel Once-Weekly Treatment for Hemophilia B
•
Pfizer Inc. (NYSE: PFE) has scored a significant win with the US Food and Drug Administration’s (FDA) approval of its drug Hympavzi (marstacimab-hncq) for routine prophylaxis in adults and pediatric patients aged 12 and older with hemophilia A, characterized by a congenital deficiency of factor VIII (FVIII), or hemophilia B,…
-
Huadong Medicine Secures NMPA Approval for Semaglutide Biosimilar, Aims to Capture Weight Loss Market
•
Nanjing-based Huadong Medicine Co., Ltd (SHE: 000963) has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its biosimilar version of Novo Nordisk’s (NYSE: NVO) weight loss drug semaglutide, which is marketed under the names Ozempic and Wegovy. Huadong Medicine’s biosimilar will be evaluated for weight management…
-
Coherent Biopharma’s CBP-1008 Earns FDA Fast Track for Platinum-Resistant Ovarian Cancer
•
Coherent Biopharma Ltd, a specialist in bispecific-ligand drug conjugates (Bi-XDCs) with operations in Suzhou, China, has been granted fast-track status by the US Food and Drug Administration (FDA) for its investigational drug CBP-1008. This drug is indicated for the treatment of platinum-resistant ovarian clear cell carcinoma (OCCC), a particularly aggressive…
-
Doma Biopharmaceutical Receives Green Light for Clinical Trial of Novel ADC DM001 Targeting Solid Tumors
•
Doma Biopharmaceutical (Suzhou) Co., Ltd, a biotech firm with a presence in China and the United States, has received approval from China’s National Medical Products Administration to commence a clinical study for its innovative Category 1 drug DM001. This bispecific antibody drug conjugate (ADC) is designed to target advanced or…
-
Harbour BioMed’s Innovative Antibody Porustobart Shows Promise in Early Clinical Trials for Melanoma
•
Harbour BioMed (HKG: 2142), a biopharmaceutical company with operations in the United States, the Netherlands, and Suzhou, China, has announced the publication of the Phase I clinical study results for its CTLA-4 antibody porustobart (HBM4003) in combination with Junshi Biosciences’ PD-1 inhibitor toripalimab. This combination is aimed at treating advanced…
-
Roche’s Genentech Scores FDA Approval for Itovebi in Advanced Breast Cancer Treatment, Advancing Personalized Oncology
•
Roche (SWX: ROG)’s Genentech, a leader in pharmaceutical innovation, has received approval from the US Food and Drug Administration (FDA) for Itovebi (inavolisib), a potent PI3Kα inhibitor. This marks a significant advancement in the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative,…
-
Johnson & Johnson’s Darzalex Combo Therapy Gets EMA Nod for Multiple Myeloma, Aims to Set New Standard
•
Johnson & Johnson (NYSE: JNJ) has taken a significant step in expanding its oncology portfolio with a market filing to the European Medicines Agency (EMA) for its drug Darzalex (daratumumab). The application seeks an indication extension for the subcutaneous (SC) formulation of daratumumab, in combination with bortezomib, lenalidomide, and dexamethasone…
-
Jiangsu Hengrui’s SHR2554 Gets Priority Review for Lymphoma Treatment, Strengthening Global EZH2 Inhibitor Market
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) is on the brink of a breakthrough in cancer treatment, with its drug SHR2554 receiving priority review status from China’s Center for Drug Evaluation (CDE). This enhancer of zeste homolog 2 (EZH2) inhibitor is set to revolutionize the treatment of patients with recurrent…
-
Jiangsu Hengrui Secures FDA Nod for Generic Abraxane, Strengthening Oncology Portfolio
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has achieved a first in the US market with the FDA’s approval of its Abbreviated New Drug Application (ANDA) for a generic version of Abraxis BioScience’s Abraxane (paclitaxel, albumin-bound). This marks a significant milestone for the Chinese pharmaceutical firm, which now leads in…
-
Sunvozertinib’s Companion Diagnostic Gets NMPA Nod, Fortifying Targeted Therapy Arsenal for NSCLC in China
•
Dizal Pharmaceutical Co., Ltd (SHA: 688192) and Burning Rock Ltd (NASDAQ: BNR, FRA: 6BU0) have announced a significant regulatory milestone in China’s precision medicine space. Their jointly developed companion diagnostic (CDx) for epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), designed to pair with the targeted therapy sunvozertinib,…
-
InnoCare Pharma’s ICP-488 Shows Promising Results in Phase II Psoriasis Study
•
China-based InnoCare Pharma (HKG: 9969; SHA: 688428) has announced positive results from a Phase II clinical study for its TYK2 (tyrosine kinase 2) JH2 allosteric inhibitor, ICP-488, in patients with moderate to severe plaque psoriasis. The study demonstrated the drug’s potential in treating psoriasis and other autoimmune diseases by inhibiting…
-
Ascletis Pharma Faces US Import Ban for NASH Drugs ASC41 and ASC43F in Trade Secrets Dispute
•
China’s Ascletis Pharma Inc. (HKG: 1672) is navigating legal proceedings involving its oral thyroid hormone receptor-beta (THRβ) agonist ASC41 and a compound preparation ASC43F, both under development for the treatment of non-alcoholic steatohepatitis (NASH). US-based Viking Therapeutics (NASDAQ: VKTX) filed a lawsuit in the United States against Ascletis in December…
-
InnoCare Pharma Achieves Positive Phase II Results for TYK2 Inhibitor ICP-488 in Psoriasis Treatment
•
China-based InnoCare Pharma (HKG: 9969; SHA: 688428) has announced positive results from a Phase II clinical study for its TYK2 (tyrosine kinase 2) JH2 allosteric inhibitor, ICP-488, in patients with moderate to severe plaque psoriasis. ICP-488 is a potent and selective TYK2 allosteric inhibitor that is being developed to treat…
-
Ascletis Pharma’s ASC40 Earns FDA Breakthrough Therapy Designation for Fibrotic MASH
•
China-based Ascletis Pharma Inc. (HKG: 1672) has announced that ASC40 (denifanstat), a fatty acid synthase (FASN) inhibitor co-developed with US partner Sagimet Biosciences Inc. (NASDAQ: SGMT), has received a breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA). The designation is for the treatment of patients with…
-
Sichuan Biokin’s BL-B01D1 Earns Breakthrough Therapy Designation for Esophageal Cancer from China’s CDE
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has announced that its bispecific antibody drug conjugate (ADC), BL-B01D1, has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) in China. The designation is for the treatment of patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC) who…
-
Merck’s Keytruda Meets Primary Endpoint in Phase III Study for Head and Neck Cancer
•
US pharmaceutical giant Merck & Co., Inc. (MRK, NYSE: MRK) has announced that the Phase III KEYNOTE-689 study for its PD-1 inhibitor Keytruda (pembrolizumab) has met its primary endpoint of event-free survival (EFS) in patients newly diagnosed with stage III or IVA, resected, locally advanced head and neck squamous cell…
-
Boehringer Ingelheim’s Survodutide Earns FDA Breakthrough Therapy Designation for MASH Treatment
•
German pharmaceutical company Boehringer Ingelheim has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for its drug candidate survodutide (BI 456906), a dual glucagon/GLP-1 receptor agonist, for the treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate or advanced fibrosis (stages 2 or…
-
Pfizer Halts Development of Sisunatovir, an RSV Antiviral, After Phase II/III Trials
•
U.S. pharmaceutical giant Pfizer (NYSE: PFE) has decided to discontinue the development of sisunatovir, an antiviral drug for respiratory syncytial virus (RSV), following challenges including drug-drug interactions with antacids. The drug had reached the Phase II/III trial stage, and the decision will see two trials discontinued, according to Endpoints News.…
-
Biogen’s China Unit Gets Conditional NMPA Nod for Qalsody (Tofersen) in ALS Treatment
•
Biogen (NASDAQ: BIIB)’s Chinese subsidiary has announced that it has received conditional approval from the National Medical Products Administration (NMPA) for its drug Qalsody (tofersen) for the treatment of adult patients with amyotrophic lateral sclerosis (ALS) who have a superoxide dismutase 1 (SOD1) gene mutation. ALS is a rare disease,…
-
Joincare Pharmaceutical Secures NMPA Approval for Triptorelin Microspheres to Treat Endometriosis
•
China-based Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380) has announced that it has received another market approval from the National Medical Products Administration (NMPA) for its triptorelin microspheres, now indicated for the treatment of endometriosis. Triptorelin microspheres are an in-house developed long-acting formulation administered via monthly intramuscular injection as…
-
CSPC Pharmaceutical Secures NMPA Approval for Omalizumab Biosimilar
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novartis’s Xolair (omalizumab), an anti-human immunoglobulin E (IgE) monoclonal antibody (mAb). CSPC Pharma’s biosimilar product is described as the first omalizumab biosimilar developed…
-
CSPC Pharmaceutical’s ADC CPO301 Earns Second Fast-Track Designation in the US for NSCLC Treatment
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its best-in-class antibody drug conjugate (ADC) CPO301 has received another fast-track status in the United States for the treatment of non-small cell lung cancer (NSCLC). The EGFR targeted ADC has been granted this status for the treatment of epidermal growth…
-
Bio-Thera Solutions Ltd Strikes Licensing Deal with Gedeon Richter for BAT1706 Biosimilar
•
Guangzhou-based Bio-Thera Solutions Ltd has announced a licensing agreement with Hungary’s Gedeon Richter Plc for BAT1706, its biosimilar version of Roche’s (SWX: RO) Avastin (bevacizumab). Under the agreement, Gedeon Richter will obtain exclusive commercialization rights for the drug in the European Union (EU), the UK, Switzerland, Australia, and other European…
-
Jiangsu Aidea Pharmaceutical Secures NMPA Approval for Expanded Indication of Fubangde in HIV Treatment
•
China-based Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) has announced that the National Medical Products Administration (NMPA) has approved an additional indication filing for its HIV treatment Fubangde (ainuovirine, lamivudine, tenofovir disoproxil). The new indication targets two groups of adults infected with human immunodeficiency virus type 1 (HIV-1) weighing over…
-
Ascentage Pharma Receives Approval for Two Phase III Trials of APG-2449 in NSCLC
•
China-based biopharmaceutical company Ascentage Pharma (HKG: 6855) has announced that it has received approval from the Center for Drug Evaluation of the National Medical Products Administration (NMPA) to conduct two separate Phase III clinical studies assessing its investigational drug APG-2449. The trials will evaluate the FAK/ALK/ROS1 tyrosine kinase inhibitor (TKI)…
-
China’s CDE Announces “Care Plan” to Include Pfizer’s Marstaximab for Rare Disease Drug Development
•
The National Health Commission (NHC) of China, through its Center for Drug Evaluation (CDE), has announced that Pfizer (NSE: PFIZER, NYSE: PFE, ETR: PFE)’s Marstaximab (PF-06741086) has been included in the “Care Plan” for patient-centered rare disease drug development. The publicity period for this decision ends on October 12, 2024.…
-
BeiGene Prices TEVIMBRA 10% Below Competitors Following FDA Approval for Esophageal Cancer Treatment
•
BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the commercial availability of TEVIMBRA (Tislelizumab) in the United States following its approval by the FDA for the treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy. The drug received FDA approval in March…
-
Unixell Advances in Cell Therapy with CDE IND Acceptance
•
Shanghai-based Unixell Biotechnology Co., Ltd. has announced that its Investigational New Drug (IND) application for “UX-DA001 Injection (Human Midbrain Dopaminergic Neuronal Precursor Cell Injection)” has been accepted by the Center for Drug Evaluation (CDE). The therapy, which aligns with the company’s inaugural pipeline, is speculated to target Parkinson’s disease. Founded…
-
Duality Biotherapeutics’ BDCA2 ADC DB-2304 Phase I Trial Registered on ClinicalTrials.gov
•
Duality Biotherapeutics, Inc., a biopharmaceutical company specializing in the development of innovative therapies, has registered a Phase I clinical trial for its drug candidate DB-2304 on ClinicalTrials.gov as of October 3, 2024. The trial is designed to enroll 70 healthy volunteers and is anticipated to conclude in the first half…
-
BeiGene’s FGFR2b ADC BG-C137 Enters Phase I Clinical Trial for Advanced Solid Tumors
•
On October 3, 2024, BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) registered a Phase I clinical trial for BG-C137, an antibody-drug conjugate (ADC) for the treatment of advanced solid tumors, on ClinicalTrials.gov. The trial plans to enroll 68 patients with advanced solid tumors and is expected to be completed by…
-
BMS Expands Opdivo Indication with FDA Approval for NSCLC Combo Therapy
•
The U.S. Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS, NYSE: BMY) Opdivo (nivolumab) for use in combination with platinum-based chemotherapy as a neoadjuvant treatment for adult patients with resectable non-small cell lung cancer (NSCLC), followed by Opdivo as an adjuvant treatment post-surgery. This decision…
-
InnoCare Pharma’s Orelabrutinib Achieves Milestone in SLE Clinical Trial Enrollment
•
InnoCare Pharma announced on October 4, 2024, that it has completed patient enrollment in a Phase II clinical trial for its novel BTK inhibitor, Orelabrutinib, for the treatment of Systemic Lupus Erythematosus (SLE). This randomized, double-blind, placebo-controlled, multicenter Phase IIb clinical study is designed to evaluate the efficacy and safety…
-
Akeso Biopharma’s PD-1/VEGF Bispecific Antibody Study Completes Enrollment
•
On October 4, 2024, Summit Therapeutics (referred to as “Summit”), a partner of Akeso Biopharma (HKG: 9926), announced the completion of subject enrollment for the HARMONi study, which evaluates the PD-1/VEGF bispecific antibody, Ivociclib (also known as AK112). The international Phase III clinical study is led by Summit and investigates…
-
FRα ADC Rina-S by Genmab Enters Late-Stage Clinical Trial Following ProfoundBio Acquisition
•
Genmab A/S (NASDAQ: GMAB) has initiated a Phase III clinical trial for its FRα ADC candidate, Rina-S, as registered on ClinicalTrials.gov on October 1, 2024. The trial aims to enroll 530 patients with platinum-resistant advanced ovarian cancer to compare Rina-S head-to-head with chemotherapy, with an anticipated preliminary completion date in…
-
Dizal Pharmaceutical’s Surufatinib Earns CDE Consideration for Breakthrough Therapy in EGFR exon20ins NSCLC
•
Dizal Pharmaceutical, a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) in China is considering its drug candidate DZD9008 for breakthrough therapy status. The drug is designed to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not received…
-
Hengrui Medicine’s HR19042 Capsules Designated as Breakthrough Therapy for Autoimmune Hepatitis by China NMPA
•
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has recently announced that Hengrui Medicine (SHA: 600276)’s Class 2.2 improved drug, HR19042 capsule, is planned to be included in the breakthrough therapy category, targeting active autoimmune hepatitis. According to previous announcements by Hengrui Medicine, HR19042 is…
-
NMPA Clears AbbVie’s ABBV-706 for Clinical Trials Targeting SCLC and Neuroendocrine Tumors
•
The China National Medical Products Administration (NMPA) has granted clinical trial approval to ABBV-706, a novel antibody-drug conjugate (ADC) developed by AbbVie (NYSE: ABBV), for the treatment of relapsed/refractory small cell lung cancer (SCLC) and other neuroendocrine tumors . ABBV-706 is a targeted therapy that binds to SEZ6, a protein…
-
CStone Pharmaceuticals’ Partner HengRui Medicine Launches Phase III Trial for CTLA-4 Antibody in HCC
•
CStone Pharmaceuticals (HKG: 2616), an innovation-driven biopharmaceutical company focused on the development of oncology drugs, announced today that its partner, HengRui Medicine, has initiated a Phase III clinical study for CS1002/SHR-8068 (an anti-CTLA-4 monoclonal antibody) in combination with adebrelimab and bevacizumab for the first-line treatment of advanced hepatocellular carcinoma (HCC).…
-
Akeso Biopharma’s Cadonilimab Secures NMPA Approval for Gastric Cancer Indication
•
Akeso Biopharma Inc. (HKG: 9926) announced that its self-developed PD-1/CTLA-4 bispecific antibody, Cadonilimab injection (AK104), has been approved by the National Medical Products Administration (NMPA) in China for a new indication. This is the second indication for the product in China and is for the first-line treatment of patients with…
-
Sichuan Biokin’s Partner Bristol-Myers Squibb Gets FDA Nod for Bispecific ADC Study
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese biopharmaceutical company, has announced that its U.S. partner Bristol-Myers Squibb has received approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase I/IIa study for BL-B01D1, an in-house developed bispecific antibody drug conjugate (ADC), in patients with advanced…
-
J&J’s Carvykti Shows 45% Reduced Risk of Death in Multiple Myeloma Patients, Landmark Trial Data Reveals
•
Johnson & Johnson (J&J, NYSE: JNJ), a U.S.-based healthcare conglomerate, has released new clinical trial data for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Carvykti (ciltacabtagene autoleucel). The data reveals long-term overall survival (OS) for the therapy’s use as a second-line treatment for multiple myeloma (MM). The three-year…
-
Yabao Pharmaceutical’s SY-009 Receives NMPA Approval for Phase II Clinical Trial in Constipation
•
Yabao Pharmaceutical Group Co., Ltd (SHA: 600351), a Chinese pharmaceutical company, has announced that SY-009 capsules, a sodium-glucose linked transporter-1 (SGLT-1) inhibitor co-developed with Eli Lilly & Co., (NYSE: LLY) have received approval from the National Medical Products Administration (NMPA) to proceed to a Phase II clinical study for the…
-
Jiangsu Hengrui Medicine Gets NMPA Green Light for Clinical Trial of TSLP-Targeted Asthma Treatment
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 product SHR1905, a thymic stromal lymphopoietin (TSLP)-targeted monoclonal antibody (mAb). The product is…
-
Huadong Medicine Gets NMPA Green Light for Clinical Trials of Roflumilast Cream
•
Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has announced that it has received clinical trial approvals from the National Medical Products Administration (NMPA) for its Zoryve cream (roflumilast) in concentrations of 0.15% and 0.3%. These formulations are indicated for the treatment of mild to moderate atopic dermatitis…
-
Qilu Pharmaceutical’s QL1706 Receives NMPA Conditional Approval for Cervical Cancer Treatment
•
Qilu Pharmaceutical, a Chinese pharmaceutical company, has announced that its combination drug QL1706, comprising iparomlimab and tuvonralimab, has received conditional marketing approval from the National Medical Products Administration (NMPA) for the treatment of recurrent or metastatic cervical cancer. QL1706 (PSB205), originally developed by the U.S. biotech Qilu Puget Sound Biotherapeutic…
-
Dupixent Secures Back-to-Back COPD Approvals from US FDA and China NMPA
•
Regeneron (NASDAQ: REGN), a leading biopharmaceutical company based in the U.S., in collaboration with its French partner Sanofi (NSE: SANOFI), announced on September 27 that Dupixent (dupilumab) has received approvals for the treatment of chronic obstructive pulmonary disorder (COPD) from both the U.S. Food and Drug Administration (FDA) and China’s…
-
AbbVie Submits First BLA for c-Met Targeting ADC Telisotuzumab Vedotin to FDA
•
AbbVie Inc. (NYSE: ABBV), a leading pharmaceutical company in the U.S., has announced the filing of a first Biologics License Application (BLA) for telisotuzumab vedotin (Teliso-V), a first-in-class antibody-drug conjugate (ADC) targeting tumors that overexpress the c-Met protein. The U.S. Food and Drug Administration (FDA) has accepted the filing for…
-
Shanghai Fosun Pharmaceutical Gets NMPA Clinical Clearance for Lymphoma Drug XS-04
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a prominent pharmaceutical company based in China, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its investigational drug XS-04 for the treatment of hematologic malignancies. XS-04, an innovative small molecule drug developed…
-
Shanghai Fosun Pharmaceutical’s SBK010 Stroke Treatment Accepted for NMPA Review
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted a market filing for its chemical drug SBK010 for review. SBK010, which is licensed from Chengdu Shibekang Biomedical Technology Co., Ltd, another…
-
Jacobio Pharma Receives NMPA Approval for Pan-KRAS Inhibitor JAB-23E73 Clinical Trial
•
Jacobio Pharma (HKG: 1167), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its investigational drug JAB-23E73, a pan-KRAS inhibitor developed in-house. This follows prior clearance from U.S. authorities to initiate a Phase I/IIa study for…
-
AstraZeneca’s Tagrisso Secures FDA Approval for Unresectable Stage III EGFRm NSCLC
•
AstraZeneca (NASDAQ: AZN, LON: AZN), a UK-based pharmaceutical giant, has announced that it has received a new indication approval from the US Food and Drug Administration (FDA) for its non-small cell lung cancer (NSCLC) drug Tagrisso (osimertinib). The FDA has approved Tagrisso for the treatment of adult patients with unresectable,…
-
FDA Panel Weighs in on Narrowing Use of PD-1 Inhibitors in Stomach and Esophageal Cancers
•
The U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) convened on September 26 to scrutinize the application of PD-1 inhibitors in oncology, particularly focusing on Bristol Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab) and Merck, Sharp & Dohme’s (NYSE: MRK) Keytruda (pembrolizumab). The committee evaluated the risk-benefit profile of these drugs for…
-
2seventy bio and BMS Discontinue Phase III Trial for Multiple Myeloma Therapy Abecma
•
2seventy bio Inc. (NASDAQ: TSVT), a U.S.-based biotechnology company partnered with Bristol-Myers Squibb (BMS, NYSE: BMY) on the development of the chimeric antigen receptor (CAR) T-cell therapy Abecma (idecabtagene vicleucel; ide-cel), has announced the discontinuation of enrollment in a Phase III clinical trial. The trial, known as KarMMa-9, was investigating…
-
Zelgen Biopharmaceuticals Receives NMPA Approval for ZG005 Clinical Trial in Advanced Solid Tumors
•
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase I/II clinical study for its pipeline drug candidate, ZG005, aimed at treating advanced solid tumors. ZG005 is an…
-
Jiangsu Hengrui Medicine Gets NMPA Green Light for Generic Vizamyl Clinical Trial
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its generic version of GE Healthcare’s Vizamyl (flutemetamol F-18). This trial aims to evaluate the positron emission tomography (PET)…
-
Sino Biopharmaceutical Receives NMPA Approval for Rivastigmine Patch for Mild-to-Moderate Alzheimer’s
•
Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its rivastigmine transdermal patch. This new treatment is intended for the management of symptoms associated with mild-to-moderate Alzheimer’s disease (AD). Rivastigmine, classified…
-
Innovent Biologics Submits Market Approval Filing for Picankibart in Plaque Psoriasis to China’s CDE
•
Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company based in China, has reportedly submitted a market approval filing to the Center for Drug Evaluation (CDE) for its investigational drug picankibart (IBI112), intended for the treatment of moderate to severe plaque psoriasis. Picankibart, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody…
-
Shanghai Haihe Pharmaceutical’s Oral Paclitaxel RMX3001 Wins NMPA Nod for Advanced Gastric Cancer
•
Shanghai Haihe Pharmaceutical Co., Ltd from China and its South Korean partner Daehwa Pharmaceutical have received approval from the National Medical Products Administration (NMPA) for their co-developed paclitaxel oral solution RMX3001. This new drug is intended for use in patients with advanced gastric cancer who have experienced disease progression during…
-
Eli Lilly’s Kisunla Secures Market Approval in Japan for Early Symptomatic Alzheimer’s
•
Eli Lilly & Co. (NYSE: LLY) has announced that its Alzheimer’s disease (AD) treatment, Kisunla (donanemab), has been granted market approval in Japan. The drug is indicated for adults with early symptomatic AD, including those with mild cognitive impairment (MCI) and/or mild dementia stage, who have confirmed amyloid pathology. Kisunla…
-
Amgen’s Tepezza Receives Approval in Japan for Treating Thyroid Eye Disease
•
Amgen (NASDAQ: AMGN), a prominent biotechnology company based in the U.S., has announced that its drug Tepezza (teprotumumab, genetical recombination) has received market approval in Japan. The country’s Ministry of Health, Labour, and Welfare (MHLW) has authorized the medication for treating active or high clinical activity score (CAS) thyroid eye…
-
Elevation Oncology’s Claudin 18.2 Targeting ADC Earns FDA Fast Track Designation for Gastric Cancer
•
Elevation Oncology, Inc. (NASDAQ: ELEV), a biopharmaceutical company based in the U.S., has announced that it has received Fast Track designation (FTD) from the U.S. Food and Drug Administration (FDA) for its investigational therapy EO-3021 (SYSA1801). This antibody-drug conjugate (ADC) targets Claudin 18.2 and is being developed for the treatment…
-
China Medical System’s Opzelura Cream Filing for Vitiligo Accepted by NMPA
•
China Medical System Holdings (CMS; HKG: 0867) has announced that its market filing for Opzelura (ruxolitinib) cream for the treatment of vitiligo has been accepted for review by the National Medical Products Administration (NMPA). Opzelura is a topical Janus kinase (JAK) inhibitor designed for external use. It received approval in…
-
Junshi Biosciences’ Toripalimab Secures EC Nod for Two Cancer Indications
•
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that it has received two indication approvals from the European Commission (EC) for its PD-1 inhibitor, Loqtorzi (toripalimab). This marks a significant expansion of the drug’s utility in the European Union, where it can now be used in combination…
-
Allist Pharma’s Partner Abbisko Receives NMPA Green Light for NSCLC Drug Trial
•
Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology company, has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for ABK3376, an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). This drug is co-developed with Allist Pharmaceuticals Inc., (SHA: 688578), and is intended…
-
UCB’s Bimzelx Gains FDA Approval for Three Additional Autoimmune Indications
•
Belgium-based biopharmaceutical company UCB has announced that the US Food and Drug Administration (FDA) has granted approval for Bimzelx (bimekizumab), an interleukin 17A (IL-17A) and IL-17F targeted antibody, in three new indications. The FDA’s approval expands the use of Bimzelx to treat adults with active psoriatic arthritis (PsA), active non-radiographic…
-
HBOW Bio’s First-in-Class Tumor Imaging Drug NC527-X Receives NMPA Clinical Trial Approval
•
HBOW Bio, a precision oncology company supported by Sherpa Healthcare Partners, has secured clinical trial approval from the National Medical Products Administration (NMPA) for its innovative drug candidate NC527-X. This first-in-class near-infrared fluorescence (NIRF) tumor imaging agent is recognized as the world’s first drug to harness low oxygen pathways for…
-
CDE’s BL-B01D1 on Track for Breakthrough Therapy Designations for EGFR Wild-Type and Mutant NSCLC
•
The Center for Drug Evaluation (CDE) has indicated on its website that two indications for its in-house developed bispecific antibody drug conjugate (ADC), BL-B01D1, are on track to receive breakthrough therapy designations (BTDs). The first indication is for patients with locally advanced or metastatic EGFR wild-type non-small cell lung cancer…
-
Shanghai Fudan-Zhangjiang Enrolls First Patient in U.S. Phase II Study for Port Wine Stain Treatment
•
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd (HKG: 1349; SHA: 688505), a leading biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase II clinical study for its hemoporfin photo-dynamic therapy (PDT) in the United States. The study is focused on treating port wine stain (PWS),…
-
Antengene’s Xpovio Receives NDA Approval in Thailand for Multiple Myeloma Treatment
•
Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced that it has received New Drug Application (NDA) approval in Thailand for its drug Xpovio (selinexor). This approval allows the use of Xpovio in combination with bortezomib and dexamethasone to treat adult patients with relapsed or refractory…
-
Wuhan YZY Biopharma Presents M701 Interim Results at 2024 ESMO Congress for NSCLC-Related Pleural Effusion
•
Wuhan YZY Biopharma Co., Ltd (HKG: 2496), a biopharmaceutical company based in China, has announced the presentation of interim analysis results from a Phase Ib clinical study for its investigational drug M701 at the 2024 European Society of Medical Oncology (ESMO) Congress. M701 is a recombinant anti-EpCAM and CD3 human…
-
Allist Pharmaceuticals’ EGFR Inhibitor AST2303 Approved for Clinical Trial in NSCLC by NMPA
•
Allist Pharmaceuticals Inc. (SHA: 688578), a Shanghai-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its AST2303, an oral small molecule epidermal growth factor (EGFR) inhibitor, for adult patients with advanced non-small cell lung cancer (NSCLC) that carries the…
-
Haisco Pharmaceutical’s HSK21542 for Itching in Dialysis Patients Receives NMPA Review
•
Haisco Pharmaceutical Group Co., Ltd (SHE: 002653), a prominent Chinese pharmaceutical company, has announced that its marketing application for HSK21542, a Category 1 drug, has been accepted for review by the National Medical Products Administration (NMPA). The drug is intended for the treatment of moderate to severe itching associated with…
-
CDE Lists Five Drugs and One Companion Diagnostic for Priority Review Status
•
The Center for Drug Evaluation (CDE) has indicated on its website that five investigational drugs and one companion diagnostic (CDx) are on track to receive priority review status. The drugs include: Novartis’ Fabhalta (iptacopan) for C3 glomerulopathy (C3G), a best-in-class specific complement factor B oral inhibitor that comprehensively controls intravascular…
-
Frontera Therapeutics Receives FDA Approval for Phase II Study of First Chinese rAAV Gene Therapy
•
Frontera Therapeutics, Inc., a Sino-US biopharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase II clinical study for its investigational gene therapy, FT-002. This recombinant adeno-associated virus (rAAV) gene therapy candidate marks a significant milestone as the…
-
Sanofi’s Sarclisa Secures FDA Approval for First-Line Multiple Myeloma Treatment
•
Sanofi (EPA: SAN; NASDAQ: SNY) has announced that the US Food and Drug Administration (FDA) has granted a third indication for its CD38 antibody Sarclisa (isatuximab) for the treatment of multiple myeloma (MM). The new approval allows for the first-line use of Sarclisa in combination with standard-of-care treatments, specifically bortezomib,…
-
Novo Nordisk’s Obesity Drug Monlunabant Phase IIa Results Lead to Share Price Drop
•
Novo Nordisk (NYSE: NVO), a Danish pharmaceutical company, has reported Phase IIa trial results for monlunabant, an oral small-molecule cannabinoid receptor 1 (CB1) inverse agonist being developed for the treatment of obesity. The trial data, which showed statistically significant weight loss across all tested doses compared to placebo, did not…
-
Sichuan Biokin’s Multi-Specific Antibody GNC-077 Gets NMPA Nod for Advanced Solid Tumor Clinical Trial
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to advance its drug candidate, GNC-077, into clinical trials for the treatment of advanced solid tumors. GNC-077 is a multi-specific antibody developed on…
-
SciClone Pharmaceuticals Gets NMPA Approval for Phase III Study of First-in-Class SERD Orserdu
•
SciClone Pharmaceuticals Inc. (HKG: 6600), a Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III bridging study for its drug Orserdu (elacestrant), the world’s first selective estrogen receptor degrader (SERD) originally developed by Eisai. The Phase III study, which is randomized,…
-
ApolloBio’s HPV Therapeutic Vaccine VGX-3100 Gets NMPA Green Light for Clinical Trial
•
ApolloBio Corp., a joint stock company of China’s leading cephalosporin manufacturer Shandong Jincheng Pharmaceutical and Chemical Co., Ltd (SHE: 300233), has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for VGX-3100. This drug, hailed as the world’s first therapeutic vaccine for human papillomavirus…
-
Jacobio Pharma’s Pan-KRAS Inhibitor JAB-23E73 Clears FDA Hurdle for Clinical Trials
•
Jacobio Pharma (HKG: 1167), a biopharmaceutical company based in China, has received the green light from the U.S. Food and Drug Administration (FDA) to commence a Phase I/IIa clinical study for its investigational new drug, JAB-23E73. This in-house developed pan-KRAS inhibitor has shown promise in simultaneously inhibiting both active and…
-
Hybribio’s Chloroquine Phosphate Gel Cleared for Clinical Trial on High-Risk HPV Infections
•
Hybribio Limited (SHE: 300639), a Guangdong-based pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its chloroquine phosphate gel, a patented pharmaceutical preparation in China. The gel, designed for topical administration, is intended to reduce systemic exposure and is formulated…
-
Ocumension Therapeutics’ OT-502 Receives NMPA Acceptance for Post-Cataract Inflammation Treatment
•
Ocumension Therapeutics (HKG: 1477) announced on September 23, 2024, that the National Medical Products Administration (NMPA) in China has accepted its New Drug Application (NDA) for OT-502 (DEXYCU, dexamethasone implant). This ophthalmic new drug is designed to treat postoperative inflammation and is indicated for suppressing inflammation and related complications in…
-
Yantai Dongcheng Pharmaceutical’s 18F-LNC1007 Receives Clinical Clearance for Solid Tumor Diagnostics
•
Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a Chinese pharmaceutical company, has received clinical trial approval from the National Medical Products Administration (NMPA) for its 18F-LNC1007 injection, a novel radioactive diagnostic drug. This drug is designed to target fibroblast activating protein (FAP) and integrin alpha-v beta-3, which are biomarkers…
-
Fosun Pharmaceutical’s PD-1 Inhibitor HanSiZhuang Recommended for Approval by EMA’s CHMP
•
Shanghai Fosun Pharmaceutical Group Co., Ltd (SHA: 600196; HKG: 2196), a leading pharmaceutical company in China, has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending the approval of its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang, in combination with carboplatin and…
-
AstraZeneca’s HIMALAYA Trial Data Showcases Significant Survival Benefits for Liver Cancer Treatment at ESMO 2024
•
At the European Society for Medical Oncology (ESMO) 2024 conference, AstraZeneca (NASDAQ: AZN, LON: AZN) presented updated data from the HIMALAYA Phase III trial, demonstrating sustained and clinically meaningful overall survival (OS) benefits for patients with unresectable hepatocellular carcinoma (HCC) who had not previously received systemic therapy and for whom…
-
Aligos Therapeutics’ ALG-055009 Achieves Positive Topline Results in Phase 2a HERALD Study for MASH
•
Aligos Therapeutics, a clinical-stage biopharmaceutical company focused on liver and viral diseases, has announced positive topline results from its Phase 2a HERALD study for ALG-055009, a thyroid hormone receptor beta (THR-β) agonist, in patients with metabolic dysfunction-associated steatohepatitis (MASH). The study, which is the first to demonstrate the benefits of…
-
Roche’s Xofluza Receives FDA Approval for Reducing Influenza Transmission in Phase III Study
•
Roche (SWX: ROG; OTCMKTS: RHHBY) has announced that its antiviral drug Xofluza (baloxavir marboxil) has received approval from the US Food and Drug Administration (FDA) based on positive results from the Phase III CENTERSTONE study. The study demonstrated that a single dose of Xofluza significantly reduced the transmission of influenza…
-
J&J’s Rybrevant Secures FDA Approval for EGFR/c-MET Non-Small Cell Lung Cancer Treatment
•
Johnson & Johnson (J&J; NYSE: JNJ)has announced that the US Food and Drug Administration (FDA) has granted approval for its EGFR/c-MET bispecific antibody, Rybrevant (amivantamab-vmjw), in combination with standard chemotherapy, for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor…
-
Beijing’s Apollobio Receives NMPA Approval for HPV Therapeutic Vaccine VGX-3100
•
Beijing’s Apollobio, has announced that the National Medical Products Administration (NMPA) has granted market approval for its innovative therapeutic vaccine VGX-3100. This vaccine, which targets HPV-16/18 related anal precancerous lesions, is a significant advancement in the treatment landscape for conditions associated with Human Papillomavirus (HPV). The vaccine’s approval follows a…
-
Insilico Medicine’s AI-Generated Drug Candidate ISM001-055 Shows Positive Phase II Results in IPF Study
•
China-based artificial intelligence (AI) drug developer Insilico Medicine has reported initial positive data from its Phase IIa study for ISM001-055, an in-house generative AI-generated drug candidate for idiopathic pulmonary fibrosis (IPF). The molecule, which targets TNIK (Traf2- and NCK- interacting kinase), has shown a positive safety profile and dose-dependent lung…
-
Lee’s Pharmaceutical’s Zhaoke Ophthalmology Receives NMPA Approval for Generic Lumigan
•
Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced that it has received market approval from China’s National Medical Products Administration (NMPA) for its generic version of Allergan’s (NYSE: AGN) Lumigan (bimatoprost), a treatment for glaucoma. The product, marketed under the Chinese trade…
-
Jiangsu Hengrui Medicine’s SHR-1701 Combo Therapy for Gastric Cancer Accepted for Review by China’s NMPA
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its market filing for SHR-1701 in combination with fluorouracil and platinum for the first-line treatment of locally advanced unresectable, recurrent, or metastatic adenocarcinoma of…
-
Ocumension Therapeutics’ Zerviate Receives Marketing Approval in China for Allergic Conjunctivitis Treatment
•
Ocumension Therapeutics (HKG: 1477), a leading ophthalmology specialist in China, has announced that its histamine H1 receptor-targeted drug Zerviate (OT-1001) has been granted marketing approval in China with priority review status. The drug is indicated for the treatment of itching symptoms associated with allergic conjunctivitis. Zerviate, originally developed by the…
-
MSD’s Keytruda Secures FDA Approval for First-Line Mesothelioma Treatment in Combination with Chemotherapy
•
Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has announced that the US Food and Drug Administration (FDA) has approved a new indication for its programmed death-1 (PD-1) inhibitor, Keytruda (pembrolizumab). The approval allows for the use of Keytruda in combination with pemetrexed and platinum chemotherapy as a first-line treatment…
-
AstraZeneca’s Fasenra Secures FDA Nod for EGPA Treatment, Strengthening Rare Disease Portfolio
•
UK pharmaceutical giant AstraZeneca (NASDAQ: AZN, LON: AZN) has announced that the US Food and Drug Administration (FDA) has approved a new indication for its interleukin-5 (IL-5)-targeted antibody, Fasenra (benralizumab), for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA), a rare and potentially fatal disease. The approval comes on the…
-
AstraZeneca’s Tagrisso Achieves Milestones in Phase III LAURA Study for EGFR-mutated NSCLC at ESMO 2024
•
Global pharmaceutical company AstraZeneca (AZ, NASDAQ: AZN, LON: AZN) has reported updated results from the Phase III LAURA study on its EGFR-tyrosine kinase inhibitor (EGFR-TKI), Tagrisso (osimertinib), at the 2024 European Society of Medical Oncology (ESMO) Congress. The study included data from the Chinese cohort, highlighting the drug’s efficacy in…
-
Keymed Biosciences’ Stapokibart Receives First Prescription in China for IL-4Rα Targeting Therapy
•
China-based biotech company Keymed Biosciences Inc. (HKG: 2162) has reached a significant milestone with its drug candidate stapokibart, as it receives its first prescription in the country. This marks a pivotal step for the IL-4Rα monoclonal antibody (mAb), which is the first drug developed by a Chinese biotech to target…
-
Adagene’s ADG126 Shows Promising Results in Phase Ib/II Study for MSS CRC at ESMO 2024
•
Adagene Inc. (NASDAQ: ADAG), a biopharmaceutical company dedicated to the discovery and development of innovative antibody-based therapies, has announced updated results from the Phase Ib/II study of its anti-CTLA-4 SAFEbody, ADG126 (Muzastotug), in combination with pembrolizumab for the treatment of advanced/metastatic microsatellite stable colorectal cancer (MSS CRC) at the 2024…
-
Transcenta’s Osemitamab Combo Therapy Shows Promising Results in G/GEJ Cancer Treatment at ESMO 2024
•
Transcenta Holdings Ltd (HKG: 6628), a leading biopharmaceutical company, has announced updated positive results from the cohort-G data of its drug candidate osemitamab (TST001) in combination with nivolumab and CAPOX for the first-line treatment of advanced gastric or gastroesophageal junction (G/GEJ) cancer at the 2024 European Society of Medical Oncology…
-
I-Mab’s Plonmarlimab Receives Breakthrough Therapy Designation in China for R/R MAS Treatment
•
China-based biopharmaceutical company I-Mab (NASDAQ: IMAB) has announced that its proprietary human granulocyte-macrophage colony-stimulating factor (GM-CSF) neutralizing antibody, plonmarlimab, is poised to receive breakthrough therapy designation (BTD) from the National Medical Products Administration (NMPA) for the treatment of recurrent/refractory hemophagocytic lymphohistiocytosis (R/R MAS), a severe and life-threatening condition. Plonmarlimab is…
-
MSD and Daiichi Sankyo’s Patritumab Deruxtecan Achieves Milestone in Phase III Lung Cancer Trial
•
Global healthcare leaders Merck, Sharp & Dohme Inc.(MSD; NYSE: MRK), known as MSD outside the US and Canada, and Daiichi Sankyo (TYO: 4568) have announced that their jointly developed anti-HER3 antibody drug conjugate (ADC), patritumab deruxtecan, has demonstrated a significant progression-free survival (PFS) benefit in the Phase III HERTHENA-Lung02 trial.…
-
GSK’s Blenrep-BorDex Combo Earns Breakthrough Therapy Designation in China for Multiple Myeloma
•
The UK-based pharmaceutical colossus, GSK (LON: GSK, NYSE: GSK), has secured a Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for its antibody-drug conjugate, Blenrep (belantamab mafodotin), used in combination with bortezomib and dexamethasone (BorDex). This regulatory milestone for the treatment of relapsed or refractory multiple myeloma…
-
AstraZeneca’s Imfinzi-Imjudo Combo Sets New Longevity Benchmark in Liver Cancer Treatment
•
UK pharmaceutical giant AstraZeneca (NASDAQ: AZN, LON: AZN) has achieved a significant milestone with its drug combination of Imfinzi (durvalumab) and Imjudo (tremelimumab), used in the treatment of patients with unresectable or metastatic oesophageal squamous cell carcinoma (ESCC). Data from the Phase III HIMALAYA trial, showcased at the 2024 European…
-
BeiGene’s Tislelizumab Receives Israeli Nod for Oesophageal Cancer Treatment
•
China-based biotech firm BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has been granted market approval in Israel for its programmed death-1 (PD-1) inhibitor, Tevimbra (tislelizumab). The Israeli Ministry of Health has approved Tevimbra for use as a monotherapy second-line treatment for adult patients with unresectable or metastatic oesophageal squamous…
-
Abbisko Therapeutics’ FGFR4 Inhibitor Irpagratinib Shows Positive Phase I Results at ESMO Congress
•
Shanghai-based biotech firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has presented updates on its innovative cancer treatments at the 2024 European Society of Medical Oncology (ESMO) Congress. The company highlighted the Phase I study results for irpagratinib, a novel small-molecule FGFR4 inhibitor, in patients with FGF19 over-expressing advanced hepatocellular carcinoma…
-
Alphamab Oncology’s JSKN003 ADC Achieves Positive Safety and Efficacy Outcomes in Phase I Studies
•
Alphamab Oncology (HKG: 9966), a leading player in the oncology space, has reported encouraging results from its Phase I clinical studies of JSKN003, a HER2-targeted antibody-drug conjugate (ADC), at the 2024 European Society of Medical Oncology (ESMO) Congress. The studies, conducted in Australia and China, targeted advanced and metastatic solid…
-
CStone Pharmaceuticals’ Sugemalimab Shows Promising Long-Term Survival Data at ESMO 202
•
CStone Pharmaceuticals (HKG: 2616), a biopharmaceutical company based in China, has presented long-term treatment and survival data for sugemalimab at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting. The data comes from the GEMSTONE-302 study, which combines sugemalimab with platinum-based chemotherapy. The Phase III trial, a multicenter, randomized,…
-
Ascletis Pharma Initiates Phase I Trials for Monthly Subcutaneous and Daily Oral Obesity Treatment ASC30 in the US
•
Ascletis Pharma Inc. (HKG: 1672), a biopharmaceutical company based in China, has announced the dosing of the first batch of patients in two Phase I clinical studies for its investigational drug ASC30 in the United States. ASC30 is positioned as the world’s first and only small molecule glucagon-like peptide-1 receptor…
-
Dizal Pharmaceutical’s Sunvozertinib Shows Promising Results in WU-KONG Series Study at ESMO 2024
•
Dizal Pharmaceutical Co., Ltd (SHA: 688192), a biopharmaceutical company based in China, has presented updates on the WU-KONG series study for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib (DZD9008), at the 2024 European Society of Medical Oncology (ESMO) Congress. Sunvozertinib received approval in China in August of the…
-
Merck’s Keytruda Gains Expanded Approval for First-Line Melanoma Treatment in China
•
Merck & Co., Inc. (NYSE: MRK), a leading US pharmaceutical company, has announced that its programmed death-1 (PD-1) inhibitor, Keytruda (pembrolizumab), has received expanded approval in China. The updated approval allows the drug’s package insert to be revised to include “pembrolizumab is suitable for the treatment of unresectable or metastatic…
-
iTeos Therapeutics and GSK’s Belrestotug/Dostarlimab Combo Shows Promising Results in NSCLC
•
iTeos Therapeutics has announced the latest data from the Phase 2 platform study GALAXIES Lung-201, led by its development partner GSK. The study evaluates the efficacy of the combination therapy consisting of the anti-TIGIT monoclonal antibody belrestotug and the anti-PD-1 monoclonal antibody dostarlimab in patients with untreated, unresectable, locally advanced,…
-
Merck and Daiichi Sankyo’s HER3-DXd ADC Patritumab Deruxtecan Passes Phase 3 Trial After FDA Rejection
•
Merck (NYSE: MRK) and Daiichi Sankyo (TYO: 4568) announced that their antibody-drug conjugate (ADC) patritumab deruxtecan (HER3-DXd) has passed Phase 3 HERTHENA-Lung 02 study, months after the drug was rejected by the U.S. FDA due to manufacturing issues following its presentation at this year’s ESMO conference. The companies will discuss…
-
Kangfang Biotech Presents Groundbreaking mCRC Treatment Data at ESMO Congress
•
At the 2024 European Society for Medical Oncology (ESMO) Congress, Kangfang Biotech (HKG: 9926) debuted its independently developed PD-1/VEGF bispecific antibody, Yivoxi, in combination with or without the next-generation CD47 monoclonal antibody, Laifali, plus FOLFOXIRI as a first-line treatment for microsatellite stable (MSS) or proficient mismatch repair (pMMR) advanced metastatic…
-
Kangfang Biotech’s Yivoxi Shows Promising Results in First-Line TNBC Treatment at ESMO Congress
•
At the 2024 European Society for Medical Oncology (ESMO) Congress, Kangfang Biotech (HKG: 9926) unveiled for the first time the results of its independently developed PD-1/VEGF bispecific antibody, Yivoxi, used in combination with chemotherapy for the first-line treatment of locally advanced unresectable or metastatic triple-negative breast cancer (TNBC). Preliminary data…
-
Kangfang Biotech’s Yivoxi Shows Promising Results in Treating R/M HNSCC at ESMO Congress
•
At the 2024 European Society for Medical Oncology (ESMO) Congress, Kangfang Biotech (HKG: 9926) unveiled the impressive Phase II clinical study results of its self-developed PD-1/VEGF bispecific antibody, Yivoxi, used in combination or alone with the next-generation CD47 monoclonal antibody, Laifali, for the first-line treatment of PD-L1 positive (CPS≥1) recurrent…
-
Shanghai Pharmaceuticals’ Dual-Targeting CAR-T Therapy Advances with IND Re-Acceptance
•
Shanghai Pharmaceuticals Group Co., Ltd. (SHA: 601607)’s biotech subsidiary has announced that its investigational ‘CD19 and CD22 targeting chimeric antigen receptor T cell injection’ has received renewed acceptance for its Investigational New Drug (IND) application by the relevant authorities. Known under the development code B019, this cellular therapy candidate has…
-
Novartis’ Cemiplimab Approved in China for Moderate-to-Severe Atopic Dermatitis
•
Novartis (SWX: NOVN, NYSE: NVS)’s Chinese arm has announced that it has received approval from the National Medical Products Administration (NMPA) for its drug candidate, cemiplimab, to be used in the treatment of adults and children aged 12 and over with moderate-to-severe atopic dermatitis (AD). The drug, known as cemiplimab…
-
Johnson & Johnson’s Tremfya Gains FDA Approval for Ulcerative Colitis Treatment
•
Johnson & Johnson (NYSE: JNJ) announced today that the US Food and Drug Administration (FDA) has granted approval for Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). With this approval, Tremfya stands out as the sole fully-human, dual-acting monoclonal antibody that not only…
-
Roche’s Tecentriq Hybreza Becomes First Subcutaneous Anti-PD-(L)1 Immunotherapy in the US
•
Roche (SWX: ROG; OTCMKTS: RHHBY) , a leading Swiss pharmaceutical company, has secured US Food and Drug Administration (FDA) approval for its subcutaneous formulation of the programmed death-ligand 1 (PD-L1) inhibitor, Tecentriq Hybreza (atezolizumab, hyaluronidase). This new formulation has been approved for all 12 adult indications of intravenous Tecentriq, covering…
-
Lilly’s Once-Monthly Atopic Dermatitis Treatment Ebglyss Gets Green Light from FDA
•
Eli Lilly & Co. (NYSE: LLY) has announced that it has received market approval from the US Food and Drug Administration (FDA) for Ebglyss (lebrikizumab), a new treatment for adults and children aged 12 years and over suffering from moderate-to-severe atopic dermatitis (AD). Ebglyss is an interleukin-13 (IL-13) inhibitor that…
-
Roche’s Ocrevus Zunovo Receives FDA Nod as First Twice-Yearly MS Treatment
•
Roche Group (SWX: ROG; OTCMKTS: RHHBY) , a Swiss pharmaceutical giant, has announced that the US Food and Drug Administration (FDA) has granted approval for Ocrevus Zunovo (ocrelizumab, hyaluronidase), marking a significant advancement in the treatment of multiple sclerosis (MS). This new formulation is the first and only twice-per-year treatment…
-
Ascentage Pharma’s Olverembatinib Shows Promise in SDH-Deficient GIST at ESMO Congress
•
Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has announced the presentation of clinical study results for its drug olverembatinib (HQP1351) at the 2024 European Society of Medical Oncology (ESMO) Congress. The study focused on patients with succinate dehydrogenase-deficient gastrointestinal stromal tumor (GIST), a rare and aggressive form…
-
Jiangsu Hengrui’s HER2-Targeted ADC SHR-A1811 Receives Priority Review from China’s NMPA
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that the National Medical Products Administration (NMPA) has accepted its market filing for trastuzumab rezetecan (SHR-A1811), an antibody-drug conjugate (ADC) targeting HER2, with priority review status. The drug is intended for the treatment of adult…
-
Johnson & Johnson Submits Second NDA for Nipocalimab to Treat Generalized Myasthenia Gravis
•
Johnson & Johnson (NYSE: JNJ), a leading healthcare company based in the U.S., has reported a second New Drug Application (NDA) filing for its FcRn blocker, nipocalimab. The company has submitted the application to the European Medicines Agency (EMA) for the treatment of adults with generalized myasthenia gravis (gMG) who…
-
Keymed Biosciences’ IL-4Rα mAb Stapokibart Receives NMPA Approval for Atopic Dermatitis Treatment
•
Keymed Biosciences Inc. (HKG: 2162), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has approved a market filing for its IL-4Rα monoclonal antibody (mAb) drug candidate, stapokibart (CM310), for the treatment of moderate to severe atopic dermatitis (AD). This marks a significant milestone…
-
Sanofi’s Dupixent Shows Promise in Phase III Trials for Rare Skin Disease and Chronic Hives
•
Sanofi (EPA: SAN; NASDAQ: SNY), a leading French pharmaceutical company, has announced positive results from two Phase III clinical trials for its drug Dupixent (dupilumab), indicating its potential for two distinct indications. The first trial, ADEPT, concentrated on the treatment of the rare skin condition bullous pemphigoid (BP), while the…
-
Suzhou GenAssist Launches First-of-Its-Kind Base Editing Drug Trial for Duchenne Muscular Dystrophy
•
Suzhou GenAssist Therapeutic Co., Ltd, a biopharmaceutical company based in China, has announced the commencement of an investigator-initiated-trial (ITT) for its base editing drug candidate, GEN6050X, in patients afflicted with Duchenne muscular dystrophy (DMD). DMD is a rare genetic disorder linked to the X-chromosome, typically caused by mutations in the…
-
Innovent Biologics’ Mazdutide Outperforms Dulaglutide in Phase III T2D Study at EASD Meeting
•
Innovent Biologics, Inc. (HKG: 1801), a biopharmaceutical company based in China, has presented significant findings from the Phase III DREAMS-2 study on its drug candidate mazdutide at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD). Mazdutide, a dual agonist targeting the glucagon-like peptide-1 receptor…
-
Qilu Pharmaceutical’s Iruplinalkib Shows Promising Results in Phase II Study for ALK+ NSCLC
•
Qilu Pharmaceutical, a leading pharmaceutical company based in China, has presented updated results from the Phase II INTELLECT study for its Category 1 drug iruplinalkib at the World Conference on Lung Cancer (WCLC). The study focuses on patients with cizotinib-resistant anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC).…
-
Nuance Pharma Completes Enrollment for Phase III COPD Trial of Ohtuvayre in China
•
Nuance Pharma, a China-based pharmaceutical company, has announced the completion of patient enrollment for the Phase III ENHANCE-CHINA study (NCT05743075) for its drug Ohtuvayre (ensifentrine). This Phase III trial is a randomized, double-blind, placebo-controlled investigation assessing the efficacy and safety of Ohtuvayre over a 24-week period in adult patients diagnosed…
-
Innovent Biologics Presents Promising Phase I Data for IBI363 in Advanced NSCLC at WCLC
•
Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has unveiled Phase I clinical data for its innovative PD-1/IL-2α-biased bispecific antibody (BsAb) fusion protein, IBI363, at the 2024 World Conference on Lung Cancer (WCLC). The data, which pertain to the treatment of advanced non-small cell lung cancer…
-
Betta Pharmaceuticals’ MCLA129 for Advanced Solid Tumors Accepted for Review by China’s NMPA
•
Betta Pharmaceuticals Co., Ltd (SHE: 300558), a pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its clinical filing for MCLA129, a Category 1 biologic product intended for the treatment of advanced solid tumors. The potential indications for MCLA129 include, but…
-
Duality Biotherapeutics Initiates Global Clinical Trial for DB-1419 in Advanced Solid Tumors
•
Duality Biotherapeutics, Inc., a biopharmaceutical company based in China, has reached a significant milestone with the dosing of the first patient in its Phase I/IIa clinical study for the in-house developed antibody drug conjugate (ADC) DB-1419. The study is aimed at evaluating the safety and efficacy of DB-1419 in patients…
-
AbbVie Accuses BeiGene of Trade Secret Theft in BTK Degrader Dispute
•
AbbVie Sues BeiGene Over Alleged Trade Secret Theft in BTK Degrader ProgramU.S. pharmaceutical titan AbbVie Inc. (ABBV) has initiated legal proceedings against BeiGene Ltd. (NASDAQ: BGNE; HKG: 6160; SHA: 688235), accusing the Chinese biotech firm of pilfering trade secrets vital to its Bruton’s tyrosine kinase (BTK) degrader program. According to…
-
Terns Pharmaceuticals’ Oral GLP-1R Agonist TERN-601 Shows Promising Weight Loss Results in Phase I Trial
•
Terns Pharmaceuticals Inc. (NASDAQ: TERN), a U.S.-based biotechnology company originally spun out from Eli Lilly’s China R&D center, has unveiled early data for its oral, once-daily glucagon-like peptide-1 receptor (GLP-1R) agonist, TERN-601. The top-line data originates from a Phase I clinical trial, which was a double-blind, placebo-controlled study involving single…
-
GSK’s Nucala Shows Promise in Phase III COPD Trial, MATINEE Results Positive
•
GSK plc (LON: GSK, NYSE: GSK), a leading UK-based pharmaceutical company, has announced positive results from a Phase III trial for its auto-immune therapy Nucala (mepolizumab) in treating chronic obstructive pulmonary disorder (COPD). The MATINEE trial demonstrated that GSK’s interleukin-5 (IL-5) inhibitor met the primary endpoint, showing a significant and…
-
CIRC’s Subsidiary HTA Co., Ltd. Secures NMPA Approval for Sodium Fluoride [18F] for Bone Imaging
•
China Isotope & Radiation Corporation’s (CIRC) subsidiary, HTA Co., Ltd. (HKG: 1763), has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its sodium fluoride [18F]. This product is primarily utilized in positron emission tomography (PET) to identify areas of altered osteogenic activity in…
-
Fosun Pharmaceutical’s Daxxify Receives NMPA Approval for Aesthetic Use in China
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has granted market approval for its product Daxxify (daxibotulinumtoxin, RT002). This type A botulinum toxin is now approved for the temporary improvement of moderate to severe eyebrow wrinkles in adults in…
-
Jiangsu Hengrui’s ANGPTL3 Inhibitor SHR-1918 Earns Breakthrough Designation for HoFH Treatment
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received Breakthrough Therapy Designation (BTD) from China’s Center for Drug Evaluation (CDE) for its drug candidate SHR-1918. This in-house developed monoclonal antibody (mAb) targeting angiopoietin-like protein 3 (ANGPTL3) is intended for the…
-
AstraZeneca and Daiichi Sankyo’s Dato-DXd Misses Overall Survival Endpoint but Shows Promise in NSCLC Subgroup
•
AstraZeneca (NASDAQ: AZN) and its co-development partner, Japan’s Daiichi Sankyo, have released data from the TROPION-Lung01 Phase III study, which focuses on the TROP-2-targeted antibody drug conjugate (ADC) datopotamab deruxtecan (Dato-DXd) as a second-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC). The molecule did not achieve…
-
Vcanbio’s Stem Cell Therapy VUM02 Gets NMPA Approval for Systemic Sclerosis Clinical Trial
•
Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645), a biotechnology company based in China, has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 therapeutic biologic product, VUM02. This product, derived from human umbilical cord mesenchymal stem cells, is designed…
-
Innovent Biologics’ Dupert Demonstrates Positive Results in Phase II NSCLC Trial
•
Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that its Phase II clinical trial results for Dupert (fulzerasib) have been selected for an oral presentation at the 2024 World Conference on Lung Cancer (WCLC). The study, known as HARMONi-2 (AK112-303), focuses on the treatment…
-
China’s CDE Issues Draft Guidelines for Biosimilar Pharmaceutical Similarity Research
•
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has released a draft proposal titled “Questions and Answers on Pharmaceutical Similarity Research of Biosimilars,” seeking public feedback until October 9th. This document, applicable to Category 3.3 biologics, provides clarity on common issues and technical requirements for…
-
Zelgen Biopharma’s ZG006 Shows Promising Anti-Tumor Efficacy in Phase I/II SCLC Study
•
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced positive preliminary results from a Phase I/II clinical study assessing the tolerability, safety, efficacy, and pharmacokinetics of ZG006 in patients with advanced small-cell lung cancer (SCLC) or neuroendocrine carcinoma. The study, which included a dosage…
-
Merck and Daiichi Sankyo’s Ifinatamab Deruxtecan Shows Promising Results in Phase II ES-SCLC Trial
•
Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK), a leading U.S. pharmaceutical company, and its co-development partner Daiichi Sankyo (TYO: 4568), have announced preliminary data from a Phase II clinical trial for the investigational B7-H3-directed antibody-drug conjugate (ADC) ifinatamab deruxtecan. The trial has identified a recommended dosage of 12mg/kg for…
-
China’s CDE Releases 86th Batch of Reference Preparations for Generic Drug Evaluation
•
China’s Center for Drug Evaluation (CDE) has unveiled its 86th roster of reference preparations for generic quality and consistency evaluation (GQCE), seeking public commentary until September 20, 2024. The latest draft opinion expands the list by incorporating 23 new drugs and 27 specifications, aiming to enhance the standardization and reliability…
-
Akeso’s Ivonescimab Shows Promising Results in Phase III Clinical Trial for Hepatocellular Carcinoma
•
Akeso Inc. (HKG: 9926), a biopharmaceutical company based in China, has announced that its first-in-class bispecific antibody, ivonescimab, in combination with lenvatinib and transcatheter arterial chemoembolization (TACE), has reached a significant milestone in its Phase III clinical trial for unresectable, non-metastatic hepatocellular carcinoma (HCC). The drug has demonstrated promising results…
-
Sinocelltech’s Herpes Zoster Vaccine SCTV04C Clears NMPA for Clinical Trial
•
Sinocelltech Group Ltd (SHA: 688520), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to commence clinical trials for SCTV04C, its proprietary recombinant herpes zoster vaccine. Herpes zoster, commonly known as shingles, is an infectious skin condition that results from the reactivation of…
-
Jiangsu Kanion Pharmaceutical Gets NMPA Go-Ahead for Psoriasis Drug Clinical Trial
•
Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557), a prominent pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to commence clinical studies for its investigational drug KYS202004A for the treatment of psoriasis. This Category 1 biologic is a novel, dual-targeted…
-
Viatris Launches First-of-Its-Kind Nasal Spray Dymista in China for Allergic Rhinitis
•
Viatris Inc. (NASDAQ: VTRS), a leading global pharmaceutical company based in the U.S., has announced the official launch of its nasal spray combination therapy, Dymista (azelastine, fluticasone), in China. This medication is now available to treat moderate to severe seasonal and perennial allergic rhinitis in adults and children aged 12…
-
Novo Nordisk Advances in China with Submission of Sogroya for Adult Growth Hormone Deficiency
•
Denmark’s pharmaceutical heavyweight, Novo Nordisk (NYSE: NVO), has reached a significant milestone with the National Medical Products Administration (NMPA) accepting its market filing for Sogroya (somapacitan), a long-acting somatotropin. This once-weekly treatment is designed to address adult growth hormone deficiency (AGHD) and has already received approval in the US in…
-
Kelun-Biotech’s ADC for Cancer Gets NMPA Review, Expands MSD Collaboration
•
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has achieved a regulatory milestone with its clinical trial application for SKB571, an innovative antibody-drug conjugate (ADC), being accepted for review by China’s National Medical Products Administration (NMPA). SKB571 is designed to target a spectrum of cancers, including those of the lung and…
-
Roche’s Columvi for Relapsed DLBCL Gets Review Nod from China’s CDE for New Indication
•
The Center for Drug Evaluation (CDE) in China has accepted for review an additional indication approval filing submitted by Swiss pharmaceutical giant Roche (SWX: ROG) for its drug Columvi (glofitamab). The filing suggests a potential use in combination with gemcitabine and oxaliplatin for the treatment of diffuse large B-cell lymphoma…
-
Jiangsu Hengrui’s Ivarmacitinib for Adult Alopecia Areata Accepted for Review by China’s CDE
•
The Center for Drug Evaluation (CDE) has given the green light for the review of a new indication submission for Jiangsu Hengrui Medicine Co., Ltd’s (SHA: 600276) ivarmacitinib, as per the latest update on the CDE’s website. The potential new indication is speculated to be adult alopecia areata, aligning with…
-
European Commission Approves Merck’s Keytruda-Padcev Combo for First-Line Urothelial Carcinoma Treatment
•
Merck & Co., Inc. (NYSE: MRK), a global healthcare leader based in the United States, has announced that the European Commission (EC) has granted approval for the use of Keytruda (pembrolizumab) in combination with Padcev (enfortumab vedotin) as a first-line treatment for adults with unresectable or metastatic urothelial carcinoma. This…
-
Manufacturing Challenges for Novo Nordisk’s Ozempic Impact Diabetes and Obesity Treatments in Europe
•
Novo Nordisk (NYSE: NVO), a leading Danish pharmaceutical company, has released a joint statement with the European Medicines Agency (EMA) addressing the ongoing supply challenges for its GLP-1 receptor agonist, Ozempic (semaglutide). The statement cites increased demand and manufacturing site capacity constraints as the primary factors contributing to the shortages,…
-
Skyline Therapeutics’ Gene Therapy Receives FDA Orphan Drug Designation for Retinitis Pigmentosa Treatment
•
Skyline Therapeutics, a biopharmaceutical company based in China, has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its proprietary adeno-associated virus (AAV) gene therapy, SKG1108, for the treatment of retinitis pigmentosa (RP). This innovative therapy utilizes a novel AAV vector, including a groundbreaking capsid…
-
Innovent Biologics’ IBI363 Earns FDA Fast-Track Designation for Advanced Melanoma Treatment
•
Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its innovative drug candidate, IBI363. This PD-1/IL-2α bispecific antibody fusion protein is under development for the treatment of unresectable locally advanced or metastatic melanoma, excluding…
-
Humanwell Healthcare’s Innovative Drug for Solid Tumors Gets Green Light from NMPA
•
Humanwell Healthcare (Group) Co., Ltd (SHA: 600079), a leading pharmaceutical entity in China, has received a significant boost with the clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug, HW071021. This novel drug, designed to combat advanced solid tumors, stands as a unique…
-
Jiangsu Hengrui and Chongqing Genrix Launch Anti-IL-17 Therapies for Psoriasis in China
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) and Chongqing Genrix Bio Pharmaceutical Co., Ltd, two leading Chinese pharmaceutical companies, have embarked on the commercialization journey of their innovative anti-IL-17 antibodies, vunakizumab and xeligekimab, respectively. These domestically developed treatments received marketing approval late last month, marking a significant milestone in addressing…
-
Sanofi’s Tolebrutinib Shows Mixed Results in Phase III Multiple Sclerosis Trials
•
PARIS—French pharmaceutical giant Sanofi (NASDAQ: SNY) has reported mixed outcomes from three Phase III trials for its Bruton’s tyrosine kinase (BTK) inhibitor, tolebrutinib, as a treatment for multiple sclerosis (MS). The drug candidate achieved success in the HERCULES study, where it met the primary endpoint of delaying the time to…
-
Bayer’s Finerenone Shows Promise in Heart Failure Treatment, Outperforms Placebo in Phase III Trial
•
FRANKFURT—Bayer AG (FRA: BAYN) has announced positive results from the Phase III FINEARTS-HF study for its mineralocorticoid receptor (MR) antagonist, finerenone. Originally approved for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes, finerenone is now being developed for heart failure, a condition with significant market potential.…
-
Henlius Biotech’s HLX17 Biosimilar to MSD’s Keytruda Wins NMPA Clinical Trial Approval
•
SHANGHAI—Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its HLX17, a biosimilar version of MSD’s (Merck & Co., known as MSD outside the US) blockbuster drug Keytruda (pembrolizumab). The biosimilar targets all indications that the…
-
Jiangsu Simcere’s Edaravone, Borneol Sublingual Tablet Earns FDA Breakthrough Therapy Designation for Stroke Treatment
•
HONG KONG—Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its edaravone, borneol sublingual tablet, intended for the treatment of acute ischemic stroke (AIS). The edaravone, borneol sublingual tablet is a solid oral…
-
GeneQuantum Healthcare’s GQ1005 ADC Receives CDE Clearance for Phase III Breast Cancer Trial
•
SUZHOU—GeneQuantum Healthcare (Suzhou) Co., Ltd has received clearance from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study for its antibody drug conjugate (ADC), GQ1005, targeting HER2 in patients with non-surgical/metastatic breast cancer. Preclinical studies have shown that…
-
Sinocelltech’s Anti-Angiogenic Biologic SCT520FF Gets NMPA Green Light for Neovascular AMD Clinical Study
•
SHANGHAI—Sinocelltech Group Ltd (SHA: 688520), a Chinese biopharmaceutical company, has announced that it has received clearance from the National Medical Products Administration (NMPA) to proceed with a clinical study for its in-house developed anti-angiogenic biologic drug, SCT520FF, for the treatment of neovascular age-related macular degeneration (nAMD). The drug SCT520FF is…
-
China’s Sinovent and UK’s GSK Eye Breakthrough Therapy Designations for Cancer Therapies
•
BEIJING/LONDON—The Center for Drug Evaluation (CDE) in China has indicated that Sinovent Inc.’s EZH2 inhibitor XNW5004 and GlaxoSmithKline’s (GSK) antibody drug conjugate (ADC) belantamab mafodotin are on track to receive breakthrough therapy designations (BTDs). Sinovent’s XNW5004 is targeting the recurrent or refractory peripheral T-cell lymphoma indication and has demonstrated potential…
-
Shandong Buchang Pharmaceuticals’ rhEPO-Fc for CKD Anemia Accepted for Review by China’s CDE
•
BEIJING—The Center for Drug Evaluation (CDE) in China has accepted the market filing for a long-acting erythropoietin (EPO) product, rhEPO-Fc, developed by Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), for review. The product is intended for the treatment of anemia associated with chronic kidney disease (CKD). Anemia is a common…
-
Biocon Biologics Resolves Patent Dispute with J&J, Secures Market Entry for Biosimilar Stelara
•
Biocon Biologics Ltd, the biosimilars division of Indian pharmaceutical company Biocon Ltd (BOM: 532523, NSE: BIOCON), has announced the signing of a comprehensive settlement and licensing agreement with Janssen Biotech Inc. and its parent company, Johnson & Johnson (J&J; NYSE: JNJ). This agreement resolves a patent dispute over Bmab 1200,…
-
Zuellig Pharma Partners with Regeneron for Libtayo Launch in South Korea and Taiwan
•
Singapore-headquartered Zuellig Pharma, a leading healthcare solutions provider, has entered into an agreement with US pharmaceutical giant Regeneron Pharmaceuticals Inc. to oversee the market launch and commercialization of Libtayo (cemiplimab), Regeneron’s proprietary programmed death-1 (PD-1) inhibitor, in South Korea and Taiwan. Financial details of the agreement were not disclosed. Libtayo…
-
HutchMed Halts China Filing for Gastric Cancer Drug Fruquintinib Following Regulatory Feedback
•
HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013), a China-based biopharmaceutical company, has announced the withdrawal of its New Drug Application (NDA) for fruquintinib, a VEGFR inhibitor, in combination with paclitaxel for the second-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJ) in China. The decision to withdraw was made…
-
Novo Nordisk to Resubmit Wegovy Heart Failure Application with Updated Clinical Data
•
Denmark’s pharmaceutical giant, Novo Nordisk (NYSE: NVO), has reported significant findings on the efficacy of its weight management drug semaglutide, marketed as Ozempic for diabetes and Wegovy for obesity, in managing heart failure conditions. The data, published in The Lancet, encompasses results from 3,743 participants across four pivotal clinical trials:…
-
AccurEdit Therapeutics’ Gene-Editing Drug ART001 Clears FDA Hurdle for US Clinical Trials
•
SUZHOU—AccurEdit Therapeutics (Suzhou) Co., Ltd, a leading Chinese specialist in gene editing therapies, has announced that it has received approval from the US Food and Drug Administration (FDA) for its investigational drug ART001, which targets transthyretin amyloidosis. This milestone marks ART001 as the first in vivo gene-edited drug based on…
-
Bio-Thera Solutions’ BAT2406 Biosimilar Gets Green Light for Clinical Trials in China
•
GUANGZHOU—Bio-Thera Solutions (SHA: 688177), a leading biopharmaceutical company based in Guangzhou, has received approval from the National Medical Products Administration (NMPA) to proceed with clinical studies for BAT2406, a biosimilar version of Sanofi’s Dupixent (dupilumab). This monoclonal antibody, which targets interleukin-4 (IL-4) and interleukin-13 (IL-13), is now set to be…
-
Hutchmed Withdraws Fruquintinib’s New Indication Application in China, Seeks Alternative Regulatory Path
•
HONG KONG—Hutchmed (HKG: 0013) has announced its decision to proactively withdraw the new indication application for Fruquintinib in combination with paclitaxel for the second-line treatment of advanced gastric cancer and gastroesophageal junction adenocarcinoma in China. The company will now evaluate a new registration pathway following discussions with the National Medical…
-
J&J Files NDA for FcRn Blocker Nipocalimab, Targets Myasthenia Gravis Market
•
US-based Johnson & Johnson (NYSE: JNJ) has made a global first New Drug Application (NDA) filing with the US FDA for its FcRn blocker nipocalimab. The drug’s initial indication is anticipated to be for the treatment of adults with generalized myasthenia gravis (gMG) who test positive for certain antibodies. This…
-
Merck Ends Phase III Keytruda Studies in NSCLC and cSCC Due to Insufficient Results
•
US-based Merck, Sharp & Dohme Inc. (NYSE: MRK) announced the discontinuation of two Phase III trials evaluating its programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab) in new indications, due to insufficient efficacy. The decisions to halt the trials were made following recommendations from their respective independent data monitoring committees. The trials…
-
Tonghua Golden-Horse, UCB Seek China Approvals for Alzheimer’s, Myasthenia Gravis Drugs
•
China’s Tonghua Golden-Horse Pharmaceutical Industry Co. Ltd. and Belgium-based UCB (FRA: UNC) are seeking marketing approvals in China for two advanced treatments targeting neurodegenerative and autoimmune conditions, according to the Center for Drug Evaluation (CDE) website. Tonghua Golden-Horse’s octohydroaminoacridine succinate, designed to treat mild to moderate Alzheimer’s disease (AD), and…
-
Doma Biopharmaceutical Receives FDA Clearance for Phase I Trial of EGFR-MET Targeting ADC, DM005
•
Doma Biopharmaceutical (Suzhou) Co., Ltd, a Chinese pharmaceutical firm, has received approval from the U.S. Food and Drug Administration (FDA) to initiate a Phase I clinical trial for its innovative bispecific antibody-drug conjugate (ADC), DM005. This development marks a significant milestone for the company as it advances its pipeline towards…
-
Jiyuan Biotechnology’s Stem Cell Therapy for Type 2 Diabetes Gains NMPA Tacit Approval for Clinical Trials
•
BEIJING—Jiyuan Biotechnology, a leading Chinese biopharmaceutical company, has secured tacit clinical trial approval from the National Medical Products Administration (NMPA) for its cutting-edge therapy targeting type 2 diabetes. This marks the first clinical trial approval in China for domestically developed gene-modified mesenchymal stem cells. The therapy in question involves the…
-
CNGB Virogin’s VG161 On Track for Breakthrough Designation in China for Advanced Liver Cancer
•
BEIJING—CNGB Virogin, a joint venture between Virogin Biotech and China National Biotec Group, is poised to secure a breakthrough therapy designation (BTD) from China’s National Medical Products Administration (NMPA) for its innovative drug VG161. The targeted indication for this recombinant human IL12/15-PDL1B herpes simplex type I oncolytic virus injection is…
-
Sinopharm and Ruidio Pharmaceutical Advance in Priority Review for Innovative Drugs and Vaccines
•
BEIJING—The Center for Drug Evaluation (CDE) has indicated that two Chinese companies, Foshan Ruidio Pharmaceutical Co., Ltd and Chengdu Institute of Biological Products Co., Ltd., part of Sinopharm, are on the path to priority review for their respective medical innovations. Ruidio’s Technetium [99mTc] hydrazine nicotinamide polyethylene glycol bicyclic RGD peptide…
-
Jiangsu Simcere and AnDiConBio’s Anti-Influenza Drug ADC189 Doses First Patient in Phase III Study
•
JIANGSU—In a significant development for the pharmaceutical industry, Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), in collaboration with AnDiConBio, has initiated a Phase III clinical study for their anti-influenza drug, ADC189. This study marks a crucial step in the advancement of pediatric treatment options, with the first patient dosed in…
-
Sino Biopharmaceutical’s Anlotinib-Penpulimab Combo Meets Milestone in Phase III HCC Study
•
HONG KONG—Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced the successful completion of a pre-set interim analysis in its Phase III clinical study. The study combines anlotinib with penpulimab as a first-line treatment for advanced hepatocellular carcinoma (HCC), achieving the optimal efficacy thresholds for…
-
Jiangxi Jemincare Secures First Generic Approval for GSK’s Requip in China
•
Jiangxi Jemincare Group, based in China, has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of GSK’s Requip (ropinirole), marking the first generic approval for this medication in China. The drug is indicated for the treatment of Parkinson’s disease (PD) and PD with non-motor…
-
Sanofi Halts Flu Vaccine Distribution in China Amid Potency Concerns
•
Sanofi (NASDAQ: SNY), the French pharmaceutical giant, has reportedly suspended the distribution and sale of its flu vaccines in China following concerns over declining potency identified during routine batch checks. According to FiercePharma.com, which cites an email from a Sanofi spokesperson, the suspension will affect supplies of both Vaxigrip and…
-
JW Therapeutics’ CAR-T Therapy Carteyva Secures NMPA Approval for Mantle Cell Lymphoma Indication
•
JW Therapeutics, a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 2126), has received additional indication approval from the National Medical Products Administration (NMPA) for its chimeric antigen receptor (CAR) T cell therapy, Carteyva (relmacabtagene autoleucel injection). This approval extends to adult patients with…
-
Shanghai-Based ANEXT Commences Clinical Trials for Exosome Product ANEXT FIT CELL in Respiratory Conditions
•
ANEXT, a Shanghai-based exosome specialist, has launched two clinical studies for their product ANEXT FIT CELL, which is derived from mesenchymal stem cells exosomes. One study aims to evaluate the product’s efficacy in treating cough symptoms following infection, while the other is focused on safety and preliminary efficacy in the…
-
Legend Biotech’s Carvykti Receives NMPA Approval for Relapsed/Refractory Multiple Myeloma After Multi-Center Phase II Study
•
Legend Biotech Corporation (NASDAQ: LEGN) has secured a significant milestone with the announcement of marketing approval from China’s National Medical Products Administration (NMPA) for its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel). This therapy is intended for patients with relapsed/refractory multiple myeloma (MM) who have undergone…
-
Jiangsu Hengrui’s Vunakizumab Receives NMPA Approval as First Homegrown Autoimmune IL-17A Drug
•
Jiangsu Hengrui Medicine Co., Ltd, a Chinese pharmaceutical company listed on the Shanghai Stock Exchange (SHA: 600276), has announced that the National Medical Products Administration (NMPA) has approved its market filing for vunakizumab, an IL-17A monoclonal antibody (mAb), for the treatment of moderate to severe plaque psoriasis suitable for systemic…
-
Hinova Pharmaceuticals’ HP515 Receives NMPA Approval for NASH Clinical Study
•
Hinova Pharmaceuticals Inc., a biotech firm headquartered in Chengdu and listed on the Shanghai Stock Exchange (SHA: 688302), has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 chemical drug candidate, HP515. The molecule is intended for the treatment of nonalcoholic…
-
Bio-Thera Solutions’ BAT8006 Receives NMPA Approval for Clinical Trial in Recurrent Ovarian Cancer Maintenance Therapy
•
Bio-Thera Solutions, a biopharmaceutical company based in Guangzhou and listed on the Shanghai Stock Exchange (SHA: 688177), has received approval from the National Medical Products Administration (NMPA) to advance its antibody drug conjugate (ADC) BAT8006 into clinical trials in combination with bevacizumab. This trial will focus on maintenance therapy for…
-
Chongqing Genrix Bio Pharmaceutical Receives NMPA Approval for Xeligekimab, First Domestic Anti-IL-17 Antibody
•
Chongqing Genrix Bio Pharmaceutical Co., Ltd, a Chinese biopharmaceutical company, has received marketing approval from China’s National Medical Products Administration (NMPA) for its self-developed Category 1 biologic product, xeligekimab. This marks the first domestically developed anti-IL-17 antibody in China approved for the treatment of moderate-to-severe plaque psoriasis. The introduction of…
-
Regeneron Secures EU Approval for Ordspono, Its First Bispecific Antibody
•
Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) has secured its first global market approval for Ordspono (odronextamab) from the European Commission (EC). This marks a significant milestone as Ordspono becomes the company’s first bispecific antibody (BsAb) to receive approval, designated for the treatment of adult patients with relapsed or refractory (R/R) follicular…
-
Shanghai Fudan-Zhangjiang Enrolls First Patient in Phase III Trial for TROP2 ADC FDA018 in TNBC
•
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd, a China-based pharmaceutical company listed on the Hong Kong Stock Exchange (HKG: 1349) and the Shanghai Stock Exchange (SHA: 688505), has announced the enrollment of the first patient in a Phase III clinical study for its drug candidate FDA018. This TROP2 antibody-drug conjugate (ADC) is…
-
China’s Guilin Sanjin Pharmaceutical Advances BC011 with NMPA Approval for Phase I Clinical Trial
•
Guilin Sanjin Pharmaceutical Co. Ltd, a Chinese pharmaceutical company listed on the Shenzhen Stock Exchange (SHE: 002275), has announced that its subsidiary, Dragon Boat Pharmaceutical (Shanghai) Co., Ltd, has obtained approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its drug candidate BC011,…
-
Changchun High & New Technology Industries Receives FDA Approval for GenSci098 Clinical Trial in Thyroid Eye Disease
•
Changchun High & New Technology Industries (Group) Inc., a Chinese corporation listed on the Shenzhen Stock Exchange (SHE: 000661), has received tacit approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its Category 1 biologic product, GenSci098. This humanized anti-TSHR antagonistic monoclonal antibody (mAb)…
-
Diversifying HPV Protection: Beijing Wantai’s Vaccine Filing Competes with Gardasil 9 in China
•
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd, a Chinese pharmaceutical company listed on the Shanghai Stock Exchange (SHA: 603392), has announced that the National Medical Products Administration (NMPA) has accepted for review the market approval filing for its innovative recombinant human papillomavirus (HPV) vaccine. This nine-valent vaccine, which targets HPV…
-
BeiGene Advances R/R CLL/SLL Treatment with FDA Fast-Tracked BGB-16673 in Phase I/II Clinical Trial
•
BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading biopharmaceutical company, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its novel compound BGB-16673. This investigational Bruton’s tyrosine kinase (BTK) targeting chimeric degradation activation compound (CDAC), known as a proteolysis-targeting chimera (PROTAC) product, represents…
-
China’s CDE Approves Multitude Therapeutics’ AMT-676 for Clinical Study in Solid Tumors
•
The Center for Drug Evaluation (CDE) of China has granted clinical study approval for Multitude Therapeutics Inc.’s proprietary injectable drug candidate, AMT-676, as indicated on the CDE website. The drug is intended for the treatment of solid tumors. AMT-676 is an antibody-drug conjugate (ADC) that targets CDH17, a gene situated…
-
Mabwell Bioscience Initiates Phase III Trial for 9MW2821 Combo in Urothelial Carcinoma Following NMPA Clearance
•
Mabwell (Shanghai) Bioscience Co., Ltd, a biopharmaceutical company listed in China (SHA: 688062), has announced the commencement of patient enrollment for a pivotal Phase III clinical trial. The study will evaluate the efficacy and safety of 9MW2821 in combination with toripalimab for the first-line treatment of patients with locally advanced…
-
US FDA Approves Updated COVID-19 mRNA Vaccines from Pfizer/BioNTech and Moderna Ahead of Winter
•
The U.S. Food and Drug Administration (FDA) has granted approval to two updated mRNA COVID-19 vaccines in anticipation of the winter season. Pfizer/BioNTech and Moderna have both received authorization for their vaccines, which are designed to address the KP.2 variant of the virus, a subset of the omicron strain. The…
-
Shouyao Holdings Receives Clinical Trial Approval for SY-7166 in Treating Multiple Myeloma
•
Shouyao Holdings (Beijing) Co., Ltd, a biopharmaceutical company headquartered in Beijing and listed on the Shanghai Stock Exchange (SHA: 688197), has announced that it has obtained clinical trial approval for its drug candidate SY-7166 for the treatment of multiple myeloma (MM) as a monotherapy. SY-7166 is a highly potent and…
-
Takeda Prepares to File Dengue Fever Vaccine for US Approval, Expanding Global Regulatory Reach
•
Takeda Pharmaceutical, a leading Japanese pharmaceutical company listed on the NYSE (NYSE: TAK), is reportedly preparing to submit its dengue fever vaccine for regulatory approval in the United States, according to the Nikkei Asian Review. At this juncture, specifics regarding the timing of the filing or the anticipated decision date…
-
Henlius Biotech’s Biosimilar Herceptin Approved by Health Canada for Breast and Gastric Cancer Treatments
•
Shanghai Henlius Biotech Inc., a leading biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 2696), has announced that its UK partner, Accord Healthcare Inc., has received marketing approval from Health Canada. This approval permits the use of Hanquyou (trastuzumab; HLX02), a biosimilar to Roche’s…
-
Jiangsu Simcere Pharmaceutical Gets NMPA Green Light for SIM0508 Clinical Trial in Advanced Solid Tumors
•
Jiangsu Simcere Pharmaceutical Co., Ltd, a Chinese pharmaceutical company listed in Hong Kong (HKG: 2096), has announced that it has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for its pipeline candidate SIM0508. This molecule is a DNA polymerase theta (Pol theta) small molecule inhibitor, which is…
-
Mabwell Bioscience Receives Approval for Phase III Trial of 9MW2821 in Cervical Cancer from China’s CDE
•
Mabwell (Shanghai) Bioscience Co., Ltd, a biopharmaceutical company listed in China (SHA: 688062), has received approval from the Center for Drug Evaluation (CDE) in China to proceed with a Phase III clinical trial for its pipeline candidate, 9MW2821. The study is designed as a randomized, open, controlled, multi-center trial, comparing…
-
Gene Cradle Initiates First Regulatory Gene Therapy Study in China for Late-Onset Pompe Disease
•
Gene Cradle, a Beijing-based gene therapy specialist, has achieved a milestone by administering its GC301 to the first patient with late-onset Pompe disease (LOPD) in a regulatory study in China. This marks the nation’s first patient dosing of an adeno-associated virus (AAV) gene therapy for LOPD. GC301 is an innovative…
-
Phase I Success for Shandong Xinhua’s OAB-14, Advancing to Phase IIa in Alzheimer’s Therapy
•
Shandong Xinhua Pharmaceutical Co., Ltd, a Chinese pharmaceutical company listed in Shenzhen (SHE: 000756), has declared the successful completion of a Phase I clinical trial for its OAB-14 drug candidate in a dry suspension formulation. Following the positive outcome, the company is now gearing up to initiate a Phase IIa…
-
Hunan Warrant Pharmaceutical’s ZG-002 Receives NMPA Approval for Clinical Trials in Plaque Psoriasis
•
Hunan Warrant Pharmaceutical Co., Ltd, a pharmaceutical company based in China and listed on the Shanghai Stock Exchange’s Science and Technology Innovation Board (SHA: 688799), has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug candidate, ZG-002. This new molecule is intended for…
-
UK MHRA Approves Eisai and Biogen’s Alzheimer’s Drug Leqembi, Despite NICE Reimbursement Rejection
•
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for Leqembi (lecanemab), a co-developed Alzheimer’s disease drug by Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB). This development, however, was met with a refusal from the National Institute for Health and Clinical Excellence (NICE), the…
-
Everest Medicines Launches Trial for Personalized mRNA Cancer Vaccine EVM16 in Solid Tumors
•
Everest Medicines, a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 1952), has announced the commencement of an investigator-initiated trial (ITT) for its cutting-edge personalized mRNA cancer vaccine, EVM16. The trial, spearheaded by Beijing Cancer Hospital and Fudan University Shanghai Cancer Center, is a…
-
Regeneron’s Linvoseltamab Faces FDA Complete Response Letter, Awaiting Reinspection of Manufacturer
•
Regeneron Pharmaceuticals Inc., a leading biopharmaceutical company based in the US and listed on the Nasdaq (NASDAQ: REGN), has encountered a setback in its pursuit of market approval for the bispecific antibody (BsAb) linvoseltamab. The US FDA has issued a Complete Response Letter (CRL) regarding the company’s filing for this…
-
CK Life Sciences’ Halneuron Receives FDA Fast-Track Designation for Chemotherapy-Induced Neuropathic Pain
•
CK Life Sciences (HKG: 0775), a biopharmaceutical company headquartered in China, has received fast-track designation from the US Food and Drug Administration (FDA) for its drug candidate Halneuron, which contains tetrodotoxin, for the treatment of chemotherapy-induced neuropathic pain (CINP). Halneuron is an innovative injectable form of tetrodotoxin, a naturally occurring…
-
Innovent Biologics’ Fulzerasib Receives NMPA Approval for Advanced NSCLC Treatment in China
•
Innovent Biologics Inc., a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 1801), has announced that it has obtained marketing approval from China’s National Medical Products Administration (NMPA) for its drug fulzerasib. This approval grants the company the green light to market fulzerasib, under…
-
Qilu Pharmaceutical’s Biosimilar Ranibizumab Receives NMPA Approval, Marking a First in China
•
Qilu Pharmaceutical, a Chinese pharmaceutical company, has announced that its biosimilar version of Novartis’s blockbuster drug Lucentis (ranibizumab) has received market approval from the National Medical Products Administration (NMPA). This regulatory nod positions the product as the first biosimilar of its kind to be approved in China. Ranibizumab, a vascular…
-
BrightGene Bio Receives FDA Clearance for Generic Eribulin APIs, Advancing in Breast Cancer Treatment
•
BrightGene Bio-Medical Technology Co., Ltd, a Chinese pharmaceutical company listed on the Shanghai Stock Exchange (SHA: 688166), has announced the receipt of a First Adequate Letter from the US FDA for the active pharmaceutical ingredients (APIs) of its generic version of Eisai’s Halaven (eribulin), signifying that the drug has successfully…
-
Daiichi Sankyo Launches Tarlige for Diabetes Peripheral Neuropathic Pain in China
•
Daiichi Sankyo (TYO: 4568), a leading Japanese pharmaceutical company, has announced the official market launch of its medication Tarlige (mirogabalin) in China, targeting the treatment of diabetes peripheral neuropathic pain (DPNP). This third-generation calcium channel regulator received marketing approval in China in July of this year and holds the potential…
-
Akeso Biopharma’s Ivonescimab Earns Category 1 Recommendation in China’s 2024 Lung Cancer Clinical Guideline
•
Akeso Biopharma, a China-based pharmaceutical company listed on the Hong Kong Stock Exchange (HKG: 9926), has achieved a significant milestone with its bispecific antibody ivonescimab (AK112). This innovative drug, which targets both programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), has been included in the “Clinical Practice Guideline for…
-
Hangzhou Biosunpharma’s OB756 New Drug Application Accepted for Myelofibrosis Treatment by China’s NMPA
•
Hangzhou Biosunpharma Co., Ltd. has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its investigational compound OB756. The company is seeking regulatory approval for the treatment of patients with medium to high-risk myelofibrosis (MF). OB756 is a novel JAK2 inhibitor…
-
Jiangsu Hansoh and GSK Receive FDA Breakthrough Designation for B7-H3 Targeted ADC in Small-Cell Lung Cancer
•
Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692), a prominent Chinese pharmaceutical company, and its UK counterpart GSK plc (NYSE: GSK) have jointly announced that they have received the prestigious Breakthrough Therapy Designation (BTD) from the US FDA for their candidate HS-20093, also known as GSK5764227. This B7-H3-targeted antibody-drug conjugate (ADC)…
-
J&J’s Rybrevant-Lazclude Combo Approved by FDA, Challenging AstraZeneca’s Tagrisso in NSCLC Treatment
•
Johnson & Johnson (J&J; NYSE: JNJ) has secured a new market approval in the United States for the combined use of its bispecific antibody Rybrevant (amivantamab) and the tyrosine kinase inhibitor (TKI) Lazclude (lazertinib). Following a priority review, the US FDA approved this dual therapy for the first-line treatment of…
-
AstraZeneca’s Strensiq Approved for Rare Disease Therapy under Greater Bay Area’s Drug Access Policy
•
AstraZeneca (NASDAQ: AZN, LON: AZN) , a leading UK pharmaceutical company, has received approval for its rare disease therapy Strensiq (asfotase alfa) from the Guangdong Medical Products Administration (MPA) bureau. This clearance allows Strensiq to be introduced to medical institutions under the “Hong Kong-Macau Drug and Device Access” policy, a…
-
Jiangsu Hansoh Pharmaceutical and GSK Win FDA Breakthrough Therapy Designation for B7-H3 Targeted ADC in Small-Cell Lung Cancer
•
LONDON/HONG KONG—Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692), in collaboration with UK-based GSK plc (NYSE: GSK), has been awarded the Breakthrough Therapy Designation (BTD) by the US FDA for their jointly developed antibody-drug conjugate (ADC) HS-20093, also known as GSK5764227. The therapy is intended for the treatment of patients with…
-
Johnson & Johnson’s Rybrevant-Lazclude Combo Approved by FDA for First-Line NSCLC Treatment
•
NEW YORK—Healthcare conglomerate Johnson & Johnson (J&J; NYSE: JNJ) has secured a significant regulatory milestone with the US FDA’s approval of its bispecific antibody Rybrevant (amivantamab) in combination with the tyrosine kinase inhibitor (TKI) Lazclude (lazertinib). The priority review has led to a green light for the combined use of…
-
AstraZeneca’s Strensiq Gains Approval for Rare Disease Therapy in Guangdong Under “Hong Kong-Macau Drug and Device Access”
•
LONDON—AstraZeneca (NASDAQ: AZN, LON: AZN) , a leading UK-based pharmaceutical company, has announced that its rare disease therapy Strensiq (asfotase alfa) has been granted market access by the Guangdong Medical Products Administration (MPA) bureau. This approval is a significant step under the “Hong Kong-Macau Drug and Device Access” policy, which…
-
Hasten Biopharmaceutical Gains NMPA Nod for Somatostatin Marketing Rights in China
•
BEIJING—Hasten Biopharmaceutical Co., Ltd, a biopharmaceutical company supported by the CBC Group, has received approval from the National Medical Products Administration (NMPA) to transfer the Marketing Authorization Holder (MAH) for its product Stilamin (somatostatin) in mainland China. The natural peptide hormone, somatostatin, is utilized in the treatment of acute bleeding…
-
Yipinhong Pharmacy’s AR882 Earns FDA Fast-Track Status for Gout Treatment
•
BEIJING—China-based Yipinhong Pharmacy Co., Ltd (SHE: 300723) has announced that its novel drug AR882 has received fast-track designation from the US Food and Drug Administration (FDA) for the treatment of visible tophi in patients with gout. This Category 1 drug, co-developed with US firm Arthrosi Therapeutics Inc., is a next-generation…
-
Astellas Pharma’s Padcev Receives NMPA Approval for Urothelial Cancer Treatment
•
TOKYO—Astellas Pharma Inc. (TYO: 4503) has announced that its anti-HER3 antibody-drug conjugate (ADC), Padcev (enfortumab vedotin), in partnership with Pfizer, has been granted approval by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) who have received prior platinum-containing…
-
BioNTech’s BNT326/YL202 Clears FDA Hurdle, Advancing in Clinical Trials for Solid Tumor Treatment
•
FRANKFURT—BioNTech SE (NASDAQ: BNTX), a leading German biotechnology company, has announced that the US Food and Drug Administration (FDA) has lifted the partial clinical hold on its Phase I clinical trial for BNT326/YL202, an anti-HER3 targeted antibody drug conjugate (ADC). This development paves the way for the resumption of trials…
-
Changchun High & New Technology Secures NMPA Approval for Turner Syndrome Treatment
•
CHANGCHUN—Changchun High & New Technology Industries (Group) Inc., (SHE: 000661), a leading biopharmaceutical company in China, has announced that it has received additional indication approval from the National Medical Products Administration (NMPA) for its polyethylene glycol recombinant human somatropin. This long-acting somatropin is now approved for use in growth disorders…
-
AstraZeneca’s Fasenra Secures NMPA Approval for Severe Eosinophilic Asthma Maintenance Therapy
•
BEIJING—The National Medical Products Administration (NMPA) of China has granted market approval for AstraZeneca (NASDAQ: AZN, LON: AZN) ‘s Fasenra (benralizumab) as a maintenance therapy for severe eosinophilic asthma (SEA) in adults and adolescents aged 12 and above. This decision follows the positive outcomes of the MIRACLE Phase III clinical…
-
Genmab’s Tepkinly/Epkinly Receives EC Nod for Relapsed Lymphoma Treatments
•
COPENHAGEN—Genmab A/S (NASDAQ: GMAB), a leading biotech company, has announced that the European Commission (EC) has granted market approval for its Tepkinly/Epkinly (epcoritamab), a CD3/CD20 bispecific T cell engager. The drug is indicated for third-line or later treatment of relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large…
-
Beijing Proposes New Regulations to Enhance Pharmaceutical Retail Standards and Services
•
The Beijing Municipal Medical Products Administration has unveiled a draft proposal titled “Guiding Opinions on Further Strengthening the Standardized Management of Pharmaceutical Retail Enterprises and Improving the Quality of Pharmaceutical Services,” inviting public feedback until September 12, 2024. The proposal outlines several key initiatives aimed at enhancing the management and…
-
AstraZeneca’s Imfinzi Gains FDA Approval for Neoadjuvant Use in Early-Stage Lung Cancer
•
AstraZeneca (NASDAQ: AZN, LON: AZN) , the UK-based pharmaceutical powerhouse, has secured US FDA approval for a new indication of its PD-L1 inhibitor, Imfinzi (durvalumab). The FDA has authorized the use of Imfinzi in combination with chemotherapy for adults with resectable early-stage non-small cell lung cancer (NSCLC) classified as IIA-IIIB,…
-
Sichuan Biokin Launches Phase III Trial for Bispecific ADC BL-B01D1 in Lung Cancer
•
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) has commenced the first patient dosing in a Phase III clinical trial for its proprietary bispecific antibody drug conjugate (ADC), BL-B01D1. This innovative therapy is being evaluated for the treatment of recurrent small-cell lung cancer (SCLC) in patients who have previously not responded…
-
Yixintang Partners with Huawei Cloud to Drive Digital Transformation in Pharma Retail
•
Yixintang Pharmaceutical Group Co., Ltd. (SHE: 002727), a prominent pharmaceutical retail chain in China, has entered into a strategic partnership with telecom giant Huawei Cloud. The collaboration aims to enhance information infrastructure, develop data-enabled platforms, and innovate within the burgeoning health industry, all while driving the digital and intelligent transformation…
-
CARsgen Completes Patient Enrollment for Phase II Trial of CT041 in Advanced Gastric Cancer
•
CARsgen Therapeutics Holdings Ltd (HKG: 2171), a leading China-based developer of chimeric antigen receptor (CAR)-T cell therapies, has announced the completion of patient enrollment in a confirmatory Phase II clinical trial for its investigational CAR-T therapy, CT041. The study aims to evaluate CT041 as a potential treatment for advanced gastric…
-
Kelun Pharmaceutical’s Sacituzumab Tirumotecan Receives Priority Review for NSCLC Treatment
•
Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422) has announced that its drug sacituzumab tirumotecan (SKB264/MK-2870) has been granted priority review status by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This designation is for the drug’s application as a treatment for locally advanced or metastatic…
-
Lykos Therapeutics Faces Setback as FDA Rejects Midomafetamine for PTSD Treatment
•
Lykos Therapeutics, a U.S.-based biotech firm, has expressed concern over the impact of the FDA’s August 9 decision to reject its New Drug Application (NDA) for midomafetamine (MDMA) as a treatment for post-traumatic stress disorder (PTSD) in adults. This ruling is seen as a pivotal moment for the emerging psychedelics…
-
Chugai Seeks Approval for Elevidys Gene Therapy in Japan, Targeting Duchenne Muscular Dystrophy
•
Chugai Pharmaceutical Co., Ltd. (TYO: 4519), a subsidiary of Roche, has submitted a product approval application in Japan for delandistrogene moxeparvovec, marketed globally as Elevidys, a gene therapy aimed at treating Duchenne muscular dystrophy (DMD). The therapy is specifically indicated for ambulatory boys aged 3 to 7 years with DMD…
-
Staidson Launches Phase Ia Trial for STSP-0902 Injection in Oligoasthenozoospermia
•
Staidson (Beijing) Pharmaceutical Co., Ltd. (SHE: 300204) has announced that it has received approval from China’s National Medical Products Administration (NMPA) to initiate a Phase Ia clinical trial for its STSP-0902 injection, targeting oligoasthenozoospermia. The randomized, double-blinded, placebo-controlled study aims to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of STSP-0902…
-
Jiangsu Hengrui Secures NMPA Approval for Clinical Trials of SHR-2106 in Primary Sjögren’s Syndrome
•
Jiangsu Hengrui Medicine Co., Ltd. (SHA: 600276) has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its investigational drug SHR-2106, targeting active primary Sjögren’s syndrome (pSS). Primary Sjögren’s syndrome is a chronic autoimmune disorder predominantly affecting middle-aged and elderly women, characterized by…
-
Vimgreen Pharma Launches Phase II Trial for A2AR Antagonist VG081821AC in Parkinson’s Disease
•
Zhejiang-based Vimgreen Pharma has announced the launch of a Phase II clinical trial for its innovative A2AR antagonist VG081821AC, targeting early to mid-stage Parkinson’s disease (PD). The company has successfully completed patient dosing for the study. This 12-week, multi-center, randomized, double-blinded trial aims to evaluate the safety and efficacy of…
-
Gilead Secures FDA Accelerated Approval for Livdelzi in Liver Disease Treatment
•
Gilead Sciences Inc. (NASDAQ: GILD) has received accelerated approval from the U.S. FDA for its liver disease treatment, Livdelzi (seladelpar), following its acquisition of CymaBay Therapeutics Inc. for $4.3 billion earlier this year. The FDA has authorized Livdelzi for use in combination with ursodeoxycholic acid (UDCA) to treat primary biliary…
-
Astellas Pharma Secures UK Approval for First-in-Class Gastric Cancer Therapy Vyloy
•
Astellas Pharma (TYO: 4503), a leading Japanese pharmaceutical company, has secured market approval in the UK for its first-in-class gastric cancer therapy, Vyloy (zolbetuximab), targeting Claudin18.2 (CLDN18.2). According to a press release from the Medicines and Healthcare products Regulatory Agency (MHRA), the approval allows Vyloy to be used as a…
-
Shandong Buchang Pharmaceuticals Partners with Lancet for BC001 Licensing in Eurasia
•
Shandong Buchang Pharmaceuticals Co., Ltd. (SHA: 603858), based in China, has announced plans to enter a licensing agreement with Russia’s Lancet Pharmaceuticals, granting the latter regulatory filing, commercialization, and other rights for Buchang’s pipeline candidate BC001 across the Eurasian Economic Union, which includes Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan, and Uzbekistan.…
-
Biogen and Eisai Secure UAE Approval for Alzheimer’s Therapy Leqembi
•
Biogen Inc. (NASDAQ: BIIB), based in the U.S., and Japan’s Eisai Co., Ltd. have announced that their Alzheimer’s disease therapy, Leqembi (lecanemab), has received approval in the United Arab Emirates (UAE) for the treatment of patients with mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and/or mild AD dementia.…
-
CStone to Manufacture Gavreto Locally Following NMPA Approval, Expanding Market Presence
•
CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to locally manufacture its Gavreto (pralsetinib tablets, 100mg), transitioning from overseas supply. Domestic production is anticipated to begin by late this year or early next year, following the approval of the 300mg…
-
Qilu Pharmaceutical Gains Approval for Generic Dasatinib, Expanding CML Treatment Options in China
•
Qilu Pharmaceutical, based in China, has received marketing approval for its generic version of Bristol-Myers Squibb’s (BMS) Sprycel (dasatinib) in China. This second-generation BCR-ABL tyrosine kinase inhibitor (TKI) is now available for the treatment of patients with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) who are resistant to or intolerant…
-
Ascentage Pharma Secures NMPA Approval for Phase III Trial of Lisaftoclax in MDS
•
Ascentage Pharma (HKG: 6855), based in China, has received approval from the National Medical Products Administration (NMPA) to initiate a multi-center, randomized, double-blind Phase III study evaluating the efficacy of its novel drug, lisaftoclax (APG-2575), in combination with azacitidine (AZA) for the first-line treatment of newly diagnosed patients with higher-risk…
-
Enhertu Gains Conditional Approval in China for Advanced HER2-Positive Gastric Cancer
•
Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody-drug conjugate co-developed by AstraZeneca (NASDAQ: AZN, LON: AZN) and Daiichi Sankyo (TYO: 4568), has received conditional approval in China for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ) who have undergone two or more…
-
Novartis Intensifies Legal Action Against FDA Over Entresto Generic Approval
•
Novartis Inc. (NYSE: NVS) is intensifying its efforts to thwart the entry of generic competitors for its heart failure and hypertension medication, Entresto (valsartan + sacubitril), following the U.S. FDA’s approval of a generic version from India-based MSN Laboratories on July 24. A federal court judge in Delaware recently denied…
-
Wantai Biological’s HPV Vaccine Receives Priority Review from China’s CDE
•
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392) has announced that its nine-valent recombinant human papillomavirus (HPV) vaccine, co-developed with Xiamen University, has received priority review status from China’s Center for Drug Evaluation (CDE). This vaccine targets seven high-risk HPV types (HPV16, 18, 31, 33, 45, 52, and 58)…
-
Hengrui Medicine Launches Phase II Trial for SHR7280 to Treat Uterine Fibroids
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical trial for its investigational drug SHR7280, aimed at treating heavy menstrual bleeding associated with uterine fibroids. SHR7280 is an oral small molecule…
-
GSK Initiates Phase III Study for RSV Vaccine in China Following U.S. Approval
•
GSK (NYSE: GSK), the UK-based pharmaceutical giant, has registered a Phase III bridging study for its recombinant RSV vaccine in China on ClinicalTrials.gov. The vaccine, which received marketing approval in the U.S. in May 2023, will undergo a study that aims to complete its primary endpoint follow-up by March 2025.…
-
Sihuan Pharmaceutical Secures NMPA Approval for First Biosimilars of Novo Nordisk’s Diabetes Drugs
•
Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has secured separate marketing approvals from China’s National Medical Products Administration (NMPA) for its biosimilars of Novo Nordisk (NYSE: NVO)’s Tresiba (insulin degludec) and Ryzodeg (insulin degludec and insulin aspart), both of which are indicated for the treatment of type 2 diabetes. These…
-
Pfizer’s Hemophilia Treatment Marstacimab Accepted for Review in China
•
The China Center for Drug Evaluation (CDE) has accepted for review a market approval filing for Pfizer Inc.’s (NYSE: PFE) Category 1 biologic drug marstacimab (PF-06741086), according to the agency’s website. This regulatory milestone in China follows similar submissions to the U.S. Food and Drug Administration (FDA) and the European…
-
Junshi Biosciences Submits Twelfth Indication for PD-1 Inhibitor Loqtorzi in China
•
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced a new indication filing with Chinese regulators for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The company is pursuing marketing approval for Loqtorzi as a first-line therapy for patients with unresectable or metastatic melanoma, marking the twelfth indication filing…
-
Nanjing Sanhome’s Oritinib Ships Widely for EGFR-mutated NSCLC Treatment in China
•
Nanjing Sanhome Pharmaceutical Co., Ltd, a notable player in the pharmaceutical sector, has announced the widespread distribution of its Category 1 chemical drug, oritinib, across key regions in China, including Jiangsu, Shanghai, Beijing, Henan, and Inner Mongolia. The drug has been made available to lung cancer specialists who are now…
-
Boehringer Ingelheim’s Zongertinib Earns Breakthrough Designation in China for HER2-Mutated NSCLC
•
Boehringer Ingelheim, a leading German pharmaceutical company, has received a significant endorsement from China’s Center for Drug Evaluation (CDE) with the breakthrough therapy designation (BTD) for its investigational HER2-targeted tyrosine kinase inhibitor (TKI), zongertinib (BI 1810631). This designation underscores the potential of zongertinib in treating adult patients with HER2-mutated advanced,…
-
IASO Biotechnology’s CAR-T Therapy Fucaso Gets FDA Green Light for Lupus Treatment
•
IASO Biotechnology, a Chinese biotech firm, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to commence trials of its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Fucaso (equecabtagene autoleucel), for the treatment of non-renal systemic lupus erythematosus (SLE) and systemic lupus nephritis…
-
Ascendis Pharma’s Hypoparathyroidism Therapy Yorvipath Wins FDA Nod, Fills Market Gap
•
This week, the U.S. Food and Drug Administration (FDA) granted market approval to Ascendis Pharma A/S (NASDAQ: ASND), a Denmark-based pharmaceutical company specializing in rare diseases, for its hypoparathyroidism treatment, palopegteriparatide. The therapy, to be marketed as Yorvipath, is a once-daily prodrug of parathyroid hormone (PTH[1-34]) designed to address the…
-
Pfizer’s RSV Vaccine Abrysvo Shows Strong Protection in Immunocompromised Adults, Phase III Sub-Study Reveals
•
Pfizer Inc. (NYSE: PFE), a pharmaceutical titan based in the US, has announced encouraging topline results from a sub-study within its ongoing Phase III clinical trial (NCT05842967) for Abrysvo, a vaccine designed to combat respiratory syncytial virus (RSV). The data indicate that Abrysvo offers robust protection against RSV infections in…
-
Chinese NMPA Approves Hengrui Med’s Generic Abraxane for Metastatic Pancreatic Cancer Treatment
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received additional indication approval from the National Medical Products Administration (NMPA) for its generic version of Abraxis BioScience’s Abraxane (paclitaxel, albumin-bound). The drug is now approved for use in combination with gemcitabine…
-
CSPC Pharmaceutical’s SYS6020 Receives NMPA Approval for Clinical Trials in Systemic Lupus Erythematosus
•
CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative therapy, SYS6020. This therapy is a BCMA-targeted chimeric antigen receptor (CAR)-T cell treatment designed for systemic lupus erythematosus (SLE),…
-
Mabwell’s Nectin-4 Targeting ADC 9MW2821 on Path to Breakthrough Designation in China for Urothelial Carcinoma
•
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that its antibody drug conjugate (ADC), 9MW2821, which targets Nectin-4, is on track to receive breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the…
-
3SBio Subsidiary Achieves Milestone in Phase III Psoriasis Trial with SSGJ-608
•
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (HKG: 1530), has announced that its Phase III clinical study for the drug candidate SSGJ-608 has successfully met all primary endpoints (PASI 75 and sPGA 0/1), key secondary efficacy endpoints (PASI 90, PASI 100, and sPGA 0), and all…
-
Guangdong Zhongsheng Pharmaceutical’s COVID-19 Drug Leritrelvir Approved in Macau
•
Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a pharmaceutical company based in China, has announced that it has obtained marketing approval for its drug Yueruiling (leritrelvir) in Macau. The drug, a 3CL protease (3CLpro) inhibitor, is now authorized for use in treating mild to moderate cases of COVID-19. Leritrelvir functions…
-
3SBio’s Subsidiary Achieves Milestone in Phase II Study for Chronic Sinusitis Treatment SSGJ-611
•
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (HKG: 1530), has announced that its Phase II clinical study for SSGJ-611, an IL-4Rα monoclonal antibody (mAb) candidate for chronic sinusitis with nasal polyps (CRSwNP), has met its primary endpoint. The study demonstrated the efficacy and safety of SSGJ-611…
-
Lee’s Pharma Subsidiary Receives Green Light for Phase III Dry Eye Study and Completes Myopia Trial
•
Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), a prominent Chinese pharmaceutical company, through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced significant advancements in its ophthalmic pipeline. The company’s cyclosporine A gel, intended for the treatment of dry eye, has received clearance to proceed to a Phase III clinical study…
-
Jiangsu Hengrui Medicine Gains NMPA Approval for Five Drug Candidates, Including IL-17A mAb for Psoriasis
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for a total of five drug candidates. This development marks a significant step in the company’s pipeline advancement. Vunakizumab, an…
-
Huadong Medicine Expands Global Footprint with Launch of Aesthetic Injection MaiLi in Singapore
•
Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has announced the international expansion of its medical aesthetics portfolio with the launch of its high-end aesthetic injection product, MaiLi, in Singapore. This marks another milestone in the company’s global foray into the medical aesthetics sector. MaiLi is a premium…
-
WestGene Biopharma’s EB Virus-Targeting mRNA Vaccine WGc-043 Clears for Clinical Trials in China
•
WestGene Biopharma Co., Ltd., a biotechnology company based in Chengdu, has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to proceed with clinical trials for its candidate drug, WGc-043. This marks a significant milestone as WGc-043 is the world’s first mRNA therapeutic…
-
Zelgen Biopharmaceuticals’ ZG006 Earns Orphan Drug Designation from FDA for Small-Cell Lung Cancer
•
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its pipeline candidate, ZG006, which is under development for the treatment of small-cell lung cancer (SCLC). ZG006 is…
-
Insilico Medicine’s ISM6331 Earns FDA Orphan Drug Designation for Mesothelioma Treatment
•
Insilico Medicine, a China-based biotechnology company at the forefront of generative artificial intelligence (AI), has announced that it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its pipeline candidate ISM6331. This potential best-in-class candidate drug is designed to treat mesothelioma, a rare and…
-
Changshan Biochemical Gets Marketing Nod for Enoxaparin in Kyrgyzstan for Venous Thromboembolic Diseases
•
Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255), a Chinese pharmaceutical company, has announced that it has received marketing approval in Kyrgyzstan for its enoxaparin products, available in 0.4mL and 0.6mL dosages. Enoxaparin, originally developed by Sanofi, is recognized for its significant efficacy in preventing venous thromboembolic diseases following…
-
Haisco Pharmaceutical’s PDE4B Inhibitor HSK44459 Gets NMPA Green Light for Interstitial Lung Disease Clinical Trial
•
Haisco Pharmaceutical Group Co., Ltd (SHE: 002653), a Chinese pharmaceutical company, has announced that it has obtained clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug HSK44459. This phosphodiesterase 4B (PDE4B) inhibitor is now set to be evaluated for its efficacy in treating…
-
Servier’s Voranigo Receives FDA Nod for IDH Inhibitor as Brain Tumor Treatment
•
The U.S. Food and Drug Administration (FDA) has granted first-time approval for Voranigo (vorasidenib), a therapy developed by Servier Pharmaceutical plc. Voranigo, an inhibitor of isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2), has been approved for the treatment of adult and pediatric patients aged 12 years and older with Grade…
-
Akeso Biopharma Initiates Phase III Clinical Trial for Cadonilimab in Hepatocellular Carcinoma
•
Akeso Biopharma (HKG: 9926), a biopharmaceutical company based in China, has announced the first patient dosing in a Phase III clinical study for its drug candidate, cadonilimab, in combination with lenvatinib and transcatheter arterial chemoembolization (TACE) for the treatment of unresectable, non-metastatic hepatocellular carcinoma (HCC). The study’s data for this…
-
Walvax Biotechnology’s HPV Vaccine Price Cut Sparks Potential Market Price War in China
•
Walvax Biotechnology Co., Ltd (SHE: 300142) has significantly reduced the price of its bivalent human papillomavirus (HPV) vaccine to a record low of RMB 27.5 per dose for domestic products, according to the Shandong Center for Disease Control and Prevention’s disclosure of the 2024 purchase transaction data for the vaccine…
-
Antengene’s Xpovio Receives NDA Approval in Malaysia for Multiple Myeloma Treatment
•
Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced the approval of its New Drug Application (NDA) for Xpovio (selinexor) in Malaysia. The drug is now approved for use in combination with bortezomib and dexamethasone to treat adult patients with relapsed or refractory multiple myeloma (r/r…
-
Hotgen Biotech’s SGC001 Receives NMPA Approval for Clinical Trials in Myocardial Infarction
•
Hotgen Biotech Co., Ltd (SHA: 688068), a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its monoclonal antibody (mAb), SGC001. This emergency use mAb is intended for the treatment of anterior ST segment elevation myocardial infarction…
-
Suzhou Zelgen Biopharmaceuticals’ ZG005 Receives NMPA Approval for Clinical Trials in Solid Tumors
•
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for its pipeline drug candidate ZG005. The approvals will pave the way for trials to evaluate the efficacy and safety…
-
Gan & Lee Pharmaceuticals Gets FDA Green Light for Phase I Clinical Trial of Insulin Aspart Biosimilar
•
Gan & Lee Pharmaceuticals (SHA: 603087), a leading pharmaceutical company based in China, has received approval from the U.S. Food and Drug Administration (FDA) to commence a Phase I clinical study for its insulin aspart 30 injection, a biosimilar version of Novo Nordisk (NYSE: NVO)’s pre-mixed NovoMix 30 used in…
-
Luye Pharma’s LY03020 Receives NMPA Approval for Schizophrenia and Alzheimer’s Psychosis Treatment
•
Luye Pharma Group (HKG: 2186), a China-based pharmaceutical company, has announced that it has received clinical approval from the National Medical Products Administration (NMPA) for its Category 1 drug candidate LY03020, intended for the treatment of schizophrenia and Alzheimer’s disease psychosis (ADP). LY03020 is developed using Luye’s innovative New Molecular…
-
CMS’s Methotrexate Injection Gains NMPA Approval for Active Rheumatoid Arthritis Treatment
•
China Medical System Holdings (CMS; HKG: 0867) has received approval from the National Medical Products Administration (NMPA) for an additional indication for its methotrexate injection. The drug is now approved for the treatment of active rheumatoid arthritis (RA) in adults. Methotrexate is internationally recognized as a first-line treatment and cornerstone…
-
Takeda’s Vonicog Alfa Receives NMPA Approval for Von Willebrand Disease Treatment in China
•
Takeda Pharmaceutical Company Limited (TYO: 4502 / NYSE: TAK), a leading Japanese pharmaceutical company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for vonicog alfa, a recombinant von Willebrand factor (rVWF), for the on-demand treatment and control of bleeding events in adult patients…
-
Shionogi Files for Chinese Approval of Cefiderocol to Combat Gram-Negative Bacterial Infections
•
Shionogi Co., Ltd, a prominent Japanese pharmaceutical company, has announced the filing of a New Drug Application (NDA) in China for its innovative next-generation siderophore cephalosporin antibiotic, cefiderocol. The drug, marketed as Fetcroja or Fetroja in 10 different markets including Europe, Japan, and the United States, is now under consideration…
-
Degen Biopharmaceutical’s DG01 PROTAC Drug Receives NMPA Clearance for Solid Tumor Studies
•
Suzhou Degen Biopharmaceutical Co., Ltd, a leading specialist in PROteolysis TArgeting Chimeras (PROTAC) technology in China, has announced that its oral dual-targeted PROTAC drug, DG01, has been granted approval by the National Medical Products Administration (NMPA) to proceed with clinical studies for advanced or metastatic castration-resistant prostate cancer and liver…
-
Chongqing Genrix’s GR1803 Earns Breakthrough Therapy Designation in China for RRMM Treatment
•
The Center for Drug Evaluation (CDE) of China has indicated that Chongqing Genrix Bio Pharmaceutical Co., Ltd (SHA: 688443) is on track to receive Breakthrough Therapy Designation (BTD) for its bispecific antibody GR1803. This designation is for the treatment of recurrent refractory multiple myeloma (RRMM) in patients who have previously…
-
Lepu Biotechnology’s MRG003 Earns FDA Breakthrough Therapy Designation for Nasopharyngeal Carcinoma
•
Lepu Biotechnology Co., Ltd (HKG: 2157), a biopharmaceutical company based in China, has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its pipeline candidate, MRG003. This designation highlights the drug’s potential in treating recurrent/metastatic nasopharyngeal carcinoma (R/M NPC), a significant…
-
Yantai Dongcheng Pharmaceutical Secures NMPA Nod for PSMA-Targeted Radiotherapeutic Drug
•
Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug, 177LuLNC1011. This novel therapeutic is a prostate specific membrane antigen (PSMA)-targeted radioactive in vivo treatment…
-
Innovent Biologics and Sanegene Bio Commence Phase I Clinical Trial for Hypertension siRNA Drug
•
Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, in collaboration with Sanegene Bio USA Inc., has announced the dosing of the first patient in a Phase I First-in-Human (FIH) clinical trial for their siRNA drug candidate, IBI3016. This investigational therapy targets angiotensinogen (AGT) and is being…
-
Walvax Biotechnology’s Bivalent HPV Vaccine Earns WHO Pre-Qualification Status
•
China-based Walvax Biotechnology Co., Ltd (SHE: 300142) has achieved a significant milestone with its bivalent human papillomavirus vaccine, which has received pre-qualification (PQ) status from the World Health Organization (WHO). This vaccine, designed to prevent cervical cancer and other diseases associated with high-risk HPV types 16 and 18, was commercially…
-
Akeso Biopharma Initiates Phase II Global Study for Ligafulimab in High-Risk MDS
•
China-based Akeso Biopharma (HKG: 9926) has reached a clinical milestone with the dosing of the first patient in a Phase II study for its investigational drug ligufalimab (AK117) in the United States. The study is a randomized, placebo-controlled, global multi-center trial that combines ligufalimab with azacitidine for the treatment of…
-
AbbVie Completes Acquisition of Cerevel Therapeutics in $8.7 Billion Deal
•
US pharmaceutical giant AbbVie Inc. (NYSE: ABBV) has announced the successful completion of its acquisition of Cerevel Therapeutics (Nasdaq: CERE), a biotech company based in Cambridge, Massachusetts. AbbVie will pay $45.00 per share for Cerevel, totaling an approximate acquisition value of $8.7 billion. The transaction, initially announced in December 2023,…
-
Lee’s Pharmaceutical Commences Phase I Clinical Trial for AI-Discovered HCC Drug AU409
•
Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), a leading biopharmaceutical company based in China, has announced the first dosing in a Phase I clinical study for AU409, an oral small molecule drug. The drug was discovered by Auransa Inc. using the AI platform SMarTR Engine and will be manufactured by Lee’s…
-
Suzhou Zelgen’s Jacktinib Tablets Achieve Positive Results in Phase II IPF Clinical Trial
•
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced the successful completion of a Phase II clinical study for its Category 1 product candidate, jacktinib tablets, in the treatment of idiopathic pulmonary fibrosis (IPF). The study demonstrated that jacktinib tablets effectively delayed the decline…
-
Sino Biopharmaceutical’s Benmelstobart Files for New Indication in China for Advanced RCC Treatment
•
Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) in China has accepted for review a new indication filing for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb), benmelstobart (TQB2450). The filing seeks regulatory approval for the use…
-
Innovent Biologics’ Mazdutide NDA for Type 2 Diabetes Accepted for Review in China
•
Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company in China, has announced that the Center for Drug Evaluation (CDE) in China has accepted for review the second New Drug Application (NDA) for its investigational drug mazdutide (IBI362). Mazdutide is a novel glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR)…
-
GSK’s Jemperli Receives EC Approval for Endometrial Cancer Treatment in Combination Therapy
•
GSK plc (NYSE: GSK), a leading UK pharmaceutical company, has announced that the European Commission (EC) has granted a new indication approval for its programmed death-1 (PD-1) inhibitor, Jemperli (dostarlimab). The approval allows for the use of Jemperli in combination with carboplatin-paclitaxel, a chemotherapy regimen, for the treatment of adult…
-
Tonghua Dongbao Pharmaceuticals Launches Phase III Clinical Trial for Semaglutide Biosimilar in China
•
Tonghua Dongbao Pharmaceuticals (SHA: 600867), a Chinese pharmaceutical company, has announced the commencement of a Phase III clinical study for its drug candidate THDB0225, a biosimilar to Novo Nordisk’s semaglutide and Ozempic, used for the treatment of type 2 diabetes patients with inadequate glycemic control following metformin therapy. The multi-center,…
-
NICE and AstraZeneca Fail to Reach Agreement on Enhertu Reimbursement for NHS
•
The UK’s National Institute for Health and Care Excellence (NICE) has announced that negotiations with AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) for the reimbursement of the antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) within the National Health Service (NHS) have concluded without an agreement. Enhertu is approved in the…
-
BioNTech’s mRNA Cancer Immunotherapy BNT111 Achieves Primary Endpoint in Phase II Trial
•
Germany-based BioNTech SE (NASDAQ: BNTX) has announced that its mRNA cancer immunotherapy BNT111, in combination with the programmed death-1 (PD-1) inhibitor Libtayo (cemiplimab), has achieved the primary endpoint in a Phase II clinical trial. The study, part of a collaboration with Regeneron, is assessing the combination and monotherapies in treating…
-
FibroGen Inc. Enters Restructuring Mode After Late-Stage Trial Failures for Pamrevlumab
•
US-based biotechnology company FibroGen Inc. (NASDAQ: FGEN), which maintains significant operations in China, is initiating damage control measures following the failure of two late-stage trials for its potential first-in-class anti-connective tissue growth factor (CTGF) fully human monoclonal antibody, pamrevlumab. In response to these setbacks, FibroGen has decided to terminate all…
-
Bio-Thera Solutions’ Bevacizumab Biosimilar Avzivi Receives European Commission Approval
•
Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that its biosimilar version of Roche’s Avastin, Avzivi (bevacizumab), has received market approval from the European Commission (EC). The approval encompasses all existing indications for Avastin, which include the treatment of a range of cancers such as metastatic colorectal cancer, metastatic breast cancer,…
-
Gan & Lee Pharmaceuticals Gains Market Foothold in Algeria with Insulin Product Approvals
•
Gan & Lee Pharmaceuticals (SHA: 603087), a leading pharmaceutical company, has announced that it has received registration approval from Algerian authorities for two of its insulin products: the insulin aspart injection pre-filled pen and the insulin aspart 30 injection pre-filled pen. These products are slated to be manufactured locally by…
-
Cutia Therapeutics’ CU-30101 NDA Accepted for Review by China’s NMPA
•
Cutia Therapeutics (HKG: 2487), a company specializing in dermatological treatments, has announced that the National Medical Products Administration (NMPA) has accepted for review its New Drug Application (NDA) for CU-30101, a topical lidocaine and tetracaine cream. This pharmaceutical product is designed to provide rapid and long-lasting anesthetic effects, leveraging the…
-
Novartis’s Scemblix Receives FDA Priority Review for First-Line CML Treatment
•
Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that the US Food and Drug Administration (FDA) has granted priority review status to Scemblix (asciminib) for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML-CP). Scemblix, the first molecule to specifically target the ABL Myristoyl…
-
Jiangsu Hengrui Medicine Receives NMPA Approval for SHR-A1921 Clinical Study in Advanced Solid Tumors
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its innovative antibody drug conjugate (ADC), SHR-A1921. The study will evaluate the efficacy and safety of SHR-A1921…
-
Organon’s Liptruzet Launches in China for Hypercholesterolemia Treatment
•
US pharmaceutical company Organon (NYSE: OGN) has announced the official market launch of its single-tablet compound preparation Liptruzet (ezetimibe, torvastatin) in China for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH). The launch marks a significant step in addressing the lipid management needs of Chinese patients. Liptruzet combines the…
-
EU Regulator Rejects Marketing Authorization for Biogen and Eisai’s Alzheimer’s Drug Leqembi
•
Biogen Inc. (NASDAQ: BIIB), a US biotechnology company, and its Japanese counterpart Eisai Co., Ltd have encountered a setback in their efforts to secure European approval for Leqembi (lecanemab), an Alzheimer’s disease therapy. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a negative…
-
Luye Pharma’s Antipsychotic Erzofri Gains FDA Nod for Schizophrenia Treatment
•
Luye Pharma Group (HKG: 2186), a leading pharmaceutical company based in China, has achieved a significant milestone with the US Food and Drug Administration’s (FDA) marketing approval of its in-house developed antipsychotic medication, Erzofri (paliperidone palmitate extended-release injectable suspension). The approval grants Erzofri the clearance for treatment of schizophrenia and…
-
3SBio’s Thrombopoietin Meets Primary Endpoint in Phase III Trial for Chronic Liver Disease Patients
•
3SBio Inc. (HKG: 1530), a biopharmaceutical company based in China, has announced the successful conclusion of the Phase III TPO106 clinical trial for its thrombopoietin drug in patients with chronic liver disease associated thrombocytopenia who are scheduled for invasive surgery. The trial has met its pre-set primary endpoint, paving the…
-
CStone Pharmaceuticals’ Sugemalimab Wins EU Nod as First-Line NSCLC Treatment
•
CStone Pharmaceuticals (HKG: 2616), a leading biopharmaceutical company based in China, has received marketing approval from the European Commission (EC) for its PD-L1 inhibitor, Cejemly (sugemalimab). The approval covers the drug’s use in combination with platinum-based chemotherapy as a first-line treatment for adults with metastatic non-small-cell lung cancer (NSCLC), excluding…
-
Alphamab’s KN057 Earns FDA Orphan Drug Designation for Hemophilia B Treatment
•
Alphamab Oncology (HKG: 9966), a biopharmaceutical company based in China, has received another orphan drug designation (ODD) from the US FDA for its monoclonal antibody (mAb) KN057, which targets the tissue factor pathway inhibitor (TFPI). This new ODD is for the potential treatment of hemophilia B, following the initial ODD…
-
Junshi Biosciences’ Toripalimab Recommended for EU Approval for Two Indications
•
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for two new indications of its PD-1 inhibitor, Loqtorzi (toripalimab). The first is in combination with cisplatin and gemcitabine for first-line treatment of…
-
Akeso Biopharma’s Ivonescimab NDA Accepted by NMPA, Strengthening NSCLC Treatment Options
•
Akeso Biopharma (HKG: 9926), a biopharmaceutical company based in China, has received a significant boost with the acceptance of its New Drug Application (NDA) by the National Medical Products Administration (NMPA) for Yidafang (ivonescimab), a pioneering bispecific antibody targeting both programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF). This…
-
Hengrui Medicine Advances in Breast Cancer Treatment with NMPA Clinical Trial Greenlight
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a pharmaceutical heavyweight based in China, has received approval from the National Medical Products Administration (NMPA) to commence clinical studies on its innovative drug candidates. The study will explore the synergistic effects of HRS-6209 in combination with HRS-1358, HRS-8080, or aromatase inhibitors, and…
-
Zhejiang Haichang Biotech Secures EU Approval for Apexelsin: A New Hope in Cancer Treatment
•
Zhejiang Haichang Biotech Co., Ltd, a partner of China-based Kexing Pharmaceutical (SHA: 688136), has secured marketing approval from the European Commission for its biosimilar, Apexelsin. This groundbreaking treatment, which mirrors the quality of BMS/Celgene’s Abraxane (paclitaxel, albumin-bound), is indicated for metastatic breast cancer, metastatic pancreatic cancer, non-small cell lung cancer,…
-
Belief BioMed’s Hemophilia B Gene Therapy BBM-H901 Slated for Priority Review in China
•
The Center for Drug Evaluation (CDE) has indicated on its website that the market application for BBM-H901, a gene therapy treatment for hemophilia B developed by Belief BioMed Group (BBM), a Shanghai-based specialist in gene therapy, is on track for priority review. BBM-H901, co-developed with Japan’s Takeda, is an adeno-associated…
-
Sinqi Pharmaceutical Gets NMPA Green Light for SQ-22031 Eye Drops to Treat Dry Eye Syndrome and Neurotrophic Keratitis
•
Shenyang Sinqi Pharmaceutical Co., Ltd (SHE: 300573), a pharmaceutical company based in China, has received clinical trial approval from the National Medical Products Administration (NMPA) for its therapeutic biologic, SQ-22031 eye drops. This Category 1 therapeutic biologic is intended for the treatment of dry eye syndrome and neurotrophic keratitis, with…
-
China’s NMPA Gives Tacit Nod to IASO Biotechnology’s IASO-782 for SLE Clinical Trials
•
IASO Biotechnology, a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has granted tacit approval for its Investigational New Drug (IND) application for IASO-782. The company’s injectable drug candidate is slated for clinical trials in China to evaluate its efficacy in treating systemic lupus…
-
Luye Pharma’s Subsidiary Gets NMPA Go-Ahead for First CD228-Targeted ADC BA1302
•
Shandong Boan Biotechnology Co., Ltd (HKG: 6955), a subsidiary of China-based Luye Pharma Group (HKG: 2186), has received approval from the National Medical Products Administration (NMPA) to commence a Phase I clinical trial for its proprietary antibody-drug conjugate (ADC), BA1302. The trial, which is multi-center, open-label, and involves multiple dosages…
-
Amoytop Biotech Opts for NASH Drug Candidate KN069 in Licensing Deal with Alphamab Oncology
•
Xiamen Amoytop Biotech Co., Ltd (SHA: 688278), a biopharmaceutical company based in China, has exercised its option rights for KN069, a drug candidate for non-alcoholic steatohepatitis (NASH), under a licensing agreement with fellow Chinese firm Alphamab Oncology (HKG: 9966). The original deal, signed in December 2023, granted Amoytop the choice…
-
Jiangsu Suzhong Pharma’s Sutetinib Earns Breakthrough Designation for NSCLC from China’s NMPA
•
Jiangsu Suzhong Pharma Group Co., Ltd, a leading pharmaceutical company based in China, has received a breakthrough therapy designation from the National Medical Products Administration (NMPA) for its drug candidate sutetinib, which is under development for locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific non-resistant rare EGFR…
-
Hainan Poly Pharm’s Novel Nanomedicine PLAT001 Cleared for Clinical Trial by NMPA
•
Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative drug candidate, PLAT001. This novel injectable drug is under evaluation for the treatment of general advanced or metastatic solid tumors.…
-
Hinova Pharmaceuticals Receives NMPA Approval to Test Myelofibrosis Drug Candidate HP560
•
Hinova Pharmaceuticals Inc. (SHA: 688302), a biopharmaceutical company based in Chengdu, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its Category 1 chemical drug candidate, HP560. The molecule is being evaluated as a potential treatment for myelofibrosis,…
-
Belief BioMed and Takeda’s Hemophilia B Gene Therapy BBM-H901 Accepted for NMPA Review
•
Belief BioMed Group (BBM), a Shanghai-based gene therapy specialist, and Takeda have announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for BBM-H901, a gene therapy for hemophilia B. This development marks a significant milestone for the treatment, which is being designed…
-
Pfizer’s Hemophilia A Gene Therapy Shows Promise in Phase III AFFINE Study
•
Pfizer Inc. (NYSE: PFE), a US pharmaceutical giant, has announced positive topline results from the Phase III AFFINE study for its gene therapy candidate, giroctocogene fitelparvovec, for the treatment of hemophilia A. With these results, Pfizer is now poised to prepare for regulatory submission for this one-time gene therapy, which…
-
Novo Nordisk’s Wegovy Approved in the UK to Reduce Cardiovascular Risks in Overweight Adults
•
Novo Nordisk (NYSE: NVO)’s anti-obesity drug Wegovy (semaglutide) has received a new indication approval in the United Kingdom, with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granting approval for its use in reducing the risk of serious heart problems or strokes in overweight or obese adults. This marks…
-
IASO Biotechnology’s CAR-T Therapy Fucaso Receives FDA IND Approval for Multiple Sclerosis
•
China-based IASO Biotechnology has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) to explore the potential of its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Fucaso (equecabtagene autoleucel), in treating multiple sclerosis (MS). This marks the second IND nod…
-
ST Phi Therapeutics’ Universal Cell Therapy for Solid Tumors Gets Green Light for Clinical Trial in China
•
ST Phi Therapeutics, a Hangzhou-based cell therapy specialist, has secured tacit approval from China’s National Medical Products Administration (NMPA) to initiate a clinical trial for its innovative cell therapy, CNK-UT002. This marks a significant milestone, as CNK-UT002 is the first universal cell therapy for solid tumors to be approved for…
-
Innorna’s Herpes Zoster mRNA Vaccine IN001 Receives Clinical Trial Approval in China
•
Shenzhen-based Innorna Co., Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to commence clinical trials for its proprietary IN001, a novel mRNA vaccine designed to combat herpes zoster. This marks a significant milestone for the company, as IN001 is the first mRNA-based herpes…
-
Bayer’s BAY 3375968 Receives NMPA Approval for Clinical Trial in Advanced Solid Tumors
•
Bayer AG (ETR: BAYN), a multinational pharmaceutical giant based in Germany, has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its Category 1 drug BAY 3375968. This novel Fc optimized anti-CCR8 antibody is currently the subject of a Phase I clinical study globally. BAY 3375968 has…
-
Chipscreen’s HDAC Inhibitor Chidamide to be Tested in Combination Therapy for CRC by NMPA
•
Shenzhen Chipscreen Pharmaceutical Co., Ltd, a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III clinical trial. The trial is designed to evaluate the efficacy and safety of Epidaza (chidamide) in combination with the PD-1 inhibitor sintilimab (Tyvyt) and…
-
ViiV Healthcare’s Dovato Shows Non-Inferior Efficacy and Less Weight Gain in Pivotal PASO DOBLE Study
•
ViiV Healthcare, the HIV-focused subsidiary majority-owned by GSK with Pfizer and Shionogi as shareholders, has reported positive topline results from the Phase IV PASO DOBLE study. This clinical trial compared ViiV’s two-drug regimen Dovato (dolutegravir/lamivudine) to Gilead’s three-drug regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide fumarate) in the treatment of HIV-1 over a…
-
Jiangsu Hansoh’s Loxenatide Matches Dapagliflozin in Diabetes Nephropathy Clinical Trial
•
Jiangsu Hansoh Pharmaceutical Co., Ltd, a leading pharmaceutical company based in China, has published the results of a clinical study for its polyethylene glycol (PEG) loxenatide—a Category 1 novel chemical drug—in the treatment of diabetes nephropathy (DKD) in the Frontiers in Endocrinology journal. The study’s data indicate that loxenatide is…
-
China’s NMPA Considers Breakthrough Designations for Xiangxue and Innostellar’s Therapies
•
Xiangxue Pharmaceutical Co., Ltd (SHE: 300147) and Innostellar Biotherapeutics Co., Ltd have both been noted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) as potential candidates for breakthrough therapy designations (BTDs). Xiangxue’s TAEST16001, a T-cell receptor TCR affinity-enhanced specific T-cell (TAEST) therapy, and Innostellar’s…
-
Johnson & Johnson Pursues FDA Approval for Spravato as Monotherapy for Treatment-Resistant Depression
•
Johnson & Johnson (J&J, NYSE: JNJ), a leading global healthcare company, is pursuing expanded approval for its anti-depression drug Spravato (esketamine) in the U.S. by submitting a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA). The application seeks to establish Spravato CIII nasal spray as…
-
RemeGen’s Telitacicept Earns Full NMPA Approval for RA Treatment and PMN Clinical Study Green Light
•
RemeGen (HKG: 9995), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has granted full approval for its drug telitacicept, which is used in combination with methotrexate for the treatment of moderate to severe rheumatoid arthritis (RA) patients who have not responded well to…
-
AccurEdit Therapeutics Receives CDE Approval for Gene Editing Drug ART001 Targeting Amyloidosis
•
AccurEdit Therapeutics (Suzhou) Co., Ltd, a leading specialist in gene editing therapies based in China, has received approval from the Center for Drug Evaluation (CDE) for its investigational drug ART001. This drug is designed to target transthyroxine protein amyloidosis, a severe genetic disorder. ART001 marks a significant advancement in China’s…
-
ICER Analysis Flags Pfizer’s ATTR-CM Therapy Vyndamax/Vyndaqel as Costly, Suggests Price Cut
•
The Institute for Clinical and Economic Review (ICER), a US-based non-profit organization specializing in drug cost-effectiveness analysis, has released a pricing analysis for treatments of the rare heart disease transthyretin amyloid cardiomyopathy (ATTR-CM). The report particularly focuses on Pfizer’s Vyndamax/Vyndaqel (tafamidis) capsules, which were approved for ATTR-CM in the US…
-
Jiangsu QYuns Therapeutics and Huadong Medicine Partner on QX005N Injection Development and Promotion
•
Jiangsu QYuns Therapeutics Co., Ltd (HKG: 2509), a biopharmaceutical company based in China, has entered into a co-development and market promotion service agreement with Huadong Medicine Co., Ltd (SHE: 000963) for the development and commercialization of QX005N injection. Under the terms of the agreement, Huadong will participate in the clinical…
-
Innovent Biologics’ Mazdutide Achieves Primary and Secondary Endpoints in Phase III T2D Trial
•
Innovent Biologics Inc. (Innovent) (HKG: 1801), a leading biopharmaceutical company based in China, has announced positive results from the Phase III DREAMS-1 clinical trial for mazdutide (IBI362), a dual agonist targeting the glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) for the treatment of type 2 diabetes (T2D) in Chinese…
-
Jiangsu Hengrui Receives NMPA Approval to Study CDK 4/6 Inhibitor Dalpiciclib in Combination with HRS-1358 for Breast Cancer
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study combining its CDK 4/6 inhibitor, Dalpiciclib (SHR6390), with HRS-1358 for the treatment of breast cancer. This marks a significant step in expanding…
-
Hansoh Pharmaceutical’s EGFR Inhibitor Ameile Files for Adjuvant Therapy Approval with NMPA
•
Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692), a leading biopharmaceutical company based in China, has announced the submission of a market filing application for its epidermal growth factor receptor (EGFR) inhibitor, Ameile (almonertinib), to the National Medical Products Administration (NMPA). The application seeks approval for Ameile as an adjuvant therapy…
-
NMPA Approves Chengdu Chipscreen’s Bilessglu for Type 2 Diabetes in Combination with Metformin
•
The National Medical Products Administration (NMPA) has granted approval for Chengdu Chipscreen Pharmaceutical Co., Ltd (SHA: 688321)’s Category 1 drug Bilessglu (chiglitazar sodium) for use in combination with metformin to treat type 2 diabetes. This decision marks another milestone for the Chinese pharmaceutical company, which has developed chiglitazar as a…
-
Apeiron Therapeutics Sells Rights to CDK7 Inhibitor GTAEXS617 to Exscientia for USD 30 Million
•
Apeiron Therapeutics, a Shanghai-based biopharmaceutical company, has reached an agreement to sell all rights to its oral CDK7 inhibitor GTAEXS617 to Exscientia plc (NASDAQ: EXAI), a US-based AI-driven pharmaceutical company. The total transaction value amounts to USD 30 million, comprising an upfront cash payment of USD 10 million and a…
-
Bio-Thera Solutions Submits BLAs for Stelara Biosimilar BAT2206 to FDA and EMA
•
Bio-Thera Solutions Ltd, a biopharmaceutical company based in Guangzhou, has announced the submission of Biologic License Applications (BLAs) to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for BAT2206, its biosimilar candidate to Johnson & Johnson’s (J&J, NYSE: JNJ) Stelara (ustekinumab), an auto-immune disease…
-
J&J Halts Development of Epilepsy Therapy ADX71149 After Phase II Trial Failure
•
Johnson & Johnson (J&J; NYSE: JNJ), a US-based multinational medical devices, pharmaceutical, and consumer packaged goods manufacturing company, has reportedly discontinued the development of its pipeline epilepsy therapy ADX71149, according to the company’s latest Q2 2024 financials report and information from FiercePharma.com. ADX71149, a positive allosteric modulator (PAM) of metabotropic…
-
Sino Biopharmaceutical Submits Market Approval Filing for CDK2/4/6 Inhibitor Culmerciclib in Breast Cancer
•
Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company in China, has announced the submission of a market approval filing for its Category 1 drug culmerciclib (TQB3616). The filing is for the use of culmerciclib in combination with fulvestrant for the treatment of hormone receptor (HR) positive and human epidermal…
-
Eli Lilly’s Mounjaro Approved by China’s NMPA for Long-Term Weight Management
•
Eli Lilly & Co. (NYSE: LLY), a leading pharmaceutical company in the US, has announced that it has received a new market approval from the National Medical Products Administration (NMPA) in China for its drug Mounjaro (tirzepatide) as a long-term weight management treatment. Administered as a once-weekly injection, Mounjaro is…
-
China’s NMPA Suspends Daewoong Bio’s Cefodizime Over Inspection Refusal
•
The National Medical Products Administration (NMPA) has issued a notice to suspend the import, sale, and use of cefodizime, an antibiotic drug produced by South Korea-based Daewoong Bio Inc. This decision was made in response to the company’s written refusal to undergo an overseas production site dynamic inspection by the…
-
Bain Capital-Backed Tenacia Wins NMPA Approval for Ganaxolone Oral Suspension for CDKL5 Deficiency
•
Tenacia, a central nervous system (CNS) specialist company incubated by Bain Capital, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its in-licensed drug, ganaxolone oral suspension. This medication is indicated for the treatment of epileptic seizures in patients aged 2 years and…
-
Anhui Anke Biotechnology Receives NMPA Clearance for Clinical Trial of mRNA Drug AFN0328 for HPV-Related Cancers
•
Anhui Anke Biotechnology (Group) Co., Ltd (SHE: 300009), a biopharmaceutical company based in China, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its drug candidate AFN0328. The drug is intended for the treatment of malignant tumors associated with HPV16/18 infection, including cervical…
-
Consun Pharmaceutical Gets NMPA Go-Ahead for CKD Drug Clinical Trial
•
Consun Pharmaceutical Group Ltd (HKG: 1681), a leading Chinese pharmaceutical company, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to commence clinical studies for SK-08. This Category 1 chemical drug, co-developed with Contract Research Organization (CRO) WuXi AppTec (HKG: 2359), is intended to target…
-
Shanghai Ruijin Hospital’s Hainan Subsidiary Adopts ANI Pharmaceuticals’ Veregen for HPV Treatment
•
ANI Pharmaceuticals’ Veregen, a topical ointment derived from green tea extract (catechins), has been implemented by Shanghai Ruijin Hospital’s Hainan subsidiary. Marking a significant step for the botanical drug in China, Veregen is the first such drug approved by the US FDA since 1962 and is already in use across…
-
Junshi Biosciences’ Loqtorzi Inches Closer to Expanded Indication with NMPA Filing Acceptance
•
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has taken a significant step forward with the submission of another indication filing for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The company has announced that the National Medical Products Administration (NMPA) in China has accepted the filing for review. This…
-
Everest Medicines’ Nefecon Receives NMPA Review, Signaling Potential Treatment Milestone for IgAN Patients
•
Everest Medicines (HKG: 1952), a biopharmaceutical company dedicated to addressing critical medical needs in Asian markets, has achieved a significant step with its supplementary market approval filing for Nefecon being accepted by China’s National Medical Products Administration (NMPA). The drug, which targets the root cause of immunoglobulin A nephropathy (IgAN),…
-
Zai Lab and argenx Receive NMPA Approval for Vygart Hytrulo (efgartigimod alfa SC) in gMG
•
Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) and its US partner argenx SE (NASDAQ: ARGX) have announced that China’s National Medical Products Administration (NMPA) has granted Biologic License Application (BLA) approval for Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). Vygart Hytrulo is indicated for use in combination with conventional therapy…
-
Mabwell Bioscience Lands Orphan Drug Status for B7-H3 Targeting ADC in Small Cell Lung Cancer
•
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has been granted Orphan Drug Designation (ODD) by the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC), 7MW3711. The drug targets B7-H3, a receptor overexpressed in various cancers, and is specifically indicated for the treatment of small cell lung cancer…
-
Shanghai Pharmaceuticals Secures NMPA Nod for Roche’s Valcyte Generic
•
Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of Roche’s Valcyte (valganciclovir). Valganciclovir is a crucial medication primarily used to treat cytomegalovirus (CMV) retinitis in adult patients with acquired immunodeficiency syndrome (AIDS)…
-
Jiangsu Simcere Pharmaceutical’s Quviviq Approval Application Accepted for Review by China’s NMPA
•
Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), in partnership with Swiss pharmaceutical firm Idorsia Pharmaceuticals Ltd, has achieved a significant milestone with the acceptance of their marketing approval filing for Quviviq (daridorexant) by China’s National Medical Products Administration (NMPA). Quviviq is an innovative anti-insomnia drug that has already gained commercial…
-
Ocumension Therapeutics and Shandong Boan Biotechnology File for Market Approval of Biosimilar Aflibercept in China
•
Ocumension Therapeutics (HKG: 1477) and Shandong Boan Biotechnology Co., Ltd (HKG: 6955) have jointly announced the submission of a market approval filing to the National Medical Products Administration (NMPA) for their co-developed biosimilar version of Bayer’s Eylea (aflibercept). This biosimilar has the potential to be the latest entry in the…
-
Sino Biopharmaceutical’s Anlotinib Achieves Milestones in Phase III Trial for Soft-Tissue Sarcoma
•
Sino Biopharmaceutical Ltd (HKG: 1177), a leading pharmaceutical company based in China, has announced positive interim data from a Phase III clinical study for its drug anlotinib. The study combines anlotinib with chemotherapy as a first-line treatment for advanced unresectable or metastatic soft-tissue sarcoma. The Independent Data Monitoring Committee (IDMC)…
-
Eli Lilly’s Lupus Treatment LY3361237 Misses Mark in Phase II Trial
•
Eli Lilly & Co. (NYSE: LLY) has encountered a setback in its drug development pipeline with the failure of the Phase II trial for LY3361237, an antibody agonist targeting the BTLA immune checkpoint, in the treatment of systemic lupus erythematosus (SLE). The trial, registered on clinicaltrials.gov as NCT05123586, was terminated…
-
BeiGene Receives NMPA Greenlight for BG-C9074 Clinical Trial in Advanced Solid Tumors
•
BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the National Medical Products Administration (NMPA) in China has approved its clinical filing for the Category 1 pipeline candidate BG-C9074. The antibody drug conjugate (ADC) is set to be initially assessed for the treatment of general advanced solid tumors, marking…
-
Celling Biotechnology’s CEL001 Earns Tacit Approval for Clinical Trials in China
•
Celling Biotechnology Co., Ltd, a Guangzhou-based biopharmaceutical company, has announced that its pipeline candidate CEL001 has received tacit clinical trial approval in China. The drug candidate is an antibody fusion protein targeting PD-1, TIGIT, and IL-15, and is intended for the treatment of advanced solid tumors, with a particular focus…
-
Sino Biopharmaceutical’s Rovadicitinib Gets CDE Nod for Review in Myelofibrosis
•
Sino Biopharmaceutical Ltd (HKG: 1177) has announced that the Center for Drug Evaluation (CDE) in China has accepted for review its market approval filing for the investigational Category 1 drug rovadicitinib (TQ05105). The drug is being developed for the treatment of moderate- to high-risk myelofibrosis (MF), a serious bone marrow…
-
Sichuan Huiyu’s HY07121 Antifungal Protein Earns NMPA Review for Clinical Trials
•
Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a Chinese biopharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted its clinical trial filing for HY07121, an innovative antibody fusion protein targeting PD-1, TIGIT, and IL-15 for the treatment of advanced solid tumors. The drug candidate, classified as…
-
Betta Pharmaceuticals’ EYP-1901 Implant Secures NMPA Clinical Trial Nod for Wet AMD
•
Betta Pharmaceuticals (SHE: 300558) has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its EYP-1901 intravitreal implant, intended for the treatment of wet age-related macular degeneration (wAMD). The drug candidate is a combination of vorolanib, a multi-target tyrosine kinase VEGFR/PDGFR inhibitor, and…
-
Shenzhen Tyercan Bio-Pharma’s TYE1001 Earns Tacit IND Approval from FDA for Advanced Solid Tumors
•
Shenzhen Tyercan Bio-pharm Co., Ltd, a biopharmaceutical company based in China, has announced that it has received tacit Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its anti-tumor drug TYE1001. The drug is intended for the treatment of advanced solid tumors and lymphomas. TYE1001…
-
Mabwell Bioscience Receives NMPA Approval for Phase II TNBC Clinical Trial of 9MW2821
•
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that China’s National Medical Products Administration (NMPA) has granted approval for a Phase II clinical study of its antibody drug conjugate (ADC) 9MW2821, which targets Nectin-4, in patients with triple negative breast cancer (TNBC). The study will evaluate the efficacy and…
-
Ipsen S.A. Receives NMPA Green Light for Six-Month Diphereline Dosage in Central Precocious Puberty
•
Ipsen S.A. (EPA: IPN; OTCMKTS: IPSEY) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its six-month dosage form of Diphereline (triptorelin), a treatment for central precocious puberty (CPP), a condition that leads to early sexual development in children. This makes Diphereline the…
-
Shanghai HeartCare Medical Secures Taiwan Approval for Homegrown Femoral Artery Occluder
•
Shanghai HeartCare Medical Technology Co., Ltd (HKG: 6609), a leading player in the Chinese medical device industry, has announced that it has received marketing approval from the Taiwan Food and Drug Administration (TFDA) for its innovative vascular closure device, the first home-grown femoral artery occluder. The device, which was approved…
-
U.S. Senate Passes Affordable Prescriptions for Patients Act to Limit Patent Thicketing
•
In a significant move to curb drug prices, the U.S. Senate unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S-150) last week. This legislation is designed to foster greater competition from generic and biosimilar drugs against their brand-name counterparts. The act’s primary objective is to impose a limit…
-
Eisai’s Next-Gen SERD, Orserdu, Begins Real-World Study in Shanghai Ruijin Hospital’s Hainan Subsidiary
•
Shanghai Ruijin Hospital’s Hainan subsidiary has initiated a real-world study for Orserdu (elacestrant), a next-generation selective estrogen receptor degrader (SERD) originally developed by Eisai (TYO: 4523). The drug was transferred to Radius Health for global development back in 2006. In a strategic move in July 2020, the Menarini Group, based…
-
Everest Medicines’ Velsipity Shows Positive Results in Largest Asian Phase III UC Trial
•
Everest Medicines (HKG: 1952), a leading biopharmaceutical company based in China, has announced positive top-line results from a multi-center Phase III clinical study for its Velsipity (etrasimod) in moderate-to-severe active ulcerative colitis (UC) during the maintenance period in Asia. This landmark trial is the largest Phase III study for moderately-to-severely…
-
Huadong Medicine’s Partner Arcutis Gets FDA Nod for Roflumilast Cream
•
Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, announced that its co-development partner Arcutis Biotherapeutics Inc., (NASDAQ: ARQT), has received approval from the U.S. Food and Drug Administration (FDA) for a supplementary New Drug Application (sNDA) for Zoryve cream (roflumilast). This clearance is for treating mild to moderate…
-
Mabwell Bioscience’s 9MW2821 Earns FDA Fast Track Designation for Triple Negative Breast Cancer
•
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that it has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for its investigational antibody-drug conjugate (ADC), 9MW2821. This candidate is designed to target Nectin-4 and is currently in development…
-
NMPA Accepts 3SBio’s Filing for Anemia Treatment SSS06, Potential Game Changer for Dialysis Patients
•
3SBio Inc. (HKG: 1530), a leading biopharmaceutical company based in China, has announced that the National Medical Products Administration has accepted its filing for market approval of SSS06, a recombinant erythropoiesis stimulating protein injection (rESP, CHO cells). This development marks a significant milestone for the company as it aims to…
-
Huadong Medicine Secures Exclusive Rights to Oral Edaravone Candidate TTYP01 in Major Licensing Deal
•
Huadong Medicine Co., Ltd (SHE: 000963), a prominent pharmaceutical company in China, has entered into an exclusive licensing agreement with Suzhou Auzone Biological Technology Co., Ltd, focusing on Auzone’s product candidate TTYP01, an oral formulation of edaravone. This strategic partnership positions Huadong to exclusively develop, regulate, manufacture, and commercialize the…
-
Oricell Therapeutics’ GPRC5D-Targeted CAR-T Therapy Earns FDA Fast Track for Multiple Myeloma
•
Oricell Therapeutics Co., Ltd, a leading biopharmaceutical company based in China, has announced that it has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its innovative therapy, OriCAR-017. This chimeric antigen receptor (CAR)-T cell therapy is targeted at GPRC5D, aiming to treat recurrent refractory multiple myeloma…
-
Simcere Pharmaceutical’s COVID-19 Therapy Xiannuoxin Earns Full Approval in China
•
Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has announced that its small-molecule COVID-19 therapy, Xiannuoxin (simnotrelvir, ritonavir), has received regular approval from the Chinese regulatory authorities, converting from its previous conditional approval status. This makes Xiannuoxin the first COVID-19 therapy of its kind to achieve full…
-
Jiangsu Hengrui’s Subsidiary Conducts First Surgical Dosing in Parkinson’s Gene Therapy Clinical Trial
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that its subsidiary, Shanghai Regenelead Therapies Co., Ltd., has conducted the first surgical dosing in a clinical study for its dual adeno-associated virus (AAV) gene therapy, RGL-193, aimed at treating Parkinson’s disease (PD). The procedure…
-
Shanghai Escugen Initiates Phase III Clinical Trial for Breast Cancer Drug Candidate ESG401
•
Shanghai Escugen, a biopharmaceutical company based in China, has announced the dosing of the first patient in a Phase III clinical study for its candidate drug ESG401. The study is assessing the efficacy of ESG401 in patients with hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-)…
-
Eisai and Biogen’s Alzheimer’s Therapy Leqembi Receives Marketing Approval in Hong Kong
•
Eisai Co., Ltd, a Japanese pharmaceutical company, along with its co-development partner Biogen Inc. (NASDAQ: BIIB), has announced that they have received marketing approval in Hong Kong for their Alzheimer’s disease (AD) therapy Leqembi (lecanemab). Known as 乐意保 in Chinese, the drug is administered intravenously every two weeks and is…
-
Pfizer’s Once-Daily Danuglipron Selected for Full Clinical Development for Type 2 Diabetes and Obesity
•
Pfizer Inc. (NSE: PFIZER), a leading pharmaceutical company in the U.S., has announced that a once-daily oral formulation of danuglipron, its investigational GLP-1 agonist for the treatment of type 2 diabetes and obesity, has been selected for full clinical development. This decision is based on positive findings from an ongoing…
-
Novo Nordisk’s Awiqli Faces FDA Setback as BLA Draws Complete Response Letter
•
Novo Nordisk A/S (NYSE: NVO) announced that the U.S. Food and Drug Administration issued a Complete Response Letter (CRL) in response to the Biologics License Application (BLA) for Awiqli, the company’s once-weekly basal insulin icodec for diabetes treatment. The CRL from the FDA highlighted specific requests concerning the manufacturing process…
-
CSPC Pharmaceutical’s RSV mRNA Vaccine SYS6016 Receives Clinical Trial Approval from NMPA
•
CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its candidate mRNA vaccine, SYS6016, targeting the respiratory syncytial virus (RSV). The vaccine, SYS6016, is designed using mRNA molecules that…
-
Sichuan Biokin Pharmaceutical Gets NMPA Approval for BL-M14D1 Clinical Trial in Solid Tumors
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its antibody-drug conjugate (ADC), BL-M14D1, intended for the treatment of advanced solid tumors. BL-M14D1 leverages the same…
-
Beijing Sun-Novo Gets NMPA Green Light for STC008 Clinical Trial in Tumor Cachexia
•
Beijing Sun-Novo Pharmaceutical Research Co., Ltd (SHA: 688621), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its investigational drug candidate STC008. This study will focus on the treatment of tumor cachexia…
-
KeChow Pharma’s Keluping, First NRAS Mutant Melanoma Therapy, Hits the Market
•
Shanghai-based KeChow Pharma has announced the official market launch of its groundbreaking drug, Keluping (tunlametinib), the world’s first targeted therapy designed specifically for NRAS mutant melanoma. Tunlametinib, a novel ATP noncompetitive MEK inhibitor that targets NRAS mutations, received marketing approval in China in March this year. The drug was granted…
-
Amgen Halts Development of Claudin 6-Targeting BiTE Immune Therapy AMG 794
•
Amgen Inc. (NASDAQ: AMGN), a leading biopharmaceutical company based in the U.S., has decided to halt the development of AMG 794, a half-life extended BiTE (bispecific T-cell engager) immune therapy that targets the oncofetal antigen Claudin 6 (CLDN6). This decision was disclosed on the clinicaltrials.gov website under the identifier NCT05317078,…
-
Kymera Therapeutics’ Stock Soars on Sanofi’s Plans to Expand KT-474 Clinical Trials
•
Kymera Therapeutics Inc. (NASDAQ: KYMR), a biopharmaceutical company based in the U.S., has announced that Sanofi intends to expand the clinical development program for the auto-immune skin disease drug KT-474 following a preliminary review that showed robust early data. Sanofi’s plan to broaden Phase II trials for the drug, which…
-
Shanghai Vitalgen BioPharma Launches Phase I/II Gene Therapy Trial for Parkinson’s Disease
•
Shanghai Vitalgen BioPharma Co., Ltd, a biopharmaceutical company based in China, has initiated a Phase I/II clinical study for its gene therapy candidate VGN-R09b at Huashan Hospital, targeting primary Parkinson’s disease (PD). VGN-R09b received clearance to proceed with clinical trials in China for primary PD and aromatic L-amino acid decarboxylase…
-
Kintor Pharmaceutical Launches Global Cosmetic Line with Hair Loss Treatment Pyrilutamide
•
Kintor Pharmaceutical Ltd (HKG: 9939), a biopharmaceutical company based in China, has announced the global launch of cosmetic products featuring pyrilutamide (KX-826) as the key ingredient. Pyrilutamide, an androgen receptor (AR) antagonist, is utilized as a topical application for the treatment of androgenic alopecia (AGA), a common condition leading to…
-
Suzhou Sanegene Bio Receives NMPA Approval for Clinical Trial of Antihypertensive siRNA Drug
•
Suzhou Sanegene Bio Inc., a leading RNAi specialist with research and development centers in both the US and China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug SGB-3908. This antihypertensive siRNA drug has been co-developed with Innovent Biologics,…
-
Shanghai Junshi Biosciences’ HDAC Inhibitor JS125 Clinical Trial Application Accepted by NMPA
•
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the National Medical Products Administration (NMPA) has accepted for review a clinical trial filing for JS125 (WJ47156), a histone deacetylases (HDAC) inhibitor co-developed with Wigen Biomedicine Technology (Shanghai) Co., Ltd. This epigenetic regulator is intended for the treatment…
-
Johnson & Johnson’s Opsumit Faces Generic Competition with Qilu Pharmaceutical’s Entry
•
Johnson & Johnson (J&J, NYSE: JNJ)’s pulmonary hypertension treatment, Opsumit (macitentan), is set to encounter intensified competition in China following the approval of a generic version by local pharmaceutical company Qilu Pharmaceutical last month. Macitentan, classified as an endothelin receptor antagonist (ERA), initially received marketing approval in the US in…
-
Shandong Buchang Pharmaceuticals Receives NMPA Approval for BC008-1A Biologic Product Clinical Trial
•
Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), a pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 biologic product BC008-1A. This product is intended for the treatment of glioblastoma and advanced…
-
HOB Biotech Receives NMPA Approval for Clinical Trials of MM09 Sublingual Spray
•
Jiangsu-based HOB Biotech Group Corp., Ltd (SHA: 688656) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its MM09 sublingual spray. The product is intended to target indications such as mild to moderate asthma and allergic rhinitis/nasal conjunctivitis, with a focus on…
-
Roche’s Susvimo Implant Cleared for Relaunch in US After Voluntary Recall
•
Roche (SWX: RO), the Swiss pharmaceutical giant, has announced the conclusion of the voluntary recall of its Susvimo (ranibizumab) 100mg/mL intravitreal ocular implant in the U.S. market. The implant, indicated for the treatment of neovascular (wet) age-related macular degeneration (nAMD), has received approval from the U.S. Food and Drug Administration…
-
Ascentage Pharma’s Olverembatinib Receives Marketing Approval from Macau SAR for CML Treatment
•
Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has announced that it has received marketing approval from the Macau Special Administrative Region (SAR) of China for its drug olverembatinib. This novel BCR-ABL1 tyrosine kinase inhibitor (TKI) is indicated for the treatment of adult patients with chronic-phase chronic myeloid…
-
Shanghai Fosun Pharmaceutical Gets NMPA Green Light for FH-2001 and Serplulimab Combo Clinical Trial
•
Shanghai Fosun Pharmaceutical Group Co., Ltd (SHA: 600196; HKG: 2196), a prominent pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its co-developed FH-2001 in combination with HanSiZhuang (serplulimab, HLX10) for the treatment of advanced…
-
CSPC Pharmaceutical’s SYS6023 Receives FDA Approval for Clinical Study in Advanced Solid Tumors
•
CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical study for its pipeline candidate SYS6023. The study will initially focus on patients with general advanced solid tumors.…
-
Allist Pharmaceuticals Receives NMPA Approval for Phase III Trial of Furmonertinib in EGFR Mutated NSCLC
•
Allist Pharmaceuticals Co., Ltd, a Shanghai-based biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study. The study will assess the efficacy and safety of Allist’s furmonertinib in combination with chemotherapy compared to osimertinib (Tagrisso) in…
-
Yantai Dongcheng Pharmaceutical Gets NMPA Approval for ⁹⁹ᵐTc Tetrofosmin Imaging Agent
•
Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its ⁹⁹ᵐTc tetrofosmin, a SPECT myocardial perfusion imaging agent. This radiopharmaceutical drug, which is utilized for myocardial perfusion imaging in…
-
Shenzhen Salubris Pharmaceuticals’ Fotagliptin Receives NMPA Approval for Type 2 Diabetes Treatment
•
Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294), a pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category 1 drug, fotagliptin. This drug is intended to improve blood sugar control in adult patients with type 2 diabetes,…
-
Roche’s Alecensa Secures NMPA Approval as Adjuvant Therapy for Early-Stage NSCLC
•
Roche (SWX: RO), the Swiss pharmaceutical giant, has announced that it has received an additional indication approval from the National Medical Products Administration (NMPA) for its drug Alecensa (alectinib). This new indication is for use as a post-surgery adjuvant therapy in patients with stage 1B to stage IIIA non-small cell…
-
Immorna Therapeutics Earns FDA Approval for Phase I/II Clinical Trial of Self-Replicating RNA Cancer Therapy
•
Immorna Therapeutics, a biotech company specializing in mRNA-based vaccines and located in Hangzhou, has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase I/II clinical study for its self-replicating RNA cancer therapy, JCXH-211-IV (intravenous injection). JCXH-211-IV is a potential first-in-class drug…
-
Novo Nordisk’s Esperoct Receives NMPA Approval, First Long-Acting Factor VIII for Hemophilia A in China
•
The National Medical Products Administration (NMPA) has granted approval to Novo Nordisk (NYSE: NVO), a Denmark-based pharmaceutical giant, for its drug Esperoct (turoctocog alfa pegol). This marks Esperoct as the first and only long-acting recombinant coagulation factor VIII approved in China for on-demand treatment and control of bleeding events, as…
-
Innovent Biologics and IASO Biotechnology Amend Partnership, Focusing on CAR-T Therapy Fucaso
•
Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced a new set of agreements with IASO Biotechnology, a domestic firm, to adjust the terms of their earlier partnership. According to the new deals, IASO will acquire from Innovent its rights to the BCMA-targeted chimeric antigen…
-
PharmaEssentia’s Besremi Receives Approval for Polycythemia Vera Treatment in China
•
PharmaEssentia Corporation (TPE: 6446, FRA: 8Z1), a biopharmaceutical company based in Taiwan, has announced that its drug Besremi (ropeginterferon alfa-2b) has been approved by the National Medical Products Administration (NMPA) to treat adult polycythemia vera (PV) in China. This ultra-long-acting interferon, developed in-house, is already registered in the European Union,…
-
Haisco Pharmaceutical’s Crisugabalin Gains NMPA Approval for Post-Herpes Neuralgia Treatment
•
Haisco Pharmaceutical Group Co., Ltd (SHE: 002653), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has approved an additional market approval filing for its drug candidate crisugabalin (HSK16149). This latest approval expands the drug’s indication to include the treatment of post-herpetic neuralgia…
-
Hinova Pharmaceuticals’ HP537 Receives FDA Approval for Phase I/II Clinical Trial in Hematologic Malignancies
•
Hinova Pharmaceuticals Inc. (SHA: 688302), a biotech company based in Chengdu, has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase I/II clinical study for its drug candidate HP537 in the treatment of hematologic malignancies. The Category 1 chemical had previously…
-
Easton Pharmaceutical Receives NMPA Approval for Generic Oxcarbazepine
•
Easton Pharmaceutical Co., Ltd (SHA: 688513), based in Chengdu, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Novartis’s oxcarbazepine. This neurogenic drug is now approved for the treatment of primary generalized tonic-clonic seizures and partial seizures, with or…
-
Amoytop Biotech’s Peginterferon α-2b Receives NMPA Approval for Primary Thrombocytosis Clinical Trial
•
Amoytop Biotech Co. Ltd (SHA: 688278), based in Xiamen, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 biologic, peginterferon α-2b, which is indicated for the treatment of primary thrombocytosis. As the first domestically developed long-acting peginterferon α-2b for…
-
Daiichi Sanky’s Mirogabalin Gets Green Light from China for Diabetic Neuropathic Pain
•
Daiichi Sanky (TYO: 4568), a pharmaceutical company based in Japan, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug Tarlige (mirogabalin) for the treatment of diabetes peripheral neuropathic pain (DPNP). Mirogabalin is a gabapentinoid drug, which belongs to the same class…
-
Antengene’s Xpovio Secures NMPA Approval for R/R Diffuse Large B-Cell Lymphoma
•
Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced that it has received new indication approval from the National Medical Products Administration (NMPA) for its drug Xpovio (selinexor). The drug is now approved for the treatment of adult patients with recurrent or refractory (R/R) diffuse large…
-
Sirnaomics’ STP122G Achieves Phase I Milestone with Positive Interim Data for Anticoagulation Treatment
•
Sirnaomics Ltd (HKG: 2257) has announced the completion of the Phase I second sequence for its drug candidate STP122G, which is being developed as an anticoagulation treatment, along with the release of interim data. The Factor XI program, to which STP122G belongs, has broad therapeutic potential as an anticoagulant across…
-
Roche’s Tiragolumab Misses Primary Endpoints in NSCLC Trial, Study Halted
•
Roche (SWX: ROG; SWX: RO; OTCMKTS: RHHBY), the Swiss pharmaceutical giant, has announced that a Phase II/III clinical trial for its TIGIT-targeted antibody tiragolumab, designed for non-small cell lung cancer (NSCLC), did not outperform Keytruda (pembrolizumab), a PD-1 inhibitor. The trial, known as SKYSCRAPER-06, was evaluating the efficacy of tiragolumab…
-
Medigene AG Secures Chinese Patent for TCR-T Therapy Targeting NY-ESO-1 and LAGE 1a
•
Medigene AG (ETR: MDG1), a biopharmaceutical company based in Germany, has announced that it has been granted patent protection in China for its T cell receptor (TCR) technology targeting NY-ESO-1 and LAGE 1a. This development pertains to the company’s lead pipeline candidate, MDG1015, which is a first-in-class, third-generation TCR-T therapy.…
-
Doma Biopharmaceutical’s Bispecific ADC DM001 Receives FDA Clearance for Clinical Trial
•
Doma Biopharmaceutical (Suzhou) Co., Ltd, a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the U.S. Food and Drug Administration (FDA) for its bispecific antibody drug conjugate (ADC), DM001. The molecule is set to be evaluated for safety, tolerability, and preliminary anti-tumor activity…
-
Jiangsu Hengrui Medicine Gets NMPA Green Light for HRS-9813 IPF Clinical Trial
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug HRS-9813, which is intended for the treatment of idiopathic pulmonary fibrosis (IPF). Preclinical efficacy data from…
-
Luye Pharma’s Oxycodone/Naloxone Product Receives NMPA Approval for Severe Pain Management
•
Luye Pharma Group (HKG: 2186), a pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its oxycodone, naloxone product, LY 021702. The drug is indicated for use in adults requiring opioid analgesics to manage severe pain, including both…
-
Semaglutide Use Linked to Rare Eye Condition NAION in New Study
•
A recent study has identified a potential link between the use of GLP-1-targeted diabetes and anti-obesity drug semaglutide, marketed as Wegovy/Ozempic by Novo Nordisk, and a rare ophthalmic condition. Research published in JAMA Ophthalmology revealed that physicians at Harvard and Brigham and Women’s Hospital in Boston discovered an increased risk…
-
J&J’s Rybrevant Earns First-Line NSCLC Approval in Canada, a Milestone for EGFR Exon 20 Patients
•
Johnson & Johnson (J&J; NYSE: JNJ) has announced that Rybrevant (amivantamab) has received its first market approval in Canada. The drug is approved as a first-line treatment in combination with chemotherapy for advanced or metastatic non-small cell lung cancer (NSCLC) in patients with activating epidermal growth factor receptor (EGFR) Exon…
-
Sanofi’s RSV Preventative Therapy Beyfortus Launches in China
•
Sanofi (NASDAQ: SNY), a leading French pharmaceutical company, has announced the commercial launch of Beyfortus (nirsevimab), a preventative therapy for Respiratory Syncytial Virus (RSV), in China. Nirsevimab, a long-acting monoclonal antibody (mAb), is the first and only RSV preventative therapy in China that covers a wide range of infants, including…
-
Full-Life Technologies’ ²²⁵Ac-FL-020 Earns FDA Fast-Track Status for mCRPC
•
Full-Life Technologies Ltd, a globally integrated radiotherapeutics company with a presence in Belgium, Germany, and China, has announced that the US Food and Drug Administration (FDA) has granted fast-track designation for its investigational drug ²²⁵Ac-FL-020 for the treatment of metastatic castration resistant prostate cancer (mCRPC). ²²⁵Ac-FL-020 is a PSMA-targeted radionuclide…
-
HutchMed’s Tazverik for Follicular Lymphoma Accepted for Review by China’s NMPA
•
HutchMed (NASDAQ: HCM), a China-based biopharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for Tazverik (tazemetostat) for review. The company is seeking initial approval for Tazverik as a treatment for recurrent or refractory follicular lymphoma (FL), and the filing has been…
-
LG Chem and Yifan Pharmaceutical Launch Hyruan ONE for Knee Osteoarthritis in China
•
LG Chem, a leading chemical company based in South Korea, and Yifan Pharmaceutical Co., Ltd (SHE: 002019) from China, have announced the market launch of Hyruan ONE (sodium hyaluronate) in China for the treatment of knee osteoarthritis. Hyruan ONE, originally developed by LG Chem, is a single-dose preparation designed to…
-
AstraZeneca’s Voydeya Receives South Korean Approval for PNH Treatment
•
AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical giant, has reportedly secured market approval in South Korea for its drug Voydeya (danicopan), the world’s first-in-class oral D-factor inhibitor. The Ministry of Food and Drug Safety (MFDS) in Korea approved Voydeya for use as an adjunct therapy for extravascular hemolysis (EVH) in…
-
Astellas Pharma’s Xtandi Secures Third Market Approval in China for Prostate Cancer Treatment
•
Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, has announced that it has secured market approval in China for a new indication of its drug Xtandi (enzalutamide), marking its third such approval in the country. The drug is now approved for the treatment of metastatic hormone-sensitive prostate cancer…
-
Eslicarbazepine Makes First Appearance in China at Sichuan University’s West China Lecheng Hospital
•
Eslicarbazepine, a voltage-gated sodium channel blocker, co-developed by Bial-Portela, Eisai, and Sumitomo Pharma, was first prescribed at the West China Lecheng Hospital of Sichuan University late last month. This epilepsy therapy marks the first special novel drug program implemented through the “first pilot, first trial” policy of the Boao Lecheng…
-
China’s Jiangsu Hengrui First to Market Generic Exparel in the US with FDA ANDA Approval
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for its generic version of Pacira’s Exparel (bupivacaine liposome). This approval positions Hengrui as the first…
-
Shanghai Henlius Biotech Advances Serplulimab Phase III Trial for First-Line Metastatic Colorectal Cancer
•
Shanghai Henlius Biotech Inc. (HKG: 2696), a biopharmaceutical company based in China, has announced that it has received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan to conduct a global, multi-center Phase III study. The study will evaluate the anti-programmed death-1 (PD-1) inhibitor HanSiZhuang (serplulimab, HLX10) in…
-
MabPharm’s Biosimilar Infliximab CMAB807 Receives Market Approval in Peru
•
MabPharm Ltd (HKG: 2181), a biosimilar specialist in monoclonal antibody (mAb) based in Taizhou, has announced that it has received market approval for CMAB807, a biosimilar version of Johnson & Johnson (J&J)’s Remicade (infliximab), in Peru. The approval encompasses all six indications, which include adult ulcerative colitis, ankylosing spondylitis, rheumatoid…
-
Legend Biotech’s Carvykti Shows Significant Overall Survival Improvement in Phase III CARTITUDE-4 Study
•
Legend Biotech Corporation (NASDAQ: LEGN) has announced positive results from the CARTITUDE-4 study, a global, randomized, open-label Phase III trial. The study assessed the efficacy and safety of Legend Biotech’s BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy Carvykti (ciltacabtagene autoleucel) compared to standard therapies of pomalidomide, bortezomib, and dexamethasone…
-
Lilly’s Kisunla Poised to Shake Up Alzheimer’s Treatment Market with FDA Approval
•
Eli Lilly & Co. (NYSE: LLY) has announced that the U.S. Food and Drug Administration (FDA) has granted approval for donanemab as a treatment for adults with early symptomatic Alzheimer’s disease (AD), including those with mild cognitive impairment (MCI) and individuals with mild AD-related dementia, confirmed to have amyloid pathology.…
-
Johnson & Johnson’s Talvey Gets Green Light in South Korea for Multiple Myeloma
•
Johnson & Johnson (J&J; NYSE: JNJ) has announced that its subsidiary Janssen Korea has received approval in South Korea for Talvey (talequetamab), a treatment for multiple myeloma (MM). The drug is indicated for monotherapy in adult patients with relapsed/refractory MM who have received at least three prior therapies, including proteasome…
-
Eli Lilly & Co. Strikes Deal for Radionetics’ GPCR-Targeted Radiopharmaceuticals
•
Eli Lilly & Co. (NYSE: LLY), a leading pharmaceutical company based in the US, has entered into a strategic partnership with fellow US firm Radionetics Oncology to gain access to Radionetics’ pipeline of innovative small molecule G protein coupled receptor (GPCR) targeted radiopharmaceuticals. Under the terms of the agreement, Lilly…
-
Boehringer Ingelheim Initiates Clinical Trial for Novel Anti-Obesity Drug
•
Boehringer Ingelheim (BI), a German pharmaceutical company, has announced the commencement of clinical development for BI 3034701, a potential first-in-class anti-obesity drug. The molecule was originally developed by Denmark-based Gubra A/S (XCSE: GUBRA) and is a long-acting triple-agonist peptide designed to target receptors associated with inducing weight loss, positioning it…
-
Tracon Pharmaceuticals Halts Development of Envafolimab After Clinical Trial Failure
•
Tracon Pharmaceuticals (OTCMKTS: TCON), a US-based biopharmaceutical company, has decided to cease development of its programmed death-ligand 1 (PD-L1) inhibitor, envafolimab, following disappointing results from a clinical trial. The company had obtained the rights to develop this molecule for soft-tissue sarcomas in North America through a 2019 agreement with China’s…
-
Innovent Biologics Presents Positive Phase I Results for IBI343 at ESMO GI Congress 2024
•
Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced the presentation of new results from a Phase I clinical study of its anti-CLDN18.2 antibody-drug conjugate (ADC), IBI343, at the ESMO Gastrointestinal Cancers (ESMO GI) Congress 2024. The study focuses on advanced gastric and gastroesophageal junction…
-
Yantai Dongcheng Pharmaceutical’s 177LuLNC1011 Gets FDA Green Light for Prostate Cancer Clinical Trial
•
Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a pharmaceutical company based in China, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its prostate specific membrane antigen (PSMA)-targeted radioactive in vivo therapeutic drug, 177LuLNC1011. The molecule is intended for evaluation…
-
SCG Cell Therapy Receives FDA Approval for HPV-Targeted SCG142 Clinical Trial
•
SCG Cell Therapy Pte. Ltd, a Singapore-headquartered biotechnology company with a presence in Shanghai, has announced that it has received clearance from the US Food and Drug Administration (FDA) to proceed with a Phase I/II clinical study for its investigational therapy, SCG142. This therapy is a human papillomavirus (HPV) specific…
-
Boao Lecheng Approves Use of Sanofi’s Tzield as First-Line Therapy for Type 1 Diabetes Delay
•
Tzield (teplizumab), recognized as the world’s first and only targeted therapy for delaying the onset of type 1 diabetes, has received approval for use in the Boao Lecheng medical tourism pilot zone as a clinically urgently needed import drug. Developed by French pharmaceutical giant Sanofi, Tzield is indicated for use…
-
Huadong Medicine’s ROR1-Targeting ADC HDM2005 Receives FDA Clinical Trial Approval
•
Huadong Medicine Co., Ltd (SHE: 000963), a pharmaceutical company based in China, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC), HDM2005. This molecule targets recombinant receptor tyrosine kinase-like orphan receptor 1 (ROR1) and is intended…
-
China’s Sichuan Huiyu Pharmaceutical Halts Generic Cytosar Launch Following Strategy Review
•
Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a pharmaceutical company based in China, has announced the withdrawal of its market filing for a generic version of Cytosar (cytarabine), a drug originally developed by US firm Viatris. The decision to withdraw the filing, which was initially submitted in September 2022, is…
-
Eisai and Biogen Launch Alzheimer’s Drug Leqembi in China Following Market Approval
•
Eisai Co., Ltd (TYO: 4523), a Japanese pharmaceutical company, in partnership with Biogen Inc. (NASDAQ: BIIB), has announced the official market launch of Leqembi (lecanemab), a therapy for Alzheimer’s disease (AD), in China. This follows the drug’s official market approval in China in January this year. Leqembi is a humanized…
-
Hinova Pharmaceuticals’ HP518 Earns FDA Fast-Track Designation for AR+ Triple Negative Breast Cancer
•
Hinova Pharmaceuticals (SHA: 688302), a biopharmaceutical company based in China, has announced that it has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its drug candidate HP518 for the treatment of androgen receptor (AR)-positive triple negative breast cancer (TNBC). The Category 1 innovative drug candidate, HP518,…
-
Jiangsu Hengrui’s Henagliflozin Gains Expanded Indication for Type 2 Diabetes Treatment in China
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received an additional indication approval from the National Medical Products Administration (NMPA) for its proline, henagliflozin. The Category 1 drug is now approved for use in combination with retagliptin and metformin to…
-
Gloria Bio’s Motixafortide Approved as Urgently Needed Import Drug by Hainan Medical Products Administration
•
Guangzhou Gloria Biosciences Co., Ltd, a biopharmaceutical company based in China, has received approval from the Hainan Medical Products Administration for its CXCR4 antagonist motixafortide (BL-8040) as a special drug for import due to clinical urgency. The drug will be implemented and administered by Hainan Boao Lu Medical Hospital, a…
-
BeiGene’s Tislelizumab Approved by China’s NMPA for First-Line Extensive Stage Small Cell Lung Cancer
•
BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a biopharmaceutical company, has announced that its programmed-death (PD)-1 monoclonal antibody (mAb), tislelizumab, has received approval from the National Medical Products Administration (NMPA) in China. The drug is now approved to be used in combination with chemotherapy for the treatment of patients with…
-
Staidson Pharmaceutical’s Bemiltenase Alfa Earns Orphan Drug Designation from US FDA for Hemophilia Treatment
•
Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a biopharmaceutical company based in China, has announced that it has received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for its Category 1 biologic bemiltenase alfa (STSP-0601). This designation is for the treatment of hemophilia A or B.…
-
Grand Pharmaceutical Group Ltd’s SIR-Spheres Set to Reach Wider Patient Base Through MediTrust Health Deal
•
Grand Pharmaceutical Group Ltd (HKG: 0512), a leading pharmaceutical company based in China, has announced a strategic partnership with MediTrust Health, an insurance, financing, and direct-to-patient pharmacy subsidiary of Shanghai Pharmaceuticals Holding Co., Ltd. This collaboration will focus on integrating Grand Pharma’s 90Y product into various commercial insurance schemes, aiming…
-
IASO Biotherapeutics’ RD118 CAR-T Therapy Receives Clinical Trial Approval for Multiple Myeloma
•
IASO Biotherapeutics, a biopharmaceutical company based in China, has announced that it has received tacit clinical trial approval from the National Medical Products Administration (NMPA) for its investigational therapy, RD118. RD118 is a fully human GPRC5D-targeted chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of relapsed/refractory multiple myeloma (r/r…
-
Henlius Pharmaceutical’s HLX15 Biosimilar Meets Phase I Clinical Endpoints
•
Shanghai Henlius Biotech Co., Ltd (HKG: 2696) has announced the successful completion of a Phase I clinical study for HLX15, its biosimilar candidate for Johnson & Johnson’s Darzalex (daratumumab). The trial involved healthy Chinese male subjects and met all pre-set endpoints. Daratumumab is a monoclonal antibody therapy indicated for the…
-
CSPC Pharmaceutical’s Enronsubaimab Gets NMPA Nod for Recurrent Cervical Cancer
•
CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) of China has approved its market approval filing for enronsubaimab, a programmed-death 1 (PD-1) monoclonal antibody (mAb). The drug is indicated for the treatment of recurrent or metastatic…
-
Johnson & Johnson Achieves Positive Phase III Results for Nipocalimab in Generalized Myasthenia Gravis
•
Johnson & Johnson (J&J, NYSE: JNJ), a leading US-based healthcare company, has announced positive results from the Phase III trial for nipocalimab, a potential first-in-class anti-FcRn (neonatal Fc receptor) antibody, for the treatment of generalized myasthenia gravis (gMG). The company has achieved its primary endpoint and is preparing for regulatory…
-
Bio-Thera Solutions’ BAT2094 Wins NMPA Nod for Acute Coronary Syndrome Treatment
•
Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug BAT2094 (Betagrin). The drug is indicated for use in patients with acute coronary syndrome who are undergoing percutaneous…
-
Takeda’s CEO Weber Eyes Further Partnerships with Chinese Biotechs Amid Innovation Surge
•
Takeda Pharmaceutical Co., (TYO: 4502, NYSE: TAK), a leading Japanese pharmaceutical company, is actively seeking potential partnerships with Chinese biotech firms, according to CEO Christophe Weber in a recent Bloomberg interview. Weber highlighted that despite finalizing two recent agreements with Chinese companies, Takeda is still “very open” to further collaborations,…
-
Luye Pharma’s Manufacturing Facility Passes FDA Inspection for Paliperidone Palmitate Product
•
Luye Pharma Group (HKG: 2186), a Chinese pharmaceutical company, has announced that it has successfully passed the Pre-Approval Inspections (PAI) by the U.S. Food and Drug Administration (FDA) for its manufacturing facility producing paliperidone palmitate extended-release injectable suspension (LY03010). The inspection was completed without any Form 483 Inspectional Observations, indicating…
-
Sirnaomics’ STP707 Shows Promising Results in Phase I Pancreatic Cancer Trial
•
Sirnaomics Ltd (HKG: 2257), a biopharmaceutical company, has announced the successful completion of a Phase I clinical study for its small interfering RNA (siRNA) drug candidate, STP707, which has shown good safety and preliminary signs of activity in pancreatic cancer. The dose-escalation study was conducted across 11 cancer clinics in…
-
Genmab and AbbVie’s Epcoritamab Earns FDA Accelerated Approval for Follicular Lymphoma
•
Genmab A/S (NASDAQ: GMAB), a Danish biotechnology company, and its co-development partner AbbVie (NYSE: ABBV), have announced that the U.S. Food and Drug Administration (FDA) has granted the first approval for Tepkinly/Epkinly (epcoritamab), an off-the-shelf T-cell engaging CD3xCD20-targeted bispecific antibody (BsAb). The molecule has received accelerated approval for the treatment…
-
Novo Nordisk Plans Cautious Wegovy Launch in China to Preserve Global Supply
•
Novo Nordisk (NYSE: NVO; CPH: NOVO-B), a leading healthcare company, has reportedly planned a cautious market launch for the anti-obesity drug Wegovy (semaglutide) in China following its recent approval. The strategy is aimed at preserving manufacturing capacity and maintaining the stability of global supply chains, according to Maziar Mike Doustdar,…
-
Hybio Pharmaceutical Gets FDA Nod for Tirzepatide Raw Materials in DMF Filing
•
Hybio Pharmaceutical Co., Ltd (SHE: 300199), a Chinese pharmaceutical company, has announced that it has received a Drug Master File (DMF) First Adequate Letter from the U.S. Food and Drug Administration (FDA) for its tirzepatide raw materials. Tirzepatide, a first-to-market dual GIP/GLP-1 receptor agonist, has been approved in the U.S.…
-
Abbisko Therapeutics Presents Positive Phase II Results for HCC Treatment at ESMO-GI
•
Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotech company, has announced the presentation of Phase II study results for its irpagratinib in combination with atezolizumab for the treatment of advanced hepatocellular carcinoma (HCC) at the 2024 ESMO-GI annual meeting. Irpagratinib, a novel FGFR4 inhibitor discovered and developed by Abbisko,…
-
Dizal Pharmaceutical’s Golidocitinib Breaks Record with Rapid Market Launch in China
•
Dizal Pharmaceutical Co., Ltd (SHA: 688192), a biopharmaceutical company based in China, has seen its drug golidocitinib go from marketing approval to first prescriptions in a record time of just two days in China. This marks a significant milestone, as golidocitinib is the first and only approved Janus kinase 1…
-
HighTide Therapeutics Completes Enrollment for Two Phase III Trials of T2DM Drug Candidate HTD1801
•
HighTide Therapeutics Inc., (HKG: 2511), a biopharmaceutical company based in China, has announced the completion of patient enrollment for two Phase III clinical studies of its drug candidate HTD1801 (berberine ursodeoxycholate, BUDCA) for the treatment of type 2 diabetes (T2DM). The studies include the multi-center, randomized, double-blind, placebo-controlled SYMPHONY-1, which…
-
Shanghai Junshi Biosciences’ Toripalimab Gains NMPA Nod for First-Line TNBC Treatment
•
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that it has received an additional indication approval from China’s National Medical Products Administration (NMPA) for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The drug can now be used in combination with Paclitaxel (Albumin bound) for the first-line treatment…
-
Harbour BioMed Resubmits Biological License Application for Batoclimab in China
•
Harbour BioMed (HKG: 2142), a biopharmaceutical company with operations in the United States, the Netherlands, and Suzhou, China, has announced the resubmission of a biological license application (BLA) to China’s National Medical Products Administration (NMPA) for its drug candidate batoclimab (HBM9161) for the treatment of generalized myasthenia gravis (gMG). Batoclimab…
-
Antengene’s Xpovio Included in South Korea’s NHIS Reimbursement Drug List
•
Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced that South Korea’s National Health Insurance Service (NHIS) has included its drug Xpovio (selinexor) in the medical insurance reimbursement drug list, effective from July 1, 2024. The drug is indicated for the treatment of adult patients with…
-
Bio-Thera Solutions’ BAT1806 Biosimilar Receives European Commission Approval
•
Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received market approval from the European Commission (EC) for BAT1806, a biosimilar version of Roche Holding AG’s (OTCM: RHHBY) Actemra/RoActemra (tocilizumab). BAT1806 is indicated for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis,…
-
Novartis’s Scemblix STAMP Inhibitor for CML Accepted for Review by China’s NMPA
•
Novartis (NYSE: NVS), the Swiss pharmaceutical giant, has had its market filing for Scemblix (asciminib) accepted for review by China’s National Medical Products Administration (NMPA). Scemblix is a Specifically Targeting the ABL Myristoyl Pocket (STAMP) inhibitor, which is filed for the treatment of chronic myeloid leukemia (CML). As the world’s…
-
Novo Nordisk’s Ocedurenone Misses Primary Endpoint in Chronic Kidney Disease Trial
•
Novo Nordisk (NYSE: NVO; CPH: NOVO-B), a Danish pharmaceutical company, has announced that its pipeline candidate ocedurenone has failed in a Phase III trial for chronic kidney disease (CKD). The drug did not meet the primary endpoint in the CLARION-CKD study, leading to the cancellation of its development for CKD.…
-
Merck’s HER3-Targeted ADC Patritumab Deruxtecan Faces FDA Complete Response Letter
•
Merck, Sharp & Dohme Inc. (NYSE: MRK), a leading U.S. pharmaceutical company, has announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for patritumab deruxtecan, a first-in-class HER3-targeted antibody-drug conjugate (ADC) discovered by Daiichi Sankyo…
-
Moderna’s RSV Vaccine Efficacy Wanes to 50% After 18 Months, Shares Slide
•
Moderna Inc. (NASDAQ: MRNA), a U.S.-based biopharmaceutical company, has announced long-term efficacy data for its recently approved respiratory syncytial virus (RSV) vaccine, mResvia, showing a decline in effectiveness to approximately 50% after 18 months. This is notably lower than the efficacy rates of RSV vaccines from competitors GSK and Pfizer,…
-
J&J Halts Mid-Stage Trial for Tremfya in Giant Cell Arteritis Due to Efficacy Concerns
•
Johnson & Johnson (J&J; NYSE: JNJ), a leading U.S.-based healthcare company, has reportedly discontinued a mid-stage trial for its autoimmune drug Tremfya (guselkumab) in the treatment of giant cell arteritis, according to a report from BioSpace. An emailed statement from J&J cited “insufficient efficacy findings” as the reason for this…
-
AstraZeneca’s Tagrisso Wins NMPA Approval for First-Line EGFR-mutated NSCLC Treatment
•
AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical company, has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its drug Tagrisso (osimertinib), an EGFR-tyrosine kinase inhibitor (EGFR-TKI). The drug is now approved for use in combination with chemotherapy as a first-line treatment for…
-
Sino Biopharmaceutical Gains NMPA Approval for Liraglutide Biosimilar for Type 2 Diabetes
•
Sino Biopharmaceutical Ltd (HKG: 1177), a major player in China’s pharmaceutical industry, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novo Nordisk’s Victoza (liraglutide), a treatment designed to control blood sugar levels in patients with type 2 diabetes…
-
CSPC Pharmaceutical’s BCMA-Targeted CAR-T Therapy SYS6020 Receives NMPA Clinical Trial Approval
•
CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for SYS6020, a BCMA-targeted chimeric antigen receptor (CAR)-T cell therapy. This marks a significant milestone for the company as SYS6020 is…
-
Novo Nordisk’s Semaglutide for Long-Term Weight Management Receives NMPA Approval
•
Novo Nordisk (NYSE: NVO, CPH: NOVO-B), a leading healthcare company from Denmark, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for semaglutide, indicated for long-term weight management. Globally, Novo Nordisk markets semaglutide under the trade name Wegovy for weight loss. The STEP series…
-
Jiangsu Simcere Pharmaceutical Wins NMPA Nod for Biosimilar Version of Erbitux
•
Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), a Chinese pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for CMAB009, a biosimilar of Merck KGaA/Bristol-Myers Squibb’s (BMS) cetuximab, which is marketed under the trade name Erbitux. The EGFR-targeted monoclonal antibody (mAb) was…
-
Merck KGaA’s Xevinapant Misses Primary Endpoint in Phase III Head and Neck Cancer Trial
•
Merck KGaA (NYSE: MRK), a leading German pharmaceutical company, has encountered a setback in the Phase III clinical trial for xevinapant, a drug licensed from Debiopharm in a deal valued at over USD 1 billion in 2021. The drug, which combines with chemoradiotherapy (CRT), was being investigated in the TrilynX…
-
J&J’s Tecvayli Earns NMPA Approval for Relapsed or Refractory Multiple Myeloma
•
Johnson & Johnson (J&J; NYSE: JNJ), a leading U.S. healthcare company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its bispecific antibody (BsAb) Tecvayli (teclistamab) for the treatment of relapsed or refractory multiple myeloma (r/rMM) in patients who have received three or…
-
Alebund Pharmaceuticals’ AP306 Earns Breakthrough Designation for Chronic Kidney Disease
•
Alebund Pharmaceuticals, based in Shanghai, has announced that its drug candidate AP306 (EOS789), a pan-inhibitor of phosphate transporter proteins NaPi-IIb, PiT-1, and PiT-2, has been granted breakthrough therapy designation (BTD) by the Center for Drug Evaluation. The drug is intended for the treatment of chronic kidney disease hyperphosphatemia. As the…
-
Staidson Pharmaceutical Gets FDA Clearance for TNFR2-Targeted mAb SBT-1901
•
Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a biopharmaceutical company based in China, has announced that it has received clinical clearance from the U.S. Food and Drug Administration (FDA) for its TNFR2-targeted monoclonal antibody (mAb), SBT-1901, for the treatment of locally advanced or metastatic solid tumors. Preclinical studies have demonstrated…
-
Hybio Pharmaceutical’s Biosimilar Liraglutide Gets Temporary FDA Nod Pending Patent Expiry
•
Hybio Pharmaceutical Co., Ltd (SHE: 300199), a Chinese pharmaceutical company, has announced that it has received temporary approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) filing for a biosimilar version of Novo Nordisk’s Victoza (liraglutide). This indicates that the drug has met…
-
Asieris Pharmaceuticals Gets NMPA Green Light for APL-1202 Clinical Trial in FLA Infections
•
Asieris Pharmaceuticals (SHA: 688176), a Chinese specialist in urogenital cancer, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate APL-1202 for the treatment of free-living amoebae (FLA) infections. APL-1202, an oral MetAP2 inhibitor, is currently in a Phase III…
-
Shanghai Haihe Pharmaceutical’s Glumetinib Earns Marketing Approval in Japan for NSCLC Treatment
•
Shanghai Haihe Pharmaceutical Co., Ltd, a Chinese pharmaceutical company, has announced that it has received marketing approval in Japan for its MET targeted tyrosine kinase inhibitor (TKI), glumetinib, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with a MET 14 exon mutation. The approval is…
-
Haisco Pharmaceutical Gets NMPA Green Light for Cofrogliptin to Treat Type 2 Diabetes
•
Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category 1 drug cofrogliptin (HSK7653), a long-acting dipeptidyl peptidase-4 (DPP-4) inhibitor. The drug is now approved for use in improving blood sugar control in patients with…
-
Gan & Lee Pharmaceuticals’ GZR18 Outperforms Market Similars in Weight Reduction Study
•
Gan & Lee Pharmaceuticals (SHA: 603087), a Chinese pharmaceutical company, has announced the presentation of results from a Phase Ib/IIa study for GZR18, a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist, at the American Diabetes Association’s (ADA’s) 84th Scientific Sessions. The study evaluated GZR18’s efficacy in weight reduction for obese/overweight Chinese…
-
Novo Nordisk’s Once-Weekly Insulin Awiqli Approved by China’s NMPA for Type 2 Diabetes
•
The National Medical Products Administration (NMPA) has granted market approval for Awiqli (insulin icodec), a type 2 diabetes treatment developed by Denmark-based Novo Nordisk (NYSE: NVO). Awiqli, the first and only weekly insulin preparation globally, marks a significant milestone as it was developed concurrently in China, the European Union, and…
-
Innovent Biologics’ Mazdutide Shows Promise in Phase III Obesity Trial
•
Innovent Biologics Inc. (HKG: 1801), a biopharmaceutical company based in China, has announced the presentation of key results from the first Phase III clinical trial of mazdutide in Chinese adults with overweight or obesity at the ADA Scientific Sessions 2024. The trial, known as GLORY-1 (NCT05607680), is a multi-center, randomized,…
-
Takeda’s Fruquintinib for Metastatic Colorectal Cancer Receives European Commission Marketing Approval
•
HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that its partner Takeda (TYO: 4502, NYSE: TAK) has received marketing approval from the European Commission for fruquintinib, a treatment for adult patients with metastatic colorectal cancer (CRC) who have previously been treated with chemotherapy regimens based on fluorouracil, oxaliplatin, and…
-
ImmuneOnco Biopharmaceuticals Receives NMPA Approval for CD47 and CD20 Dual-Targeted BsAb in SLE
•
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for IMC-002, a bispecific antibody (BsAb) targeting CD47 and CD20 for the treatment of systemic lupus erythematosus (SLE). IMC-002 is designed to enhance antibody dependent cell phagocytosis…
-
Sichuan Biokin Pharmaceutical Gets NMPA Go-Ahead for BL-M17D1 Solid Tumor Clinical Study
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its bispecific antibody drug conjugate (ADC), BL-M17D1, which is designed for the treatment of advanced solid tumors.…
-
StarryGene Initiates Phase I Clinical Trial for XMVA09 Gene Therapy in wAMD
•
StarryGene, a biotech company specializing in gene therapy and based in Hefei, China, has announced that the first patient has been dosed in a Phase I clinical study for its gene therapy XMVA09 injection, which is designed to treat wet age-related macular degeneration (wAMD). XMVA09 is positioned as the world’s…
-
Gilead’s Lenacapavir Shows 100% Efficacy in Phase III HIV PrEP Study
•
Gilead Sciences Inc. (NASDAQ: GILD), a U.S. biopharmaceutical company, has announced topline results from the Phase III PURPOSE 1 study. The study indicates that lenacapvir has successfully demonstrated its potential as a twice-yearly pre-exposure prophylaxis (PrEP) drug to prevent HIV infection. The trial involved 5,300 cisgender women and adolescent girls…
-
Zai Lab’s Partner Argenx Receives FDA Approval for CIDP Treatment Vygart Hytrulo
•
Argenx SE (NASDAQ: ARGX), the U.S. partner of China-based biopharmaceutical company Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), has announced that the U.S. Food and Drug Administration (FDA) has granted approval for VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).…
-
Qilu Pharmaceutical’s Generic Version of Vyndaqel Receives NMPA Marketing Approval
•
The National Medical Products Administration (NMPA) has granted marketing approval to Qilu Pharmaceutical’s generic version of Pfizer’s Vyndaqel (tafamidis meglumine), marking it as the first generic to pass the generic quality consistency evaluation (GQCE) in China. This development is highlighted on the NMPA’s official website. Tafamidis meglumine is indicated for…
-
Zhangzhou Pien Tze Huang’s PZH2113 Receives NMPA Clinical Trial Approval for Lymphoma Treatment
•
Zhangzhou Pien Tze Huang Pharmaceutical Co., Ltd. (SHA: 600436), a renowned traditional Chinese medicine (TCM) company in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its PZH2113. This is an in-house developed Category 1 chemical drug intended for the treatment…
-
Tonghua Dongbao Pharmaceuticals’ THDBH120 Receives NMPA Approval for Phase II Clinical Trial
•
Tonghua Dongbao Pharmaceuticals (SHA: 600867), based in China, has announced that the National Medical Products Administration (NMPA) has approved the Phase Ib clinical study for its drug candidate THDBH120, a glucagon-like peptide-1/gastrin inhibitor (GLP-1/GIP) dual-targeted receptor agonist. The drug is intended for the treatment of overweight or obese adults. THDBH120…
-
Luye Pharma’s Once-Weekly Parkinson’s Disease Treatment Receives NMPA Approval
•
Luye Pharma Group (HKG: 2186) has announced that it has received marketing approval from the National Medical Products Administration for its once-weekly rotigotine extended-release microspheres for injection (LY03003), indicated for the treatment of Parkinson’s disease (PD). Parkinson’s disease is a prevalent neurodegenerative condition among middle-aged and elderly individuals, characterized by…
-
Fudan-Zhangjiang Bio-Pharmaceutical Advances Aminolevulinic Acid Study for Glioma Visualization
•
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd (HKG: 1349; SHA: 688505) has announced that the first subject has been enrolled in a confirmatory clinical study for its aminolevulinic acid used in the intraoperative visualization of advanced gliomas. This development comes as the company seeks to enhance surgical outcomes for patients with this…
-
Dizal Pharmaceutical’s Golidocitinib Wins NMPA Approval for Relapsed/Refractory PTCL
•
Dizal Pharmaceutical Co., Ltd (SHA: 688192), a spin-off from AstraZeneca China established in 2017, has announced that the National Medical Products Administration (NMPA) has granted approval for its drug golidocitinib. The drug is indicated for the treatment of adult patients with relapsed or refractory (r/r) peripheral T-Cell lymphoma (PTCL) who…
-
Keymed Biosciences’ CM313 Shows Promise in Treating Immune Thrombocytopenia, NEJM Study Says
•
Keymed Biosciences Inc. (HKG: 2162), a biopharmaceutical company based in China, has published results from an exploratory clinical study on its Category 1 drug CM313 in the New England Journal of Medicine. CM313 is a CD38-targeted monoclonal antibody (mAb) being investigated for the treatment of primary immune thrombocytopenia (ITP). The…
-
AbbVie’s Skyrizi Secures FDA Approval for Ulcerative Colitis, Expands Treatment Portfolio
•
AbbVie (NYSE: ABBV) has announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Skyrizi (risankizumab), marking it for use in treating adults with moderate to severely active ulcerative colitis (UC). This approval positions Skyrizi as the first IL-23 specific inhibitor to be approved for…
-
NMPA Releases 81st Batch of Reference Drugs for Generic Quality Consistency Evaluation
•
The National Medical Products Administration (NMPA) has released the 81st batch of reference drugs for generic quality consistency evaluation (GQCE) work, comprising a total of 84 specifications. This batch includes 44 new specifications and 40 specifications that have undergone modifications.- Flcube.com
-
Kanghong Pharmaceutical’s Lumitin Approved in Myanmar for Neovascular AMD Treatment
•
Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773), a Chinese pharmaceutical company, has announced that it has received marketing approval in Myanmar for its product Lumitin (conbercept) for the treatment of neovascular age-related macular degeneration (nAMD). Lumitin, a fusion protein of VEGF receptor and human immunoglobulin Fc segment, is a…
-
Suzhou Zelgen’s Recombinant Human Thyroid Stimulating Hormone Accepted for NMPA Review
•
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its market approval filing for recombinant human thyroid stimulating hormone (rhTSH). The biomacromolecular drug is intended for use in radioactive iodine (131I) whole body…
-
Clover Biopharmaceuticals’ RSV Vaccine Candidate Shows Promising Results in Elderly
•
Clover Biopharmaceuticals Ltd. (HKG: 2197), a biopharmaceutical company based in China, has announced positive preliminary results from the Phase I clinical study of its pipeline candidate SCB-1019 in the elderly population. The molecule is a respiratory syncytial virus (RSV) PreF trimeric subunit candidate vaccine. A total of 48 subjects were…
-
China Medical System’s Methylthioninium Tablets Get NMPA Green Light for Colonoscopy Use
•
China Medical System Holdings (CMS; HKG: 0867) has announced that it has received New Drug Application (NDA) approval from the National Medical Products Administration (NMPA) for its methylthioninium enteric coated sustained-release tablets. This oral formulation is the first of its kind in China and is indicated for enhancing the visualization…
-
AstraZeneca’s AKT Inhibitor Truqap Misses Primary Endpoints in Phase III TNBC Trial
•
AstraZeneca (NASDAQ: AZN), a leading UK-based pharmaceutical company, has encountered a setback in the Phase III clinical trial for its first-in-class adenosine triphosphate (ATP)-competitive AKT inhibitor, Truqap (capivasertib). The trial, known as CAPItelo-290, failed to meet its dual primary endpoints of improved overall survival (OS) in both the overall trial…
-
MSD’s Capvaxive Vaccine Targets 21 Serotypes of Streptococcus Pneumoniae
•
Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK), a leading U.S. pharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has granted approval for Capvaxive (Pneumococcal 21-valent conjugate vaccine). The vaccine is indicated to prevent invasive disease caused by a range of Streptococcus pneumoniae serotypes in adults,…
-
Envonalkib, Chia Tai Tianqing’s Next-Gen ALK Inhibitor, Wins NMPA Approval for Untreated ALK+ NSCLC
•
Chia Tai Tianqing’s next-generation ALK inhibitor, envonalkib, has received approval from the National Medical Products Administration (NMPA) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that tests positive for anaplastic lymphoma kinase (ALK) and have not been previously treated with ALK inhibitors. A…
-
Ascentage Pharma Presents Positive Clinical Results for Olverembatinib and Lisaftoclax at EHA Meeting
•
Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has presented the results of multiple clinical trials for two of its pipeline candidates at the 29th European Hematology Association (EHA) Annual Meeting. The candidates are olverembatinib, a Category 1 drug and approved BCR-ABL inhibitor, and the investigational BCL-2 inhibitor…
-
Nanjing Sanhome’s Oritinib Wins NMPA Approval for EGFR T790M Positive NSCLC
•
Nanjing Sanhome Pharmaceutical Co., Ltd has received approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug oritinib, indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) positive for EGFR T790M mutation in patients who have confirmed disease progression during or…
-
MicroPort Endovascular’s Vewatch Filter Gets NMPA Green Light for Pulmonary Embolism Prevention
•
Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), a Chinese medical device company, has announced that its Vewatch vena cava filter has received approval from the National Medical Products Administration (NMPA) for the prevention of pulmonary embolism caused by thrombus detachment in the inferior vena cava system. This product marks…
-
Kintor Pharmaceutical Initiates Phase II Clinical Trial for Acne Treatment GT20029 in China
•
Kintor Pharmaceutical Ltd (HKG: 9939), a biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase II clinical study for its drug candidate GT20029, which is being investigated for the treatment of acne in China. The Phase II study is a multi-center, randomized, double-blinded,…
-
RemeGen’s Telitacicept Receives NMPA Approval for Clinical Trial in IgG4 Related Diseases
•
RemeGen (HKG: 9995), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate telitacicept in IgG4 related diseases (IgG4 RD), which are at risk of recurrence. Telitacicept is a novel recombinant fusion protein that targets both…
-
Jiangsu Hengrui Medicine Gets NMPA Green Light for Breast Cancer Drug Combo
•
Jiangsu Hengrui Medicine (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate HRS7415 in combination with HRS-8080 for the treatment of breast cancer. HRS7415 is an anti-tumor agent that works by…
-
Shenzhen Chipscreen Biosciences Receives NMPA Approval for Chiauranib Phase II Trial in Pancreatic Cancer
•
Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its Category 1 innovative drug, chiauranib. The drug will be evaluated in combination with chemotherapy…
-
Walvax Biotechnology Halts COVID-19 Vaccine Clinical Trials Citing Low Benefits
•
Walvax Biotechnology Co., Ltd (SHE: 300142), a biopharmaceutical company based in China, has announced the termination of clinical studies for its recombinant COVID-19 vaccine (CHO cell) and recombinant COVID-19 variant vaccine (CHO cell), due to the assessment of low economic and social benefits. The vaccines were approved for clinical trials…
-
Sichuan Kelun-Biotech Receives NMPA Clearance for SKB518 Clinical Trial in Solid Tumors
•
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that it has received clearance from the National Medical Products Administration (NMPA) in China for a clinical trial filing of its pipeline candidate, SKB518. The novel antibody-drug conjugate (ADC) is slated for assessment in patients with general advanced solid tumors. Developed…
-
BioNTech and MediLink’s HER3 ADC BNT326 Faces Partial Clinical Hold in the US
•
BioNTech SE (NASDAQ: BNTX), a German biotechnology company, and its Chinese co-development partner MediLink Therapeutics (Suzhou) Co., Ltd, are facing a partial clinical hold in the U.S. for Phase I development of the HER3-targeted antibody drug conjugate (ADC) BNT326/YL202. The U.S. Food and Drug Administration (FDA) has decided to pause…
-
Takeda’s Soticlestat Misses Primary Endpoints in Phase III Epilepsy Trials
•
Takeda Pharmaceutical Co., Ltd (TYO: 4502; NYSE: TAK), a leading Japanese pharmaceutical company, has announced that its drug candidate soticlestat did not meet the primary endpoints in two Phase III trials. The drug is currently under development for the treatment of two rare forms of epilepsy—Dravet syndrome and Lennox-Gastaut syndrome—and…
-
Amgen’s Blincyto Secures New Indication Approval for B-ALL Consolidation Treatment in the US
•
Amgen (NASDAQ: AMGN) has announced that its bispecific T-cell engager (BiTE) Blincyto (blinatumomab) has received a new indication approval from the U.S. Food and Drug Administration (FDA) for the U.S. market. The drug is now approved for the treatment of adult and pediatric patients aged one month or older with…
-
MSD’s Keytruda Secures FDA Approval for Advanced or Recurrent Endometrial Carcinoma
•
Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that the U.S. Food and Drug Administration (FDA) has granted an additional indication for its programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab). The drug is now approved for use in combination with chemotherapy for adults with primary advanced or recurrent endometrial carcinoma,…
-
FDA Approves Broadened Use of BMS’ Next-Gen TKI Augtyro for Advanced Solid Tumors
•
The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an accelerated approval for its next-generation tyrosine kinase inhibitor (TKI), Augtyro (repotrectinib), for the treatment of locally advanced, metastatic, or unresectable NTRK fusion-positive solid tumors. This decision follows the drug’s progression after treatment or in…
-
Takeda Secures Global Rights to Ascentage Pharma’s Olverembatinib Outside of China and Select Territories
•
Takeda Pharmaceuticals, a leading biopharmaceutical company based in Japan (TYO: 4502), has entered into an option agreement with China-based Ascentage Pharma (HKG: 6855), securing exclusive development and commercialization rights for olverembatinib, a third-generation BCR-ABL tyrosine kinase inhibitor (TKI), in markets outside of China, Hong Kong, Macau, Taiwan, and Russia. The…
-
CARsgen Therapeutics’ Saikaize and CT071 Show Strong Results in EHA Clinical Trials
•
CARsgen Therapeutics, a biopharmaceutical company listed on the Hong Kong Stock Exchange (HKG: 2171), has announced promising results from two pivotal clinical trials at the 29th European Hematology Association Annual Meeting. The data presented highlights the potential of two CAR-T therapies: Saikaize (zevorcabtagene autoleucel), an autologous BCMA-targeted therapy for multiple…
-
RemeGen’s Disitamab Vedotin Shows Positive Results in Phase III Trial for HER2 Positive Breast Cancer
•
RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced positive results from a Phase III clinical trial for its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), in patients with HER2 positive advanced breast cancer with liver metastasis, achieving the trial’s primary endpoint. The open, parallel-controlled, multi-center Phase…
-
CStone Pharmaceuticals Gets NMPA Green Light for Local Production of Gavreto
•
CStone Pharmaceuticals (HKG: 2616), a leading biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to begin local manufacturing of Gavreto (pralsetinib tablets, 300mg), moving away from overseas supply. The company anticipates that domestic production will start by the end…
-
Innovent Biologics’ IBI363 Shows Promising Results in Phase Ia/Ib Trial for Advanced Solid Tumors
•
Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company based in China, has announced the results of a Phase Ia/Ib clinical trial for its investigational PD-1/IL-2 bispecific antibody fusion protein, IBI363. The study’s findings were presented at the European Society for Medical Oncology (ESMO) Annual Congress 2024, highlighting the molecule’s…
-
Cellbri Bio Secures Nearly RMB 200 Million in Series B Financing to Boost CGT Commercialization
•
Shenzhen Cellbri Bio-Innovation Technology Co., Ltd, a prominent player in China’s cell and gene therapy (CGT) sector, has reportedly secured nearly RMB 200 million in a Series B financing round. The round was led by 3E Bioventures, with participation from HongSheng Capital and existing investors including Beijing Shuimu Guoding Investment,…
-
Apeloa Pharmaceutical Partners with Beijing Highthink for CRO Services on Semaglutide Generic
•
Apeloa Pharmaceutical Co., Ltd (SHE: 000739), a China-based pharmaceutical company, has forged a strategic partnership with Beijing Highthink Pharmaceutical Technology Service Co., Ltd. The collaboration is aimed at providing Contract Research Organization (CRO) services, specifically to support a clinical study for Apeloa’s generic version of semaglutide. Under the terms of…
-
Pfizer’s Gene Therapy for Duchenne Muscular Dystrophy Misses Late-Stage Trial Endpoints
•
Pfizer Inc. (NYSE: PFE) has announced that a late-stage clinical trial for its investigational gene therapy, fordadistrogene movaparvovec, in children aged 4 to 7 with Duchenne muscular dystrophy (DMD) failed to meet its primary endpoint of improving motor function. Additionally, secondary endpoints related to motor function showed no significant improvement…
-
AstraZeneca’s Farxiga Receives FDA Approval for Pediatric Type-2 Diabetes Treatment
•
The US Food and Drug Administration (FDA) has granted regulatory approval to AstraZeneca (AZ; NASDAQ: AZN) for its SGLT2 inhibitor, Farxiga (dapagliflozin), expanding its use to pediatric patients aged 10 and above with type-2 diabetes (T2D). This approval supplements the drug’s original indication for adult patients. The FDA’s decision was…
-
Amgen’s Prolia Secures NMPA Approval for Treating Glucocorticoid-Induced Osteoporosis in High-Risk Patients
•
Biopharmaceutical giant Amgen has received marketing approval from China’s National Medical Products Administration (NMPA) for its drug Prolia (denosumab) to treat glucocorticoid-induced osteoporosis (GIOP) in patients at high risk of fractures. This approval marks a significant expansion of Prolia’s indication in China, where it is already approved to treat osteoporosis…
-
Eli Lilly’s Baqsimi Gains NMPA Approval for Diabetes Hypoglycemia Treatment
•
The National Medical Products Administration (NMPA) in China has granted approval to Eli Lilly & Co. (NYSE: LLY) for its Baqsimi (glucagon nasal powder spray), marking a significant advancement in the treatment of severe hypoglycemia in diabetic patients aged four and above. Hypoglycemia, a common and potentially dangerous complication of…
-
Boehringer Ingelheim’s Survodutide Earns Breakthrough Designation for MASH Treatment in China
•
Boehringer Ingelheim (BI), the German pharmaceutical colossus, has declared that it has been granted Breakthrough Therapy Designation (BTD) by China’s Center for Drug Evaluation (CDE) for its experimental drug candidate, survodutide (BI 456906). This designation underscores the drug’s promising therapeutic potential for patients suffering from metabolic dysfunction-associated steatohepatitis (MASH). Derived…
-
Innovent Biologics’ CLDN18.2-Targeted ADC IBI343 Earns FDA Fast-Track Status
•
Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that the US Food and Drug Administration (FDA) has granted Fast-Track designation to its antibody-drug conjugate (ADC), IBI343. This CLDN18.2-targeted therapy has been previously cleared for clinical studies in patients with advanced unresectable or metastatic pancreatic…
-
Zelgen Biopharmaceuticals’ Jacktinib Meets Primary Endpoint in Severe Alopecia Areata Trial
•
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that its Phase III clinical trial for jacktinib tablets, a Category 1 product candidate for severe alopecia areata, has successfully met its primary endpoint. The multi-center, randomized, double-blinded, placebo-controlled trial was conducted to evaluate the…
-
Joincare Pharmaceutical Receives NMPA Approval for Generic Seretide
•
Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380), a leading pharmaceutical company based in China, has announced that it has obtained marketing approval from the National Medical Products Administration (NMPA) for its generic version of GlaxoSmithKline’s (GSK) Seretide (salmeterol, fluticasone). This compound inhalable preparation is now approved for use as…
-
Eli Lilly’s Tirzepatide Hits Primary Endpoint in MASH Trial, Outperforming Placebo
•
Eli Lilly and Company (NYSE: LLY), a global healthcare conglomerate, has announced positive outcomes from a Phase II clinical trial of tirzepatide, a novel GIP/GLP-1 receptor agonist, in patients with metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis. The study successfully achieved its primary endpoint, demonstrating resolution of MASH without exacerbation of…
-
AbbVie-Calico Partnership Advances with FDA Approval for Fosigotifator Trial in Rare Brain Disorder
•
The US Food and Drug Administration (FDA) has welcomed an experimental therapy, fosigotifator, developed by AbbVie Inc. (NYSE: ABBV) and Calico Life Sciences, into its Rare Disease Therapy Pilot Program. The investigational eIF2B activator is currently undergoing a Phase Ib/II clinical trial for the treatment of vanishing white matter (VWM)…
-
Junshi Biosciences’ Toripalimab Scores New Indication for First-Line ES-SCLC Treatment in China
•
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced an expansion of indications for its immunotherapy drug Loqtorzi (toripalimab) following approval from China’s National Medical Products Administration (NMPA). The programmed death-1 (PD-1) inhibitor is now approved for use in combination with chemotherapy for the first-line treatment of patients…
-
Kyowa Kirin’s Evocalcet Wins NMPA Nod for Chronic Kidney Disease Treatment
•
Kyowa Kirin Co. (TYO: 4151), a Japanese pharmaceutical firm, has secured marketing approval from China’s National Medical Products Administration (NMPA) for its novel drug evocalcet. The drug is indicated for the treatment of secondary hyperparathyroidism (SHPT) in patients undergoing maintenance dialysis due to chronic kidney disease (CKD). Evocalcet, classified as…
-
Sperogenix Launches Early Access Program for DMD Therapy Agamgree in Hainan
•
Switzerland-based Santhera Pharmaceuticals (SWX: SANN) has announced that its Chinese partner Sperogenix Therapeutics has initiated an early access program (EAP) for the rare disease therapy Agamgree (vamorolone) in Hainan’s Bo’ao Lecheng Pilot Zone, with the first patients now receiving treatment for Duchenne muscular dystrophy (DMD). Sperogenix secured the rights to…
-
Zymeworks and BeiGene Submit BLA in China for Zanidatamab as Second-Line HER2-Positive BTC Treatment”
•
Zymeworks Inc. (NASDAQ: ZYME), a Canadian biotech company, in partnership with BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235), has submitted a Biologics License Application (BLA) to Chinese regulators for zanidatamab, a bispecific antibody for the treatment of HER2-positive biliary tract cancer (BTC) as a second-line therapy. Zymeworks’ zanidatamab is designed…
-
FDA Committee Backs Eli Lilly’s Donanemab for Early Symptomatic Alzheimer’s Disease
•
This week, a US Food and Drug Administration (FDA) advisory committee endorsed the safety and efficacy of Eli Lilly and Co.’s (NYSE: LLY) donanemab, a biologic therapy that targets amyloid plaques, for its use in treating early symptomatic Alzheimer’s disease (AD). The recommendation follows a request from the regulator earlier…
-
Luye Pharma’s Paliperidone Palmitate Injection Wins NMPA Nod for Schizophrenia Treatment
•
Luye Pharma Group (HKG: 2186), a leading pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its paliperidone palmitate injection. This second-generation antipsychotic long-acting injection is now approved for the treatment of schizophrenia during both the acute and…
-
Junshi Biosciences’ Toripalimab-Bevacizumab Combo Meets Primary Endpoints in HCC Phase III Trial
•
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has declared a significant milestone with its multi-center, randomized Phase III HEPATORCH study. The trial evaluated the combination of Loqtorzi (toripalimab) with bevacizumab for first-line treatment of advanced hepatocellular carcinoma (HCC) and successfully met its primary endpoints, which included progression-free survival…
-
SinoMab BioScience’s SM17 Atopic Dermatitis Drug Reaches First Patient Milestone in Phase Ib Trial
•
SinoMab BioScience Ltd (HKG: 3681), a biotech firm based in Hong Kong, has announced the first patient dosing in a Phase Ib clinical study for SM17, a pioneering drug for atopic dermatitis (AD). The study is designed to evaluate the safety, tolerability, and pharmacokinetics of SM17, along with preliminary efficacy,…
-
CGP’s GPN00884 Myopia Drug Enters Phase I Clinical Trial with First Patient Dosed
•
China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced the commencement of a Phase I clinical study for GPN00884, an innovative ophthalmic drug aimed at arresting the progression of childhood myopia, with the first patient now dosed. This randomized, double-blind, placebo-controlled, dose-escalation study is designed to evaluate…
-
Sino Biopharmaceutical’s KRAS Inhibitor Garsorasib Earns Breakthrough Designation in China
•
Sino Biopharmaceutical Ltd (HKG: 1177), a prominent biopharmaceutical company in China, has announced that its candidate garsorasib (D-1553), a KRAS G12C inhibitor co-developed with InventisBio (Shanghai) Co., Ltd, has been granted Breakthrough Therapy Designation (BTD) by China’s Center for Drug Evaluation (CDE). The designation covers two indications: the treatment of…
-
Ascentage Pharma Gets Green Light for Global Phase III Trial of Olverembatinib in SDH-Deficient GIST
•
Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has announced that it has received approval from the Center for Drug Evaluation (CDE) in China to initiate a global regulatory Phase III study for its Category 1 drug olverembatinib. The study aims to evaluate the efficacy of olverembatinib in…
-
Bayer’s HER2 Targeting Drug BAY 2927088 Earns Breakthrough Designation in China
•
The Center for Drug Evaluation (CDE) in China has granted Breakthrough Therapy Designation (BTD) to German pharmaceutical giant Bayer (ETR: BAYN)’s drug candidate BAY 2927088 for the treatment of HER2 mutant non-small cell lung cancer (NSCLC), as indicated on the CDE’s official website. This marks a significant regulatory milestone for…
-
InnoCare Pharma’s TYK2 Inhibitor ICP-332 Receives FDA IND Approval for Atopic Dermatitis
•
InnoCare Pharma (HKG: 9969, SHA: 688428), a biopharmaceutical company based in China has announced that the US Food and Drug Administration (FDA) has granted Investigational New Drug (IND) approval for its TYK2 inhibitor, ICP-332. This development marks a significant step forward for the company as it seeks to expand its…
-
Novartis’s Tabrecta Earns NMPA Nod for MET-Positive Advanced NSCLC in China
•
Swiss pharmaceutical titan Novartis has secured marketing approval from China’s National Medical Products Administration (NMPA) for its drug Tabrecta (capmatinib), intended for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a mesenchymal–epithelial transition (MET) exon 14 skipping mutation, who have not received…
-
Biosion’s Bosakitug Shows Positive Results in Atopic Dermatitis Phase II POC Study
•
Biosion, a clinical-stage biotechnology company with operations in Delaware, U.S., and China, has announced key findings from its Phase II proof-of-concept (POC) ADAMANT study for bosakitug, a candidate in its pipeline for the treatment of atopic dermatitis (AD). Bosakitug is a monoclonal antibody (mAb) that targets thymic stromal lymphopoietin (TSLP),…
-
Ascletis Pharma’s ASC41 Shows Promise in Phase II Study for Metabolic Dysfunction-Associated Steatohepatitis
•
Ascletis Pharma Inc. (HKG: 1672), a biopharmaceutical company based in China, has announced positive interim results from a 12-week Phase II clinical study of its thyroid hormone receptor β (THRβ) agonist, ASC41, in patients with metabolic dysfunction-associated steatohepatitis (MSAH). The randomized, double-blinded, placebo-controlled, and multi-center Phase II trial demonstrated significant…
-
Shanghai Pharmaceuticals Halts Development of B001 and I022 for Selected Indications
•
Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607) has announced the discontinuation of clinical studies and further development for its drug candidates B001, B001-A, I022, and I022-K. B001, a monoclonal antibody (mAb) intended for the treatment of CD20-positive B-cell non-Hodgkin’s lymphoma (B-NHL), has been suspended following the completion of Phase I,…
-
AI-Powered Biotech Insilico Medicine Initiates Phase I Clinical Trial for Inflammatory Bowel Disease Drug
•
Insilico Medicine, a China-based biotechnology company at the forefront of generative artificial intelligence (AI), has announced that the first patient has been dosed in a Phase I clinical study for its candidate drug ISM5411. This follows the drug’s initial entry into clinical studies in Australia. ISM5411 is an orally administered…
-
Jiangxi Fushine’s Subsidiary LinkChem Eyes Hong Kong IPO Amid Strong Revenue Growth
•
Jiangxi Fushine Pharmaceutical Co., Ltd. (SHE: 300497), a Chinese pharmaceutical company, has announced that its subsidiary, LinkChem, intends to conduct an initial public offering (IPO) on the Hong Kong Stock Exchange. At this stage, no further details regarding the IPO have been disclosed. Established in 2011 and headquartered in Shanghai,…
-
AbbVie’s Telisotuzumab Vedotin Earns Breakthrough Therapy Designation in China for c-Met Positive NSCLC
•
AbbVie Inc. (NYSE: ABBV), a leading pharmaceutical company based in the U.S., has announced that its cutting-edge antibody-drug conjugate (ADC) telisotuzumab vedotin has been granted breakthrough therapy designation (BTD) in China. This designation is for the treatment of advanced or metastatic epidermal growth factor receptor (EGFR) wild-type (WT) non-squamous (NSq)…
-
Qilu Pharmaceutical’s Generic Pomalidomide Wins NMPA Nod for Multiple Myeloma Treatment
•
Qilu Pharmaceutical, a leading pharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) for its generic version of Celgene’s pomalidomide, expanding treatment options for multiple myeloma patients in China. This drug, a derivative of the immunomodulator thalidomide, is recognized for its anti-tumor efficacy. It…
-
Fosun Pharma’s FCN-159 Receives Priority Review Status from NMPA for Pediatric Neurofibromatosis
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has accepted for review its market approval filing for the novel small-molecule drug candidate FCN-159, granting it priority review status. The filing seeks approval for the treatment of plexiform neurofibroma (PN)…
-
Luye Pharma Submits Market Approval Application for Rivastigmine Patch in Japan
•
Luye Pharma Group (HKG: 2186), a leading pharmaceutical company based in China, has announced a market approval filing with the Japanese regulatory authorities for its rivastigmine twice-weekly transdermal patch, LY03013. The company is seeking marketing authorization for the drug to treat symptoms of mild-to-moderate Alzheimer’s disease (AD). Developed on Luye’s…
-
HutchMed Initiates Phase I Clinical Trial for HMPL-506 in Hematologic Malignancies
•
HutchMed (HKG: 0013, NASDAQ: HCM) has announced the commencement of a Phase I clinical study for its investigational compound HMPL-506 in China, with the first patient having already been dosed. The molecule is being evaluated as a potential treatment for various hematologic malignancies. This multi-center, open-label Phase I study is…
-
Sino Biopharmaceutical Presents FS222 Phase I Results at ASCO Annual Meeting
•
Sino Biopharmaceutical Ltd (HKG: 1177), a prominent biopharmaceutical company in China, has presented updates from a Phase I clinical trial for its tetravalent bispecific antibody (BsAb), FS222, at the American Society of Clinical Oncology (ASCO) annual meeting. The study focuses on the use of FS222 in treating advanced solid tumors…
-
Jiangsu Hengrui’s HER2 Targeted ADC SHR-A1811 Poised to Earn Breakthrough Designation in China
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that its HER2 targeted antibody-drug conjugate (ADC), SHR-A1811, is on track to receive breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. This designation is for the treatment of HER2…
-
J&J’s Tecvayli Shows Promising Response Rates in Multiple Myeloma Trial
•
Johnson & Johnson (J&J; NYSE: JNJ) has reported updates from a Phase I/II clinical trial for its bispecific antibody (BsAb) Tecvayli (teclistamab) in patients with relapsed or refractory multiple myeloma (r/rMM) who have received three or more prior lines of treatment. With a median follow-up of 30.4 months, the trial…
-
Bristol Myers Squibb’s Breyanzi Shows Promising Results in Three Lymphoma Trials
•
Bristol Myers Squibb (BMS; NYSE: BMY) has announced results from three distinct clinical trials assessing the efficacy of its CAR-T therapy Breyanzi (lisocabtagene maraleucel) in treating patients with relapsed or refractory large B-cell lymphoma (LBCL), mantle cell lymphoma (MCL), and relapsed or refractory follicular lymphoma (FL). In a placebo-controlled, late-stage…
-
AbelZeta and AstraZeneca’s C-CAR031 Shows Promising Results in HCC Treatment
•
AbelZeta, a Sino-US biotech company with operations in Rockville, Maryland, and Shanghai, has presented data for its armored autologous GPC3-targeted chimeric antigen receptor (CAR) T cell therapy candidate, C-CAR031, at the American Society of Clinical Oncology (ASCO) annual meeting. The CAR-T therapy, co-developed with AstraZeneca (NASDAQ: AZN), is currently in…
-
InnoCare’s Tafasitamab-Lenalidomide Combo on Track for Priority Review in China for DLBCL Treatment
•
The Center for Drug Evaluation (CDE) website has indicated that InnoCare (HKG: 9969; SHA: 688428), a biopharmaceutical company based in China, is on track to receive priority review status for its drug candidate Minjuvi (tafasitamab) in combination with lenalidomide. This treatment is intended for adult patients with recurrent or refractory…
-
Jiangsu Hengrui Receives NMPA Approval to Begin Clinical Trials for New Anticancer Biologic
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational SHR-4849 injection. The therapy is intended for the treatment of advanced malignant solid tumors. The biologic preparation,…
-
AIM Vaccine Submits Pre-IND Applications for mRNA Vaccines Targeting RSV and Herpes Zoster to NMPA
•
AIM Vaccine Co., Ltd (HKG: 6660), a biopharmaceutical company based in China, has announced the submission of pre-Investigational New Drug (pre-IND) filings to China’s National Medical Products Administration (NMPA) for two of its mRNA vaccine candidates. These candidates target the respiratory syncytial virus (RSV) and herpes zoster, respectively. RSV infection…
-
Olymvax Bio Receives Ethical Approval for Oral Helicobacter pylori Vaccine Trial in Australia
•
Olymvax Biopharmaceuticals Inc. (SHA: 688319), a leading vaccine specialist headquartered in Chengdu, China, has announced that it has received ethical approval for a Phase I study for its oral recombinant Helicobacter pylori (HP) vaccine (Escherichia coli) in Australia. The company has completed the clinical trial filing for this proprietary product.…
-
Sanofi Receives NMPA Approval for Phase III Clinical Trial of RSV Vaccine SP0125
•
Sanofi (EPA: SAN), a major French multinational pharmaceutical company, has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for SP0125, a nasal spray respiratory syncytial virus (RSV) attenuated live vaccine intended for use in infants and young children. RSV is among the most…
-
Huadong Medicine’s ROR1-Targeting ADC HDM2005 Cleared for Clinical Trials by China’s NMPA
•
Huadong Medicine Co., Ltd (SHE: 000963), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with clinical trials for HDM2005, an antibody-drug conjugate (ADC) that targets the recombinant receptor tyrosine kinase-like orphan receptor 1 (ROR1). The molecule…
-
Gilead and Arcus Biosciences Report Positive Combination Therapy Results in mCRC Trial
•
Biopharmaceutical companies Gilead (NASDAQ: GILD) and Arcus Biosciences (NYSE: RCUS) have announced safety and efficacy data from a Phase Ib/II clinical trial for a combination therapy in third-line metastatic colorectal cancer (mCRC). The trial evaluated the combination of adenosine receptor antagonist etrumadenant, anti-PD-1 drug zimberelimab, VEGF inhibitor bevacizumab, and chemotherapy…
-
AstraZeneca’s Tagrisso Achieves Milestone Progression-Free Survival in Late-Stage Lung Cancer Study
•
AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical and biopharmaceutical company, has announced preliminary results from a late-stage study for its EGFR inhibitor, Tagrisso (osimertinib), in patients with unresectable, stage III EGFR-mutated non-small cell lung cancer (NSCLC) characterized by exon 19 deletions or exon 21 mutations. The trial successfully met its…
-
MicuRx Pharmaceuticals’ MRX-8 Achieves Positive Results in Phase I Clinical Study
•
MicuRx Pharmaceuticals (SHA: 688373), a Shanghai-based developer of antibacterial drugs, has announced the successful completion of a Phase I clinical study in China for its new drug candidate MRX-8, which targets gram-negative drug-resistant bacteria. The randomized, double-blinded, placebo-controlled Phase I study aimed to evaluate the safety, tolerability, and pharmacokinetic characteristics…
-
Bio-Thera Solutions’ Bevacizumab Biosimilar Avzivi Recommended for Approval by EMA’s CHMP
•
Bio-Thera Solutions (SHA: 688177), a biopharmaceutical company based in Guangzhou, has received notification that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of its biosimilar product, Avzivi (bevacizumab), which is a biosimilar version of Roche’s Avastin. The CHMP’s positive…
-
Akeso Expands Licensing Deal with Summit Therapeutics for Ivonescimab Bispecific Antibody
•
Akeso Inc. (HKG: 9926), a biopharmaceutical company based in China, has announced a supplementary licensing agreement with Summit Therapeutics Inc. (NASDAQ: SMMT) for ivonescimab, Akeso’s bispecific antibody (BsAb) that targets PD-1 and VEGF. The original agreement, valued at a potential USD 5 billion, was signed in December 2022 and granted…
-
Jiangsu Aidea Pharmaceutical Gets Green Light from NMPA for AINUOVirine APIs
•
Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to manufacture the active pharmaceutical ingredients (APIs) for ainuovirine. The APIs correspond to ainuovirine tablets, which are a Category 1 oral therapy for…
-
Allergan Aesthetics’ Botox Secures New Indication for Masseter Muscle Protrusion in China
•
Allergan Aesthetics, a division of AbbVie (NYSE: ABBV), has announced that it has received approval for a new indication from the National Medical Products Administration (NMPA) for its Botox (botulinum toxin type A) product. The drug is now approved for the temporary improvement of significant or very significant masseter muscle…
-
Legend Biotech’s Carvykti Shows Durable Responses in Multiple Myeloma Patients Post ASCT
•
Legend Biotech Corporation (NASDAQ: LEGN) has announced results from the Phase II CARTITUDE-2 Cohort D study of its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), in multiple myeloma (MM) patients. The data was presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, along…
-
CSPC Pharmaceutical Secures NMPA Nod for Generic Version of AstraZeneca’s Lynparza
•
CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of AstraZeneca’s PARP inhibitor Lynparza (olaparib). This marks CSPC Pharmaceutical’s entry into the segment with the third generic…
-
Akeso Biopharma’s Ivonescimab Outshines Keytruda in NSCLC Trial, Raises FDA Concerns
•
FiercePharma.com has reported on the reactions of multinational corporation executives to the recent news that Akeso Biopharma (HKG: 9926) and partner Summit Therapeutics’ ivonescimab, a PD-1/VEGF bispecific antibody (BsAb), has become the first molecule to outperform Merck Sharp & Dohme’s (MSD) leading PD-1 therapy Keytruda (pembrolizumab) in a head-to-head trial…
-
Gilead and Arcus Biosciences Report Positive Interim Phase II Data for Domvanalimab Combo in GI Cancers
•
Gilead (NASDAQ: GILD) and Arcus Biosciences (NYSE: RCUS) have announced interim Phase II data for their anti-TIGIT biologic domvanalimab in combination with the anti-PD-1 drug zimberelimab. The treatment is being investigated for locally advanced unresectable or metastatic upper gastrointestinal cancers. The study, which has a median time on treatment of…
-
Eli Lilly’s KRAS Inhibitor Olomorasib Shows Promise in Phase I/II Trial for Advanced Solid Tumors
•
Eli Lilly and Company (NYSE: LLY) has presented an update on a Phase I/II clinical trial for its KRAS inhibitor, olomorasib, in patients with KRAS G12C-mutant advanced solid tumors. The trial also explores the combination of olomorasib with Merck, Sharp & Dohme’s (MSD; NYSE: MRK) top-selling checkpoint inhibitor, Keytruda (pembrolizumab),…
-
Bristol Myers Squibb’s Krazati Meets Primary Endpoint in Late-Stage Lung Cancer Study
•
Bristol Myers Squibb (BMS; NYSE: BMY) has announced that a late-stage study for its KRAS inhibitor, Krazati (adagrasib), has successfully met its primary endpoint in patients with previously treated locally advanced or metastatic KRASG12C-mutated non-small cell lung cancer (NSCLC). The study demonstrated that Krazati increased median progression-free survival (PFS) from…
-
Pfizer’s Lorbrena Outperforms Xalkori in 5-Year ALK-Positive NSCLC Follow-Up
•
Pfizer Inc. (NYSE: PFE) has announced the release of five-year follow-up data for its kinase inhibitor Lorbrena/Lorviqua (lorlatinib) in untreated ALK-positive advanced non-small cell lung cancer (NSCLC). The data revealed that Lorbrena demonstrated an 81% reduction in the rate of disease progression or death compared to Xalkori (crizotinib), and increased…
-
Astellas Resubmits FDA Application for Vyloy as Treatment for CLDN18.2-Positive Cancer
•
Astellas Pharma Inc. (TYO: 4503), a Japanese pharmaceutical company, has resubmitted its first-in-class anti-CLDN18.2 biologic Vyloy (zolbetuximab) to the US Food and Drug Administration (FDA) for the treatment of locally advanced unresectable or metastatic HER2-negative CLDN18.2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. This resubmission follows an earlier rejection and comes…
-
Simcere Pharma’s Suvemcitug Shows Positive Results in Platinum-Resistant Ovarian Cancer Study
•
Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has presented updated data from the SCORES study for its drug candidate suvemcitug at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Suvemcitug, also known as sevacizumab; APX-003; BD-0801, is being studied in platinum-resistant ovarian cancer. The…
-
Ascentage Pharma’s APG-2449 Shows Positive Results in ROS1 and ALK Positive NSCLC at ASCO 2024
•
Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in Suzhou, has announced a wall poster presentation showcasing the latest data for its FAK/ALK/ROS1 inhibitor APG-2449 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The study determined the recommended Phase II dosage (RP2D) of APG-2449 to be 1200…
-
Jacobio Pharma’s KRAS G12C Inhibitor Combo Shows Promising Results in NSCLC at ASCO 2024
•
Jacobio Pharma (HKG: 1167), a biopharmaceutical company based in China, presented updated data at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting for its KRAS G12C inhibitor glecirasib (JAB-21822) in combination with an SHP2 inhibitor (JAB-3312) as a frontline treatment for non-small cell lung cancer (NSCLC) patients with…
-
Innovent Biologics Presents Clinical Data for Pipeline Candidates at ASCO 2024
•
Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, presented updates on several pipeline candidates at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. IBI343 Phase I Study:The study of IBI343, a CLDN18.2 antibody-drug conjugate (ADC), for advanced pancreatic ductal adenocarcinoma or biliary tract cancer (BTC),…
-
Gilead’s Trodelvy Misses Overall Survival Endpoint in Late-Stage Urothelial Cancer Study
•
Gilead (NASDAQ: GILD) has announced that a late-stage study for its antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) did not meet the primary endpoint of overall survival (OS) in patients with previously treated locally advanced or metastatic urothelial cancer (mUC). This result casts uncertainty over the drug’s accelerated approval indication in…
-
Chipscreen’s Chidamide in Sight of Breakthrough Therapy Designation in China for MSS/pMMR Colorectal Cancer
•
Shenzhen Chipscreen Pharmaceutical Co., Ltd (SHA: 688321), a biopharmaceutical company based in China, has announced that its drug Epidaza (chidamide) is on track to receive a breakthrough therapy designation (BTD) in China. The potential designation is for the use of chidamide in combination with PD-1 inhibitor sintilimab and bevacizumab for…
-
Simcere Pharma’s Anti-Insomnia Drug Daridorexant Meets Primary Endpoint in Phase III Clinical Trial
•
Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced topline results from a Phase III clinical study for Quviviq (daridorexant), an anti-insomnia drug co-developed with Idorsia Pharmaceuticals Ltd, a Swiss pharmaceutical company. The study evaluated the efficacy and safety of daridorexant in Chinese patients with insomnia and successfully met its…
-
ImmuneOnco Receives NMPA Approval for Phase III Clinical Trial of Timdarpacept in CMML
•
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study for its investigational drug timdarpacept (IMM01). IMM01 is an SIRPαFc fusion protein that is being studied for use in combination with…
-
CStone Pharmaceuticals’ Sugemalimab Receives Positive CHMP Opinion for NSCLC Treatment in Europe
•
CStone Pharmaceuticals (HKG: 2616), a biopharmaceutical company based in China, has announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The recommendation is for the approval of sugemalimab in combination with chemotherapy as a first-line…
-
FDA Extends Indication for BMS’ CAR-T Therapy Breyanzi to Include Relapsed MCL in Adults
•
The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension approval for its CAR-T therapy Breyanzi (lisocabtagene maraleucel). The therapy is now approved as a treatment for relapsed or refractory mantle cell lymphoma (MCL) in adults who have received at least two…
-
Novartis Halts Development of KRAS Inhibitor Opnurasib Due to Competitive Market
•
Swiss pharmaceutical giant Novartis AG (NYSE: NVS) has reportedly halted the development of its Phase III KRAS inhibitor candidate, opnurasib, citing an increasingly competitive landscape in the sector. The drug was under development for the treatment of solid tumors, including non-small cell lung cancer (NSCLC). This decision comes in the…
-
Eli Lilly Launches New Formula of Taltz in China with Reduced Injection Site Pain
•
Eli Lilly and Company (NYSE: LLY), a leading pharmaceutical company in the U.S., has announced the launch of a new formula for Taltz (ixekizumab) in China, following its approval in the country in November of the previous year. The new formula of the IL-17A monoclonal antibody (mAb) is free from…
-
Hengrui Medicine Advances Two Drug Candidates Following NMPA Clinical Trial Green Lights
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for two of its drug candidates: HRS-5346 tablets and SHR-9539 injection. HRS-5346, a small molecule drug developed in-house, is…
-
JW Therapeutics Presents Positive Clinical Data for Carteyva in SLE at EULAR 2024
•
JW Therapeutics (HKG: 2126), a biopharmaceutical company based in China, has presented new clinical data for its chimeric antigen receptor (CAR) T cell therapy, Carteyva (relmacabtagene autoleucel injection), at the European Alliance of Associations for Rheumatology (EULAR) 2024 annual meeting. The data was for adult patients in China with active…
-
Akeso Inc.’s Ivonescimab Shows Positive Interim Analysis in Phase III NSCLC Study
•
Akeso Inc. (HKG: 9926), a biopharmaceutical company based in China, has announced positive interim analysis results from the regulatory Phase III HARMONi-2 (AK112-303) study. The study assessed ivonescimab as a monotherapy against pembrolizumab in patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC), specifically targeting patients with…
-
Laekna Therapeutics Initiates Phase III Trial for Breast Cancer Candidate LAE002 in Combination with Fulvestrant
•
Laekna Therapeutics Shanghai Co., Ltd, a biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase III clinical study for its pipeline candidate LAE002 (afuresertib) in combination with fulvestrant. This new treatment regimen targets HR+/HER2- locally advanced or metastatic breast cancer. The multi-center, randomized,…
-
Jiangsu QYuns Therapeutics Initiates Phase III Trial for Skin Disease Candidate QX005N
•
Jiangsu QYuns Therapeutics Co., Ltd (HKG: 2509), a biopharmaceutical company based in China, has announced the enrollment of the first patient in a pivotal Phase III clinical study. The multi-center, randomized, double-blinded, placebo-controlled trial is designed to evaluate the efficacy of QX005N, a monoclonal antibody (mAb) targeting IL-4Rα for the…
-
Wanbangde’s Huperzine A Earns Orphan Drug Status from FDA for Treating Neonatal Brain Injury
•
Wanbangde New Building Materials Co., Ltd (SHE: 002082), a company operating in China, has announced that its drug candidate, huperzine A, has been granted an orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of neonatal hypoxic-ischemic encephalopathy (HIE). This designation is a significant…
-
Zelgen Biopharmaceuticals Gets NMPA Approval for Jacktinib Vitiligo Trial in Adolescents and Adults
•
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II/III study for its Category 1 product candidate, jacktinib tablets. The study will focus on adolescent and adult patients suffering from non-segmental vitiligo.…
-
Hengrui Medicine’s Vitiligo Treatment SHR0302 and Diabetes Drug HRS9531 Get Green Light from China’s NMPA
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading biopharmaceutical company based in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for two of its drug candidates, SHR0302 and HRS9531. SHR0302, a highly selective Janus kinase 1 (JAK1) inhibitor, has…
-
Amgen’s Bkemv Becomes First Biosimilar to Challenge AstraZeneca’s Soliris with FDA Approval
•
Amgen Inc. (NASDAQ: AMGN), a leading biopharmaceutical company, has been granted regulatory approval by the US Food and Drug Administration (FDA) for Bkemv, marking a significant milestone as the first biosimilar in the US to compete with AstraZeneca’s (AZ; NASDAQ: AZN) Soliris (eculizumab). Both the originator drug from AstraZeneca and…
-
Full-Life Technologies Receives FDA Green Light for ²²⁵Ac-FL-020 Clinical Study in mCRPC
•
Full-Life Technologies Ltd, a globally integrated radiotherapeutics company with a presence in Belgium, Germany, and China, has received approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its investigational drug ²²⁵Ac-FL-020 in patients with metastatic castration-resistant prostate cancer (mCRPC). ²²⁵Ac-FL-020 is a PSMA (prostate-specific…
-
Alphamab Oncology’s KN046 Misses Primary Endpoint in Phase III Pancreatic Cancer Study
•
Alphamab Oncology (HKG: 9966), a biopharmaceutical company based in China, has announced disappointing results from the Phase III KN046-303 study for its bispecific antibody (BsAb) KN046. The drug, which targets both programmed cell death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), failed to meet its primary endpoint when used in…
-
Boan Biotech’s Dulaglutide Biosimilar Accepted for Review by China’s CDE
•
Boan Biotech (HKG: 6955), a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) has accepted its marketing filing for BA5101, a biosimilar version of Trulicity (dulaglutide) for blood glucose control in adults with type 2 diabetes. Trulicity, developed by Eli Lilly, a leading pharmaceutical…
-
Hinova Pharmaceuticals to Present Phase I Data for PROTAC Drug HP518 at ASCO 2024
•
Hinova Pharmaceuticals (SHA: 688302), a biopharmaceutical company based in China, is poised to present data from the first-in-human, non-randomized, open-label, multi-center Phase I dosage escalation study of its drug candidate HP518 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. HP518 is an androgen receptor (AR)-targeted PROteolysis TArgeting…
-
Henlius Biotech’s Biosimilar Rituximab Receives First Overseas Marketing Approval from Peru
•
Shanghai Henlius Biotech Co., Ltd (HKG: 2696), a biopharmaceutical company based in China, has announced that it has received marketing approval from the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) of Peru for Hanlikang, its biosimilar version of Roche’s MabThera/Rituxan (rituximab). This marks the first international marketing approval for…
-
Hotgen Biotech Receives FDA Approval to Begin Clinical Trials for Acute Myocardial Infarction Drug
•
Hotgen Biotech Co., Ltd (SHA: 688068), a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the U.S. Food and Drug Administration (FDA) for its innovative drug candidate, SGC001. SGC001, a monoclonal antibody (mAb) co-developed with Capital Medical University, is intended for the emergency…
-
Innovent Biologics’ Picankibart Achieves Positive Results in Phase III Psoriasis Trial
•
Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, has announced the successful completion of a Phase III trial for its pipeline candidate drug, picankibart (IBI112). The drug, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection, has met all primary and key secondary endpoints in the Phase III…
-
Boan Biotech’s Dulaglutide Biosimilar Accepted for Review by China’s CDE
•
Boan Biotech (HKG: 6955), a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) has accepted its marketing filing for BA5101, a biosimilar version of Trulicity (dulaglutide) for blood glucose control in adults with type 2 diabetes. Trulicity, originally developed by US pharmaceutical giant Eli…
-
Hinova Pharmaceuticals to Present HP518 Data at ASCO, Marking First-in-Human Trial Milestone
•
Hinova Pharmaceuticals (SHA: 688302), a biopharmaceutical company based in China, is scheduled to present data from the first-in-human Phase I clinical study of its drug candidate HP518 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The study is an open-label, multi-center dose escalation trial designed to evaluate…
-
Henlius Biotech’s Biosimilar Rituximab Receives First Overseas Marketing Approval from Peru
•
Shanghai Henlius Biotech Co., Ltd (HKG: 2696), a biopharmaceutical company based in China, has announced that it has received marketing approval from the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) of Peru for Hanlikang, a biosimilar version of Roche’s MabThera/Rituxan (rituximab). This marks the first international marketing approval for…
-
Hotgen Biotech Receives FDA Clearance to Initiate Clinical Trials for SGC001
•
Hotgen Biotech Co., Ltd (SHA: 688068), a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the U.S. Food and Drug Administration (FDA) for its innovative drug candidate, SGC001. SGC001 is an investigational monoclonal antibody (mAb) co-developed with Capital Medical University, designed for the…
-
Innovent Biologics’ Picankibart Achieves Positive Results in Phase III Psoriasis Trial
•
Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, has announced the successful conclusion of a Phase III trial for its pipeline candidate drug, picankibart (IBI112). The recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection has met all primary and key secondary endpoints in the Phase III registrational study…
-
Luye Pharma’s Subsidiary Gets NMPA Green Light for Biosimilar Xgeva
•
Shandong Boan Biotechnology Co., Ltd (HKG: 6955), a controlling subsidiary of China-based Luye Pharma Group (HKG: 2186), has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for BA1102, a biosimilar version of Amgen’s Xgeva (denosumab). BA1102 is now approved for use in treating giant…
-
RareStone Group’s Pitolisant Secures NMPA Approval to Treat Narcolepsy in Children and Adolescents
•
RareStone Group, a China-based company specializing in rare diseases (formerly known as Citrine Medicine), has secured marketing approval from the National Medical Products Administration (NMPA) for pitolisant, its in-licensed drug candidate. The histamine 3 (H3) receptor antagonist/inverse agonist is now approved for treating excessive daytime sleepiness (EDS) or cataplexy in…
-
Sanofi’s Sarclisa Receives FDA Priority Review for Newly Diagnosed Multiple Myeloma Treatment
•
Sanofi plc (NYSE: SNY), a leading pharmaceutical company based in France, has announced that the U.S. Food and Drug Administration (FDA) has granted priority review status to a supplemental approval filing for its drug Sarclisa (isatuximab). The priority status is in recognition of the molecule’s potential use in treating adult…
-
Yantai Dongcheng Pharmaceutical Receives NMPA Approval for SSTR2 Targeted Radioactive Drug
•
Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate, 177LuLNC1010. This investigational therapy is a somatostatin receptor 2 (SSTR2) targeted radioactive drug designed for the…
-
Jiangsu Hengrui’s SHR-A1921 Anticipated to Gain NMPA Breakthrough Designation for Ovarian Cancer
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its drug candidate SHR-A1921 is on track to receive breakthrough therapy designation (BTD) from the National Medical Products Administration (NMPA) for the treatment of platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. SHR-A1921 is an antibody…
-
Chinese Biopharma Companies Set to Showcase Oncology Pipelines at ASCO 2024
•
A cohort of Chinese biopharmaceutical companies, including Wuhan YZY Biopharma Co., Ltd (HKG: 2496), Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), JW Therapeutics (HKG: 2126), and CStone Pharmaceuticals (HKG: 2616), are preparing to present updates on their pipeline products at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting,…
-
Novartis’ Fabhalta Shows Promise in Late-Stage C3 Glomerulopathy Trial
•
Novartis AG (NYSE: NVS), a leading Swiss pharmaceutical company, last week announced positive preliminary data from a late-stage study for its complement inhibitor Fabhalta (iptacopan) in patients with the ultra-rare kidney disease C3 glomerulopathy (C3G). The study showed that compared to placebo, iptacopan achieved a 35.1% reduction in proteinuria and…
-
Kexing Pharmaceutical Secures NMPA Approval for Childhood Growth Hormone Deficiency Study
•
Kexing Pharmaceutical (SHA: 688136), based in China, has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study targeting childhood growth hormone deficiency. The clinical trial will investigate a Category I innovative product candidate, an Fc fusion protein designed as a long-acting growth hormone. This molecule…
-
Henlius Biotech’s Denosumab Biosimilar Secures EMA Review for European Market Entry
•
Shanghai Henlius Biotech Inc. (HKG: 2696), a biopharmaceutical company based in China, has announced that the European Medicine Agency (EMA) has accepted two marketing approval filings for its drug candidate HLX14, a biosimilar version of Amgen’s Prolia/Xgeva (denosumab). Denosumab, a recombinant anti-RANKL human monoclonal antibody injection, is utilized for various…
-
Bio-Thera Solutions Receives NMPA Approval for BAT6005 and BAT1308 Combination Therapy Trial
•
Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its drug candidates BAT6005 in combination with BAT1308 for the treatment of locally advanced or metastatic solid tumors. BAT6005…
-
Novartis’ Atrasentan Shows Significant Reduction in Proteinuria in IgA Nephropathy Trial
•
Novartis AG (NYSE: NVS), a Swiss pharmaceutical company, last week presented interim results for the primary endpoint of a Phase III trial for atrasentan in patients with IgA nephropathy (IgAN). The trial indicated that the endothelin A (ETA) receptor antagonist demonstrated a 36.1% reduction in proteinuria at 36 weeks compared…
-
AccurEdit Therapeutics Publishes Positive Data for Gene-Edited Drug ART001 in Amyloidosis Treatment
•
AccurEdit Therapeutics (Suzhou) Co., Ltd., a leading gene editing therapy specialist based in China, has published the efficacy and safety data for its drug candidate ART001, which is being investigated as a treatment for transthyroxine protein amyloidosis. ART001, the first non-viral vector in vivo gene-edited drug in China to enter…
-
Shanghai Fosun Pharma’s FCN-159 File for Dendritic and Histiocytic Tumors Accepted by China’s NMPA
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for the novel small-molecule drug FCN-159 for review. The drug is being considered for the treatment of dendritic and histiocytic tumors, indications that have previously…
-
Akeso Biopharma’s Ivonescimab Approved for NSCLC Treatment in China
•
Akeso Biopharma (HKG: 9926), a biopharmaceutical company based in China, has announced that its bispecific antibody (BsAb) ivonescimab (AK112), which targets programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), has been approved for use in combination with chemotherapy to treat locally advanced or metastatic non-squamous non-small cell lung cancer…
-
Chinese Pharma Companies Set to Showcase Cancer Treatments at ASCO 2024
•
The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 31 to June 4 in Chicago, will feature updates from Chinese pharmaceutical companies Ascentage Pharma (HKG: 6855), Lepu Biotechnology Co., Ltd (HKG: 2157), Transcenta Holding Ltd, and Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) on their…
-
J&J’s Tremfya Meets Primary Endpoints in Phase III Crohn’s Disease Trial
•
Johnson & Johnson (J&J; NYSE: JNJ) has announced that a Phase III trial for its dual-acting biologic Tremfya (guselkumab) has successfully met its composite co-primary endpoints in patients with moderately to severely active Crohn’s disease (CD) when compared to placebo. The study also demonstrated that the IL-23-focused subcutaneous maintenance therapy…
-
Sandoz Receives European Commission Approval for Biosimilars Wyost and Jubbonti
•
The European Commission (EC) has granted registration approval to Sandoz, a Switzerland-headquartered pharmaceutical company (SWX: SDZ), for its biosimilars Wyost and Jubbonti. These products are reference treatments for Amgen’s (NASDAQ: AMGN) bone treatments Xgeva (denosumab) and Prolia (denosumab), respectively. Sandoz anticipates launching the biosimilars in November 2025. Wyost is indicated…
-
Roche’s Genentech Gets Green Light for Vixarelimab UC Clinical Trial in China
•
Roche (SWX: ROG)’s Genentech, a leading biotechnology company based in Switzerland, has received approval to initiate a clinical study in China for its Category 1 drug vixarelimab. The drug will be evaluated as a potential treatment for ulcerative colitis (UC). Vixarelimab is a selective, fully human monoclonal antibody that targets…
-
RemeGen’s Disitamab Vedotin on Track for Breakthrough Designation in Muscle Invasive Bladder Cancer
•
RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced that its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), is poised to receive breakthrough therapy designation (BTD) in China. This designation underscores the molecule’s potential in treating perioperative treatment of muscle invasive bladder cancer (MIBC) with HER2 expression,…
-
Gan & Lee Pharmaceuticals Gains Marketing Approval for Insulin Glargine in Mexico
•
Gan & Lee Pharmaceuticals (SHA: 603087), a Chinese pharmaceutical company, has announced that it has received marketing approval for its insulin glargine pre-filled pen in Mexico. This marks the company’s first marketing authorization as a holder (MAH) in the Mexican market. Insulin glargine, a long-acting insulin analogue that requires daily…
-
Keymed Biosciences’ Stapokibart Earns Priority Review for Chronic Sinusitis Treatment in China
•
Keymed Biosciences Inc., (HKG: 2162), a biopharmaceutical company based in China, has announced that its drug candidate stapokibart (CM310) has been granted priority review status by China’s Center for Drug Evaluation (CDE) for its potential as a treatment for chronic sinusitis with nasal polyps (CRSwNP). The IL-4Rα monoclonal antibody (mAb)…
-
Sino Biopharmaceutical’s Benmelstobart Shows Positive Results in RCC Combination Therapy Study
•
Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced positive interim analysis results from a Phase III clinical study for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450) in combination with anlotinib for the treatment of advanced unresectable or metastatic renal cell carcinoma…
-
Fosun Pharmaceutical’s Humira Biosimilar Gains New Indications with NMPA Approval
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its biosimilar drug HanDaYuan has received additional indication approvals from China’s National Medical Products Administration (NMPA). HanDaYuan, a biosimilar version of AbbVie’s Humira (adalimumab), an autoimmune disease therapy, is now approved to treat a wider range of…
-
Simcere Pharmaceutical’s Quviviq Secures Hong Kong Marketing Approval for Insomnia Treatment
•
Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced that it has received marketing approval from the Hong Kong health authorities for Quviviq (daridorexant), an anti-insomnia drug co-developed with Idorsia Pharmaceuticals Ltd. The dual orexin receptor antagonist (DORA) will now be available in 50mg and 20mg dosages in the region,…
-
NK CellTech’s NK-Cell Therapy Gets Green Light from China’s NMPA for Solid Tumor Treatment
•
NK CellTech, a Shanghai-based developer of natural killer (NK) cell therapies, has announced that it has received clinical clearance from China’s National Medical Products Administration (NMPA) for its proprietary genetically modified NK-cell therapy. This marks a significant milestone as the company’s molecule is set to be assessed as a treatment…
-
Laekna Therapeutics’ mCRPC Drug Combo Advances to Phase III with FDA Approval
•
Laekna Therapeutics Shanghai Co., Ltd, a biopharmaceutical company based in China, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase III clinical study for its drug combination LAE001 and LAE002 (afuresertib) in patients with metastatic castration-resistant prostate cancer (mCRPC) who…
-
Changchun High & New Technology Industries Gets Green Light for Jinnamab Clinical Trial
•
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661), a leading biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 biologic product, jinnamab. This marks a significant milestone for the…
-
Jiangsu Hengrui’s Fluzoparib Gains NMPA Approval as Maintenance Therapy for Ovarian Cancer
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that the National Medical Products Administration (NMPA) has approved a new indication for its PARP inhibitor, fluzoparib. The drug is now approved for use as a maintenance therapy in patients with advanced epithelial ovarian cancer,…
-
Sichuan Biokin’s BL-B01D1 Advances to Phase III for HR+/HER2- Breast Cancer
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese biopharmaceutical company, has announced the enrollment of the first patient in a Phase III clinical study for its investigational bispecific antibody-drug conjugate (ADC), BL-B01D1. This in-house developed molecule is designed to target locally advanced, recurrent, or metastatic HR+/HER2- breast cancer. The…
-
Alphamab Oncology’s JSKN016 Begins Phase I Clinical Trial for Solid Tumor Treatment
•
Alphamab Oncology (HKG: 9966), a biopharmaceutical company, has announced that the first patient has been dosed in a Phase I clinical study for JSKN016, its innovative antibody-drug conjugate (ADC) targeting both HER3 and TROP2 in patients with solid tumors. The open-label, multi-center Phase I study is designed to conduct a…
-
Jacobio Pharma’s Gecirasib Gets Priority Review for NSCLC Treatment by China’s NMPA
•
Jacobio Pharma (HKG: 1167), a leading biopharmaceutical company based in China, has announced that its New Drug Application (NDA) for glecirasib has been accepted by China’s National Medical Products Administration (NMPA) with priority review status. The KRAS G12C inhibitor is being reviewed for its potential as a treatment for second-line…
-
Shanghai Fosun Pharma’s FCN-159 Receives Priority Review for Pediatric Neurofibromatosis Treatment
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has achieved a significant milestone with its novel small-molecule chemical drug FCN-159, as indicated on the Center for Drug Evaluation’s (CDE) website. The drug has been granted priority review status for the treatment of plexiform neurofibroma (PN) in children aged…
-
Eli Lilly’s Tirzepatide Earns China Approval for Type 2 Diabetes Treatment
•
Eli Lilly & Co. (NYSE: LLY), a leading US pharmaceutical company, has announced that it has received its first market approval from the National Medical Products Administration (NMPA) in China for Mounjaro (tirzepatide). The drug is indicated for the treatment of type 2 diabetes mellitus (T2DM) in patients who have…
-
Gilead’s Seladelpar Shows Interim Benefits in PBC-Related Itch Clinical Trial
•
Gilead Sciences (NASDAQ: GILD) has announced interim results from a long-term study assessing the safety and efficacy of seladelpar, a PPAR-delta agonist, in treating pruritus associated with primary biliary cholangitis (PBC). The trial involved patients who had an inadequate response or were intolerant to ursodeoxycholic acid (UDCA), with 70% of…
-
BMS’s Sotyktu Sustains Clinical Response in Long-Term Psoriasis Treatment
•
Bristol Myers Squibb (BMS; NYSE: BMY) has announced the release of long-term clinical data for Sotyktu (deucravacitinib), the company’s tyrosine kinase 2 (TYK2) inhibitor, used in the treatment of moderate-to-severe plaque psoriasis. The data, which spans a four-year period, indicates that the first-in-class drug has maintained a clinical response rate…
-
Jiangsu Hengrui’s SHR1905 Anti-TSLP mAb Gets Green Light for COPD Clinical Trial
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent Chinese pharmaceutical company, announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its Category 1 product, SHR1905. This product is a hymic stromal lymphopoietin (TSLP)-targeted monoclonal antibody (mAb) intended for…
-
Innovent Biologics’ IBI311 New Drug Application Accepted for Review by China’s CDE
•
Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company in China, has announced that the New Drug Application (NDA) for its investigational drug candidate IBI311 has been accepted for review by the Center for Drug Evaluation (CDE). IBI311 is a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody developed for…
-
Zai Lab and Innoviva Win China Approval for SUL-DUR to Treat Hospital-Acquired Pneumonia
•
Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a China-based biopharmaceutical company, in collaboration with US partner Innoviva Specialty Therapeutics, has announced the marketing approval of Sulbactam-Durlobactam (SUL-DUR) by China’s National Medical Products Administration (NMPA). The novel intravenous combination antibiotic is now approved for the treatment of hospital-acquired bacterial pneumonia (HABP)…
-
FDA Gives Accelerated Nod to Amgen’s Imdelltra in Small Cell Lung Cancer
•
The US Food and Drug Administration (FDA) has granted accelerated approval to Amgen (NASDAQ: AMGN) for its bispecific T-cell engager (BiTE), Imdelltra (tarlatamab), for the treatment of extensive-stage small cell lung cancer (ES-SCLC) that has proven unresponsive to chemotherapy. This accelerated approval is based on early Phase II data highlighting…
-
Eli Lilly’s Weekly Insulin Efsitora Alfa Matches Daily Basal Insulins in Reducing A1C Levels
•
Eli Lilly and Company (NYSE: LLY), a global healthcare company, has announced results from a comparative study on its once-weekly insulin efsitora alfa. The study demonstrated that efsitora alfa is non-inferior in reducing A1C levels compared to daily basal insulins degludec or glargine in adults with type 2 diabetes (T2D).…
-
Biotherus Inc. Advances PM8002 Bispecific Antibody to Phase III for Triple Negative Breast Cancer
•
China’s Biotheus Inc. has announced the initiation of a Phase III clinical study for its investigational bispecific antibody, PM8002, which targets both PD-L1 and VEGF. The study will evaluate the safety and efficacy of PM8002 in combination with chemotherapy as a first-line treatment for patients with locally advanced or metastatic…
-
Jiangsu Hengrui’s Camrelizumab/Apatinib Combo Denied FDA Approval Over Manufacturing Issues
•
The US Food and Drug Administration (FDA) has issued a complete response letter to Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a Chinese pharmaceutical company, regarding its application for camrelizumab, a programmed death-1 (PD-1) monoclonal antibody (mAb), in combination with small-molecule targeted cancer therapy apatinib. The treatment was being considered…
-
ImmuneOnco Biopharmaceuticals’ CD47 Inhibitor Receives NMPA Go-Ahead for Phase III Trial
•
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study for timdarpacept (IMM01), the first SIRPαFc fusion protein targeting CD47 to be designed in China. The study will evaluate the safety and efficacy…
-
CSPC Pharmaceutical’s βKlotho Monoclonal Antibody JMT202 Receives Clinical Trial Approval from NMPA
•
CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its βKlotho monoclonal antibody (mAb), JMT202. This molecule is intended to reduce triglyceride (TG) levels in patients…
-
Roche’s CT-388 Shows Significant Weight Loss in Phase I Clinical Trial for Obesity
•
Switzerland-based healthcare giant Roche (SWX: ROG) has announced preliminary results from a Phase I study of its investigational dual GLP-1/GIP receptor agonist, CT-388. The study is assessing the drug’s effects in obese adults, both healthy and those with type 2 diabetes (T2D). Initial data from the healthy cohort showed that…
-
Eisai to Support Grassroots Healthcare in China with Significant Pariet Donation
•
Eisai (TYO: 4523), a leading Japanese pharmaceutical company, has announced its commitment to donate 100,000 boxes of the gastresophageal reflux disease (GERD) medication Pariet (rabeprazole) to the Beijing Health Alliance Charitable Foundation. This initiative is designed to support a new program aimed at enhancing the capabilities of grassroots health care…
-
North China Pharmaceutical’s Ormutivimab Approved for Pediatric Use in China
•
North China Pharmaceutical Group Corporation (SHA: 600812) has announced that it has received approval from the National Medical Products Administration (NMPA) for a new indication for its Category 1 therapeutic biologic, ormutivimab. The drug, a recombinant humanized rabies virus monoclonal antibody (mAb), is now approved for use in children aged…
-
HutchMed’s Sovleplenib Phase III Results to be Showcased at EHA 2024
•
HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013), a biopharmaceutical company based in China, is preparing to unveil the topline and subgroup results from the Phase III ESLIM-01 study at the European Hematology Association’s (EHA) 2024 annual conference. Additionally, the company will present updated clinical data for its hematological malignancy therapies…
-
Shanghai UniCAR-Therapy’s Innovative CAR-T Therapy Targets Breakthrough Designation with IL-6 Silencing
•
Shanghai UniCAR-Therapy Bio-Medicine Technology Co., Ltd, a leading biopharmaceutical company based in China, is on track to secure breakthrough therapy designation (BTD) for its innovative autologous CD19 targeted chimeric antigen receptor (CAR) T-cell therapy. This therapy features a unique function of silencing interleukin-6 (IL-6) expression and is intended for the…
-
Bayer’s 225Ac-PSMA-Trillium Therapy Begins Early-Stage Clinical Trial for mCRPC
•
Bayer AG (ETR: BAYN), a multinational pharmaceutical company based in Germany, has this week commenced an early-stage trial for its targeted radionuclide therapy, 225Ac-PSMA-Trillium. The trial is focused on treating advanced metastatic castration-resistant prostate cancer (mCRPC). This innovative therapeutic candidate incorporates a PSMA-targeting small molecule designed to deliver an alpha…
-
Olymvax Biopharmaceuticals Gets Green Light for Tetravalent Influenza Vaccine Clinical Trial
•
Olymvax Biopharmaceuticals Inc. (SHA: 688319), a leading vaccine specialist headquartered in Chengdu, China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its tetravalent influenza virus split vaccine (MDCK cells). This vaccine is designed to prevent influenza caused by…
-
Insilico Medicine’s ISM8207 Enters Phase I Clinical Trial for Lymphoma and Solid Tumors
•
China’s generative artificial intelligence (AI)-driven biotech firm, Insilico Medicine, has announced the first patient dosing in a Phase I clinical study for ISM8207, a potential first-in-class drug candidate co-developed with Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196). The open-label, multi-center Phase I study aims to evaluate the…
-
Everest Medicines Commences Commercial Sales of Nefecon in China Post-Launch
•
Everest Medicines (HKG: 1952), a leading pharmaceutical company based in China, has announced the official commercialization of Nefecon (targeted-release formulation budesonide) in China, marking a significant milestone with the issuance of the first prescription in the country. Nefecon is a patented oral, delayed-release formulation of budesonide, a corticosteroid with significant…
-
Fosun Pharmaceutical Advances Lasofocine Clinical Trials for Breast Cancer after NMPA Nod
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct two clinical studies for lasofociene. The first trial is a Phase I study in healthy subjects, while the second is a global multi-center Phase…
-
Zai Lab Advances Vygart Hytrulo for CIDP with sBLA Filing in China
•
Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a biopharmaceutical company based in China, has announced the filing of a supplemental Biologics License Application (sBLA) in China for Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). The sBLA seeks to expand Vygart’s indication to include the treatment of chronic inflammatory demyelinating polyneuropathy…
-
Jiangsu Hengrui’s SHR-2173 Gets Green Light for Clinical Trial in IgA Nephropathy
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for SHR-2173, an investigational biologic, in patients with IgA nephropathy. Developed in-house, SHR-2173 is designed to target abnormally…
-
ViiV Healthcare’s HIV-PreP Therapy Approved by China’s NMPA, Offers Alternative to Daily Medication
•
GlaxoSmithKline’s (GSK; NYSE: GSK) subsidiary, ViiV Healthcare, has announced that it has received marketing approvals from China’s National Medical Products Administration (NMPA) for both cabotegravir tablets and cabotegravir injection. These medications are intended for pre-exposure prophylaxis (PrEP) of HIV-1 in adults and adolescents weighing at least 35kg who are at…
-
Tonghua Dongbao Pharmaceuticals Begins Clinical Trial for Xultophy Biosimilar
•
Tonghua Dongbao Pharmaceuticals (SHA: 600867), a Chinese pharmaceutical company, has announced the dosing of the first patient in a Phase I clinical study for its insulin degludec and liraglutide combination drug. This molecule is a biosimilar version of Novo Nordisk’s Xultophy, the first compound preparation to combine a basal insulin…
-
Novo Nordisk’s Wegovy Shows Durable Weight Loss and Heart Health in Extended Trials
•
At the 31st European Congress on Obesity (ECO), Denmark’s pharmaceutical giant Novo Nordisk (CPH: NOVO-B) presented findings from two studies on its weight loss therapy Wegovy (semaglutide). The data indicated that Wegovy’s weight loss effects can be sustained for up to 4 years, along with cardiovascular benefits, irrespective of the…
-
RemeGen’s Telitacicept Achieves Full Enrollment in Phase III Primary Sjogren’s Syndrome Trial
•
China-based pharmaceutical company RemeGen (HKG: 9995) has announced the completion of patient enrollment in a Phase III clinical study for its drug candidate telitacicept in primary Sjogren’s syndrome (pSS) in China. The study aims to evaluate the efficacy and safety of telitacicept in pSS, with a total of 381 patients…
-
Bayer’s Q1 2024 Report Shows Slight Dip in Sales Amid Pharmaceutical Unit’s Growth
•
Germany-based Bayer (ETR: BAYN) has released its financial report for the first quarter of 2024, showing a slight 0.6% year-on-year (YOY) decrease in group sales to EUR 13.8 billion (USD 14.9 billion), excluding portfolio and exchange rate effects. The pharmaceuticals business segment reported a 3.9% increase in sales, reaching EUR…
-
Novo Nordisk’s Bispecific Antibody Mim8 Achieves Milestone in Haemophilia A Trial
•
Novo Nordisk (CPH: NOVO-B), a pharmaceutical company based in Denmark, has announced that its bispecific antibody (BsAb) Mim8 has successfully met the primary endpoints in a late-stage trial for haemophilia A. The trial focused on the reduction of treated bleeding episodes, with once-weekly and once-monthly doses of Mim8 showing reductions…
-
Novo Nordisk’s Mim8 for Haemophilia A Exceeds Endpoints in Late-Stage Trial
•
Denmark-based healthcare company Novo Nordisk (CPH: NOVO-B) has announced positive results from a late-stage trial of its bispecific antibody (BsAb) Mim8, used for the treatment of haemophilia A. The trial successfully met its primary endpoints, which focused on the reduction of treated bleeding episodes. The study demonstrated that once-weekly and…
-
Roche and Genprex Initiate Phase I Trial Combining Tecentriq and Reqorsa for ES-SCLC
•
Switzerland-based Roche (SWX: ROG) is advancing the evaluation of its anti-PD-L1 drug, Tecentriq (atezolizumab), in combination with Genprex’s (NASDAQ: GNPX) gene therapy, Reqorsa (quaratusugene ozeplasmid), for the treatment of extensive-stage small cell lung cancer (ES-SCLC). Genprex has initiated the dose escalation phase of a Phase I clinical trial, with the…
-
BeiGene’s Brukinsa Secures Conditional Approval in China for R/R Follicular Lymphoma
•
BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading biopharmaceutical company based in China, has received conditional approval from the National Medical Products Administration (NMPA) for its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib). The approval is for the use of Brukinsa in combination with the CD20-targeted obinutuzumab for…
-
MSD Discontinues Vibostolimab and Keytruda Combo Trial in High-Risk Melanoma
•
Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced its decision to cease development of the anti-TIGIT antibody vibostolimab in combination with its anti-PD-1 drug Keytruda (pembrolizumab) as an adjuvant treatment for resected high-risk melanoma. This strategic move follows an interim analysis that failed to meet the primary endpoint of…
-
HutchMed’s HMPL-306 Advances to Phase III Trial in R/R AML Patients
•
HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced the commencement of the RAPHAEL study, a pivotal multi-center, randomized, open-label, regulatory Phase III trial. The study aims to evaluate the efficacy and safety of HMPL-306 in patients with recurrent/refractory (R/R) acute myeloid leukemia (AML) featuring isocitrate dehydrogenase (IDH) 1 or…
-
Zai Lab’s ROS1 Inhibitor Augtyro Earns NMPA Nod for Advanced NSCLC Treatment
•
Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a biopharmaceutical company based in China, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Augtyro (repotrectinib). This treatment is intended for adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).…
-
NMPA Accepts Jiangsu Yahong Meditech’s Application for Cervical HSIL Treatment Cevira
•
Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176), a specialist in urogenital cancer treatments in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its market approval filing for Cevira (APL-1702) for the treatment of high-grade squamous intraepithelial lesions (HSIL) of the cervix, excluding in…
-
Mabwell’s 9MW2821 ADC for Triple Negative Breast Cancer Accepted for Review by NMPA
•
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review a clinical trial filing for its pipeline candidate, 9MW2821. This antibody drug conjugate (ADC) targets Nectin-4 and is planned to be assessed in combination…
-
Huadong Medicine’s EGFR Inhibitor Mefatinib for NSCLC Accepted by NMPA for Review
•
Huadong Medicine Co., Ltd (SHE: 000963), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its filing for market approval of mefatinib. The drug is proposed as a first-line treatment for locally advanced or metastatic non-small cell lung cancer…
-
Shenzhen Hepalink’s Enoxaparin Sodium Gets Green Light in Singapore
•
Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399), a leading pharmaceutical company based in China, has announced that it has received marketing approval from the Health Sciences Authority of Singapore for its enoxaparin sodium injection in four specifications: 0.2ml:20mg, 0.4ml:40mg, 0.6ml:60mg, and 0.8ml:80mg. The approval is valid for a period…
-
BMS’s Opdivo/Yervoy Combo Misses PFS Endpoint in Unresectable Stage III NSCLC Trial
•
Bristol-Myers Squibb (BMS; NYSE: BMY) has announced that a late-stage trial for its checkpoint inhibitors Opdivo (nivolumab) and Yervoy (ipilimumab) in patients with unresectable stage III non-small cell lung cancer (NSCLC) did not achieve its primary endpoint of progression-free survival (PFS). The study compared the efficacy and safety of Opdivo…
-
FDA Reviews BMS’ Opdivo Subcutaneous Formulation for Broad Indications
•
The US Food and Drug Administration (FDA) has agreed to review a submission from Bristol-Myers Squibb (BMS; NYSE: BMY) for a subcutaneous formulation of its anti-PD-1 therapy Opdivo (nivolumab). The new formulation utilizes Halozyme Therapeutics’ (NASDAQ: HALO) proprietary hyaluronidase (rHuPH20) and aims to cover all previously approved indications for the…
-
Yunnan Baiyao’s Radiopharmaceutical INR101 Advances to Clinical Trial Stage with NMPA Approval
•
Yunnan Baiyao Group Co., Ltd (SHE: 000538), a traditional Chinese medicine (TCM) company based in Kunming, has received approval from the National Medical Products Administration (NMPA) in China to conduct a clinical study for its Category 1 chemical drug, INR101. The study will initially assess the drug in healthy volunteers…
-
Eisai’s Fycompa Gains New Indication for Generalized Tonic-Clonic Seizures in China
•
Eisai Co Ltd (TYO: 4523), a Japanese pharmaceutical company, has announced that its antiepilepsy drug (AED) Fycompa (perampanel) has received a new indication approval from China’s National Medical Products Administration (NMPA). The drug is now approved for use as an additional treatment for adults and children aged 12 and above…
-
Jacobio Pharma’s KRAS G12C Inhibitor Gains NMPA Approval for Phase III CRC Study
•
Jacobio Pharma (HKG: 1167), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a regulatory Phase III clinical study. The study will evaluate the combination of the company’s KRAS G12C inhibitor, glecirasib, with Erbitux (cetuximab) for…
-
Qilu Pharmaceutical Achieves First Approval for Generic Bendamustine in China
•
The National Medical Products Administration (NMPA) has granted marketing approval to Qilu Pharmaceutical’s generic bendamustine, marking it as the first of its kind in China for the treatment of malignant tumors. Bendamustine, a bifunctional nitrogen mustard derivative, is recognized for its ability to induce cell death through multiple mechanisms, thereby…
-
MSD’s Keytruda Adjuvant Treatment for High-Risk Endometrial Cancer Fails to Meet Primary Endpoint
•
Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that a late-stage trial for its blockbuster drug Keytruda (pembrolizumab) as an adjuvant treatment in newly diagnosed, high-risk endometrial cancer failed to meet the primary endpoint of disease-free survival (DFS). Although the analysis of the co-primary endpoint of overall survival (OS)…
-
WestGene Biopharma’s Groundbreaking mRNA Vaccine for EB Virus Tumors Gets FDA Green Light
•
WestGene Biopharma Co., Ltd., a biopharmaceutical company based in Chengdu, has announced that its drug candidate WGc-043 has been approved for clinical trials by the US Food and Drug Administration (FDA). WGc-043 is recognized as the world’s first clinically approved mRNA therapeutic vaccine targeting Epstein-Barr (EB) virus-related tumors. The vaccine…
-
ReJuKon Biopharm’s RJK002 Earns Tacit Approval for Amyotrophic Lateral Sclerosis Clinical Trial
•
Shanghai-based ReJuKon Biopharm Inc. has announced that its Category 1 drug RJK002 has received tacit clinical trial approval from China’s Center for Drug Evaluation (CDE) for the treatment of amyotrophic lateral sclerosis (ALS). RJK002 is recognized as the first clinically approved adeno-associated virus (AAV) gene therapy for ALS in China…
-
BioNTech Secures Global Rights to Biotheus Inc.’s Pre-Clinical Bispecific Antibody
•
Biotheus Inc., a biopharmaceutical company based in China, has announced that its German partner BioNTech (NASDAQ: BNTX) has exercised a global exclusive option right, securing the rights to globally develop, manufacture, and commercialize Biotheus’s in-house developed pre-clinical bispecific antibody (BsAb) candidate drug. Upon the option exercise, Biotheus will receive option…
-
China Grants Marketing Nod to Ferring Pharmaceuticals’ Rekovelle for Assisted Reproduction
•
Switzerland-based Ferring Pharmaceuticals Ltd announced that its recombinant human follicle stimulating hormone δ injection, Rekovelle, has been granted marketing approval in China. This product, a recombinant follicle stimulating hormone (rFSH) known as follitropin delta derived from human cell lines, has already received approvals across numerous countries and regions. It is…
-
Chia Tai Tianqing’s PD-L1 Antibody Benmelstobart Wins NMPA Nod for ES-SCLC
•
China-based Chia Tai Tianqing has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450). The drug is approved as a first-line treatment for extensive stage small cell lung cancer (ES-SCLC) in combination with anlotinib…
-
Sichuan Biokin Pharmaceutical Advances BL-B16D1 to Clinical Trial for Advanced Solid Tumors
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its in-house developed bispecific antibody drug conjugate (ADC), BL-B16D1, in patients with advanced solid tumors. Biokin Pharma,…
-
Bio-Thera Solutions’ PD-1 and ADC Combo Gets NMPA Approval for Clinical Trial in Solid Tumors
•
Bio-Thera Solutions, Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for a combination therapy of BAT1308 and BAT8006 in patients with advanced solid tumors. BAT1308 is an in-house developed programmed death-1 (PD-1) monoclonal…
-
Sandoz Q1 2024 Results Highlight 6% Growth, Led by Biosimilars and European Strength
•
Switzerland-based Sandoz (SWX: SDZ) has reported its financial results for the first quarter of 2024, announcing sales of USD 2.5 billion, marking a 6% year-on-year (YOY) increase in constant currency terms. This growth was driven by contributions from all regions. Generics sales experienced a modest 1% YOY increase to USD…
-
Jiangsu QYuns Therapeutics Gets NMPA Green Light for CSU Treatment QX013N
•
Jiangsu QYuns Therapeutics Co., Ltd (HKG: 2509), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its monoclonal antibody (mAb), QX013N. The drug is intended to treat chronic spontaneous urticaria (CSU), a common…
-
Laekna’s ActRIIA Monoclonal Antibody LAE102 Gets Green Light from China’s CDE for Obesity Treatment
•
Sino-US biotech firm Laekna has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) for its monoclonal antibody drug candidate, LAE102, intended for the treatment of obesity. This development follows the drug’s previous clinical trial approval in the US last month. In-house developed, LAE102…
-
Novo Nordisk’s Q1 2024 Global Sales Surge 24% YOY on Strength of GLP-1 Therapies
•
Denmark-based pharmaceutical giant Novo Nordisk (CPH: NOVO-B) reported a substantial 24% year-on-year (YOY) increase in global sales for the first quarter of 2024, reaching DKK 65.3 billion (USD 9.4 billion) at constant exchange rates (CER). The growth was primarily attributed to strong performances in glucagon-like peptide-1 (GLP-1)-based drugs and obesity…
-
Jiangsu Hengrui Medicine Advances HRS-5965 with NMPA Clinical Trial Approval for Glomerular Diseases
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company based in China, has been granted approval by the National Medical Products Administration (NMPA) to initiate a clinical study for HRS-5965, a novel therapeutic targeting primary or secondary glomerular diseases. The conditions include IgA nephropathy, idiopathic membranous nephropathy, C3…
-
Innovent Biologics’ Mazdutide Shows Superiority in Type 2 Diabetes Phase III Trial
•
Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that its Phase III DREAMS-2 study for mazdutide (IBI362), a dual agonist targeting both glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR), has met its primary endpoint in Chinese subjects with type 2 diabetes (T2D). The…
-
Abbisko and Allist Pharmaceuticals Initiate Phase II Trial for NSCLC Drug Combination
•
Abbisko Therapeutics Co., Ltd (HKG: 2256) and Allist Pharmaceuticals Co., Ltd have announced the upcoming start of a multi-center, open Phase II clinical study to evaluate the combination of Abbisko’s ABSK043 and Allist’s furmonertinib in patients with advanced non-small cell lung cancer (NSCLC). The study aims to establish the optimal…
-
Boehringer Ingelheim’s Anti-Sema3A BI 764524 Shows Promise in Diabetic Macular Ischemia Trial
•
Boehringer Ingelheim (BI) has announced the publication of results from a Phase I/IIa clinical trial for its anti-Sema3A antibody candidate, BI 764524, used in the treatment of diabetic macular ischemia (DMI), a serious complication of diabetic retinopathy (DR) that can result in blindness. The trial successfully met its primary safety…
-
Pfizer Pauses Dosing in DMD Gene Therapy Trial Following Participant’s Sudden Death
•
This week, Pfizer Inc. (NYSE: PFE) announced the unfortunate sudden death of a participant in a Phase II study for its investigational gene therapy, fordadistrogene movaparvovec, used to treat Duchenne muscular dystrophy (DMD). The patient, aged between 2 and 4 years, had received the treatment in the previous year. In…
-
J&J’s Erleada Plus ADT Shows 0% Biochemical Recurrence Rate in High-Risk Prostate Cancer Trial
•
Johnson & Johnson (J&J; NYSE: JNJ) has announced that its Phase II clinical trial for the androgen receptor inhibitor Erleada (apalutamide), in combination with androgen deprivation therapy (ADT), successfully met its primary endpoint of biochemical recurrence (BCR) in patients with high-risk localized prostate cancer (HRLPC) following radical prostatectomy (RP). The…
-
Everest Medicines’ Velsipity for UC Receives First Asian Approval in Macau
•
Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that the regulatory authority in Macau has approved the New Drug Application (NDA) for Velsipity (etrasimod) for the treatment of moderate-to-severe active ulcerative colitis (UC). This makes Macau the first region in Everest’s licensed territory in Asia to grant approval…
-
Wanbangde Pharmaceutical’s Huperzine A Earns FDA Rare Pediatric Disease Designation for HIE Treatment
•
China’s Wanbangde New Building Materials Co., Ltd (SHE: 002082) has announced that its subsidiary, Wanbangde Pharmaceutical Group, has received a rare pediatric disease (RPD) designation from the US Food and Drug Administration (FDA) for its drug huperzine A. This designation is for the treatment of neonatal hypoxic-ischemic encephalopathy (HIE), a…
-
LEO Pharma’s Enstilar Outperforms Daivobet in Phase III Psoriasis Trial in China
•
Denmark-based dermatology specialist LEO Pharma A/S has announced positive outcomes for its drug candidate Enstilar (LEO 90100) in a Phase III clinical trial conducted in China. The trial focused on evaluating Enstilar as a potential treatment for Chinese patients with stable plaque psoriasis. The primary objective of the study was…
-
Mabwell Bioscience’s 9MW2821 Earns Orphan Drug Status from FDA for Esophageal Cancer
•
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its pipeline candidate, the antibody-drug conjugate (ADC) 9MW2821. This designation is for the drug’s potential in treating esophageal…
-
Innovent Biologics’ CLDN18.2 ADC IBI343 Receives Breakthrough Designation in China
•
Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that its antibody-drug conjugate (ADC), IBI343, targeting CLDN18.2, has been granted breakthrough therapy designation (BTD) status in China. This designation highlights the potential of IBI343 as a third-line treatment option for patients with advanced gastric or…
-
Sichuan Biokin’s EGFR/HER3 ADC Expands Phase II Clinical Program with NMPA Approval
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese biopharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct seven Phase II clinical studies for its antibody-drug conjugate (ADC), BL-B01D1, in combination with a PD-1 inhibitor, with or without chemotherapy. The combo therapy, previously approved for…
-
Merus’s Zenocutuzumab Receives Priority Review Status from FDA for Lung and Pancreatic Cancer Indications
•
Dutch biotechnology company Merus (NASDAQ: MRUS) has announced that the US Food and Drug Administration (FDA) has accepted for review its market approval filing for zenocutuzumab, a first-in-class HER2/HER3 bispecific antibody (BsAb), for the treatment of NRG1+ non-small cell lung cancer (NSCLC) and pancreatic cancer. The application has been granted…
-
Betta Pharmaceuticals Files for Market Approval of CDK4/6 Inhibitor BPI-16350 in China
•
Betta Pharmaceuticals Co., Ltd (SHE: 300558), a Chinese pharmaceutical company, has announced that it has filed for market approval in China for its drug candidate BPI-16350. The cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor is being developed in combination with fulvestrant for the treatment of locally advanced or recurrent hormone…
-
Tonghua Dongbao Pharmaceuticals Commences Phase IIa Trial for Dual-Targeted Gout Drug Candidate
•
Tonghua Dongbao Pharmaceuticals (SHA: 600867), a China-based pharmaceutical company, has announced that the first patient has been dosed in a Phase IIa clinical study for its dual-targeted drug candidate, THDBH151, which is being evaluated for the treatment of gout. THDBH151 is designed to target both xanthine oxidase (XO) and the…
-
Henlius’ HER2 Dual-Targeted Therapy Gets Green Light for Global Phase III Trial by FDA
•
Shanghai Henlius Biotech Co., Ltd (HKG: 2696) has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a global multi-center Phase III clinical study. The study will evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy for the first-line…
-
Jacobio Pharma Applies for Approval of KRAS G12C Inhibitor Gecirasib in China
•
Jacobio Pharma (HKG: 1167), a China-based biopharmaceutical company, has announced the submission of a New Drug Application (NDA) to China’s Center for Drug Evaluation (CDE) for its investigational drug glecirasib. The KRAS G12C inhibitor is being sought after for approval as a treatment for second-line and above advanced or metastatic…
-
China’s CDE Gives Tacit Approval to Keymed Biosciences’ Alzheimer’s Drug CM383 for Clinical Trials
•
The Center for Drug Evaluation (CDE) has indicated on its website that China-based Keymed Biosciences Inc. (2162.HK) has received tacit approval for its pipeline candidate drug CM383 to proceed to clinical studies. The monoclonal antibody (mAb) is intended for the treatment of Alzheimer’s disease (AD). CM383 targets amyloid-beta (Aβ), a…
-
EyePoint Pharmaceuticals’ Durvayu Fails to Meet Primary Endpoint in NPDR Trial
•
EyePoint Pharmaceuticals Inc., (NASDAQ: EYPT) has announced that its drug candidate Durvayu (vorolanib intravitreal insert; EYP-1901) did not meet its primary endpoints in the Phase II PAVIA clinical trial for non-proliferative diabetic retinopathy (NPDR). Although the trial data showed some treatment effect, including a reduction in NPDR progression rates at…
-
Kelun-Biotech’s RET Inhibitor A400 Advances to Phase II Trial with FDA Approval
•
Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), a Chinese pharmaceutical company, has announced that its innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase II clinical study for its RET inhibitor A400/EP0031…
-
Everest Medicines’ Nefecon Secures Market Approval for IgAN Treatment in Hong Kong
•
Everest Medicines (HKG: 1952), a China-based pharmaceutical company, announced that it has received market approval from the Hong Kong Department of Health for its drug Nefecon (targeted-release budesonide) for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults who are at risk of disease progression. This approval marks the…
-
HuidaGene’s MECP2 Duplication Syndrome Therapy Earns Positive EMA Opinion
•
HuidaGene (Shanghai) Biotechnology Co., Ltd, a biotech company based in China, has announced that it has received positive opinions from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) regarding its orphan drug filing for HG204. HG204 is an RNA editing therapy developed independently by HuidaGene,…
-
Hansoh Pharmaceutical Secures Exclusive Rights to QYuns Therapeutics’ QX004N in Greater China
•
Jiangsu QYuns Therapeutics Co., Ltd, a biopharmaceutical company based in China, has entered into a partnership with compatriot firm Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) for the development and commercialization of its Category biologic product, QX004N. QX004N is an in-house developed monoclonal antibody (mAb) that specifically binds to IL-23…
-
Jacobio Pharma’s Glecirasib Shows Promise in Phase II Study for NSCLC Presented at ASCO
•
Jacobio Pharma (HKG: 1167), a biopharmaceutical company based in China, has announced the presentation of results from a Phase II regulatory study for its KRAS G12C inhibitor, glecirasib, at the 2024 American Society of Clinical Oncology (ASCO) Plenary Series. In terms of efficacy, the study reported a confirmed objective response…
-
BeiGene’s Anti-PD-1 Therapy Tislelizumab Expands Indication for Gastric Cancer in China
•
BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that its anti-PD-1 therapy, tislelizumab, has received approval from the National Medical Products Administration (NMPA) in China for the first-line treatment of locally advanced unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction (G/GEJ) in combination with fluorouracil and platinum-based…
-
China’s NMPA Approves Shenzhen Chipscreen’s Chidamide for DLBCL Indication
•
Shenzhen Chipscreen Pharmaceutical Co., Ltd, a biopharmaceutical company based in China, announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug Epidaza (chidamide). The drug is indicated for the treatment of treatment-naïve diffuse large B-cell lymphoma (DLBCL) patients with positive MYC and BCL2…
-
Keymed Biosciences’ IL-4Rα Monoclonal Antibody for Allergic Rhinitis Accepted by China NMPA
•
China-based biopharmaceutical company Keymed Biosciences Inc. (HKG: 2162) has announced that the National Medical Products Administration (NMPA) has accepted for review its market filing for stapokibart (CM310), an IL-4Rα monoclonal antibody (mAb) drug candidate, for the treatment of seasonal allergic rhinitis (SAR). The market filing is supported by a Phase…
-
Bristol-Myers Squibb’s Camzyos Approved by China’s NMPA for Hypertrophic Cardiomyopathy Treatment
•
Bristol-Myers Squibb (BMS; NYSE: BMY) has received marketing approval from China’s National Medical Products Administration (NMPA) for its innovative drug Camzyos (mavacamten) for the treatment of patients with obstructive hypertrophic cardiomyopathy (HCM) graded as II to III under the New York Heart Association (NYHA) functional classification. The drug is indicated…
-
Cutia Therapeutics Submits New Drug Application for Androgenic Alopecia Treatment in Hong Kong
•
Cutia Therapeutics (HKG: 2487), a dermatology-focused pharmaceutical company, has announced the submission of a New Drug Application (NDA) for its proprietary CU-40102 (external einasteride spray) for the treatment of androgenic alopecia to the Department of Health of Hong Kong, China. CU-40102 is positioned as the world’s first and currently only…
-
Zhejiang Huahai Pharmaceutical Wins IND Approval for Antibody-Drug Conjugate from China’s NMPA
•
Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a China-based pharmaceutical company, has announced that it has received Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) for its innovative injectable drug candidate, HB0052. The drug is initially intended for evaluation in patients with general advanced solid tumors.…
-
EOC Pharma’s Entinostat Secures Chinese Approval for Breast Cancer Treatment
•
US-China biotech firm EOC Pharma has received market approval from China’s National Medical Products Administration (NMPA) for its entinostat, an oral histone deacetylase (HDAC) inhibitor, for the treatment of locally advanced or metastatic breast cancer in patients with hormone receptor (HR) positive and human epidermal growth factor receptor-2 (HER2) negative…
-
iRegene’s Pioneering Cell Therapy NouvNeu001 Administered in Wuhan for Parkinson’s Disease
•
Wuhan-based cell therapy developer iRegene has reached a clinical milestone with the administration of its novel treatment, NouvNeu001, to a patient at Zhongnan Hospital of Wuhan University. The patient’s postoperative condition has been reported as good. In August 2023, NouvNeu001 received approval to be evaluated in a multi-center, open Phase…
-
Chengdu Kanghong Pharmaceutical Gets US FDA Nod for Clinical Trial of KH658 for Wet AMD
•
Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773), a leading pharmaceutical company based in China, has announced that it has received approval from the US Food and Drug Administration (FDA) to commence clinical trials for its KH658 eye injection. The drug is designed for the treatment of neovascular (wet) age-related…
-
CARsgen Therapeutics Submits CAPA Report to US FDA Following Clinical Hold
•
CARsgen Therapeutics Holdings Ltd (HKG: 2171), a specialist in chimeric antigen receptor (CAR)-T cell therapies based in China, has announced the filing of its Corrective And Preventive Actions (CAPAs) report with the US Food and Drug Administration (FDA). This follows a previous request by the FDA in December last year…
-
Yantai Dongcheng Pharmaceutical Receives NMPA Approval for Advanced Solid Tumor Therapy
•
Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a leading pharmaceutical company based in China, has announced that it has been granted clinical trial approval by the National Medical Products Administration (NMPA) for its innovative drug, 177Lu-LNC1008. This targeted radioactive in vivo therapeutic drug is designed to treat general advanced…
-
Keymed Biosciences’ Stapokibart Meets Primary Endpoint in Phase III Seasonal Allergic Rhinitis Study
•
China-based biopharmaceutical company Keymed Biosciences Inc. (HKG: 2162) has announced that its IL-4Rα monoclonal antibody (mAb) drug candidate, stapokibart (CM310), has successfully achieved its primary endpoint in a Phase III clinical trial for seasonal allergic rhinitis (SAR). The Phase III study, which was multi-center, randomized, double-blinded, and placebo-parallel-controlled, aimed to…
-
Pfizer’s Gene Therapy Beqvez Wins FDA Nod for Moderate-to-Severe Hemophilia B
•
The US Food and Drug Administration (FDA) has granted marketing authorization to Pfizer (NYSE: PFE) for its gene therapy Beqvez (fidanacogene elaparvovec) for the treatment of adults with moderate-to-severe hemophilia B. The one-time treatment is indicated for patients using factor IX prophylaxis therapy, those experiencing life-threatening hemorrhages, or those with…
-
Bio-Thera Solutions’ BAT1806 Receives Positive CHMP Recommendation for EU Approval
•
China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the market approval filing of BAT1806, a biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab). The CHMP’s recommendation…
-
HutchMed’s Partner Takeda Gets CHMP Nod for Fruquintinib as CRC Treatment in Europe
•
HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that its collaborator Takeda (TYO: 4502, NYSE: TAK) has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the approval of fruquintinib for the treatment of adult patients with…
-
Novartis’s Iptacopan (Fabhalta) Receives Marketing Approval in China for PNH Treatment
•
Swiss pharmaceutical giant Novartis (NYSE: NVS) has received marketing approval from China for its iptacopan (trade name: Fabhalta) for the treatment of adult paroxysmal nocturnal hemoglobinuria (PNH) in patients previously untreated with complement inhibitor. PNH is a rare and life-threatening blood disorder characterized by anemia, hemoglobinuria, bone marrow failure, and…
-
AbbVie’s Rinvoq Outperforms Sanofi’s Dupixent in Moderate-to-Severe Atopic Dermatitis Trial
•
AbbVie (NYSE: ABBV) has announced positive results from a head-to-head Phase IIIb/IV clinical trial comparing its JAK inhibitor Rinvoq (upadacitinib) with Sanofi’s (NASDAQ: SNY) interleukin blocker Dupixent (dupilumab) in patients with moderate-to-severe atopic dermatitis. The trial demonstrated that Rinvoq was superior in improving eczema area and severity as well as…
-
Wuhan Bio-Raid Biotechnology Secures NMPA Approval for First-in-Class CD99-Targeted CAR-T Therapy
•
Wuhan Bio-Raid Biotechnology Co., Ltd, a leading developer of chimeric antigen receptor (CAR)-T cell therapies in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its proprietary BRD-03. This autologous CD99-targeted CAR-T therapy is classified as a Category 1 biologic therapeutic…
-
US FDA Greenlights Henlius Biotech’s Hanquyou as Biosimilar to Roche’s Herceptin
•
Shanghai Henlius Biotech Inc. (HKG: 2696) has achieved a significant milestone with the US Food and Drug Administration’s (FDA) approval for marketing Hanquyou (trastuzumab; HLX02), a biosimilar to Roche (SWX: ROG)’s cancer treatment Herceptin (trastuzumab). The biosimilar will be available in the US under the trade name Hercessi. Originally approved…
-
Novartis Receives Positive Interim Results for Antimalarial Coartem in Infants
•
Swiss pharmaceutical company Novartis (NYSE: NVS) has announced interim results from a Phase II/III clinical trial for its antimalarial drug Coartem (artemether + lumefantrine) in infants with uncomplicated Plasmodium falciparum malaria. The trial data indicates that the tablet formulation meets pharmacokinetic (PK), efficacy, and safety requirements, achieving the primary PK…
-
Hebei Changshan Biochemical’s Albenatide File for Type 2 Diabetes Accepted by China’s NMPA
•
Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255) has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for albenatide (CJC‑1134‑PC) for review. The company is seeking initial approval for the drug as an adjunct to diet and exercise to improve blood glucose control…
-
Betta Pharmaceuticals’ BPI-16350 Combo Therapy Shows Improved PFS in Breast Cancer Trial
•
China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced an update on its Phase III clinical study for BPI-16350, a cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, used in combination with fulvestrant for the treatment of locally advanced or recurrent hormone receptor positive (HR+) HER2-negative metastatic breast cancer in patients…
-
Novartis’s Lutathera Secures FDA Approval for Pediatric Gastroenteropancreatic NETs
•
The US Food and Drug Administration (FDA) has granted regulatory approval to Novartis (NYSE: NVS) for its radioligand therapy (RLT) Lutathera (lutetium Lu 177 dotatate) for the treatment of SSTR+ gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in patients aged 12 and older. This expansion of the drug’s original indication for adult patients…
-
Shanghai Junshi Biosciences’ PD-1 Inhibitor Toripalimab Files for Two Indications in Hong Kong
•
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the Hong Kong Drug Office (DO) has accepted two indication approval filings for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The filings seek approval for the drug in combination with chemotherapy as a first-line treatment for metastatic or…
-
Abbisko Therapeutics’ Irpagratinib Earns Orphan Drug Designation from US FDA for Hepatocellular Carcinoma
•
Shanghai-based biotechnology company Abbisko Therapeutics Co., Ltd (HKG: 2256) has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its novel small-molecule FGFR4 inhibitor, irpagratinib. The designation is in recognition of the drug’s potential in treating hepatocellular carcinoma (HCC). Irpagratinib, an FGFR4 inhibitor originally discovered…
-
Sanofi’s Rilzabrutinib Meets Primary Endpoint in Phase III ITP Trial
•
French pharmaceutical company Sanofi (NASDAQ: SNY) has announced that its Phase III trial for rilzabrutinib, a potential best-in-class BTK inhibitor, has successfully met its primary endpoint of durable platelet response in patients with immune thrombocytopenia (ITP). The trial also produced positive results in key secondary endpoints and did not raise…
-
European Commission Approves Pfizer’s Antibiotic Emblaveo for Multiple Indications
•
The European Commission (EC) has granted approval for Pfizer’s (NYSE: PFE) antibiotic Emblaveo (aztreonam + avibactam) for the treatment of complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), complicated urinary tract infections (cUTI), and infections caused by aerobic Gram-negative organisms in adults. The drug was reviewed under an accelerated assessment process…
-
BeiGene’s Tislelizumab Secures EC Approval for Three NSCLC Indications
•
BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the European Committee (EC) has granted approval for its programmed death-1 (PD-1) inhibitor, tislelizumab, for three distinct non-small cell lung cancer (NSCLC) indications. The approvals allow for the use of tislelizumab in the following scenarios: The approvals were supported by…
-
Shanghai Henlius Biotech Achieves First Patient Dosing in Phase I Trial for Fibrosis Treatment HLX6018
•
Shanghai Henlius Biotech Inc. (HKG: 2696), a biopharmaceutical company based in China, has announced the completion of the first patient dosing in a Phase I clinical study for HLX6018, a GARP/TGF-β1 compound monoclonal antibody (mAb). The drug is under development for the treatment of fibrosis-related diseases and has been tested…
-
China Medical System Holdings’ Desidustat NDA Accepted for Review by China’s NMPA
•
China Medical System Holdings (CMS; HKG: 0867) has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its desidustat. The oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) is under development to treat anemia in adult chronic kidney disease (CKD) patients who…
-
Akeso Biopharma Submits sNDA for Cadonilimab in Cervical Cancer to China’s CDE
•
China-based Akeso Biopharma (HKG: 9926) has announced the submission of a supplementary New Drug Application (sNDA) for its innovative bispecific antibody, cadonilimab (AK104), which targets both programmed death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). The sNDA filing seeks to expand the use of cadonilimab in combination with chemotherapy and…
-
Huadong Medicine’s HDM1005 Receives US FDA Clinical Trial Approval for Weight Management
•
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its investigational drug HDM1005. This long-acting agonist targets the GLP-1 receptor and GIP receptor and is under development for weight management in overweight or obese…
-
Sandoz’s Partner Samsung Bioepis Scores EC Approval for Stelara Biosimilar Pyzchiva
•
Switzerland-headquartered Sandoz (SWX: SDZ) has announced that the European Commission (EC) has granted approval for Pyzchiva, a biosimilar version of Johnson & Johnson’s (J&J; NYSE: JNJ) IL-12/23 blocker Stelara (ustekinumab), developed in partnership with South Korea’s Samsung Bioepis. Both biologics are indicated for the treatment of plaque psoriasis, psoriatic arthritis,…
-
Jiangsu Hengrui Medicine Gets NMPA Go-Ahead for Camrelizumab Combination Therapy Study in Pancreatic Cancer
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a multi-center, randomized, controlled Phase II/III clinical study. The study will assess the efficacy and safety of its programmed death-1 (PD-1)…
-
CanSino Biologics Receives NMPA Approval for Haemophilus influenzae type B (Hib) Conjugate Vaccine Clinical Trial
•
China-based biopharmaceutical company CanSino Biologics (HKG: 6185) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its freeze-dried Haemophilus influenzae type B (Hib) conjugate vaccine. Haemophilus influenzae, a Gram-negative bacterium, is a leading cause of acute lower respiratory tract infections in children.…
-
CANbridge Pharmaceuticals’ CAN008 Fails to Meet Phase II Endpoints in Glioblastoma Multiforme
•
CANbridge Pharmaceuticals (HKG: 1228) has announced that its Phase II clinical study for CAN008 (asunercept) in newly diagnosed glioblastoma multiforme (GBM) did not achieve progression-free survival (PFS) or overall survival (OS) benefits. As a result, the Sino-US biopharma company has decided to discontinue the development of CAN008 for GBM. The…
-
GenScript’s Subsidiary Legend Biotech Expands EU Approval for CAR-T Therapy Carvykti
•
China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), has secured an expanded indication approval from the European Union for its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel). The therapy is now approved as a…
-
Ipsen’s Somatuline Receives First Prescription in China for GEP-NETs Treatment
•
French biopharmaceutical company Ipsen (EPA: IPN; OTCMKTS: IPSEY) has announced that the first prescription of its Somatuline (lanreotide) sustained-release injection has been issued in China for the treatment of gastrointestinal pancreatic neuroendocrine tumors (GEP-NETs). Somatuline, the only somatostatin analogue (SSA) for deep subcutaneous self-injection, received approval in China in December…
-
Jiangsu Hengrui’s SHR-A2102 Earns FDA Fast Track Status for Urothelial Carcinoma Treatment
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for its pipeline candidate, SHR-A2102. This designation is in recognition of the drug’s potential to treat advanced urothelial carcinoma,…
-
Hengrui Medicine Gets Green Light from NMPA for Two Anti-Cancer Drugs
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for two of its drug candidates, SHR-3276 and HRS2398. SHR-3276 is slated for study in patients with general advanced solid…
-
GSK’s Gepotidacin Shows Non-Inferior Efficacy in Phase III Gonorrhoea Tria
•
GlaxoSmithKline (GSK; NYSE: GSK, LON: GSK), a leading UK pharmaceutical company, last week announced positive results from a Phase III clinical trial for gepotidacin, a first-in-class triazaacenaphthylene antibiotic, in the treatment of uncomplicated urogenital gonorrhoea (GC). The study demonstrated non-inferiority to the standard azithromycin-based treatment, with a microbiological response rate…
-
Joincare Pharmaceutical’s TG-1000 Shows Promise in Phase III Flu Treatment Trial
•
Joincare Pharmaceutical Group Co., Ltd (SHA: 600380), a Chinese pharmaceutical company, has reportedly completed the unblinding of a Phase III trial for TG-1000, an investigational influenza antiviral drug. The trial has shown positive preliminary data, indicating that the company is now preparing to file a New Drug Application (NDA) in…
-
Roche’s Alecensa approved by FDA as First ALK Inhibitor for Adjuvant Treatment of NSCLC
•
Roche Holding AG (SWX: ROG; OTCMKTS: RHHBY), a Swiss multinational healthcare company, announced last week that the US Food and Drug Administration (FDA) has granted regulatory approval for Alecensa (alectinib) as an adjuvant treatment for patients with ALK-positive non-small cell lung cancer (NSCLC). This marks the first approval of an…
-
Takeda Scores FDA Nod for Subcutaneous Vedolizumab to Treat Inflammatory Bowel Disease
•
The US Food and Drug Administration (FDA) has granted Takeda Pharmaceutical Company Limited (NYSE: TAK), a Japanese pharmaceutical company, registration authorization for a subcutaneous formulation of its alpha4beta7 integrin antagonist Entyvio (vedolizumab). This new formulation is intended for use as a maintenance therapy in patients with moderately to severely active…
-
China’s Health Authorities Investigate Alleged Price Manipulation in Pharma Procurement Tenders
•
Chinese health regulators are delving into allegations of irregular pricing practices during the national volume-based procurement (VBP) tenders for several pharmaceutical products. A joint statement issued by the National Drug Alliance Procurement Office and the Shanghai Pharmaceutical Centralized Bidding Procurement Management Office cited public complaints regarding the bidding and pricing…
-
Sichuan Biokin Gets NMPA Green Light for BL-B01D1 ADC in NSCLC Clinical Trial
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a leading biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative antibody-drug conjugate (ADC), BL-B01D1. The approval allows for the combination of BL-B01D1 with a PD-1 inhibitor, with…
-
Innovent Biologics’ Pemazyre Wins Macau Approval for Cholangiocarcinoma Treatment
•
Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company in China, has received marketing approval from Macau for its cancer therapy Pemazyre (pemigatinib). The drug is indicated for patients with advanced, metastatic, or unresectable cholangiocarcinoma, who have been previously treated with at least one systemic therapy and have confirmed FGFR2…
-
Kintor Pharmaceutical’s GT20029 Meets Primary Endpoint in Phase II AGA Trial
•
Kintor Pharmaceutical Ltd (HKG: 9939), a clinical-stage biotechnology company, has announced that its Phase II clinical study for GT20029, a first-in-class proteolysis targeting chimera (PROTAC) compound, has met its primary endpoint in the treatment of male androgenetic alopecia (AGA) in China. The multi-center, randomized, double-blind, placebo-controlled study aimed to evaluate…
-
GSK’s Shingrix Vaccine Maintains High Efficacy for Over a Decade, Phase III Data Show
•
GlaxoSmithKline (GSK, LON: GSK, NYSE: GSK), the UK-based pharmaceutical giant, has this week released long-term data from a follow-up Phase III trial of its recombinant herpes zoster vaccine, Shingrix. The vaccine demonstrated robust efficacy in adults aged 50 and above, with a 79.7% efficacy rate sustained from year 6 to…
-
AbbVie’s Rinvoq Meets Main Goal in Late-Stage Giant Cell Arteritis Trial
•
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, has announced that a late-stage clinical trial for its JAK inhibitor Rinvoq (upadacitinib) in combination with corticosteroids has successfully met the primary endpoint in patients with giant cell arteritis (GCA). The study demonstrated sustained remission from week 12 through week 52. The…
-
Chia Tai Tianqing’s Rovadicitinib Meets Main Goal in Myelofibrosis Trial, Eyes Market Filing
•
Chia Tai Tianqing, a renowned pharmaceutical company based in China, has declared that it has successfully met the primary endpoint in a pivotal study for its Category 1 drug, rovadicitinib, for the treatment of medium-to-high-risk myelofibrosis (MF). The company is advancing towards filing for market approval in China, following consultations…
-
Novartis’s Kesimpta Shows Sustained Efficacy in 6-Year Relapsing MS Study
•
Swiss pharmaceutical giant Novartis (NYSE: NVS) has this week unveiled six-year efficacy data for its anti-CD20 drug Kesimpta (ofatumumab) in the treatment of recently diagnosed relapsing multiple sclerosis (MS) in treatment-naive patients. The data shows that first-line continuous Kesimpta treatment, as compared to a teriflunomide regimen switched to Kesimpta, resulted…
-
ImmuneOnco Receives NMPA Approval for Phase III Clinical Trial of CD47 Inhibitor TIMDARPACEPT
•
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study for its investigational drug timdarpacept (IMM01). This drug is the first SIRPαFc fusion protein targeting CD47 to be designed in China.…
-
Shanghai Henlius Biotech Advances TIGIT-Targeting HLX53 to Phase II Clinical Trial for Hepatocellular Carcinoma
•
Shanghai Henlius Biotech Inc., (HKG: 2696), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to commence a Phase II clinical study. The study will evaluate the tolerability, safety, and efficacy of HLX53, an Fc fusion protein targeting T cell immunoglobulin and ITIM…
-
Amgen’s Tezspire Shows Promise in Phase IIa COPD Trial, Reduces Exacerbations
•
Amgen (NASDAQ: AMGN), a multinational biopharmaceutical company, has this week announced results from a Phase IIa proof-of-concept trial for its anti-thymic stromal lymphopoietin (TSLP) biologic, Tezspire (tezepelumab), in patients with moderate-to-very-severe chronic obstructive pulmonary disease (COPD). The trial indicated that Tezspire reduced the annualized rate of moderate or severe exacerbations…
-
Sichuan Biokin’s BL-B01D1 Earns Breakthrough Designation for Nasopharyngeal Carcinoma Treatment
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a biopharmaceutical company based in China, has announced that it has received Breakthrough Therapy Designation (BTD) from the National Medical Products Administration for its antibody-drug conjugate (ADC), BL-B01D1. This designation is for the treatment of patients with late-stage locally advanced or metastatic nasopharyngeal…
-
Innovent Biologics’ IBI133 Receives Tacit Approval for Clinical Trial from China’s CDE
•
The Center for Drug Evaluation (CDE) in China has granted tacit clinical trial approval to Innovent Biologics, Inc. (HKG: 1801) for its antibody drug conjugate (ADC) IBI133. The molecule is slated for assessment as a treatment for irresectable locally advanced or metastatic solid tumors. Previously, in December 2023, IBI133 had…
-
Shionogi’s Xofluza Gains Approval in Taiwan for Pediatric Influenza Treatment and Prophylaxis
•
Shionogi & Co., Ltd, a leading Japanese pharmaceutical company, has announced that it has received approval for a supplemental new drug application (sNDA) in Taiwan for its influenza treatment and prophylaxis drug, Xofluza (baloxavir marboxil). This first-in-class, oral anti-viral medication is now approved for use in children aged between 5…
-
Kangtai Biological Receives NMPA Approval for 20-Valent Pneumococcal Vaccine Clinical Trial
•
Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601), a leading biopharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its 20-valent pneumococcal polysaccharide conjugate vaccine. The vaccine is designed to prevent infectious diseases caused by…
-
KPC Pharmaceuticals Gets NMPA Green Light for Clinical Trial on Familial Mediterranean Fever Treatment
•
Yunnan-based KPC Pharmaceuticals Inc., (SHA: 600422) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 2.2 product KPC-149, which is intended for the treatment of familial Mediterranean fever (FMF). FMF is an autosomal recessive autoimmune disease associated with mutations in…
-
Carvykti CAR-T Therapy Sales Reach $157 Million in Q1 2024, Reports GenScript Subsidiary Legend Biotech
•
GenScript Biotech Corporation (HKG: 1548), a leading Contract Research Organization (CRO) based in China, has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), achieved sales of USD 157 million for its BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), in the first quarter of 2024, which…
-
China’s NMPA Releases 79th Batch of Reference Drugs for Generic Quality Evaluation
•
The National Medical Products Administration (NMPA) in China has released the 79th batch of reference drugs for Generic Quality Consistency Evaluation (GQCE) work, marking a significant step in ensuring the quality and consistency of generic drugs in the country. This batch includes 64 new specifications and 34 modified specifications for…
-
AstraZeneca’s Imfinzi Shows Sustained Survival Benefit in Advanced Biliary Tract Cancer Trial
•
AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical and biopharmaceutical company, has this week announced 3-year results from a Phase III clinical trial of its anti-PD-L1 therapy Imfinzi (durvalumab) in combination with chemotherapy for the treatment of advanced biliary tract cancer (BTC). The trial, after a median follow-up of 41.3 months,…
-
Sirnaomics Receives FDA Feedback on STP705 Development Plan for isSCC Treatment
•
Sirnaomics Ltd (HKG: 2257), a leading biopharmaceutical company focused on the discovery and development of RNAi therapeutics, has announced receiving a written response from the U.S. Food and Drug Administration (FDA) regarding the required Class C meeting for STP705, a treatment for in situ squamous cell carcinoma (isSCC). The Class…
-
China Medical System’s Opzelura Approved in Macau for Vitiligo Treatment
•
China Medical System Holdings (CMS; HKG: 0867) has announced that it has received market approval in Macau for Opzelura (ruxolitinib) cream, a topical treatment indicated for patients aged 12 and above with non-segmental vitiligo involving the face. Opzelura, a topical Janus kinase (JAK) inhibitor, was initially approved in the U.S.…
-
Easton Pharmaceutical Gets NMPA Nod for Generic Version of Merck KGaA’s Concor
•
Easton Pharmaceutical Co., Ltd (SHA: 688513), based in Chengdu, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of Concor, which contains bisoprolol and amlodipine, a compound preparation used as an alternative therapy for hypertension. The approval signifies that Easton’s…
-
Sanofi Advances Phase I/II Trial of Trifunctional NK Cell Engager in Blood Cancers
•
Sanofi (NASDAQ: SNY), a French multinational pharmaceutical company, has administered the first dose to a patient in the second part of a Phase I/II clinical trial for the trifunctional NK cell engager SAR443579, targeting blood cancers. The announcement was made by fellow French biotechnology company Innate Pharma (NASDAQ: IPHA) this…
-
Roche’s Columvi Meets Overall Survival Endpoint in Diffuse Large B-Cell Lymphoma Trial
•
Roche (SWX: RO), a leading Swiss pharmaceutical company, has announced that a late-stage clinical trial for its bispecific antibody Columvi (glofitamab) has successfully met its primary endpoint of overall survival (OS) in patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL). The trial involved patients who had received…
-
Novartis’s Fabhalta Shows Promise in Phase III IgA Nephropathy Trial
•
Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced positive preliminary results from a Phase III clinical trial of its complement inhibitor Fabhalta (iptacopan) for the treatment of IgA nephropathy (IgAN). The trial data showed that after a nine-month treatment period, the Factor B inhibitor Fabhalta reduced proteinuria by 38.3% when…
-
Keymed Biosciences Achieves First Dosing in Global Phase III Trial for Claudin 18.2 Targeting ADC
•
Keymed Biosciences Inc., (HKG: 2162), a biopharmaceutical company based in China, has announced the completion of the first dosing in a global multi-center Phase III study for its Claudin 18.2 (CLDN18.2)-targeted antibody-drug conjugate (ADC) CMG901 (AZD0901). The ADC is being evaluated as a treatment for advanced solid tumors in the…
-
Hengrui Medicine Gets NMPA Approval for Clinical Study of CDK 4/6 Inhibitor Combo in Breast Cancer
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for the combination of dalpiciclib (SHR6390) and HRS8807 in the treatment of breast cancer. Dalpiciclib, the first domestically-developed…
-
3SBio Secures NMPA Approval for Pediatric Thrombopoietin Treatment of ITP
•
3SBio Inc. (HKG: 1530), a leading biopharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its thrombopoietin product, used in the treatment of persistent or chronic primary immune thrombocytopenia (ITP) in children or adolescents. This marks a significant…
-
AbbVie’s Aquipta/Qulipta Shows Promise in Migraine Prevention Trial
•
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, last week released interim results from a Phase III open-label trial of its CGRP receptor antagonist, Aquipta/Qulipta (atogepant), for the prevention of migraines in patients with chronic or episodic migraine. The data, collected between weeks 13 to 16, indicated that the average…
-
Laekna’s Anti-ActRIIA Antibody LAE102 Clears FDA Hurdle for Obesity Treatment Trial
•
Sino-American biotech firm Laekna has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its proprietary monoclonal antibody, LAE102. The molecule is set to be evaluated as a potential treatment for obesity, a condition that affects a significant portion of the global…
-
AstraZeneca’s Fasenra Gains FDA Approval for Pediatric Severe Asthma Treatment
•
AstraZeneca (AZ; NASDAQ: AZN) has secured an indication extension from the U.S. Food and Drug Administration (FDA) for its anti-eosinophil biologic Fasenra (benralizumab). The drug is now approved as an add-on maintenance treatment for severe asthma in pediatric patients aged 6 to 11 years with an eosinophilic phenotype, expanding its…
-
Qilu Pharmaceutical Gets NMPA Green Light for Generic Romiplostim for ITP Treatment
•
The National Medical Products Administration (NMPA) in China has granted marketing approval to Qilu Pharmaceutical for its generic version of Amgen’s romiplostim, a treatment for chronic idiopathic thrombocytopenia (ITP) that has not responded well to other treatments such as corticosteroids and immunoglobulins. This marks the first approval of its kind…
-
Suzhou Zelgen Receives NMPA Approval for Jacktinib Cream Trial in Vitiligo Patients
•
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II/III study for its Category 1 product, jacktinib cream, in adolescent and adult patients suffering from non-segmental vitiligo. Jacktinib, a Janus kinase (JAK) inhibitor, exhibits…
-
Haisco Pharmaceutical Gets NMPA Green Light for HSK31858 COPD Trial
•
Haisco Pharmaceutical Group Co., Ltd (SHE: 002653), a Chinese pharmaceutical company, has announced that it has received additional clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug HSK31858. The drug, a reversible dipeptidyl peptidase 1 (DPP1) inhibitor, is now approved for assessment in chronic obstructive…
-
Teva’s Ajovy Achieves Positive Results in Phase III Migraine Prevention Trial in China
•
Teva Pharmaceutical Industries Ltd (NYSE: TEVA), headquartered in Israel, has announced positive results from a Phase III study for Ajovy (fremanezumab) as a preventive treatment for migraine in adult Chinese patients. The study met its primary and all secondary endpoints, demonstrating Ajovy’s efficacy in reducing the number of migraine days…
-
Enhertu Shows 58.3% Response Rate in Phase II Lung Cancer Study, AstraZeneca and Daiichi Sankyo Report
•
The Phase II DESTINY-Lung05 study results for Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate co-developed by AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568, OTCMKTS: DSNKY), were unveiled at the American Association for Cancer Research (AACR) 2024 annual meeting. The study reported an objective response rate (ORR) of 58.3% (95% CI:…
-
Yantai Dongcheng Secures Approval for Phase I Study of 68Ga-LNC1007 in Singapor
•
Yantai Dongcheng Pharmaceutical Group Co., Ltd. (SHE: 002675) has received approval from the Health Sciences Authority of Singapore to initiate a Phase I clinical study for its radiopharmaceutical candidate, 68Ga-LNC1007. This diagnostic agent targets fibroblast activating protein (FAP) and integrin αvβ3, and is being developed to aid in the treatment…
-
Sino Biopharmaceutical to Present Phase II Data for Garsorasib at AACR 2024
•
Sino Biopharmaceutical Ltd. (HKG: 1177) announced that it will present the results of a Phase II study for garsorasib (D-1553), a KRAS G12C inhibitor co-developed with InventisBio (Shanghai) Co., Ltd., at the American Association for Cancer Research (AACR) 2024 annual meeting. The study focuses on non-small cell lung cancer (NSCLC)…
-
Roche Secures CE Mark for Ventana HER2 Test, Enhancing Access to AstraZeneca’s Enhertu
•
Roche (SWX: ROG), based in Switzerland, has received CE marking from the European Commission (EC) for a new indication of its antibody-based test, Ventana HER2 (4B5). This test serves as a companion diagnostic to identify breast cancer patients eligible for AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo’s (TYO: 4568) antibody-drug…
-
Pfizer Reports Positive Phase III Results for RSV Vaccine Abrysvo in Younger Adults
•
Pfizer (NYSE: PFE) has announced interim results from a Phase III trial evaluating its respiratory syncytial virus (RSV) vaccine, Abrysvo, in adults aged 18 to 59 at risk of severe RSV-associated lower respiratory tract disease (LRTD). Currently, the vaccine is approved for preventing RSV-associated LRTD in older adults and for…
-
Jiangsu Hengrui Secures NMPA Approval for Clinical Study of SHR-A2102 and SHR-8068 in Advanced Tumors
•
Jiangsu Hengrui Medicine Co., Ltd. (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its SHR-A2102 in combination with SHR-8068 in patients with advanced solid tumors. SHR-A2102 is an internally developed antibody-drug conjugate (ADC) that targets Nectin-4, a protein whose high…
-
Simcere Pharmaceutical’s SIM0500 Earns FDA Fast-Track Designation for Multiple Myeloma
•
Simcere Pharmaceutical Group (HKG: 2096), a leading China-based pharmaceutical company, has announced that its trispecific antibody SIM0500 has received fast-track designation from the US Food and Drug Administration (FDA) for the treatment of multiple myeloma (MM). The drug targets GPRC5D, BCMA, and CD3, and is intended for patients who have…
-
Roche’s Inavolisib Earns Priority Review Status in China for PIK3CA-Mutated Breast Cancer
•
Swiss pharmaceutical giant Roche (SWX: ROG) has received priority review status from China’s Center for Drug Evaluation (CDE) for its investigational drug inavolisib (GDC-0077), a phosphatidylinositol-3 kinase α (PI3Kα) inhibitor. The drug is being evaluated for the treatment of PIK3CA-mutated, hormone receptor (HR) positive, human epidermal growth factor receptor 2…
-
Sichuan Biokin Pharmaceuticals Initiates Phase III Trial for BL-M05D1 in Esophageal Cancer
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has announced the commencement of patient enrollment in a Phase III clinical trial for its antibody-drug conjugate (ADC), BL-M05D1, in patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC). This milestone marks a significant advancement in the development of BL-M05D1, which targets…
-
Jiangsu Hengrui Medicine Advances Pipeline with NMPA Approvals for Three Drugs
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received clinical trial approvals from China’s National Medical Products Administration (NMPA) for three of its pipeline drugs: HRS-9231, SHR-4597, and SHR-2173. This regulatory milestone marks a significant step forward in the company’s commitment to innovate and address unmet medical needs in China…
-
Jiangsu Hengrui Medicine Gains NMPA Approval for HRS-4642 Clinical Trial in KRAS G12D Mutated Tumors
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its drug candidate HRS-4642 in patients with advanced solid tumors harboring the KRAS G12D mutation. This marks a significant step in the company’s endeavor to address the…
-
Alphamab Oncology’s JSKN003 Demonstrates Promising Results in Phase I HER2-Targeted Solid Tumor Study
•
Alphamab Oncology (HKG: 9966) presented compelling data from a Phase I clinical trial of its HER2-targeted antibody-drug conjugate (ADC), JSKN003, at the AACR 2024 annual meeting. Conducted in Australia, the study focused on advanced solid tumors with HER2 expression. JSKN003, which utilizes a click reaction for conjugation, showcased superior serum…
-
Gan & Lee Pharmaceuticals Commences Clinical Trial for Innovative GLP-1 Agonist GZR18
•
Gan & Lee Pharmaceuticals (SHA: 603087), a leading Chinese pharmaceutical company, has announced the commencement of dosing in a Phase I clinical study for its investigational GLP-1 receptor agonist, GZR18 tablets. This oral formulation is designed to target GPRC5D, BCMA, and CD3, and is intended to treat patients with recurrent…
-
Shanghai’s 9th People’s Hospital Launches Groundbreaking Gene Therapy Trial for Congenital Deafness
•
In a medical first, Shanghai’s 9th People’s Hospital has initiated the world’s inaugural clinical trial for a gene-editing therapy targeting congenital deafness attributed to otoferlin (OTOF) gene mutations. The therapy, developed by HuidaGene Therapeutics Co., Ltd, represents a significant advance in the treatment of auditory neuropathy, a leading cause of…
-
GSK’s ViiV Healthcare Expands Dovato Indication to Include Adolescents with HIV-1 Infection
•
GlaxoSmithKline’s (GSK; NYSE: GSK) ViiV Healthcare has received an indication extension from the US Food and Drug Administration (FDA) for its antiretroviral treatment Dovato (dolutegravir + lamivudine). The drug is now approved for use in virologically suppressed or treatment-naive adolescents aged 12 years and older with HIV-1 infection, a demographic…
-
Clover Bio’s SCB-1019 Vaccine Candidate Shows Promising Results in Phase I Trial
•
Clover Biopharmaceuticals (HKG: 2197), a leading biotechnology company based in China, has announced robust preliminary data from the Phase I clinical trial of its bivalent RSV candidate vaccine, SCB-1019. The vaccine, which targets both RSV-A and RSV-B, demonstrated significant increases in neutralizing titers, a key indicator of immune response. Specifically,…
-
Bristol Myers Squibb Reports Positive Long-Term Data for KarXT in Schizophrenia Trial
•
Pharmaceutical giant Bristol Myers Squibb (BMS, NYSE: BMY) has announced preliminary long-term data from a late-stage extension trial of its muscarinic antipsychotic drug KarXT (xanomeline + trospium) in adult patients with schizophrenia. The 52-week study demonstrated significant improvements, with participants showing an average reduction of 34% in the positive and…
-
Beijing Aosaikang Pharmaceuticals Achieves Clinical Milestone for c-MET Inhibitor ASKC202
•
Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced the presentation of promising data from a Phase I dosage escalation study (ASKC202-001) for its investigational small-molecule c-MET inhibitor, ASKC202, in advanced solid tumors at the American Association for Cancer Research (AACR) 2024 annual meeting. This development underscores the company’s commitment…
-
Transcenta Holdings Ltd Collaborates with Agilent Technologies on Companion Diagnostic for Osemitamab
•
China-based biotech company Transcenta Holdings Ltd (HKG: 6628) has announced a strategic agreement with Agilent Technologies to co-develop Claudin18.2 companion diagnostic reagents, marking a significant step in the global development of osemitamab combined with nivolumab plus chemotherapy for first-line treatment of locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ)…
-
CStone Pharmaceuticals Submits New Drug Application for Gavreto in China, Eyes Local Manufacturing
•
CStone Pharmaceuticals (HKG: 2616), a leading biopharmaceutical company based in China, has submitted a market approval filing to the National Medical Products Administration (NMPA) for Gavreto (pralsetinib), an oral, once-daily, highly selective RET inhibitor. The company plans to manufacture the drug locally, marking a strategic shift from overseas supply. Gavreto…
-
Jiangsu Hengrui Medicine Secures IND Approvals for Two Drug Candidates from China’s NMPA
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received Investigational New Drug (IND) approvals from China’s National Medical Products Administration (NMPA) for two of its drug candidates, marking a significant step in the company’s pharmaceutical development pipeline. The approvals clear the way for a Phase Ib/II study combining adebrelimab (SHR-1316)…
-
Abbisko Therapeutics Achieves Milestone in Global Phase III Trial for Pimicotinib in Tendon Sheath Giant Cell Tumor
•
Shanghai-based biotech firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced the completion of subject enrollment and dosing in its ABSK021-301 study, a pivotal Phase III trial evaluating the efficacy and safety of its investigational drug ABSK021 (pimicotinib) in treating tendon sheath giant cell tumor (TGCT). This marks the first…
-
Luye Pharma’s Subsidiary Boan Biotech Completes Phase III Trial for Eylea Biosimilar BA9101
•
Shandong Boan Biotechnology Co., Ltd., a subsidiary of China-based Luye Pharma Group (HKG: 2186), has achieved a significant milestone with the completion of a Phase III clinical study for its proprietary ophthalmology product BA9101. This biosimilar version of Bayer’s Eylea (aflibercept) targets the treatment of recurrent or metastatic esophageal squamous…
-
AstraZeneca’s Imfinzi Achieves Positive Results in Late-Stage Trial for Small Cell Lung Cancer
•
UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced that a late-stage trial for its anti-PD-L1 drug Imfinzi (durvalumab) has successfully met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients with limited-stage small cell lung cancer (LS-SCLC). The trial’s success marks a significant milestone…
-
Novartis’s Leqvio Showcases Real-World Efficacy in Managing Cholesterol in ASCVD Patients
•
Swiss pharmaceutical giant Novartis (NYSE: NVS) has presented compelling real-world data for its innovative small interfering RNA (siRNA) therapy, Leqvio (inclisiran), which is used for the treatment of atherosclerotic cardiovascular disease (ASCVD) in patients who have not responded well to statins. The data, unveiled last week, demonstrated that the early…
-
AstraZeneca and Daiichi Sankyo’s Enhertu Secures FDA Approval for HER2-Positive Solid Tumors
•
Partners AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) have been granted an additional indication by the US Food and Drug Administration (FDA) for their antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan). The new indication authorizes the use of Enhertu as a treatment for unresectable or metastatic HER2-positive solid…
-
Bristol Myers Squibb’s Abecma Receives FDA Approval for Wider Use in Multiple Myeloma Treatment
•
The US Food and Drug Administration (FDA) has granted an indication extension for Bristol Myers Squibb’s (BMS; NYSE: BMY) CAR-T therapy Abecma (idecabtagene vicleucel), approving it for use in adult patients with triple-class exposed relapsed or refractory multiple myeloma (r/rMM) who have received two or more prior lines of therapy.…
-
Dizal Pharmaceutical’s Sunvozertinib Earns FDA Breakthrough Therapy Designation for NSCLC
•
Dizal Pharmaceutical Co., Ltd (SHA: 688192), a leading Chinese pharmaceutical company, has announced that its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib, has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA). This designation is in recognition of sunvozertinib’s potential as a first-line treatment for…
-
Sichuan Kelun-Biotech Presents Positive Results for Sacituzumab Tirumotecan at AACR 2024
•
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced the presentation of favorable results from two clinical studies on sacituzumab tirumotecan (sac-TMT, SKB264/MK-2870), a TROP2-targeted antibody drug conjugate (ADC), at the American Association for Cancer Research (AACR) 2024 annual meeting. The drug is under global co-development with Merck, Sharp &…
-
Huadong Medicine Gets NMPA Approval for Clinical Trial of FRα-Targeting ADC Elahere
•
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for Elahere (mirvetuximab soravtansine), the company’s antibody drug conjugate (ADC) that targets folate receptor α (FRα). The study will evaluate Elahere as a…
-
Hinova Pharmaceuticals Receives NMPA Greenlight for HP501 Clinical Trial in Gout Patients
•
Shanghai-based Hinova Pharmaceuticals Inc. (SHA: 688302) has announced that it has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its investigational drug HP501 in combination with febuxostat for the treatment of primary gout with hyperuricemia. This marks a significant step forward in addressing…
-
Junshi Biosciences’ Toripalimab Approved for First-Line RCC Treatment in China
•
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has received a new indication approval from China’s National Medical Products Administration (NMPA) for its anti-PD-1 therapy, Loqtorzi (toripalimab). The drug is now approved for use in combination with axitinib to treat first-line moderate- to high-risk unresectable or metastatic renal cell…
-
Ascletis Pharma Halts ASC42 Phase II Study in Primary Biliary Cholangitis
•
China-based Ascletis Pharma Inc. (HKG: 1672) has announced its decision to terminate the Phase II clinical study for ASC42 in primary biliary cholangitis (PBC) following a comprehensive data analysis. The farnesoid X receptor (FXR) agonist will also see the cancellation of studies in non-alcoholic steatohepatitis (NASH) and hepatitis B virus…
-
IASO Biotherapeutics Gains FDA Nod for Fucaso CAR-T Study in Myasthenia Gravis
•
China-based IASO Biotherapeutics has received approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical study for Fucaso (equecabtagene autoleucel), a BCMA-directed CAR-T cell therapy targeting refractory systemic myasthenia gravis (MG). Earlier this year, IASO began a clinical trial for Fucaso in China for the same indication.…
-
Ipsen Secures NMPA Approval for Somatuline in Advanced Neuroendocrine Tumors
•
Ipsen (EPA: IPN; OTCMKTS: IPSEY), a France-based biopharmaceutical company, has received new indication approval from the National Medical Products Administration (NMPA) for its Somatuline (lanreotide) sustained-release injection. This approval allows for the treatment of unresectable, highly differentiated or moderately differentiated, locally advanced, or metastatic gastrointestinal pancreatic neuroendocrine tumors (GEP-NETs), aimed…
-
Shanghai Henlius Reports Phase III Success for HLX14 in Osteoporosis Treatment
•
Shanghai Henlius Biotech Inc. (HKG: 2696), based in China, has announced that its global, multi-center Phase III clinical trial for HLX14, a biosimilar of Amgen’s Prolia/Xgeva (denosumab), has successfully met its primary endpoints in treating postmenopausal osteoporosis in women at high risk of fracture. The Phase III study aims to…
-
Mabwell Bioscience Receives NMPA Approval for Biosimilar Version of Amgen’s Xgeva
•
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that it has received market approval from China’s National Medical Products Administration (NMPA) for its biosimilar product 9MW0321, a version of Amgen’s Xgeva (denosumab). This makes Mabwell the first company to gain approval for a biosimilar version of the drug in…
-
Walvax Biotechnology’s COVID-19 Variant Vaccine RQ3033 Shows Positive Phase III Results
•
China-based Walvax Biotechnology Co., Ltd (SHE: 300142) has announced positive results from a Phase III immunogenic bridge study for its COVID-19 variant mRNA vaccine candidate, RQ3033, co-developed with Fudan University and RNACure. The vaccine is specifically targeting the Omicron XBB.1.5 variant and has demonstrated good efficacy and safety in the…
-
Legend Biotech’s Carvykti Secures FDA Approval for Expanded Use in Multiple Myeloma
•
China-based Legend Biotech Corporation (NASDAQ: LEGN) has announced that the US Food and Drug Administration (FDA) has granted another indication approval for its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel). The therapy has now received an expanded indication for the treatment of relapsed/refractory multiple myeloma (r/r…
-
European Commission Approves Reblozyl for First-Line Treatment of MDS-Related Anemia
•
The European Commission (EC) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension for its erythropoietic agent Reblozyl (luspatercept) as a first-line treatment for transfusion-dependent anemia associated with lower-risk myelodysplastic syndromes (MDS) in adult patients. Originally indicated for anemia related to beta-thalassemia, Reblozyl is now positioned to address…
-
AstraZeneca and Daiichi Sankyo File for FDA Approval of Datopotamab Deruxtecan in Breast Cancer
•
AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, and its Japanese partner Daiichi Sankyo (TYO: 4568) have submitted a filing to the U.S. Food and Drug Administration (FDA) for their antibody-drug conjugate (ADC) datopotamab deruxtecan, aimed at treating unresectable or metastatic HR-positive, HER2-negative breast cancer in adults who have previously…
-
Sichuan Biokin Secures NMPA Approval for Phase II Study of BL-M07D1 in Advanced Solid Tumors
•
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506), based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its antibody-drug conjugate (ADC) BL-M07D1 in patients with advanced solid tumors. The trial will evaluate BL-M07D1 in combination…
-
Jiangsu Hengrui’s Fluzoparib Receives Breakthrough Therapy Designation for HER2-Negative Breast Cancer
•
Jiangsu Hengrui Medicine Co., Ltd. (SHA: 600276), a China-based pharmaceutical company, has announced that its indication approval filing for fluzoparib—a poly (ADP-ribose) polymerase (PARP) inhibitor—has been awarded breakthrough therapy designation (BTD) by China’s Center for Drug Evaluation (CDE). The designation applies to fluzoparib, both as a monotherapy and in combination…
-
Jiuyuan Gene’s Semaglutide Biosimilar Market Filing Accepted for Review in China
•
Hangzhou Jiuyuan Gene Engineering Co., Ltd., based in China, has announced that its market approval filing for a biosimilar version of semaglutide, originally developed by Denmark’s Novo Nordisk, has been accepted for review in China. This biosimilar is aimed at controlling blood glucose levels in patients with type 2 diabetes…
-
RemeGen Secures Fast-Track FDA Designation for Telitacicept in Sjögren’s Syndrome Treatment
•
China-based pharmaceutical company RemeGen (HKG: 9995) has announced that it has received fast-track designation (FTD) from the U.S. Food and Drug Administration (FDA) for its telitacicept in the treatment of Sjögren’s syndrome (SS). This follows the drug’s clearance for a global, multi-center Phase III study in the U.S. for the…
-
Hepalink Secures TFDA Approval for Enoxaparin Sodium Injection, Expanding Thrombosis Treatment Options in Thailand
•
Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399), based in China, has announced that it has received marketing approval from the Thailand Food and Drug Administration (TFDA) for its enoxaparin sodium for injection. The approved specifications include 0.2ml (20mg) and 0.4ml (40mg), indicated for the prevention of venous thromboembolic diseases,…
-
Junshi Biosciences Files for Approval of Ongericimab, Targeting Key Cholesterol Disorders
•
China’s Junshi Biosciences (HKG: 1877; SHA: 688180) has announced the submission of two market approval filings for its PCSK9 monoclonal antibody, ongericimab (JS002). The filings target heterozygous familial hypercholesterolemia and primary hypercholesterolemia, as well as mixed dyslipidemia in patients who are intolerant to or contraindicated for statins. The National Medical…
-
Zai Lab Announces Positive Phase III Data for Krazati in KRASG12C-mutated NSCLC, Plans NDA Filing in China
•
Zai Lab (NASDAQ: ZLAB; HKG: 9688), a China-based biotech company, has announced positive Phase III results for Krazati (adagrasib) in the treatment of KRASG12C-mutated non-small cell lung cancer (NSCLC) as a second-line therapy. The company is now preparing to submit a New Drug Application (NDA) to China’s National Medical Products…
-
Alexion’s Voydeya Earns FDA Nod as Add-on Therapy for PNH-Associated Extravascular Hemolysis
•
Alexion, the rare disease unit of AstraZeneca (AZ; NASDAQ: AZN) based in the UK, has secured regulatory approval from the US Food and Drug Administration (FDA) for its Factor D inhibitor Voydeya (danicopan). The drug is approved as an add-on therapy to ravulizumab or eculizumab, which are marketed as Ultomiris…
-
Viatris Launches Ryzumvi in the US for Rapid Reversal of Pharmacologically-Induced Pupil Dilation
•
Viatris Inc. (NASDAQ: VTRS) has launched its alpha-adrenergic blocker Ryzumvi (phentolamine) in the US market, targeting the reversal of pharmacologically-induced pupil dilation caused by adrenergic agonists or parasympatholytic agents. The ophthalmic solution, which received regulatory approval last year, demonstrated in clinical trials that it could reverse eye dilation within 90…
-
J&J’s Nipocalimab Fast-Tracked by FDA for Reducing FNAIT Risk in Pregnant Adults
•
The US Food and Drug Administration (FDA) has accepted Johnson & Johnson’s (J&J; NYSE: JNJ) FcRn blocker nipocalimab into its fast-track program for development as a therapy to reduce the risk of fetal neonatal alloimmune thrombocytopenia (FNAIT) in alloimmunized pregnant adults. This move comes after the drug was classified as…
-
Shanghai Fosun Pharma and Meiji Seika Pharma Launch Phase III Studies for Anti-Infective Nacubactam
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based in China, has announced the commencement of two Phase III clinical studies in collaboration with Japan’s Meiji Seika Pharma. These studies are focused on their co-developed anti-infective, Nacubactam (OP0595), which is being tested in combination…
-
Junshi Biosciences Gets Green Light for Global Phase III Study of Tifcemalimab Combination Therapy in LS-SCLC
•
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877), a leading biotech company based in China, has received approval from the Pharmaceuticals and Medical Devices Agency of Japan to initiate a global multi-center Phase III study. The study will be a randomized, double-blind, placebo-controlled trial investigating the combination of tifcemalimab (TAB004/JS004) and…
-
FDA Reviews Eisai’s Monthly Maintenance Therapy for Early Alzheimer’s with Leqembi
•
Last week, the US Food and Drug Administration (FDA) announced the acceptance of an indication extension filing from Japan’s Eisai (TYO: 4523) for Leqembi (lecanemab), an amyloid-beta (Aβ)-targeting therapy intended as a once-monthly maintenance treatment for early Alzheimer’s disease (AD). Currently, the intravenous therapy has conditional approval in the United…
-
Bristol Myers Squibb’s Krazati Trial Yields Positive Phase III Results in NSCLC
•
Last week, Bristol Myers Squibb (BMS; NYSE: BMY) unveiled preliminary results from a Phase III confirmatory trial for its KRAS inhibitor Krazati (adagrasib) in patients with pretreated locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying a KRASG12C mutation. This encouraging data reinforces BMS’s strategic 2023 acquisition of original…
-
China’s CNIPA Upholds Patent for Nobel-Winning CRISPR/Cas9 Gene Editing Technology
•
The China National Intellectual Property Administration (CNIPA) has upheld a key patent surrounding the CRISPR/Cas9 gene editing technology, rejecting an invalidation challenge. The decision was announced by ERS Genomics Ltd, an Ireland-based company founded by Dr. Emmanuelle Charpentier, the Nobel prize-winning co-inventor of the technology, to manage and license access…
-
AstraZeneca’s AKT Inhibitor Truqap Approved in Japan for HR+, HER2- Breast Cancer
•
AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, has registered with Japan’s Ministry of Health, Labour, and Welfare (MHLW) its first-in-class AKT inhibitor, Truqap (capivasertib), in combination with endocrine therapy Faslodex (fulvestrant). This combination therapy is intended for the treatment of unresectable or recurrent PIK3CA-, AKT1-, or PTEN-altered HR-positive, HER2-negative…
-
Kobayashi Pharmaceutical Faces Expanding Scandal Over Contaminated Red Yeast Rice Supplements
•
Kobayashi Pharmaceutical, based in Japan, is facing a deepening scandal over contaminated red yeast rice health supplements, branded as Benji-koji Choleste Help. By the end of last week, the situation had escalated to include 5 patient deaths and 100 hospitalizations linked to the consumption of the cholesterol-lowering supplement, with hundreds…
-
Bristol Myers Squibb’s Zeposia Fails to Meet Primary Endpoint in Crohn’s Disease Trial
•
Bristol Myers Squibb (BMS; NYSE: BMY) has announced that a Phase III study for its S1P receptor modulator Zeposia (ozanimod) in patients with moderate-to-severe active Crohn’s disease (CD) did not meet its primary endpoint of clinical remission at week 12. The trial’s outcome means that Zeposia joins a number of…
-
Regenxbio Reports Stable Visual Acuity Improvements with AbbVie’s Gene Therapy in Wet AMD Trial
•
Regenxbio (NASDAQ: RGNX), the development partner for AbbVie’s (NYSE: ABBV) gene therapy ABBV-RGX-314, has announced results from a Phase I/IIa trial focused on wet age-related macular degeneration (wAMD). This announcement complements the preliminary results shared earlier in the year. The 2-year data from the trial indicate that a single administration…
-
Jiangsu Hengrui’s SHR-A1921 Earns FDA Fast-Track Status for Platinum-Resistant Ovarian Cancer Therapies
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a distinguished pharmaceutical entity, has announced that it has been granted Fast-Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for its proprietary antibody-drug conjugate (ADC), SHR-A1921. This designation is for the treatment of platinum-resistant recurrent epithelial ovarian cancer, fallopian tube…
-
Allergan Aesthetics Launches SKINMEDICA in China, Targeting Booming Skincare Market
•
Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), has announced the market launch of its premium skincare product line, SKINMEDICA, in China. Known for its safety, efficacy, and clinical use backed by extensive medical research, SKINMEDICA is poised to offer Chinese consumers healthier and more confident skin solutions. This move…
-
InnoCare Pharma Initiates Phase Ib Study Combining ICP-189 with Furmonertinib for NSCLC
•
InnoCare Pharma (HKG: 9969, SHA: 688428), a biopharmaceutical company , has announced that the first patient has been dosed in a Phase Ib clinical study. The study is evaluating the combination of InnoCare’s SHP2 allosteric inhibitor, ICP-189, with the selective EGFR inhibitor furmonertinib for the treatment of advanced or metastatic…
-
Novatim Immune Therapeutics’ KQ-2003 Gains Tacit Approval for POEMS Syndrome Clinical Trial in China
•
Novatim Immune Therapeutics (Zhejiang) Co., Ltd, a China-based specialist in cancer immunotherapy, has received tacit clinical trial approval from Chinese regulatory authorities for its investigational therapy, KQ-2003. This autologous chimeric antigen receptor (CAR)-T cell therapy targets BCMA and CD19 and is poised to be evaluated for the treatment of recurrent/refractory…
-
Hepalink’s Enoxaparin Sodium Injection Receives Marketing Approval in New Zealand
•
Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399), a prominent pharmaceutical company based in China, has announced that it has received marketing approval from New Zealand’s Medicines and Medical Devices Safety Authority (MEDSAFE) for its enoxaparin sodium injection, which will be marketed under the trade name Exarane. Enoxaparin sodium injection…
-
IASO Biotherapeutics Gets NMPA Go-Ahead for BCMA-Targeted CAR-T Therapy Clinical Trial
•
IASO Biotherapeutics, a China-based biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its drug candidate CT103A, known as equecabtagene autoleucel. This investigational treatment is a BCMA-targeted chimeric antigen receptor (CAR) T cell therapy designed for patients…
-
BeiGene and GenFleet Join Forces for DLBCL Trial Combining Brukinsa and GFH009
•
BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a China-based biotechnology company, has entered into a clinical research and drug supply cooperation agreement with fellow Chinese firm GenFleet Therapeutics. The partnership will kick off a Phase Ib/II clinical trial to evaluate the safety and efficacy of a combination regimen featuring…
-
Takeda Gains MHLW Approval for Adzynma, Targeting Rare Blood Disorder cTTP
•
Takeda Pharmaceutical Company (TYO: 4502) has secured regulatory approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its enzyme replacement therapy, Adzynma (apadamtase alfa), to treat congenital thrombotic thrombocytopenic purpura (cTTP) in patients aged 12 and older. cTTP is a rare and potentially life-threatening blood clotting disorder resulting…
-
HutchMed’s Orpathys Files for Expanded Indication in NSCLC Treatment in China
•
HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that the National Medical Products Administration (NMPA) in China is currently reviewing a new market approval filing for Orpathys (savolitinib), a MET inhibitor co-developed with AstraZeneca. The company is seeking a new indication for the drug as a first-line treatment for…
-
Astellas Pharma’s Padcev Combo Therapy Accepted for Review in China for Urothelial Carcinoma
•
Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, has announced that China’s Center for Drug Evaluation (CDE) has accepted for review a supplementary Biologic License Application (sBLA) for its drug Padcev (enfortumab vedotin). The application seeks to expand the use of Padcev in combination with pembrolizumab for the…
-
Zai Lab and Novocure Report Positive Phase III Results for TTFields in NSCLC Brain Metastases
•
Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a biopharmaceutical company based in China, and Novocure (Nasdaq: NVCR), a UK-based oncology innovator, have announced positive results from the Phase III METIS trial. The trial evaluated the efficacy of the Tumor Treating Fields (TTFields) therapeutic device in combination with supportive care for…
-
Jiangsu Hengrui Receives NMPA Approval for SHR-7631 ADC Clinical Study in Solid Tumors
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 antibody drug conjugate (ADC), SHR-7631, in patients with advanced solid tumors. While the…
-
Wuhan YZY Biopharma Initiates Phase II Study for M701 in Malignant Pleural Effusion Treatment
•
Wuhan YZY Biopharma Co., Ltd (HKG: 2496), a biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase II clinical study for its investigational drug M701. M701 is a recombinant anti-EpCAM and CD3 human murine chimeric bispecific antibody (BsAb) injection, currently under assessment as…
-
Innovent Biologics Initiates Phase III Neoshot Study for MSI-H/dMMR Colon Cancer Treatment
•
Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced the first subject dosing in the randomized, multi-center Phase III Neoshot study for its anti-CTLA-4 monoclonal antibody IBI310. The study combines IBI310 with the PD-1 inhibitor sintilimab as a neoadjuvant treatment for patients with resectable MSI-H/dMMR…
-
Alexion’s Ultomiris Secures FDA Approval for Anti-AQP4 Positive NMOSD Treatment
•
AstraZeneca’s (AZ; NASDAQ: AZN) rare disease unit, Alexion, has registered its biologic Ultomiris (ravulizumab) with the US Food and Drug Administration (FDA) for the treatment of anti-AQP4 antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD) in adults. This registration follows an initial rejection by the FDA last year and positions Ultomiris…
-
MSD’s Winrevair Approved by FDA as First Activin Signaling Inhibitor for Pulmonary Arterial Hypertension
•
The US Food and Drug Administration (FDA) has granted Merck, Sharp & Dohme (MSD; NYSE: MRK) regulatory approval for Winrevair (sotatercept), marking it as the first activin signaling inhibitor for the treatment of pulmonary arterial hypertension (PAH) in adults. This milestone concludes a review process under the breakthrough therapy designation…
-
FDA Grants Full Approval to AbbVie’s Elahere for Advanced Ovarian Cancer Treatment
•
This week, the U.S. Food and Drug Administration (FDA) granted full approval to AbbVie’s (NYSE: ABBV) antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine) for the treatment of FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer following up to three prior therapies. This approval marks an upgrade from the 2022…
-
Biocytogen and ABL Bio Forge Partnership to Advance Bispecific ADC Development
•
China-based Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (HKG: 2315) has entered into a partnership with South Korea’s ABL Bio Inc. (KOSDAQ: 298380) to advance the development of bispecific antibody drug conjugates (ADCs). ABL Bio is a research-driven biotechnology firm recognized for its pioneering work in bispecific antibodies aimed at treating immuno-oncology…
-
CanSino Biologics Launches Phase III Study for Menhycia Vaccine in Indonesia
•
China-based CanSino Biologics (HKG: 6185) has announced the launch of a Phase III clinical study for its ACYW135 Meningococcal Conjugate Vaccine (CRM197), branded as Menhycia, in Indonesia, with the first subject already enrolled. This pivotal study aims to evaluate both the safety and immunogenicity of the vaccine in individuals aged…
-
Guangdong Zhongsheng Reports Positive Phase I Results for Innovative Weight Loss Drug RAY1225
•
Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a China-based biopharmaceutical company, has announced promising top-line results from a Phase I clinical trial for its innovative polypeptide drug candidate, RAY1225. This long-acting glucagon-like peptide-1 (GLP-1) therapy features dual activation of both the GLP-1 and glucose-dependent insulin-promoting polypeptide (GIP) receptors. The randomized,…
-
Jiangsu Hengrui’s Generic Version of Tepadina Approved for Transplantation Conditioning in China
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic version of Tepadina (thiotepa), originally developed by Switzerland-based Adienne S.r.l. The infusion is indicated as a conditioning treatment…
-
MSD’s Phase III Trial of Keytruda Plus Lynparza Misses Primary Endpoints in NSCLC
•
Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced an unfavorable outcome for a Phase III trial combining Keytruda (pembrolizumab) and Lynparza (olaparib) in the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC). The study, which aimed to evaluate the efficacy of this combination therapy, was halted after…
-
Shanghai Institute’s Biosimilar Rituximab Approved by NMPA for Lymphoma Treatments
•
Shanghai Institute of Biological Products Co., Ltd has announced that its biosimilar version of Roche/Genentech’s Mabthera (rituximab) has received approval from the National Medical Products Administration (NMPA) for the treatment of Non-Hodgkin’s lymphoma, including follicular non-Hodgkin’s lymphoma and CD20 positive diffuse large B-cell non-Hodgkin’s lymphoma, as well as chronic lymphoblastic…
-
EMA Panel Backs Novartis’s Fabhalta for PNH Treatment, Awaits EC Decision
•
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Novartis’s (NYSE: NVS) Factor B inhibitor Fabhalta (iptacopan) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults with hemolytic anemia. The European Commission (EC) is anticipated to make a…
-
Sanofi Projects EUR 13 Billion in Dupixent Sales for 2024 Despite Q1 Challenges
•
Sanofi (NASDAQ: SNY), a leading French pharmaceutical company, has released its guidance for the first quarter of 2024. Despite expectations that its top-selling interleukin blocker Dupixent (dupilumab) will face challenges from a co-pay assistance program in the first quarter, the company projects that the drug’s sales will reach EUR 13…
-
FibroGen’s Roxadustat Approved in Macau for Chronic Kidney Disease-Related Anemia
•
FibroGen Inc. (NASDAQ: FGEN), a biopharmaceutical company based in the US, has announced that it has received marketing approval in Macau for its drug roxadustat. The drug is indicated for the treatment of anemia caused by chronic kidney disease (CKD), encompassing both dialysis and non-dialysis patients. Roxadustat, an oral hypoxia-inducible…
-
Yifan Pharmaceutical’s F-627 Approved by European Commission for Marketing in EU
•
Yifan Pharmaceutical Co., Ltd (SHE: 002019), a Chinese pharmaceutical company, has announced that its subsidiary Evive Biotech Ltd’s drug Ryzneuta (efbemalenograstim alfa, F-627) has received marketing approval from the European Commission (EC) in the European Union (EU), following a recommendation by the European Medicines Agency’s Committee for Medicinal Products for…
-
Grand Pharma Receives NMPA Approval for Global Phase III Study of RDC ITM-11 in GEP-NETs
•
Grand Pharmaceutical Group Ltd (HKG: 0512), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct the COMPOSE study. This is a prospective, randomized, controlled, open-label, global multi-center Phase III study designed to assess the efficacy, safety,…
-
Joincare Pharmaceuticals Secures Rights to Bayer’s Respiratory Drug in China
•
Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380), a Chinese pharmaceutical company, has announced a significant licensing agreement with German healthcare giant Bayer. Under the terms of this agreement, Joincare has obtained development, commercialization, and manufacturing rights to Bayer’s small-molecule inhibitor in the respiratory field within China. The financial specifics…
-
Lynk Pharmaceuticals Doses First Patient in Phase III Trial for Atopic Dermatitis Treatment
•
Lynk Pharmaceuticals Co., Ltd, based in China, has announced the dosing of the first patient in a Phase III clinical study for its highly selective JAK1 inhibitor, LNK01001, aimed at treating atopic dermatitis (AD). This randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of LNK01001 in…
-
HutchMed Launches Phase II/III Study for Sovleplenib in Autoimmune Hemolytic Anemia
•
HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced the initiation of the Phase II/III ESLIM-02 study for its investigational drug, sovleplenib, in patients with warm antibody autoimmune hemolytic anemia (wAIHA) in China. The ESLIM-02 trial is a randomized, double-blind, placebo-controlled study aimed at confirming the safety and efficacy of…
-
NeuExcell Therapeutics Doses First Patient in Groundbreaking Clinical Trial for NeuroD1 Gene Therapy
•
NeuExcell Therapeutics, a Shanghai-based developer of in vivo neural regenerative therapies, has announced the first patient dosing in a clinical trial for its first-in-class (FIC) NeuroD1 gene therapy product, NXL-004, targeting malignant glioma. This marks NXL-004 as the world’s first gene therapy of its kind to enter the clinical setting.…
-
FDA Grants Accelerated Approval for Takeda’s Iclusig in Newly Diagnosed Ph+ ALL
•
The U.S. Food and Drug Administration (FDA) has granted accelerated indication extension approval to Japan’s Takeda Pharmaceutical Company (TYO: 4502) for its tyrosine kinase inhibitor (TKI) Iclusig (ponatinib) in combination with chemotherapy for the treatment of newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). This follows the drug’s previous…
-
iRegene’s NouvSight001 Gains Orphan Drug Designation for Retinitis Pigmentosa Treatment
•
Wuhan-based cell therapy innovator iRegene has secured Orphan Drug Designation (ODD) from the U.S. FDA for its ophthalmic product NouvSight001, aimed at treating retinitis pigmentosa (RP). NouvSight001 is heralded as the world’s first universal ophthalmic cell therapy derived from induced pluripotent stem cells (iPSCs), developed through an innovative “AI+chemical induction”…
-
BMS Reports Positive Phase III Results for Opdivo and Yervoy in Advanced HCC
•
Bristol Myers Squibb (BMS; NYSE: BMY) announced this week that its Phase III study evaluating the combination of anti-PD-1 drug Opdivo (nivolumab) and anti-CTLA-4 biologic Yervoy (ipilimumab) as a first-line treatment for advanced hepatocellular carcinoma (HCC) has yielded promising top-line results. According to data from a pre-specified interim analysis, the…
-
Antengene’s ATG-022 Advances to Dose Expansion Phase in Phase II CLINCH Study for Solid Tumors
•
Antengene Corporation Ltd (HKG: 6996), a leading biopharmaceutical company based in China, has announced that ATG-022, an antibody drug conjugate (ADC) targeting Claudin 18.2 (CLDN18.2), has progressed into the dosage expansion phase of the Phase II CLINCH study. This trial is evaluating ATG-022 as a monotherapy for advanced or metastatic…
-
CSPC Pharmaceutical Secures NMPA Approval for Clinical Study of SYS6023 in Advanced Solid Tumors
•
CSPC Pharmaceutical Group Ltd (HKG: 1093), a prominent China-based biopharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its antibody drug conjugate (ADC) SYS6023 in patients with advanced solid tumors. SYS6023 is designed to target specific receptors on tumor surfaces, allowing…
-
Jiangsu Hengrui Receives NMPA Approval for Phase Ib/II Study of HRS2398 in Advanced Solid Tumors
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate an open, multi-center Phase Ib/II study. The study will assess the drug candidate HRS2398 in combination with HRS-1167 or adebrelimab…
-
CSPC Pharmaceutical Gets NMPA Greenlight for SYH2039 Clinical Study in Advanced Malignant Tumors
•
CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its Category 1 chemical drug candidate, SYH2039, which targets advanced malignant tumors. SYH2039 is a potent inhibitor of methionine adenosine…
-
Everest Medicines’ Nefegan Approved by Singapore HSA for Primary IgAN Treatment
•
Everest Medicines (HKG: 1952), a China-based biotechnology company, has received marketing approval from the Singapore Health Sciences Authority (HSA) for its drug Nefegan, also known as Nefecon, which is indicated for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults who are at risk of disease progression. Nefecon is…
-
Dr. Reddy’s Launches Biosimilar Versavo in UK to Challenge Roche’s Cancer Therapy Avastin
•
Dr. Reddy’s Laboratories (NYSE: RDY), a prominent Indian pharmaceutical company, has launched its biosimilar Versavo (bevacizumab) in the UK market, presenting a challenge to Roche’s established cancer therapy Avastin. Versavo, a biosimilar to Avastin, has been approved for the treatment of various metastatic cancers, including colorectal cancer, non-squamous non-small cell…
-
Bayer’s Elinzanetant Achieves Primary Endpoint in Late-Stage Menopause Symptom Trial
•
Bayer (ETR: BAYN), a leading German pharmaceutical company, has announced positive results from a placebo-controlled late-stage trial of its NK-1,3 receptor antagonist, elinzanetant. The trial successfully met its primary endpoint, demonstrating a significant reduction in the frequency of moderate-to-severe vasomotor symptoms (VMS) associated with menopause by week 12. The 52-week…
-
China Medical System Gets Green Light for Phase III Clinical Trial of Opzelura in Atopic Dermatitis
•
China Medical System Holdings (CMS; HKG: 0867) has received approval from the National Medical Products Administration (NMPA) to commence a Phase III clinical study for its Opzelura (ruxolitinib) cream, which is indicated for the treatment of atopic dermatitis (AD). This development marks a significant step forward for CMS in expanding…
-
AstraZeneca’s Lynparza-Imfinzi Combo Shows Promising Results in Endometrial Cancer Study
•
AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical giant, has presented interim results from a late-stage study combining the PARP inhibitor Lynparza (olaparib) with the anti-PD-L1 Imfinzi (durvalumab) for the treatment of newly diagnosed advanced or recurrent endometrial cancer. The study has shown promising outcomes, with the combination therapy extending the…
-
Teruisi Pharma’s TRS005 Receives Support for Breakthrough Designation in China for CD20-Positive Lymphoma
•
The Center for Drug Evaluation (CDE) in China has signaled that Teruisi Pharma’s antibody drug conjugate (ADC), TRS005, which targets CD20, is on track to receive breakthrough therapy designation (BTD) for the treatment of recurrent or refractory CD20-positive diffuse large B-cell lymphoma (DLBCL). The drug is being developed specifically for…
-
Pfizer’s Elrexfio Anticipated for Priority Review in China for Relapsed/Refractory Multiple Myeloma
•
The Center for Drug Evaluation (CDE) in China has indicated that Pfizer (NYSE: PFE)’s Elrexfio (elranatamab), a bispecific antibody targeting BCMA and CD3, is on track for priority review as a potential treatment for triple-class exposed (TCE) relapsed or refractory multiple myeloma (r/r MM). This development signifies a significant step…
-
AstraZeneca Caps Monthly Costs for US Patients with Asthma and COPD Inhalers
•
AstraZeneca (AZ; NASDAQ: AZN), a leading UK-based pharmaceutical company, has announced an expansion of its accessibility program for inhaled respiratory drugs in the US. The initiative will cap monthly expenses at USD 35 for eligible patients suffering from asthma and chronic obstructive pulmonary disease (COPD). The savings program includes coverage…
-
Jiangsu Yahong Meditech to Present Phase III Results for Cervical Cancer Treatment at SGO Annual Meeting
•
Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176), a specialist in urogenital cancer treatments, is preparing to unveil key findings from a global multicenter Phase III clinical study on its Cevira (APL-1702) at the Society of Gynecologic Oncology (SGO) annual meeting. The study focuses on the treatment of high-grade squamous…
-
GSK’s Jemperli Shows Survival Benefits in Phase III Endometrial Cancer Study
•
GlaxoSmithKline (GSK; NYSE: GSK), a leading UK pharmaceutical company, has presented early results from a Phase III study for its PD-1-blocking antibody Jemperli (dostarlimab) in the treatment of primary advanced or recurrent endometrial cancer. The placebo-controlled trial aims to expand the current indication for frontline mismatch repair deficient (dMMR)/microsatellite instability-high…
-
Boehringer Ingelheim Partners with Sosei Group to Develop GPR52 Agonists for Schizophrenia
•
Boehringer Ingelheim (BI), headquartered in Germany, has entered into a global collaboration and exclusive option-to-license agreement with Sosei Group Corporation (TSE: 4565), a Japanese firm. This strategic partnership aims to develop and commercialize Sosei Heptares’ portfolio of first-in-class GPR52 agonists, targeting a novel G protein-coupled receptor (GPCR) to address the…
-
BeiGene’s Tislelizumab Receives FDA Approval for Esophageal Squamous Cell Carcinoma
•
BeiGene (NASDAQ: BGNE) has announced that the US Food and Drug Administration (FDA) has granted approval for its programmed death-1 (PD-1) inhibitor, tislelizumab, as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC). The approval is for patients who have been previously treated…
-
Legend Biotech’s Carvykti Earns FDA Committee’s Unanimous Recommendation for Expanded Use
•
GenScript Biotech Corporation (HKG: 1548), a Contract Research Organization (CRO) based in China, has announced that its subsidiary Legend Biotech Corporation’s (NASDAQ: LEGN) BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), has received a recommendation from the US FDA’s Oncologic Drugs Advisory Committee (ODAC). Following a review…
-
Simcere Pharmaceutical’s Suvemcitug Files for Approval in China for Recurrent Ovarian Cancer
•
Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has announced that an approval filing for its drug candidate suvemcitug (also known as sevacizumab; APX-003; BD-0801) has been submitted in China and accepted for review by the National Medical Products Administration (NMPA). The filing seeks the first indication…
-
Bristol Myers Squibb’s Breyanzi Receives FDA Accelerated Approval for CLL/SLL Treatment
•
The US Food and Drug Administration (FDA) has granted accelerated approval to Bristol Myers Squibb’s (BMS; NYSE: BMY) CAR-T cell therapy Breyanzi (lisocabtagene maraleucel) for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have undergone at least two prior lines…
-
Sino Biopharmaceutical Advances Lanifibranor and TQA2225 into Late-Stage Clinical Trials for MASH
•
Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced the commencement of Phase III and Phase II clinical studies for two of its drug candidates. Lanifibranor, a PPAR agonist, and TQA2225, an FGF21-Fc fusion protein, are both being evaluated as potential treatments for metabolic dysfunction-associated…
-
Mabwell’s Nectin-4 Targeting ADC 9MW2821 Shows Promise in Cervical Cancer Clinical Study
•
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced positive results from a clinical study of its pipeline candidate, the antibody drug conjugate (ADC) 9MW2821, which targets Nectin-4. The data, highlighting the potential of 9MW2821 in treating cervical cancer, is set to be presented…
-
Novo Nordisk’s Wegovy Leads in Total US Prescriptions for Weight-Loss Market
•
Novo Nordisk (CPH: NOVO-B), a leading pharmaceutical company, has seen its weight-loss drug Wegovy (semaglutide) take the lead in total US prescriptions over its competitor Eli Lilly’s (NYSE: LLY) Zepbound (tirzepatide), according to Reuters. Despite this, Zepbound has seen more new prescriptions filled, indicating a close competition in a market…
-
FDA Advisory Committee Backs Wider Use of Abecma in Relapsed or Refractory Multiple Myeloma
•
An advisory committee to the US Food and Drug Administration (FDA) has recommended the use of Abecma (idecabtagene vicleucel), a CAR-T therapy developed by Bristol Myers Squibb (BMS; NYSE: BMY) and 2seventy bio (NASDAQ: TSVT), for the treatment of triple-class exposed (TCE) relapsed or refractory multiple myeloma (r/rMM). This recommendation…
-
Shanghai Henlius Initiates Phase I Trial for HLX42, an Innovative ADC Targeting EGFR
•
Shanghai Henlius Biotech Inc. (HKG: 2696) has announced the first subject dosing in a Phase I clinical trial for HLX42, an antibody-drug conjugate (ADC) co-developed with Suzhou-based Medilink Therapeutics. The study will initially evaluate HLX42 in patients with advanced or metastatic solid tumors in China. HLX42 is an innovative ADC…
-
KeChow Pharma Secures Conditional Approval for HL-085, a First-of-Its-Kind MEK Inhibitor for Advanced Melanoma
•
Shanghai-based KeChow Pharma has received conditional marketing approval from the National Medical Products Administration (NMPA) for its Category 1 drug HL-085, aimed at treating advanced melanoma with NRAS mutations in patients who have experienced failure with anti-PD-1/PD-L1 therapies. HL-085 is a groundbreaking ATP non-competitive MEK inhibitor that specifically targets NRAS…
-
Pfizer’s Sugemalimab Secures NMPA Approval for Gastric and Gastroesophageal Junction Adenocarcinoma
•
Pfizer (NYSE: PFE), a leading pharmaceutical company in the US, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for sugemalimab, a programmed death-ligand 1 (PD-L1) inhibitor, for the first-line treatment of inoperable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma (G/GEJ) expressing…
-
Madrigal Pharmaceuticals’ Rezdiffra Earns FDA Accelerated Approval for NASH in Adults
•
The US Food and Drug Administration (FDA) has granted an accelerated approval to Madrigal Pharmaceuticals’ (NASDAQ: MDGL) Rezdiffra (resmetirom) for the treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) in adults with moderate-to-advanced liver fibrosis. This marks the first approval in the US for a therapy indicated for liver scarring due to…
-
CNIPA Invalidates AbbVie Patents, Setting New Precedent for Pharmaceutical Disclosure
•
The China National Intellectual Property Administration (CNIPA)’s Patent Re-examination Board (PRB) has reportedly invalidated two patents associated with AbbVie (NYSE: ABBV)’s JAK inhibitor, upadacitinib, listed in China’s version of the ‘Orange Book’. This ruling, highlighted by Lusheng Law Firm’s Terry Lu, could set a critical precedent for innovative pharmaceutical companies,…
-
European Commission Approves Pfizer’s Prevenar 20 for Pediatric Use
•
The European Commission (EC) has granted regulatory approval to Pfizer (NYSE: PFE) for its 20-valent pneumococcal vaccine, Prevenar 20, aimed at preventing invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae in individuals aged 6 weeks to 18 years. This vaccine was previously approved for use in adults…
-
Merck Plans Broader HPV Vaccine Development, Targeting African and Asian Populations
•
Merck, Sharp & Dohme (MSD; NYSE: MRK) has unveiled plans to develop a multi-valent human papillomavirus (HPV) vaccine aimed at providing broader protection than the currently approved 9-valent Gardasil 9. This new candidate will include additional virus-like particles (VLPs) targeting HPV types that disproportionately affect populations in Africa and Asia,…
-
Allist Pharmaceuticals Secures NMPA Approval for Phase I Study of AST2169 Liposome in KRAS G12D Tumors
•
Shanghai-based biotech Allist Pharmaceuticals Co., Ltd. (SHA: 688578) has received clearance from the National Medical Products Administration (NMPA) in China to commence a Phase I clinical study of its AST2169 liposome. This study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of AST2169 in patients with advanced solid tumors…
-
Sichuan Biokin Gains NMPA Approval for Phase I Study of BL-M05D1 in Advanced Solid Tumors
•
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its antibody drug conjugate (ADC) BL-M05D1, targeting locally advanced solid tumors. BL-M05D1 utilizes the same “linker+toxin” platform as BL-B01D1, an EGFR/HER3-targeted ADC that was the…
-
Genor Biopharma Secures NMPA Review for Lerociclib in Advanced Breast Cancer Indication
•
Genor Biopharma Co., Ltd. (HKG: 6998) has announced that the National Medical Products Administration (NMPA) has accepted its filing for another indication approval of lerociclib (GB491), a cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor. The new indication seeks to utilize lerociclib in combination with letrozole for patients with hormone receptor-positive…
-
Pfizer’s Adcetris Combo Shows Improved Survival in Relapsed/Refractory DLBCL Late-Stage Trial
•
Pfizer (NYSE: PFE) has announced positive results from a late-stage clinical trial for its antibody-drug conjugate (ADC) Adcetris (brentuximab vedotin) in combination with lenalidomide and rituximab for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The study successfully met its primary endpoint, demonstrating an improvement in overall survival (OS)…
-
Bio-Thera Solutions Gets Green Light for Phase Ib/II Study of ADC BAT8008 in Advanced Solid Tumors
•
Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that it has received approval from the National Medical Products Administration to conduct a Phase Ib/II study for its antibody drug conjugate (ADC) BAT8008 in combination with BAT1308 for the treatment of advanced solid tumors. BAT8008 is an innovative ADC that consists of…
-
Betta Pharmaceuticals’ Ensartinib Accepted for FDA Review for First-Line ALK+ NSCLC Treatment
•
Betta Pharmaceuticals (SHE: 300558), a pharmaceutical company based in China, has announced that the market filing for its ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor co-developed with its affiliate Xcovery, has been accepted for review by the US Food and Drug Administration (FDA). The drug is intended for the first-line…
-
Ji Xing Pharmaceuticals Gets CDE Green Light for Phase III Aficamten Study in nHCM
•
Ji Xing Pharmaceuticals, a China-based pharmaceutical company, has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct the Phase III ACACIA-HCM study for its drug aficamten (CK-3773274) in symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) in China. Aficamten, a next-generation cardiac myosin inhibitor, is under development…
-
InnoCare Pharma Receives IND Approval in China for BCL2 Inhibitor Combo Therapy
•
InnoCare Pharma (HKG: 9969; SHA: 688428), a Beijing-based biotech company, has announced that it has received approval for an Investigational New Drug (IND) clinical trial filing in China. The company is set to initiate a clinical trial for its pipeline B-cell lymphoma-2 (BCL2) inhibitor, ICP-248, in combination with its Bruton’s…
-
Simcere Pharmaceutical Gets NMPA Approval for Clinical Study of Trispecific Antibody SIM0500
•
Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for SIM0500, a trispecific antibody targeting GPRC5D, BCMA, and CD3. This molecule is intended for the treatment of recurrent or…
-
Fosun Pharmaceutical Gets NMPA Green Light for Phase I Study of Fibrosis Drug HLX6018
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its drug candidate HLX6018. This investigational compound is a GARP/TGF-β1 compound…
-
Kelun-Biotech’s A400 Receives Fast-Track Status from FDA for RET Fusion-Positive NSCLC
•
Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) announced that its innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its investigational RET inhibitor, A400/EP0031. This drug is being developed for the treatment of RET fusion-positive…
-
Sinocelltech Gains NMPA Approval for Clinical Study of SCTB35 in B-Cell Non-Hodgkin’s Lymphoma
•
Sinocelltech Group Ltd (SHA: 688520), based in China, has announced that it has received clearance from the National Medical Products Administration (NMPA) to initiate a clinical study for its investigational bispecific antibody (BsAb), SCTB35. This novel molecule targets both CD20 and CD3 and is being evaluated as a treatment for…
-
Huadong Medicine Secures NMPA Approval for HDM1005, Targeting Type 2 Diabetes and Obesity
•
Huadong Medicine Co., Ltd (SHE: 000963), based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug HDM1005. This long-acting agonist targets both the GLP-1 and GIP receptors and is being developed for the treatment of type 2…
-
Innovent and HutchMed’s Combination Therapy Set for Priority Review in China for Advanced Endometrial Cancer
•
China’s Center for Drug Evaluation (CDE) has indicated that the combination therapy of Innovent Biologics Inc.’s (HKG: 1801) PD-1 inhibitor Tyvyt (sintilimab injection) and HutchMed’s (HKG: 0013, NASDAQ: HCM) Elunate (fruquintinib) is on track to receive priority review status in China. This designation pertains to the treatment of advanced mismatch…
-
Sanofi’s Amlitelimab Shows Promising Phase IIb Results in Atopic Dermatitis, Potential for 12-Week Dosing
•
Sanofi (NASDAQ: SNY) announced this week promising results from a Phase IIb study of its OX40-ligand blocker, amlitelimab, in patients with moderate to severe atopic dermatitis. The study focused on participants who demonstrated a favorable response after an initial 24-week treatment period. Following a subsequent 28-week maintenance or withdrawal phase,…
-
J&J’s Tremfya Files for Ulcerative Colitis Indication with FDA, Building on Positive Late-Stage Data
•
The US Food and Drug Administration (FDA) has accepted an indication extension filing from Johnson & Johnson (J&J; NYSE: JNJ) for its IL-23p19-subunit inhibitor Tremfya (guselkumab) as a potential treatment for moderately to severely active ulcerative colitis (UC). The regulatory body will now review data from a late-stage study that…
-
Simcere Secures FDA Approval for Clinical Study of Trispecific Antibody SIM0500 in Multiple Myeloma
•
Simcere Pharmaceutical Group (HKG: 2096), based in China, has received approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical study for its trispecific antibody, SIM0500, which targets GPRC5D, BCMA, and CD3. This innovative molecule is being evaluated as a treatment for recurrent or refractory multiple myeloma…
-
Everest Medicines’ Velsipity NDA Accepted in Macau, Poised for First Asian Approval
•
Everest Medicines (HKG: 1952), based in China, has announced that its New Drug Application (NDA) for Velsipity (etrasimod) for the treatment of moderate-to-severe active ulcerative colitis (UC) has been accepted for review by the regulatory authority in Macau. This marks Macau as the first region in Asia, within Everest’s licensed…
-
Lepu Biotechnology’s MRG004A ADC Gains Fast Track Designation for Pancreatic Cancer
•
Lepu Biotechnology Co., Ltd. (HKG: 2157), based in China, has announced that its in-house developed antibody-drug conjugate (ADC) MRG004A has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. This indication previously secured the ADC an orphan drug designation (ODD)…
-
ClouDr Launches Dapagliflozin, Generic Version of AstraZeneca’s Forxiga, After NMPA Approval
•
Hangzhou Kang Ming Information Technology Co., Ltd. (HKG: 9955), known as “ClouDr,” has officially launched dapagliflozin, its self-operated product with marketing rights. This drug serves as a generic version of AstraZeneca (NASDAQ: AZN)’s Forxiga, a leading treatment for type 2 diabetes. The approval for dapagliflozin was secured through Nanjing F&S…
-
BeiGene Launches Legal Action Against Sandoz and MSN Over Brukinsa Patent Infringement
•
BeiGene Ltd. (NASDAQ: BGNE; HKG: 6160; SHA: 688235), the China-based biotech firm, has initiated patent infringement proceedings against two generics manufacturers: Switzerland’s Sandoz Inc. (OTCMKTS: SDZNY) and U.S.-based MSN Pharmaceuticals. This legal action follows notifications received from both companies regarding their Abbreviated New Drug Applications (ANDAs) submitted to the U.S.…
-
Eli Lilly Delays Donanemab Action Date as FDA Calls for Advisory Committee Review
•
Eli Lilly (NYSE: LLY) has announced a delay in the action date for its Alzheimer’s disease candidate, donanemab, with the U.S. Food and Drug Administration (FDA) pushing the timeline beyond the fourth quarter of 2024. The delay follows the FDA’s request for an advisory committee meeting to evaluate donanemab’s Phase…
-
FDA Approves Wegovy for Cardiovascular Risk Reduction in Obese Patients, First of Its Kind
•
The U.S. Food and Drug Administration (FDA) granted an indication extension approval last week to Novo Nordisk (NYSE: NVO) for its GLP-1 receptor agonist Wegovy (semaglutide), allowing it to be used for the reduction of major adverse cardiovascular events (MACE) in overweight or obese adults with established cardiovascular disease (CVD).…
-
Amgen Reports Positive Results for Otezla in Pediatric Psoriasis Trial
•
Amgen (NASDAQ: AMGN) provided an update last week on a late-stage trial evaluating its PDE4 inhibitor Otezla (apremilast) for the treatment of moderate to severe plaque psoriasis in patients aged 6 to 17 years. The one-year data revealed that 56.3% of participants achieved clear or almost clear skin, while 71.4%…
-
BMS’s Opdivo Secures FDA Approval for First-Line Urothelial Carcinoma Treatment
•
The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension approval for its anti-PD-1 drug Opdivo (nivolumab). The drug is now approved in combination with cisplatin and gemcitabine for the first-line treatment of unresectable or metastatic urothelial carcinoma (UC) in adults. The…
-
BeiGene’s Brukinsa Receives FDA Approval for Relapsed or Refractory Follicular Lymphoma
•
BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading biotech company based in China, has announced its latest indication approval in the United States for its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib). The US Food and Drug Administration (FDA) has granted approval for Brukinsa in combination with the…
-
Visen Pharmaceuticals’ TransCon hGH Accepted for Review by China’s NMPA
•
Visen Pharmaceuticals, a joint venture between Denmark-based Ascendis Pharma and Chinese healthcare-focused investment firm Vivo Capital, has announced that the National Medical Products Administration (NMPA) has accepted for review a marketing approval filing for its lonapegsomatropin, TransCon hGH, a once-weekly long-acting growth hormone. This drug, which is the first long-acting…
-
Shanghai Fosun Pharma Gets NMPA Green Light for Universal NK Cell Therapy GCK-01 Clinical Study
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its universal NK cell therapy, GCK-01. This Category 1 innovative therapeutic…
-
Novo Nordisk’s Anti-Obesity Drug Wegovy Eyed for China Launch in 2024
•
Novo Nordisk (NYSE: NVO), a leading diabetes company based in Denmark, has reportedly informed investors that its anti-obesity drug Wegovy (semaglutide) is anticipated to receive approval and launch in China by the end of this year. Christine Zhou Xiaping, the head of Novo Nordisk’s China business, shared this update during…
-
China Grand Pharmaceutical Receives FDA Approval for Post-Surgical Ophthalmic Drug GPN00833
•
China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its hormone nanosuspension eye drops GPN00833 (APP13007), designed for anti-inflammatory and analgesic effects following ophthalmic surgery. Additionally, the company has gained clinical trial…
-
Shanghai Fosun Pharma Gets NMPA Green Light for XS-02 Solid Tumor Clinical Study
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its drug candidate XS-02 in patients with advanced solid tumors. XS-02 is a…
-
Boehringer Ingelheim’s Spevigo Receives NMPA Approval for GPP Treatment in China
•
German pharmaceutical giant Boehringer Ingelheim (BI) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its biologic drug Spevigo (spesolimab) subcutaneous injection. The drug is indicated for reducing the incidence of generalized pustular psoriasis (GPP) in adolescents aged 12 and above weighing at…
-
Luye Pharma Launches Small-Cell Lung Cancer Treatment Zepzelca in Hong Kong and Macau
•
Luye Pharma Group (HKG: 2186), a China-based pharmaceutical company, has announced the official market launch of Zepzelca (lurbinectedin), a novel drug for the treatment of small-cell lung cancer (SCLC), in Hong Kong and Macau. Lurbinectedin, discovered and developed by Spain-based Pharma Mar, S.A. (MCE: PHM), is a selective inhibitor of…
-
CARsgen Launches BCMA-Targeted CAR-T Therapy in China with High Price Point
•
China-based CAR-T cell therapy specialist CARsgen Therapeutics Holdings Ltd. (HKG: 2171) has launched its BCMA-targeted CAR-T cell therapy, CT053 (zevorcabtagene autoleucel; zevor-cel), with a price tag of RMB 1.15 million (USD 160,000), as reported by The Paper, a local media outlet. The company anticipates that the drug’s annual end sales…
-
Xian Janssen’s Tremfya Heads for Priority Review in China for Crohn’s Disease Treatment
•
The Center for Drug Evaluation (CDE) has indicated that Xian Janssen Pharmaceutical’s Tremfya (guselkumab), an IL-23 monoclonal antibody, is set to undergo priority review for the treatment of moderate to severe active Crohn’s disease (CD). The drug, which previously received breakthrough therapy designation (BTD) status, is already approved for use…
-
EMA Reviews J&J’s Darzalex Subcutaneous Formulation for Newly Diagnosed Multiple Myeloma
•
The European Medicines Agency (EMA) has this week received an indication extension filing from Johnson & Johnson (J&J; NYSE: JNJ) for a subcutaneous formulation of its anti-CD38 drug Darzalex (daratumumab). The filing seeks approval for the combination therapy with bortezomib, lenalidomide, and dexamethasone as a treatment for newly diagnosed multiple…
-
Gilead and MSD Report Positive Interim Data for Once-Weekly HIV Treatment in Phase II Trial
•
Gilead Sciences Inc. (NASDAQ: GILD) and Merck & Co., Inc., known as MSD (NYSE: MRK), have this week unveiled preliminary findings from a Phase II clinical trial of their investigational antiretroviral combination therapy, islatravir plus lenacapavir, as a potential once-weekly oral treatment for HIV/AIDS. Despite the primary endpoint being influenced…
-
Henlius Biotech’s HER2 Targeting Biosimilar Secures Thai and Philippine Approvals
•
Shanghai Henlius Biotech Inc., (HKG: 2696) a leading China-based biotech firm, has announced that its biosimilar version of Roche’s Herceptin, known as Hanquyou (trastuzumab; HLX02), has been granted marketing authorization in both Thailand and the Philippines. The drug, which is marketed under the trade names TRAZHER and Hertumab in these…
-
Duality Biologics’ DB-1303 on Track for Breakthrough Designation for HER2+ Endometrial Cancer
•
The Center for Drug Evaluation (CDE) website has indicated that DB-1303, a HER2 targeted antibody drug conjugate (ADC) developed by Duality Biologics, a biotech company with operations in both the United States and China, is poised to receive breakthrough therapy designation (BTD). The proposed use for the treatment is for…
-
Formosa Pharmaceuticals Secures FDA Nod for New Steroidal Eye Drug, Set to Launch via Eyenovia
•
Taiwan-based Formosa Pharmaceuticals (TPE: 6838) has received approval from the US Food and Drug Administration (FDA) for its new formulation of the steroidal eye drug clobetasol propionate (0.05%), designed to treat post-operative inflammation and pain following ocular surgery. The drug will be commercialized in the US by Eyenovia Inc., (Nasdaq:…
-
Bayer Posts 1.2% YOY Sales Decline in 2023 with Pharmaceuticals and Consumer Health Segment Updates
•
Germany’s Bayer (ETR: BAYN) has released its financial results for 2023, marking a year of declining sales that culminated in a 1.2% year-on-year (YOY) drop in constant currency and portfolio-adjusted terms, reaching €47.6 billion (USD 51.7 billion). The Pharmaceuticals segment generated €18.1 billion (USD 19.6 billion) with a 0.4% decline…
-
Novo Nordisk’s Ozempic Meets Phase III Endpoints in Type 2 Diabetes and Chronic Kidney Disease Study
•
Novo Nordisk (NYSE: NVO), a Denmark-based pharmaceutical company, has this week published results from a Phase III study assessing the impact of the GLP-1 receptor agonist Ozempic (semaglutide) on the progression of renal impairment in individuals with type 2 diabetes (T2D) and chronic kidney disease (CKD). Following the trial’s discontinuation…
-
Sandoz Achieves FDA Milestone with Approval of First US Denosumab Biosimilars
•
The US Food and Drug Administration (FDA) has granted Sandoz (SWX: SDZ), a Switzerland-based pharmaceutical company, registration approvals for its biosimilars Wyost (denosumab) and Jubbonti (denosumab). These biosimilars reference and share the same indications as Amgen’s (NASDAQ: AMGN) bone treatments Xgeva and Prolia, respectively. With this approval, Sandoz’s drugs become…
-
Hybio Pharmaceutical Gets FDA Nod for Liraglutide Raw Materials with DMF Adequacy Letter
•
Hybio Pharmaceutical Co., Ltd (SHE: 300199), a China-based pharmaceutical company, has announced that it has received a Drug Master File (DMF) First Adequate Letter from the US Food and Drug Administration (FDA) for its liraglutide raw materials. The letter indicates no comments and no deficiencies, which is a significant step…
-
Shanghai RAAS Receives NMPA Approval to Initiate Clinical Trial for Hemophilia Preventive Treatment
•
Shanghai RAAS (SHE: 002252), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to commence a Phase I clinical study for SR604. The drug candidate is intended as a preventive treatment for bleeding episodes in patients with hemophilia and…
-
Bio-Thera Solutions Receives NMPA Approval for Three Cancer Treatments Including a Novel ADC
•
Bio-Thera Solutions Ltd (SHA: 688177), a China-based biopharmaceutical company, has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for three of its drug candidates. These include BAT8010 in combination with BAT1006 for the treatment of locally advanced or metastatic solid tumors, as well as BAT7205 as…
-
EMA Reviews Datopotamab Deruxtecan Filings from AstraZeneca and Daiichi Sankyo for Oncology Indications
•
The European Medicines Agency (EMA) has accepted for review two oncology filings for the antibody-drug conjugate (ADC) datopotamab deruxtecan, developed jointly by UK-based AstraZeneca (AZ; NASDAQ: AZN) and Japan’s Daiichi Sankyo (TYO: 4568). The indications submitted for review are for the treatment of locally advanced or metastatic nonsquamous non-small cell…
-
Pfizer’s Cibinqo Secures NMPA Approval for Expanded Use in Atopic Dermatitis
•
The National Medical Products Administration (NMPA) has released drug approval certificate delivery information that points to a new indication approval for Pfizer (NYSE: PFE)’s JAK1 inhibitor Cibinqo (abrocitinib), a small molecule targeted therapy. This approval expands the drug’s use to include the treatment of moderate to severe atopic dermatitis (AD)…
-
Novartis Gene Therapy Zolgensma Shows Continued Benefits in Broader SMA Patient Group
•
Swiss pharmaceutical giant Novartis (NYSE: NVS) has presented Phase III data this week, demonstrating that the clinical benefits of its gene therapy Zolgensma (onasemnogene abeparvovec) for spinal muscular atrophy (SMA) extend beyond patients up to 2 years of age. The new study has shown similar benefits in older children, including…
-
Luye Pharma Initiates Phase III Clinical Trial for Irinotecan Liposome Injection in Small-Cell Lung Cancer
•
Luye Pharma Group (HKG: 2186), a China-based pharmaceutical company, has announced the enrollment of the first patient in a Phase III clinical study for its irinotecan liposome injection, LY01610. The Phase III study, which is multi-center, randomized, open-label, and parallel-designed, aims to evaluate the efficacy and safety of LY01610 in…
-
Aosaikang’s Marketing Approval Filing for Delafloxacin Accepted by China’s NMPA
•
Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755), a Chinese pharmaceutical company, has announced that the National Medical Product Administration (NMPA) in China has accepted for review its marketing approval filing for the Category III chemical injectable drug delafloxacin. Delafloxacin is a new generation broad-spectrum fluoroquinolone antibiotic indicated for the treatment…
-
Huadong Medicine’s Arcalyst Filing for Recurrent Pericarditis Accepted by China’s NMPA
•
Huadong Medicine Co., Ltd, (SHE: 000963) a Chinese pharmaceutical company, has announced that the National Medical Products Administration (NMPA) in China has accepted for review its market approval filing for the injectable Arcalyst (rionacept). The drug is indicated for the treatment of recurrent pericarditis (RP) in adults and adolescents aged…
-
Hengrui Medicine Gets NMPA Green Light for KRAS G12C Inhibitor Clinical Trial in Advanced Solid Tumors
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for HRS-7058, an innovative and selective drug candidate, in patients with advanced solid tumors harboring the KRAS G12C mutation. This development marks a significant step for Hengrui Medicine…
-
HitGen Secures CDE Approval for Lipisense IND Filing, Advancing Development for Dyslipidemia Treatment
•
HitGen Inc., (SHA: 688222) a China-based pharmaceutical company, has announced that the Investigational New Drug (IND) filing for its Lipisense (A24110He for injection) has received approval from China’s Center for Drug Evaluation (CDE). Lipisense, an innovative antisense oligonucleotide (ASO) drug originally developed by Swiss firm Lipigon Pharmaceuticals AB, is designed…
-
ViiV Healthcare Presents Phase I Data for Ultra-Long-Acting Cabotegravir in HIV Treatment and Prevention
•
GlaxoSmithKline (GSK; NYSE: GSK) unit ViiV Healthcare has presented Phase I results for an ultra-long-acting formulation of the antiretroviral cabotegravir, which is being investigated for the treatment and prevention of HIV. The safety and pharmacokinetic data from the study support the potential to double dosing intervals to four months or…
-
BMS Reports Positive Long-Term Data for Zeposia in Multiple Sclerosis Trials
•
Bristol Myers Squibb (BMS; NYSE: BMY) has unveiled results from several Phase III trials for its S1P receptor modulator Zeposia (ozanimod) in the treatment of relapsing forms of multiple sclerosis (MS). In a long-term study, the oral medication demonstrated a low annualized relapse rate, with disability progression observed in only…
-
BeiGene’s Brukinsa Outperforms Acalabrutinib in MAIC for Relapsed/Refractory CLL, Says BeiGene
•
BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the results of a matching-adjusted indirect comparison (MAIC) between its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib), and acalabrutinib in terms of efficacy. The comparison is based on data from the Phase III ALPINE and Phase III ASCEND studies, which…
-
Merck’s Mavenclad Demonstrates Lasting Efficacy in RMS Patients, New Data Show
•
Merck KGaA (ETR: MRK), a German multinational pharmaceutical, chemical, and life sciences company, has this week unveiled new clinical data for its cytotoxic drug Mavenclad (cladribine) in the treatment of highly active relapsing multiple sclerosis (RMS). The results indicate that over 95% of participants noted clinically meaningful improvements in cognitive…
-
AIM Vaccine Advances Pneumococcal Vaccine and Initiates Phase II Meningococcal Study
•
AIM Vaccine Co., Ltd (HKG: 6660) has delivered a series of updates on the development progress of its vaccine candidates. The company has submitted a preliminary market filing for its 13-valent pneumococcal conjugate vaccine, designed to prevent invasive diseases caused by 13 pneumococcal serotypes, including bacteremic pneumonia, meningitis, sepsis, and…
-
Hainan Poly Pharm Secures Tentative FDA Approval for Generic Version of UCB’s Briviact
•
Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it has received tentative marketing approval from the US Food and Drug Administration (FDA) for its generic version of Belgium-based UCB’s Briviact (brivaracetam). Briviact is recognized as a selective high-affinity synaptic vesicle protein 2A (SV2A) ligand,…
-
BMS’s Yervoy-Opdivo Combo on Track for Breakthrough Therapy Designation in China for CRC
•
The China Center for Drug Evaluation (CDE) website has indicated that the market approval filing for Bristol-Myers Squibb’s (BMS, NYSE: BMY) combination regimen of Yervoy (ipilimumab) and Opdivo (nivolumab) for first-line unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) is on track to receive…
-
Pfizer’s RSV Vaccine Demonstrates Durable Efficacy with Abrysvo Phase III Results
•
Pfizer Inc. (NYSE: PFE) last week reported the outcomes of a Phase III trial for its respiratory syncytial virus (RSV) bivalent vaccine, Abrysvo, in adults aged 60 and above following the second RSV season. The vaccine’s efficacy against RSV-associated lower respiratory tract disease (LRTD) experienced a decline from 88.9% in…
-
Shanghai Fosun Pharma’s GCK-01 CAR-NK Cell Therapy Gets Tacit Clinical Approval from China’s CDE
•
The China Center for Drug Evaluation (CDE) website has indicated that Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), has received tacit approval for a Category 1 biologic preparation, GCK-01, to proceed with clinical trials. The therapeutic candidate is intended for the treatment of recurrent or refractory follicular…
-
J&J’s Rybrevant Secures Full FDA Approval for NSCLC with EGFR Exon 20 Insertions
•
The US Food and Drug Administration (FDA) has granted Johnson & Johnson (J&J; NYSE: JNJ) full approval for the use of Rybrevant (amivantamab) in combination with chemotherapy for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. This bispecific antibody (BsAb)…
-
Astellas Launches Late-Stage Trial in Japan for Nonhormonal Menopause Treatment
•
Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, last week initiated a late-stage trial in Japan for fezolinetant, a neurokinin B (NKB) blocker, as a potential treatment for vasomotor symptoms (VMS) associated with menopause in women. This placebo-controlled study aims to evaluate the efficacy and safety of the…
-
Sino-US Laekna’s LAE102 Clinical Trial Filing Accepted for Review in Obesity and Metabolic Disorders
•
Sino-US Laekna (HKG: 2105) has announced that its clinical trial application for LAE102, an antibody targeting adult obesity and metabolic disorders, has been accepted for review by the Center for Drug Evaluation (CDE). LAE102 is a potent and selective monoclonal antibody against ActRIIA, known for its regulatory roles in tumor…
-
Fosun Pharmaceutical Secures NMPA Approval for Phase II Study of FCN-338 and FCN-647 in Chronic Lymphocytic Leukemia
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its Bcl-2 inhibitor FCN-338 in combination with the BTK inhibitor FCN-647, targeting chronic lymphocytic leukemia/small lymphocytic lymphoma. FCN-338…
-
Shanghai Pharmaceuticals’ MediTrust Health Teams Up with Eisai to Enhance Alzheimer’s Prevention and Treatment
•
Shanghai Pharmaceuticals Holding Co., Ltd (SHA: 601607, HKG: 2607)’s subsidiary MediTrust Health, which specializes in insurance, financing, and direct-to-patient pharmacy services, has entered into a partnership with Japan’s Eisai to jointly address the prevention, control, and security of Alzheimer’s disease (AD). The collaboration aims to develop a comprehensive health management…
-
Fosun Pharmaceutical’s HanDaYuan Seeks NMPA Approval for Expanded Indications in Autoimmune Treatments
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has accepted additional indication approval filings for its biosimilar HanDaYuan, which is modeled after AbbVie’s autoimmune therapy Humira (adalimumab). The company is seeking approval for HanDaYuan to treat polyarthritic juvenile idiopathic…
-
Jiangsu Hengrui Receives NMPA Approval for HRS-1167 Clinical Trials in Advanced Solid Tumors
•
Jiangsu Hengrui Pharmaceutical Co., Ltd (SHA: 600276) has secured clinical trial approval from the National Medical Products Administration (NMPA) for its investigational therapy HRS-1167, which will be evaluated in combination with SHR-A1921, bevacizumab, or abiraterone plus prednisone/prednisolone for the treatment of advanced solid tumors. HRS-1167 is a second-generation PARP inhibitor…
-
Innovent Biologics Launches Phase I Study for IBI3002, a Bispecific Antibody Targeting Asthma
•
Innovent Biologics, Inc. (HKG: 1801), based in China, has announced the initiation of its Phase I clinical study for IBI3002, a pioneering bispecific antibody designed to target Interleukin 4 receptor α (IL-4Rα) and thymic stromal lymphopoietin (TSLP). This innovative therapy aims to address asthma and other type 2 inflammatory diseases…
-
CDE Grants Priority Review to Jiu An’s Adrenaline and AnHeart’s Taletrectinib; Two Others Earn Breakthrough Therapy Designation
•
The Center for Drug Evaluation (CDE) has announced that Jiu An Pharmaceutical’s adrenaline and AnHeart Therapeutics’ taletrectinib are set for priority review, while Biotheus Inc.’s PM8002 and Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422)’s SKB264 have been designated as breakthrough therapies (BTDs). Adrenaline is gaining priority status due to new…
-
Huadong Medicine’s MaiLi Extreme Achieves Clinical Study Milestone for Chin Retraction Treatment
•
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that a Chinese clinical study for MaiLi Extreme, an injectable lidocaine-containing sodium hyaluronate by its UK subsidiary Sinclair, has successfully met its primary endpoint, demonstrating good safety data. The study aimed to evaluate the efficacy and safety of MaiLi Extreme injections…
-
CARsgen Therapeutics’ BCMA-targeted CAR-T Cell Therapy Approved by China’s NMPA
•
CARsgen Therapeutics Holdings Ltd (HKG: 2171), a specialist in chimeric antigen receptor (CAR)-T cell therapies based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its product CT053 (zevorcabtagene autoleucel; zevor-cel). This B-cell maturation antigen (BCMA)-targeted CAR-T cell therapy is now…
-
FDA Withdraws Approval for Multiple Myeloma Drug Pepaxto Over Safety and Efficacy Concerns
•
The US Food and Drug Administration (FDA) has announced its final decision to withdraw approval for Pepaxto (melphalan flufenamide), a drug initially approved for use in combination with dexamethasone to treat certain patients with multiple myeloma (MM). The decision stems from two key factors: (1) a confirmatory study, conducted as…
-
Chia Tai Tianqing’s Anlotinib-Benmelstobart Combo Therapy Receives CDE Review for Endometrial Cancer
•
Chia Tai Tianqing, a renowned biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) has accepted for review a new indication filing for its anlotinib (trade name: FOCUS V) in combination with the anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450). The proposed indication…
-
CanSino Biologics’ 13-Valent Pneumococcal Vaccine CRM197 Accepted for NMPA Review
•
CanSino Biologics Inc., (HKG: 6185), a leading Chinese biopharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its CRM197, a 13-valent pneumococcal polysaccharide conjugate vaccine (TT vector). This development marks a significant step forward in the advancement of…
-
AstraZeneca’s AZD0486 Receives NMPA Greenlight for Clinical Study in B-Cell Leukemia
•
AstraZeneca (NASDAQ: AZN), a leading UK pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) in China to initiate a clinical study for its drug candidate AZD0486 (TNB-486) in patients with recurrent or refractory B-cell acute lymphoblastic leukemia. AZD0486 is a bispecific antibody (BsAb) that targets both…
-
BMS’s Azacitidine, First Oral AML Therapy, Reaches GBA Patients via Special Policy
•
Bristol-Myers Squibb (BMS, NYSE: BMY), a leading US pharmaceutical company, has announced the clinical application of its drug azacitidine in Shenzhen, within the Guangdong Hong Kong Macao Greater Bay Area (GBA). This marks the use of the world’s first and only oral maintenance therapy for acute myeloid leukemia (AML) in…
-
Abbisko Therapeutics Reports Positive Phase I Results for ABSK061 in Solid Tumors at ESMO TAT 2024
•
Shanghai-based Abbisko Therapeutics Co., Ltd. (HKG: 2256) has revealed promising outcomes from a global, multi-center Phase I trial evaluating the safety, tolerability, pharmacokinetics (PK), and anti-tumor efficacy of its oral FGFR2/3 inhibitor, ABSK061, in treating solid tumors. These findings were presented at the European Society for Medical Oncology (ESMO) TAT…
-
Cutia Therapeutic’s CU-20401 Shows Promising Safety and Efficacy in Phase I Abdominal Fat Reduction Study
•
Cutia Therapeutic (HKG: 2487), a China-based dermatology specialist, has announced the successful completion of a Phase I study for its potential Category 1 drug CU-20401, a recombinant mutant collagenase, which is being investigated for the treatment of abdominal fat accumulation. The single-center, open-label, placebo-controlled, dosage-escalation study enrolled 48 subjects in…
-
Shandong Buchang Pharmaceuticals Gets NMPA Greenlight for Phase I Study of BC001 in Solid Tumors
•
Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), a Chinese pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I study for its investigational biologic product BC001. The study will assess the safety, tolerability, efficacy, and pharmacokinetics of BC001, a…
-
Bayer’s BAY 2927088 Receives FDA Breakthrough Therapy Designation for HER2-Mutated NSCLC
•
The US Food and Drug Administration (FDA) has granted Germany-based Bayer AG (ETR: BAYN) breakthrough therapy designation for its tyrosine kinase inhibitor (TKI) BAY 2927088. The drug is under review as a potential treatment for unresectable or metastatic non-small cell lung cancer (NSCLC) with activating HER2 (ERBB2) mutations that have…
-
Haisco Pharmaceutical Gets NMPA Greenlight for HSK39775 Solid Tumor Drug Candidate
•
Haisco Pharmaceutical Group Co., Ltd (SHE: 002653), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative drug candidate HSK39775, intended for the treatment of advanced solid tumors. Preclinical study results have demonstrated HSK39775’s potential efficacy across…
-
Gilead’s Biktarvy Receives FDA Approval for Expanded HIV Treatment Indication
•
Gilead (NASDAQ: GILD), a leading US pharmaceutical company, has been granted an indication extension approval for its antiretroviral combination Biktarvy (bictegravir + emtricitabine + tenofovir alafenamide) by the Food and Drug Administration (FDA). The approval expands Biktarvy’s use as an HIV treatment for individuals who have suppressed viral loads and…
-
AstraZeneca’s Fasenra Matches Nucala in EGPA Trial and Shows Steroid Reduction Benefits
•
UK pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has presented results from a Phase III trial that previously announced the non-inferiority of its IL-5 antagonist Fasenra (benralizumab) against GlaxoSmithKline’s (GSK; NYSE: GSK) Nucala (mepolizumab), the current standard of care for relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The data revealed…
-
BeiGene’s Tislelizumab Receives CHMP Recommendation for Three NSCLC Indications in Europe
•
BeiGene (NASDAQ: BGNE) has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended its programmed death-1 (PD-1) inhibitor tislelizumab for a marketing license for three non-small cell lung cancer (NSCLC) indications. The CHMP’s positive opinion is for: Patients with EGFR or ALK mutation-positive…
-
Everest Medicines Gets CDE Approval for Global Phase IIb Study of Zetomipzomib in Lupus Nephritis
•
Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that it has received approval from the Center for Drug Evaluation (CDE) to proceed with the global, placebo-controlled Phase IIb PALIZADE study. The study aims to assess the efficacy and safety of zetomipzomib in patients with active lupus nephritis (LN).…
-
Alvotech Scores FDA Nod for Interchangeable High-Concentration Biosimilar to Humira
•
The US Food and Drug Administration (FDA) has granted approval to Iceland-based Alvotech’s (NASDAQ: ALVO) Simlandi, marking it as the first interchangeable high-concentration, citrate-free biosimilar to AbbVie’s (NYSE: ABBV) immunosuppressant Humira (adalimumab). Humira faced patent expiration in the US last year, leading to biosimilar competition. Simlandi is approved for various…
-
Kelun-Biotech Launches Clinical Trials for SKB264, Triggering $75 Million Milestone Payment from MSD
•
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) has announced the initiation of clinical trials for SKB264 (MK-2870), an antibody-drug conjugate (ADC) co-developed with Merck, Sharp & Dohme (MSD, NYSE: MRK) for the treatment of non-small cell lung cancer (NSCLC) and endometrial carcinoma (EC). This development triggers a clinical milestone payment…
-
AstraZeneca Launches Phase I Trial for siRNA Therapy in Collaboration with Silence Therapeutics
•
AstraZeneca (AZ; NASDAQ: AZN) has commenced a Phase I trial for a short interfering RNA (siRNA) therapy targeting an undisclosed disease, marking the first clinical candidate to emerge from its 2020 collaboration with UK-based Silence Therapeutics (NASDAQ: SLN). This partnership aims to develop up to ten siRNA therapeutics across cardiovascular,…
-
Sanofi’s Dupixent Receives FDA Priority Review for COPD Indication Extension
•
Sanofi (NASDAQ: SNY), a French multinational pharmaceutical company, announced last week that the US Food and Drug Administration (FDA) has accepted for priority review an indication extension filing for its interleukin blocker Dupixent (dupilumab). The drug is proposed as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD),…
-
GenScript’s Subsidiary Legend Biotech Gets CHMP Nod for Carvykti Label Expansion in Multiple Myeloma
•
GenScript Biotech Corporation (HKG: 1548), a China-based Contract Research Organization (CRO), has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), has received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the label expansion of its (BCMA)-directed chimeric antigen receptor T…
-
Takeda’s Recombinant Pig FVIII Drug for Acquired Hemophilia A Approved in China
•
The National Medical Products Administration (NMPA) website has indicated that Takeda (TYO: 4502)’s Obizur (susoctocog alfa), intended for on-demand treatment and control of bleeding events in adult patients with acquired hemophilia A, has received approval in China. This drug marks the first recombinant pig FVIII (rpFVIII) to be approved by…
-
Mabwell Bioscience’s Nectin-4 Targeting ADC Earns FDA Fast-Track Designation for Esophageal Cancer
•
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that it has received fast-track designation from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) 9MW2821. This candidate targets Nectin-4 and is under investigation for the treatment of advanced, recurrent,…
-
Polpharma Biologics’ Biosimilar Candidate PB016 Shows Comparable Profiles to Takeda’s Entyvio
•
Polish biotechnology firm Polpharma Biologics has announced positive results from a comparability study for its late-stage biosimilar candidate PB016, which references Takeda’s (TYO: 4502) inflammatory bowel disease (IBD) blockbuster Entyvio (vedolizumab). The study’s data indicate that PB016 demonstrates similar pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and safety profiles compared to the…
-
Jiangsu Hengrui Receives NMPA Approval for Adjuvant Therapy Clinical Study of Adebrelimab in NSCLC
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its PD-L1 monoclonal antibody (mAb) adebrelimab (SHR-1316) in combination with chemotherapy as adjuvant therapy for patients with resectable stage II or III…
-
BioCity Biopharma Achieves Full Enrollment in Phase II Study of SC0062 for IgA Nephropathy
•
BioCity Biopharma, a Chinese biotechnology company, has announced the completion of enrollment for all 120 subjects in the Phase II clinical study for its small molecule ETA receptor antagonist, SC0062, in the IgA nephropathy cohort. The study, which first dosed in June 2023, marks a significant milestone in the development…
-
Livzon Pharmaceutical Gets CDE Green Light for JP-1366 Reflux Esophagitis Clinical Study
•
Livzon Pharmaceutical Group Inc. (HKG: 1513), a leading Chinese pharmaceutical company, has announced that its drug candidate JP-1366 has received clearance from the Center for Drug Evaluation (CDE) to proceed with clinical studies for reflux esophagitis. JP-1366, also known as zastaprazan, is a potassium-competitive acid-blocking (P-CAB) class drug originally developed…
-
Hinova Pharmaceuticals’ HP537 Receives CDE Approval for Clinical Study in Hematologic Malignancies
•
Hinova Pharmaceuticals Inc. (SHA: 688302), a biotech company based in Chengdu, has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a clinical study for its Category 1 chemical drug HP537, targeting hematologic malignancies. This development marks a significant step for Hinova Pharmaceuticals as…
-
Jiangsu Hengrui’s CD79b Targeting ADC SHR-A1912 Earns FDA Fast-Track Designation for R/R DLBCL
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that it has received Fast-Track Designation (FTD) from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) SHR-A1912, targeting CD79b, in the treatment of recurrent/refractory diffuse large B-cell lymphoma (R/R DLBCL) in…
-
AstraZeneca’s Tagrisso Meets PFS Endpoint in Late-Stage NSCLC Trial and Expands FDA Approval
•
AstraZeneca (AZ; NASDAQ: AZN), a leading UK-based pharmaceutical company, has announced that a late-stage trial for Tagrisso (osimertinib), an EGFR-tyrosine kinase inhibitor (EGFR-TKI), has successfully met its primary endpoint of progression-free survival (PFS) in patients with unresectable, stage III EGFR-mutated non-small cell lung cancer (NSCLC). The trial evaluated a once-daily…
-
Pfizer’s Velsipity Approved by European Commission for Moderately to Severely Active Ulcerative Colitis
•
The European Commission (EC) has granted regulatory approval to Pfizer (NYSE: PFE) for its S1P receptor modulator Velsipity (etrasimod) as a treatment for patients aged 16 and older with moderately to severely active ulcerative colitis (UC). The approval applies to patients who have had an inadequate response, lost response, or…
-
FDA Authorizes Biweekly Dosing for J&J’s Tecvayli in Multiple Myeloma Treatment
•
The US Food and Drug Administration (FDA) has granted authorization for a biweekly dosing regimen of Johnson & Johnson’s (J&J; NYSE: JNJ) bispecific T-cell engager (BiTE) Tecvayli (teclistamab). Tecvayli received accelerated approval in 2022 for the treatment of relapsed or refractory multiple myeloma (r/rMM) in patients who have undergone at…
-
Immune-Onc Therapeutics’ IO-202 Earns Orphan Drug Designation for CMML from US FDA
•
Immune-Onc Therapeutics, the Hangzhou-based subsidiary of US company Immune-Onc Therapeutics Inc., has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its drug candidate IO-202, which is being developed to treat chronic myelomonocytic leukemia (CMML). This potential first-in-class LILRB4 antagonist was…
-
Innovent Biologics’ Tyvyt Receives Marketing Approval for Multiple Indications in Macau
•
Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company based in China, has announced that it has received marketing approval for Tyvyt (sintilimab injection), a PD-1 inhibitor co-developed with US pharmaceutical giant Eli Lilly, for multiple indications in Macau. The drug has been approved to treat classic Hodgkin’s lymphoma (cHL),…
-
MSD’s Belzutifan and Sperogenix’s Vamorolone Targeted for Priority Review by China’s CDE
•
The Center for Drug Evaluation (CDE) website has indicated that Merck, Sharp & Dohme’s (MSD; NYSE: MRK) belzutifan and Sperogenix Therapeutics Ltd’s vamorolone are on track to receive priority review statuses in China. Belzutifan, which targets von Hippel Lindau (VHL) disease-associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastoma,…
-
Zhongsheng Pharmaceutical Initiates Phase II Trials for Polypeptide Drug RAY1225 in Diabetes and Obesity
•
Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a Chinese pharmaceutical company, has announced the initiation of two Phase II clinical studies, SHINING and REBUILDING, for its Category 1 innovative polypeptide drug candidate RAY1225. These studies aim to assess the efficacy of RAY1225 as a treatment for type 2 diabetes and…
-
Bayer Advances BAY3018250 into Phase II Trial Following Successful Phase I Completion
•
Germany’s Bayer (ETR: BAYN) has launched a double-blind, placebo-controlled mid-stage trial for its potential first-in-class anti-alpha2 antiplasmin (anti-α2ap) drug, BAY3018250, aimed at treating symptomatic proximal deep vein thrombosis (DVT). This advancement comes on the heels of a successful Phase I study. The investigational antibody works by modulating the breakdown of…
-
BMS Seeks FDA Priority Review for Krazati in Advanced Colorectal Cancer
•
Bristol Myers Squibb (BMS; NYSE: BMY) has submitted a priority review application to the U.S. Food and Drug Administration (FDA) for an additional indication of its KRASG12C inhibitor, Krazati (adagrasib), in combination with cetuximab (Merck’s Erbitux) for pre-treated patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC). The FDA…
-
WuXi ATU’s Philadelphia Facility Approved for Amtagvi Production Following FDA Nod
•
WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec (SHA: 603259, HKG: 2359) based in China, has announced the U.S. FDA’s approval of its Philadelphia facility to commence analytical testing and manufacturing of Amtagvi (lifileucel) for Iovance. This novel therapy received accelerated approval for its Biologics License…
-
HitGen’s Vernalis Partners with Hox Therapeutics to Develop Novel Cancer Inhibitors
•
HitGen Inc. (SHA: 688222), based in China, announced that its wholly owned subsidiary Vernalis (R&D) Ltd will collaborate with Hox Therapeutics Ltd, a private biotech firm dedicated to developing highly targeted cancer therapies, to create inhibitors aimed at undisclosed targets. Vernalis will leverage its advanced protein science capabilities and Hit…
-
Merck’s Keytruda Under Priority Review for New Indication in Endometrial Carcinoma
•
This week, the U.S. FDA granted priority review status to an indication extension filing from Merck, Sharp & Dohme (MSD; NYSE: MRK) for its blockbuster drug Keytruda (pembrolizumab), seeking approval as a treatment for primary advanced or recurrent endometrial carcinoma, the most prevalent gynecological cancer. The FDA anticipates reaching a…
-
Mabwell Bioscience Receives FDA Green Light for B7-H3 Targeting ADC 7MW3711
•
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its antibody drug conjugate (ADC) 7MW3711, which targets B7-H3. The molecule is intended to be assessed…
-
Jacobio Pharma Gets CDE Green Light for Phase III Study Combining Gleevec Inhibitors in NSCLC
•
Jacobio Pharma (HKG: 1167), a China-based pharmaceutical company, has announced that it has received approval from the Center for Drug Evaluation (CDE) in China to initiate a regulatory Phase III clinical study. The study will assess the combination of its KRAS G12C inhibitor glecirasib with pipeline SHP2 inhibitor JAB-3312 for…
-
Neurophth Biotechnology Completes Enrollment and Dosing in US Clinical Study for ND4-LHON Gene Therapy
•
Neurophth Biotechnology Ltd, a leading gene therapy specialist based in China, has announced the completion of patient enrollment and dosing in a Phase I/II clinical study for its investigational drug NR082 (rAAV2-ND4; NFS-01) in the United States. The study targets ND4-mediated Leber’s hereditary optic neuropathy (ND4-LHON). The single-arm, multi-center Phase…
-
Phanes Therapeutics’ PT886 Receives CDE Approval for Clinical Trials in Advanced Solid Tumors
•
Sino-US biotechnology company Phanes Therapeutics Inc. has announced that it has received clinical trial approval from China’s Center for Drug Evaluation (CDE) for its first-in-class claudin 18.2/CD47 bispecific antibody (BsAb) PT886, intended for the treatment of advanced solid tumors including gastric cancer, gastroesophageal junction cancer, and pancreatic cancer. PT886, a…
-
ImmunoTech Biopharm Gets NMPA Green Light for Clinical Study of aT19 Injection for B-ALL
•
ImmunoTech Biopharm Ltd (HKG: 6978), a specialist in chimeric antigen receptor T-cell (CAR-T) therapies based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its aT19 injection. The treatment is designed as a sequential therapy for patients…
-
AstraZeneca’s Tagrisso Wins Expanded FDA Approval for EGFR-mutated NSCLC
•
UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has received a new indication approval from the US Food and Drug Administration (FDA) for its lung cancer therapy Tagrisso (osimertinib). The fresh indication allows for the use of Tagrisso in combination with chemotherapy for patients with advanced or metastatic epidermal growth factor…
-
Innovent Biologics’ IBI311 Achieves Primary Endpoint in Phase III Study for Thyroid Eye Disease
•
Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, has announced that its Phase III regulatory study in China for IBI311, a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, has successfully achieved its primary endpoint. The study targeted thyroid eye disease (TED), with a New Drug Application…
-
Denali Therapeutics Faces Setback as ALS Trial Fails to Meet Primary Endpoint
•
Denali Therapeutics (NASDAQ: DNLI) has announced disappointing results from a Phase II trial of its RIPK1-targeted small-molecule drug for amyotrophic lateral sclerosis (ALS). The drug, developed in partnership with France-based Sanofi Inc. (NASDAQ: SNY), failed to meet the primary endpoint in the Phase II HIMALAYA study, which assessed the change…
-
Hainan Poly Pharm Wins FDA Nod for Generic Version of UCB’s Vimpat
•
Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it has received marketing approval from the US Food and Drug Administration for its generic version of UCB’s Vimpat (lacosamide), originally developed by the Belgium-headquartered UCB. The approved generic will be used for the treatment of…
-
Roche’s Xolair Gains FDA Approval to Combat IgE-Mediated Food Allergies in Patients Aged 1 and Up
•
Roche (SWX: ROG) has announced that the U.S. Food and Drug Administration (FDA) has granted a new indication for Xolair (omalizumab) to mitigate allergic reactions, including anaphylaxis, associated with IgE-mediated food allergies in both adult and pediatric patients aged 1 and older. While Xolair is designed to reduce the risk…
-
Ipsen Secures FDA Approval for Onivyde Regimen as First-Line Treatment for Metastatic Pancreatic Adenocarcinoma
•
Ipsen (EPA: IPN, OTCMKTS: IPSEY), the France-based biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for the NALIRIFOX regimen, which combines Onivyde (irinotecan liposome injection) with oxaliplatin, fluorouracil, and leucovorin. This new approval allows for the use of the regimen as…
-
FDA Approves Takeda’s Eohilia as First Oral Therapy for Eosinophilic Esophagitis in Patients Aged 11 and Up
•
The U.S. Food and Drug Administration (FDA) has granted approval to Takeda Pharmaceutical Company (TYO: 4502)’s Eohilia (budesonide oral suspension) for the treatment of eosinophilic esophagitis (EoE). This marks Eohilia as the first and currently only oral therapy available for EoE patients aged 11 and older. Previously, Novartis (NYSE: NVS)’s…
-
Roche’s Piasky (Crovalimab) Secures NMPA Approval for Untreated Paroxysmal Nocturnal Hemoglobinuria
•
The National Medical Products Administration (NMPA) has granted marketing approval to Swiss pharmaceutical giant Roche (SWX: ROG) for Piasky (crovalimab) under priority review status. This approval is specifically for the treatment of adult and adolescent patients aged 12 and older with paroxysmal nocturnal hemoglobinuria who have not previously received treatment…
-
Roche Secures NMPA Approval for Rozlytrek to Treat Pediatric NTRK Fusion-Positive Tumors
•
Swiss pharmaceutical giant Roche (SWX: ROG) has received a new indication approval from the National Medical Products Administration (NMPA) for its drug Rozlytrek (entrectinib). The approval allows the treatment of pediatric patients aged at least one month with NTRK fusion-positive solid tumors. Entrectinib is a TRK/ROS1 tyrosine kinase inhibitor known…
-
FDA Grants Priority Review for GSK’s Arexvy to Expand RSV Vaccine Age Range to 50-59
•
The U.S. Food and Drug Administration (FDA) has initiated a priority review of GlaxoSmithKline’s (GSK; NYSE: GSK) application to extend the age range for its respiratory syncytial virus (RSV) vaccine, Arexvy, to include individuals aged 50 to 59 who are at increased risk for RSV disease. Arexvy was previously approved…
-
CMS Secures NMPA Approval for Clinical Trials of TYK2 Inhibitor CMS-D001 and GnRH Antagonist CMS-D002
•
China Medical System Holdings Ltd (CMS, HKG: 0867) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for two of its drug candidates: CMS-D001 and CMS-D002. CMS-D001 is a highly selective TYK2 (tyrosine kinase 2) inhibitor aimed at treating immune inflammatory diseases, including…
-
Sinovent Enrolls First Patient in Phase III Trial for Gout Drug XNW3009
•
Suzhou-based Sinovent Inc. has announced the enrollment of its first patient in a Phase III clinical study for XNW3009, a novel gout drug candidate designed to inhibit the human urate transporter 1 (URAT1) and address gout-related hyperuricemia. Founded in 2016, Sinovent operates across multiple locations, including Beijing, Shanghai, Australia, and…
-
ChinaGene Secures CDE Approval for ZVS101e Gene Therapy Targeting Retinitis Pigmentosa
•
Beijing-based ChinaGene Technology Co., Ltd. has announced that it has received tacit clinical approval from the Center for Drug Evaluation (CDE) for its ophthalmic gene therapy ZVS101e, designed to treat retinitis pigmentosa (RP) patients with the RHO-R135W (RHO c.403C>T) mutation. This follows a tacit trial approval granted in the United…
-
Nanjing Zenshine’s ZX-7101A NDA Accepted by NMPA for Uncomplicated Influenza Treatment
•
Nanjing Zenshine Pharmaceuticals Co., Ltd., a China-based small molecule drug developer, has announced that the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for ZX-7101A, an anti-influenza treatment targeting uncomplicated influenza in adults. The NDA is supported by data from a multi-center, randomized, double-blinded, placebo-controlled Phase…
-
Jiangsu Hengrui Receives NMPA Approval for Phase II Study of GLP-1 Agonist for Weight Loss
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study for its small molecule GLP-1 receptor agonist, HRS-7535, for weight loss treatment. This development marks…
-
Shanghai Procurement Platform Offers Price Cut Leeway to Escape ‘High-Priced Drugs’ Tag
•
Shanghai’s Sunshine Medical Procurement All-in-One (SMPA) platform has announced a significant policy shift regarding non-winning bids in the 9th round of volume-based procurement (VBP). The notification suggests that drugs which did not secure a winning bid and are eligible for online procurement in Shanghai may be exempted from the “high-priced…
-
BioNTech and Duality’s DB-1305 Earns Fast-Track Status for Platinum-Resistant Cancers
•
German biotechnology company BioNTech SE (NASDAQ: BNTC) and its partner Duality Biologics (Suzhou) Co., Ltd have received fast-track designation from the U.S. Food and Drug Administration for their jointly developed drug candidate DB-1305/BNT325. This designation is in recognition of the drug’s potential to treat platinum-resistant epithelial ovarian cancer, fallopian tube…
-
MSD’s Keytruda Secures 13th Indication Approval in China for Biliary Carcinoma Treatment
•
Merck, Sharp & Dohme (MSD; NYSE: MRK), a leading US pharmaceutical company, has announced that its drug Keytruda (pembrolizumab) has received approval from the National Medical Products Administration (NMPA) in China for a new indication. The drug is now approved as a first-line treatment for locally advanced or metastatic biliary…
-
Healthstar Medical Commences Phase III Clinical Trial for KC1036 in Esophageal Cancer
•
Healthstar Medical Development Co., Ltd (SHA: 603590), a Beijing-based pharmaceutical company, has announced the first patient dosing in a Phase III clinical study for its drug candidate KC1036, which is aimed at treating patients with advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC). This marks a significant milestone in…
-
Joincare Pharmaceuticals Gets Green Light for Semaglutide Biosimilar Clinical Trial
•
Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380), a Chinese pharmaceutical entity, has announced that it has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for its biosimilar version of Denmark’s major pharmaceutical company, Novo Nordisk’s semaglutide. Joincare is progressing with the development of this product candidate,…
-
CSPC Pharmaceutical’s rhTNK-tPA Gets NMPA Approval for Acute Ischemic Stroke Treatment
•
CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has approved a supplementary market approval filing for its recombinant human TNK tissue-type plasminogen activator for injection (rhTNK-tPA). The drug is now approved for use as a thrombolytic…
-
Roche’s Faricimab Shows Sustained Vision Benefits in Phase III Study for Retinal Vein Occlusion
•
Swiss pharmaceutical giant Roche (SWX: ROG) has released interim Phase III data for its bispecific antibody (BsAb) Vabysmo (faricimab) in the treatment of macular edema resulting from branch and central retinal vein occlusion (BRVO and CRVO). The biologic demonstrated significant vision improvements, with gains of 17 to 19 letters on…
-
J&J’s Gene Therapy for X-linked Retinitis Pigmentosa Receives CDE Nod for Breakthrough Designation
•
The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J, NYSE: JNJ)’s AAV5-hRKp.RPGR (JNJ-5340, botaretigene sparoparvovec) intraocular injectable solution is on track to receive breakthrough therapy designation (BTD). This product, an adeno-associated virus vector (AAV) based gene therapy co-developed with MeiraGTx Holdings plc, is aimed at…
-
Johnson & Johnson’s Talquetamab and Daiichi Sankyo’s Enhertu Eye Priority Review in China
•
The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J, NYSE: JNJ)’s Talvey (talquetamab) and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) are on track to receive priority review statuses. Talquetamab, a bispecific GPRC5D-directed CD3 T-cell engager, is in development for the treatment of adult patients with recurrent/refractory…
-
SciClone and Menarini File for Import License of Antibacterial Drug Vaborem in Macau
•
SciClone Pharmaceuticals Inc (HKG: 6600) has announced that its Italy-based strategic partner Menarini has submitted an import drug pre-license filing for Vaborem (meropenem vaborbactam) in Macau. The company is seeking regulatory approval for the new antibacterial drug to treat complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), and complicated complex urinary…
-
Biotech Pharmaceutical Secures Approval for Nimotuzumab in Head and Neck Cancer Treatment
•
Sino-Cuban joint venture Biotech Pharmaceutical Limited (BPL) has secured another indication approval in China for its biologic drug nimotuzumab, now authorized for the treatment of locally advanced head and neck squamous cell carcinoma (HNCC). Nimotuzumab, an EGFR monoclonal antibody (mAb), previously received marketing approvals in China for nasopharyngeal carcinoma (NPC)…
-
BMS Sees Mixed Results in 2023: Growth in New Products Offset by Loss of Exclusivity
•
Bristol Myers Squibb (BMS; NYSE: BMY) reported a 2% year-on-year contraction in 2023 revenues, excluding foreign exchange effects, totaling $45.0 billion, according to its recently released financial report. The company’s global sales were bolstered by a 4% increase in in-line products, generating $34.3 billion, and a remarkable 76% surge in…
-
Chongqing Genrix Bio Pharmaceutical Gets NMPA Clearance for IL-4Rα mAb Candidate GR1802
•
Chongqing Genrix Bio Pharmaceutical Co., Ltd (SHA: 688443), a Chinese biopharmaceutical company, has announced that it has received clinical trial clearance from the National Medical Products Administration (NMPA) for its investigational drug candidate GR1802, an interleukin-4 receptor α (IL-4Rα) monoclonal antibody (mAb). The drug is intended to be assessed as…
-
Inmagene Biopharmaceuticals Secures Exclusive License for HutchMed’s Drug Candidates IMG-007 and IMG-004
•
HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that Sino-US biotech Inmagene Biopharmaceuticals has exercised its option to license two drug candidates discovered by HutchMed, IMG-007 and IMG-004, under the terms of a strategic partnership signed on January 11, 2021. Upon the exercise of these options and subject to…
-
China Medical System Reclaims Rights to Velphoro from WinHealth in Greater China
•
China Medical System Holdings Ltd (CMS, HKG: 0867) has announced a rights assignment agreement with fellow Chinese firm WinHealth Investment (HK) Ltd concerning Velphoro (sucroferric oxyhydroxide). Initially, CMS entered into a licensing agreement with WinHealth in June of the previous year, which granted WinHealth exclusive rights for regulatory filing, import,…
-
Sichuan’s Ancocare Gets FDA Green Light for Phase I/III Study of Oncolytic Virus in Neuroblastoma
•
Sichuan-based Flavivirus technology platform developer Ancocare has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I/III clinical study for its double spear type I oncolytic virus DS1-H2-1 in neuroblastoma. The product, which leverages the Flavivirus technology platform, is a positive…
-
Roche Posts Modest 2023 Growth Amid Shifts in Demand for COVID-Related Products
•
Swiss pharmaceutical giant Roche (SWX: ROG) has published its 2023 financial results, showing a modest 1% year-on-year (YOY) increase in global sales at constant exchange rates (CER) to CHF 58.7 billion (USD 68.5 billion). This growth was primarily due to a 6% YOY expansion in the pharmaceutical business to CHF…
-
Merck KGaA’s Tepmetko Launches in China, Expanding Access to MET Inhibitor for Lung Cancer Patients
•
Merck KGaA (NYSE: MRK), a leading German science and technology company, has announced the commercial launch of its targeted lung cancer therapy, Tepmetko (tepotinib), in China. This marks a significant milestone as multiple hospitals across the country have begun writing the first prescriptions for this MET inhibitor. Tepmetko, which has…
-
Shanghai Junshi Biosciences’ Toripalimab Aims for Singapore Approval in Nasopharyngeal Carcinoma
•
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has submitted market approval applications in Singapore for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The drug is proposed for use as a first-line treatment for metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC)…
-
Takeda Reports Flat 9-Month Revenue Growth Amid Pipeline Optimization Efforts
•
Takeda (TYO: 4502), a leading Japanese pharmaceutical company, has released its financial results for the 9-month period ended December 31, 2023, reporting a revenue of JPY 3.2 trillion (USD 21.9 billion) with a 0.0% growth at constant exchange rates (CER). The company’s performance was impacted by declines in oncology, neuroscience,…
-
Beijing Tiantan Biological Halts Phase III Clinical Trial for CMV Immunoglobulin Citing Strategic Reasons
•
Beijing Tiantan Biological Products Co., Ltd (SHA: 600161), a biopharmaceutical firm based in China, has declared its decision to discontinue a Phase III clinical study for its intravenous injection of cytomegalovirus human immunoglobulin (pH4). The company cited prevailing market conditions and internal strategic planning as the key factors influencing this…
-
Gilead’s Kite Subsidiary Reduces CAR T-Cell Therapy Turnaround Time with FDA Approval
•
Kite, a subsidiary of Gilead (NASDAQ: GILD), has announced a significant enhancement in the treatment process for its CAR T-cell therapy, Yescarta (axicabtagene ciloleucel). The median turnaround time (TAT) for this life-saving therapy is set to decrease from 16 days to 14 within the United States, following an approval by…
-
Sandoz Launches Biosimilar Natalizumab in Germany, Challenging Biogen’s Tysabri
•
Sandoz, a division of Novartis and a leader in generic drugs and biosimilars headquartered in Switzerland (SWX: SDZ), has announced the launch of Tyruko (natalizumab), the first biosimilar version of Biogen’s (NASDAQ: BIIB) blockbuster Tysabri, in the German market. This move marks a significant advancement in the treatment options for…
-
European Commission Approves Takeda’s Hyqvia for Chronic Inflammatory Demyelinating Polyneuropathy
•
The European Commission (EC) has granted regulatory approval to Takeda Pharmaceutical Company Limited (TYO: 4502) for its plasma-derived therapy Hyqvia (human immune globulin infusion 10% with recombinant human hyaluronidase) as a maintenance treatment for chronic inflammatory demyelinating polyneuropathy (CIDP). This follows a similar indication extension for the subcutaneous drug in…
-
Hengrui Medicine Scores First-Mover Status with FDA Approval for Generic Astagraf XL
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its sustained-released generic version of Astagraf XL (tacrolimus), originally developed by Japan-based Astellas. With this…
-
Takeda’s Gammagard Liquid Approved by FDA for Chronic Inflammatory Demyelinating Polyneuropathy
•
The US Food and Drug Administration (FDA) has granted regulatory approval for Takeda’s (TYO: 4502) plasma-derived therapy Gammagard Liquid, a human immune globulin, for use as induction therapy and treatment for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. This decision is supported by clinical data demonstrating that the intravenous immunoglobulin…
-
AstraZeneca’s Enhertu Receives Priority Review for Expanded HER2-positive Solid Tumor Indication
•
UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced that an indication extension filing for Enhertu (trastuzumab deruxtecan), submitted in partnership with Japan’s Daiichi Sankyo (TYO: 4568) to the US Food and Drug Administration (FDA), has been granted priority review. The treatment is now under consideration for unresectable or metastatic…
-
Bristol Myers Squibb’s Subcutaneous Opdivo Shows Noninferiority in Phase III ccRCC Trial
•
Bristol Myers Squibb (BMS; NYSE: BMY) this week announced preliminary Phase III data demonstrating that its subcutaneous formulation of Opdivo (nivolumab), developed in partnership with Halozyme Therapeutics (NASDAQ: HALO), is noninferior to the intravenous version for patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC). The equivalence trial…
-
Johnson & Johnson’s Rybrevant and Lazertinib Filings Accepted for Review by CDE
•
The Center for Drug Evaluation (CDE) has confirmed that Johnson & Johnson’s (J&J, NYSE: JNJ) market filings for Rybrevant (amivantamab) and lazertinib, designated as JXSS2400004 and JXHS2400009 respectively, have been accepted for review. Amivantamab-vmjw, a bispecific antibody targeting EGFR and MET, received its initial approval in May 2021 for the…
-
EMA’s CHMP Endorses Bristol Myers Squibb’s CAR-T Therapy Abecma for Multiple Myeloma
•
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has endorsed Bristol Myers Squibb’s (BMS; NYSE: BMY) CAR-T cell therapy, Abecma (idecabtagene vicleucel), for the treatment of relapsed and refractory multiple myeloma (r/r MM) in adults who have undergone at least two prior therapies.…
-
Dupixent by Sanofi and Regeneron Approved by FDA for Eosinophilic Esophagitis in Younger Pediatric Patients
•
The US Food and Drug Administration (FDA) has concluded a priority review and granted approval to Sanofi (NASDAQ: SNY) and Regeneron (NASDAQ: REGN) for their interleukin blocker Dupixent (dupilumab) as a treatment for eosinophilic esophagitis (EoE) in patients aged 1 to 11 years. This indication expansion makes Dupixent the sole…
-
Shandong Boan Biotechnology Strikes Licensing Deal with Joincare for Long-Acting mAb BA2101
•
Shandong Boan Biotechnology Co., Ltd (HKG: 6955), based in China, has announced a licensing agreement with fellow Chinese firm Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380) for its in-house developed long-acting monoclonal antibody (mAb) BA2101. According to the agreement, Joincare will obtain exclusive rights to develop, regulate, and commercialize…
-
Apeloa Pharmaceutical Halts Phase III Trial of Salfaprodil for Acute Ischemic Stroke
•
Apeloa Pharmaceutical Co., Ltd (SHE: 000739), a China-based pharmaceutical company, has announced the termination of a Phase III clinical study for its salfaprodil injection, which is being developed as a treatment for acute ischemic stroke. Salfaprodil is a novel NMDA receptor antagonist. According to the public data, Apeloa first filed…
-
Laekna Therapeutics Reports Phase II Data for Afuresertib in Platinum-Resistant Ovarian Cancer
•
Laekna Therapeutics Shanghai Co., Ltd, a China-based pharmaceutical company, has announced topline data from the global multi-center Phase II PROFECTA-II study for its afuresertib combined with paclitaxel in the treatment of platinum-resistant ovarian cancer (PROC). The Sino-US study aimed to assess the efficacy and safety of the combination therapy in…
-
Yantai Dongcheng’s Radiopharmaceutical 68GaLNC1007 Gets FDA Nod for Diagnostic Use in Solid Tumors
•
Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a Chinese pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) for its radiopharmaceutical 68GaLNC1007. This diagnostic agent targets fibroblast activating protein (FAP) and integrin αvβ3 and is under development to support the treatment…
-
Joincare Pharmaceutical Partners with QYuns Therapeutics for Exclusive Rights to QX008N in China and Hong Kong
•
Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380), a Chinese pharmaceutical company, has announced a strategic cooperation and licensing agreement with Jiangsu QYuns Therapeutics Co., Ltd concerning QX008N, a monoclonal antibody (mAb) that targets thymic stromal lymphopoietin (TSLP). According to the agreement, Joincare will secure exclusive rights to research and…
-
Eisai’s Alzheimer’s Drug Leqembi Earns Marketing Approval in China
•
Eisai (TYO: 4523), a leading Japanese pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug Leqembi (lecanemab), an amyloid-beta (Aβ)-targeting therapy indicated for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD). This…
-
Henlius Biotech Ships First International Batch of HanSiZhuang for Cancer Treatment to Indonesia
•
Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biotech company from China, has announced the first international shipment of its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab), from Shanghai Pudong Airport to Indonesia. HanSiZhuang, the inaugural innovative monoclonal antibody (mAb) developed by Henlius, has gained approval from the National Medical Products…
-
Shanghai Fosun Pharmaceutical Receives NMPA Approval for Phase II Study of FCN-338 for Light Chain Amyloidosis
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study for its pipeline drug candidate, FCN-338. This small-molecule Bcl-2 inhibitor will…
-
Gan & Lee Pharmaceuticals Receives Bolivian Approval for Insulin Aspart, Expanding Access to Rapid-Acting Insulin
•
Gan & Lee Pharmaceuticals (SHA: 603087), a Chinese pharmaceutical company, has announced that it has received marketing approval from Bolivia’s Agencia Estatal de Medicamentos y Tecnologías en Salud (AGEMED) for its Insulin Aspart (cartridge bottle). Insulin Aspart, a rapid-acting insulin analogue, begins to take effect within 10-20 minutes of subcutaneous…
-
Roche Commences Phase II Trial of Repare Therapeutics’ ATR Inhibitor, Camonsertib, in Solid Tumors
•
Swiss pharmaceutical giant Roche (SWX: ROG) has reached a significant milestone this week with the dosing of the first patient in an open-label Phase II trial using its Canadian partner Repare Therapeutics’ (NASDAQ: RPTX) ATR inhibitor, camonsertib. The trial aims to evaluate the safety and efficacy of various targeted therapies…
-
Roche’s Tecentriq in Combination with Exelixis’s Cabometyx Meets Primary Endpoint in mCRPC Phase III Study
•
Roche (SWX: ROG), the Swiss pharmaceutical giant, has announced positive results from a Phase III study showcasing the efficacy of its anti-PD-L1 drug Tecentriq (atezolizumab) in combination with Exelixis’s (NASDAQ: EXEL) tyrosine kinase inhibitor (TKI) Cabometyx (cabozantinib) for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The study focused on…
-
Pfizer’s Nurtec Approved by China’s NMPA for Acute Treatment of Migraines
•
Pfizer Inc. (NYSE: PFE), a leading pharmaceutical company in the U.S., has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for Nurtec (rimegepant), indicated for the acute treatment of migraine with or without aura. Rimegepant, developed originally by Biohaven, is the first oral CGRP…
-
Novo Nordisk’s Rybelsus Approved for Type 2 Diabetes in China, Setting New Oral Treatment Standard
•
Novo Nordisk (NYSE: NVO), a major Danish pharmaceutical company, has received approval from China’s National Medical Products Administration (NMPA) for its drug Rybelsus (semaglutide) for the treatment of type 2 diabetes. The approval covers filing numbers JXSS2200016, JXSS2200017, and JXSS2200018. Rybelsus, recognized as the world’s first and currently only oral…
-
Eli Lilly’s Subsidiary Akouos Reports Positive Preliminary Results for Gene Therapy in Hearing Loss
•
Eli Lilly (NYSE: LLY) has announced preliminary results from a Phase I/II study conducted by its subsidiary Akouos for gene therapy AK-OTOF, which is being investigated for the treatment of sensorineural hearing loss due to mutations in the otoferlin gene (OTOF). The press release reported that the first participant in…
-
Biosion’s SIRPα-Targeting Monoclonal Antibody BSI-082 Clears US FDA Clinical Trial Hurdle
•
Biosion, a global clinical-stage biotechnology company dedicated to developing antibody-based therapies for immune and oncologic diseases, has announced that it has received clinical trial clearance from the US Food and Drug Administration (FDA) for its pipeline candidate BSI-082. This monoclonal antibody (mAb) targets SIRPα and is under development for the…
-
IASO Biotechnology Secures NMPA Approval for Fucaso in Refractory Myasthenia Gravis
•
China-based IASO Biotechnology has received clinical trial approval from the National Medical Products Administration (NMPA) for its BCMA-directed CAR T cell therapy, Fucaso (equecabtagene autoleucel), now indicated for the treatment of refractory systemic myasthenia gravis (MG). Originally approved for marketing in China in June 2022 for recurrent and refractory multiple…
-
MSD’s Keytruda Combines with PharmAbcine’s PMC-309 in Phase Ia/b Solid Tumor Trial
•
Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its blockbuster anti-PD-1 drug Keytruda (pembrolizumab) has entered a Phase Ia/b trial in combination with South Korea-based PharmAbcine’s (KOSDAQ: 208340) VISTA-inhibiting biologic PMC-309 for the treatment of advanced or metastatic solid tumors. The study aims to determine the recommended dose,…
-
China Grand Pharmaceutical Gets NMPA Green Light for mRNA Cancer Vaccine ARC01 Phase I Study
•
China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct an open-label, dosage escalation Phase I study for its therapeutic cancer vaccine ARC01 (A002). The study will assess the safety, tolerability, immunogenicity, pharmacokinetics, and…
-
Boan Biotech Secures FDA Orphan Drug Designations for Two Claudin18.2 Targeting Candidates
•
Boan Biotech (HKG: 6955), a Chinese biotechnology company, has announced that it has received orphan drug designation (ODD) awards from the US Food and Drug Administration (FDA) for two of its pipeline candidates. The ODDs were granted to the antibody BA1105 and the antibody-drug conjugate (ADC) BA1301, both of which…
-
Lingyi Biotechnology’s Gene Therapy Candidate LY-M001 Gets FDA Green Light for Gaucher’s Disease
•
Lingyi Biotechnology Co., Ltd, a China-based gene therapy developer, has secured clinical trial approval from the US Food and Drug Administration (FDA) for its proprietary AAV gene therapy candidate, LY-M001, which is being developed to treat type I or III Gaucher’s disease. LY-M001 utilizes a recombinant adeno-associated virus (rAAV) as…
-
Phanes Therapeutics’ First-in-Class BsAb PT217 Accepted for Review by China’s CDE
•
Sino-US biotechnology company Phanes Therapeutics Inc. has announced that the Investigational New Drug (IND) filing for its potential first-in-class in-house bispecific antibody (BsAb) PT217 has been accepted for review by China’s Center for Drug Evaluation (CDE). PT217 is designed to directly kill tumor cells through the antibody-dependent cellular phagocytosis (ADCP)…
-
Zhaoke Ophthalmology Secures NMPA Approval for Presbyopia Treatments Brimochol PF and CarbacholPF
•
Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), a China-based pharmaceutical company, through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced receiving clinical trial approvals from the National Medical Products Administration (NMPA) for two of its products, Brimochol PF and CarbacholPF, which are designed to treat presbyopia. Brimochol PF and Carbachol…
-
Eli Lilly’s Olumiant Patent Invalidated in China, Generic Version Approved
•
The China National Intellectual Property Administration (CNIPA) has declared the compound patent CN200980116857.7 for Eli Lilly’s (NYSE: LLY) JAK inhibitor Olumiant (baricitinib) invalid in its entirety, as per a recent public document. The decision came after a challenge from Nanjing SiPake Pharmaceutical Technology Co., Ltd. Baricitinib, a JAK1/JAK2 inhibitor originally…
-
BMS’s Opdivo-Yervoy Combo Cuts Cancer Progression Risk by 79% in Phase III Study
•
Bristol Myers Squibb (BMS; NYSE: BMY) has published late-stage and long-term data for its anti-PD-1 drug Opdivo (nivolumab) across various cancer indications. Early results from a Phase III trial in microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) indicate that the combination of Opdivo with anti-CTLA-4…
-
Tcelltech’s B7-H3 Targeting CAR-T Therapy TX103 Gets Tacit Clinical Approval for Glioblastoma
•
The Center for Drug Evaluation (CDE) website in China has indicated that Tcelltech’s TX103, a chimeric antigen receptor (CAR) T cell therapy targeting B7-H3, has received tacit approval to proceed with clinical trials for the treatment of malignant glioblastoma. Suzhou Porton Biologics Ltd, Tcelltech’s Contract Development and Manufacturing Organization (CDMO)…
-
Merck’s Bavencio Shows Promising Survival Data in Real-World Urothelial Carcinoma Studies
•
German pharmaceutical company Merck (NYSE: MRK) has released data from real-world studies for its anti-PD-L1 biologic Bavencio (avelumab), used as a maintenance therapy in eligible patients with locally advanced or metastatic urothelial carcinoma (UC). Preliminary results indicate that the median overall survival (OS) in patients without progression after first-line chemotherapy…
-
BriSTAR Immunotech’s LILRB4-Targeted Cell Therapy YTS104 Gets Tacit Approval for Clinical Trial in China
•
BriSTAR Immunotech, a clinical-stage cell therapy company based in Beijing, has received tacit clinical trial approval from the Center for Drug Evaluation (CDE) in China for its YTS104, a specific LILRB4-targeted cell therapy based on its STAR-T platform. The targeted indications for YTS104 include recurrent/refractory acute myeloid leukemia (AML), chronic…
-
Legend Biotech’s Carvykti Files for European Approval as Second-Line MM Treatment
•
GenScipt Biotech Corp. (HKG: 1548), a China-based Contract Development and Manufacturing Organization (CDMO), through its subsidiary Legend Biotech Corporation (NASDAQ: LEGN), has announced a market approval filing in Europe for its chimeric antigen receptor (CAR)-T therapy Carvykti (ciltacabtagene autoleucel). The therapy is proposed as a second-line treatment for recurrent/refractory (R/R)…
-
Visirna Therapeutics Completes Enrollment in Phase III Study for FCS Drug VSA001
•
Visirna Therapeutics, a Shanghai-based biopharmaceutical company, has announced the completion of patient enrollment in a Phase III clinical study for its investigational drug VSA001, which is being studied for the treatment of familial chylomicronemia syndrome (FCS) in China. A total of 36 FCS patients have been enrolled and will be…
-
Eisai’s Uric Acid Excretion Drug Urece Accepted for Review in China
•
The Center for Drug Evaluation (CDE) in China has indicated on its website that it has accepted for review the New Drug Application (NDA) filed by Japan-based Eisai (TYO: 4523) for its drug Urece (dotinurad). This marks a significant step towards potentially bringing the uric acid excretion promoting drug to…
-
Hansoh Pharmaceutical Gets NMPA Approval for Type 2 Diabetes and Obesity Drug Trial
•
Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692), a leading Chinese pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) in China to commence a clinical study of its Category 1 drug candidate, HS-10501. The study aims to assess the efficacy and safety of…
-
HuidaGene Therapeutics’ CRISPR Therapy Earns Orphan Drug Status for Duchenne Muscular Dystrophy
•
China-based biotechnology company HuidaGene Therapeutics has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its CRISPR-Cas12 DNA editing therapy, HG302, intended for the treatment of Duchenne muscular dystrophy (DMD), a severe and often fatal neuromuscular genetic disorder. This designation follows…
-
AstraZeneca Wins FDA Nod for Airsupra in Asthma Treatment
•
AstraZeneca (AZ; NASDAQ: AZN), a leading UK pharmaceutical company, announced this week that it has received regulatory approval from the US Food and Drug Administration (FDA) for its respiratory drug Airsupra (albuterol + budesonide). The drug is now approved for the treatment or prevention of asthma symptoms and for the…
-
Gilead’s Trodelvy Misses Primary Endpoint in Late-Stage NSCLC Trial
•
Gilead Sciences (NASDAQ: GILD) has announced that a late-stage trial for its antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) in metastatic or advanced non-small cell lung cancer (NSCLC) did not meet its primary endpoint of overall survival (OS) in patients who had previously received treatment for metastatic NSCLC. Despite this setback,…
-
NMPA Grants Marketing Approval for Hui Sheng Bio-pharmaceutical’s Janagliflozin
•
The National Medical Products Administration (NMPA) has granted marketing approval for Hui Sheng Bio-pharmaceutical Co., Ltd’s Category 1 drug janagliflozin, which is indicated for the control of blood sugar levels in adults with type 2 diabetes. The drug can be used as a monotherapy or in combination with metformin. Janagliflozin,…
-
Novartis Lutathera Combo Therapy Shows Significant Progress in GEP-NETs
•
Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced preliminary results from a Phase III study that evaluated the efficacy of radioligand therapy (RLT) Lutathera (lutetium (177Lu) oxodotreotide) in combination with the symptom-control drug octreotide as a first-line therapy for SSTR+ well-differentiated grade 2/3 advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The clinical…
-
AstraZeneca’s Imfinzi Meets Primary Endpoint in Hepatocellular Carcinoma Trial
•
UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced the successful completion of the primary endpoint in a Phase III trial for its anti-PD-L1 drug Imfinzi (durvalumab). The trial investigated the combination of Imfinzi with bevacizumab, originally developed by Roche (SWX: ROG) as Avastin, and transarterial chemoembolization (TACE) for embolization-eligible hepatocellular…
-
J&J’s Balversa Receives Full FDA Approval for Urothelial Carcinoma Treatment
•
The US Food and Drug Administration (FDA) has converted the 2019 accelerated approval for Johnson & Johnson’s (J&J; NYSE: JNJ) FGFR kinase inhibitor Balversa (erdafitinib) into a full registration. Balversa is indicated for the treatment of locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 mutations in patients who…
-
Uni-Bio Science Group Wins NMPA Nod for Generic Forteo Injection for Osteoporosis
•
Hong Kong-listed biopharmaceutical company Uni-Bio Science Group Ltd (HKG: 0690) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of Eli Lilly Inc (NYSE: LLY)’s Forteo (teriparatide) injection, indicated for the treatment of osteoporosis in postmenopausal women who are at…
-
Sichuan Kelun-Biotech Secures NMPA Nod for Generic Lynparza Equivalent
•
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a Chinese pharmaceutical company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of AstraZeneca (AZ, NASDAQ: AZN)’s PARP inhibitor Lynparza (olaparib). This marks the second approval for a Lynparza generic in China,…
-
InnoCare Makes Minjuvi Combo Treatment Available to Patients in China’s GBA
•
InnoCare (HKG: 9969; SHA: 688428), a China-based biopharmaceutical company, has announced that the combination treatment of Minjuvi (tafasitamab) plus lenalidomide is now accessible to patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT) in the Guangdong-Hong Kong-Macao Greater Bay Area (GBA).…
-
BeiGene Submits Additional Application for Tislelizumab in NSCLC in China
•
BeiGene (NASDAQ: BGNE) has announced the submission of a supplementary Biologic License Application in China for its programmed death-1 (PD-1) inhibitor, tislelizumab. The company is seeking regulatory approval for a new indication in the perioperative (neoadjuvant + adjuvant) treatment of patients with resectable non-small cell lung cancer (NSCLC). The Center…
-
Tasly Pharmaceuticals Gets NMPA Go-Ahead for Clinical Trial of Stem Cell Therapy in Heart Failure
•
Tasly Pharmaceuticals (SHA: 600535), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its human umbilical cord mesenchymal stem cell injection, B2278. The study aims to evaluate the efficacy of this therapy…
-
Sinocelltech Granted NMPA Approval for Phase I Clinical Trial in Hematological Malignancies
•
Sinocelltech Group Ltd (SHA: 688520), a biopharmaceutical company based in China, has announced that it has received clearance from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its monoclonal antibody SCTC21C, targeting CD38+ hematological malignant tumors. This development marks a significant step forward in…
-
Sanofi’s Dupixent Receives FDA Label Update for Atopic Dermatitis Patients with Hand or Foot Involvement
•
Sanofi (NASDAQ: SNY) has been granted authorization by the US Food and Drug Administration (FDA) to update the label of Dupixent (dupilumab) to include efficacy and safety data for patients aged 12 and older with atopic dermatitis that involves uncontrolled moderate-to-severe hand or foot symptoms. The data from a late-stage…
-
Luzhu Biotechnology’s LZ901 Herpes Zoster Vaccine Trial Fully Enrolls 26,000 Participants
•
Beijing Luzhu Biotechnology Co., Ltd (HKG: 2480), a leading manufacturer of human vaccines and therapeutic biologics, has declared the successful completion of patient enrollment for the Phase III clinical study of its vaccine candidate LZ901 in China. Over 98% of the participants have received the requisite two doses of either…
-
CARsgen Therapeutics’ CT041 Shows Promising Results in Advanced Solid Tumors at ASCO GI 2024
•
China-based CAR-T cell specialist CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced the presentation of interim results from the Phase Ib ELIMYN18.2 study’s dosage escalation phase for its pipeline asset, CT041. The data will be showcased at the esteemed 2024 ASCO Gastrointestinal Cancers Symposium (ASCO GI 2024). The study is…
-
Beijing Aosaikang Initiates Phase III Trial for Advanced Gastric Cancer Treatment
•
Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755), a Chinese pharmaceutical company, has registered a Phase III clinical study with Clinicaltrials.gov for its Claudin18.2-targeted antibody ASKB589. The trial will investigate the use of ASKB589 in combination with tislelizumab and chemotherapy as a first-line treatment for advanced gastric cancer. The study aims…
-
FDA Approves Casgevy, the First CRISPR-Based Gene Editing Therapy for β-Thalassemia
•
Casgevy (exagamglogene autotemcel), the pioneering gene editing therapy based on CRISPR technology, has received approval from the US Food and Drug Administration (FDA) for the treatment of patients aged 12 and above with transfusion-dependent β-Thalassemia (TDT). This marks a significant milestone as Casgevy becomes the world’s first CRISPR-based gene editing…
-
Shanghai-Based NK CellTech Earns FDA IND Clearance for Non-Genetically Modified NK Cell Therapy
•
NK CellTech, a Shanghai-based developer of NK cell therapies, has announced that it has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for its proprietary non-genetically modified natural killer cell therapy, NK010, for the treatment of ovarian cancer. This milestone marks NK CellTech as…
-
Eisai and Medivir’s Combo Therapy Advances in Liver Cancer with Positive Trial Results
•
Japanese pharmaceutical company Eisai’s (TYO: 4523) kinase inhibitor Lenvima (Lenvatinib), combined with Swedish partner Medivir’s (STO: MVIR) chemotherapy fostroxacitabine bralpamide (fostrox), has demonstrated positive outcomes in an open-label Phase Ib/IIa trial for advanced hepatocellular carcinoma (HCC), Medivir announced. Following last year’s encouraging early data, these results are expected to pave…
-
Hansoh Pharmaceutical Advances Schizophrenia Treatment with HS-10509 Clinical Trial Approval
•
Hansoh Pharmaceutical (HKG: 3692) has announced that it has received approval to commence clinical trials for HS-10509, a Category 1 drug developed in-house for the treatment of schizophrenia. The specific indication for the drug will be determined through the clinical trial process.- Flcube.com
-
Sino Biopharmaceutical Receives NMPA Approval for Generic Revolade Equivalent
•
Sino Biopharmaceutical Ltd (HKG: 1177), a major player in the Chinese pharmaceutical industry, announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Novartis’s Revolade (eltrombopag olamine). The drug is indicated for the treatment of adults and children aged six and…
-
Luye Pharma’s Biosimilar Bevacizumab Gets GMP Certification in Brazil
•
Luye Pharma Group (HKG: 2186), a leading pharmaceutical company based in China, has announced that it has received Good Manufacturing Practice (GMP) certification from Brazil’s National Health Surveillance Agency (ANVISA) for its biosimilar version of Roche’s blockbuster drug Avastin (bevacizumab). This certification marks a significant step forward in Luye’s efforts…
-
Regenxbio’s One-Time Gene Therapy for Wet AMD Shows Promise in Phase II Study
•
Gene therapy specialist Regenxbio (NASDAQ: RGNX) has announced preliminary results from a Phase II study for ABBV-RGX-314, a VEGF pathway inhibitor developed in partnership with AbbVie (NYSE: ABBV) for the treatment of wet age-related macular degeneration (wet AMD). The therapy is designed to be administered as a one-time injection, aiming…
-
Takeda’s Hyqvia Approved by FDA for Chronic Inflammatory Demyelinating Polyneuropathy
•
Japanese pharmaceutical company Takeda (TYO: 4502) has received an indication extension approval from the US Food and Drug Administration (FDA) for its plasma-derived therapy Hyqvia (human immunoglobulin 10%). The therapy is now approved for use as a maintenance treatment in chronic inflammatory demyelinating polyneuropathy (CIDP). Initially approved in the US…
-
Qilu Pharmaceutical’s Iruplinalkib Gains Additional Indication Approval in China for ALK-Positive NSCLC
•
The National Medical Products Administration (NMPA) website has indicated that Qilu Pharmaceutical’s Category 1 drug, Iruplinalkib, has received additional indication approval in China. The new indication is for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Previously approved in China…
-
Changchun High & New Technology Industries to Launch GenSci125 Phase I Trial in US
•
Changchun High & New Technology Industries (Group) Inc., (SHE: 000661), a leading Chinese pharmaceutical company, has announced the upcoming initiation of a Phase I clinical study for its investigational drug GenSci125 in the United States. The study is designed to evaluate the drug’s efficacy in luteal supplementation or replacement for…
-
Hengrui Medicine Receives NMPA Approval for Phase II Cervical Cancer Study
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study. The study will investigate the combination of its PD-L1 monoclonal antibody adebrelimab (SHR-1316) with concurrent chemotherapy for the treatment of locally…
-
Roche’s Tecentriq SC Receives European Nod as First Subcutaneous PD-(L)1 Therapy
•
Halozyme Therapeutics (NASDAQ: HALO) has announced that the European Commission (EC) has granted marketing authorization to Roche (SWX: ROG) for its anti-PD-L1 drug Tecentriq SC (atezolizumab). This subcutaneous formulation utilizes Halozyme’s proprietary hyaluronidase Enhanze (rHuPH20) and is now approved for the same indications as the original intravenous version of Roche’s…
-
Sino Biopharmaceutical Commences Phase III Trial for Semaglutide Biosimilar in China
•
Sino Biopharmaceutical Ltd (HKG: 1177), a leading Chinese pharmaceutical company, has announced the initiation of a Phase III clinical study for its semaglutide biosimilar in China. The study is assessing the drug as a potential treatment for type 2 diabetes. Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist originally developed by…
-
Yifan Pharmaceutical Wins Nod for Generic Diazoxide Oral Suspension in China
•
Yifan Pharmaceutical Co., Ltd (SHE: 002019), a Chinese pharmaceutical company, has announced that it has received marketing approval from the National Medical Products for its generic version of German pharmaceutical giant Bayer’s diazoxide oral suspension. This signifies that the drug has successfully passed the generic quality consistency evaluation (GQCE) process…
-
RemeGen’s MSLN-Targeted ADC RC88 Clears to Begin Phase I/IIa Study in China
•
RemeGen Co., Ltd (HKG: 9995; SHA: 688331), a leading Chinese biotech firm, has announced that it has received approval from China’s Center for Drug Evaluation (CDE) to initiate a Phase I/IIa clinical study for RC88, a mesothelin (MSLN)-targeted antibody drug conjugate (ADC). The trial will assess the safety and efficacy…
-
Drug Farm’s DF-003 Earns FDA Rare Pediatric Disease Designation for ROSAH Syndrome
•
Sino-US biotech company Drug Farm has announced that it has received Rare Pediatric Disease Designation (RPDD) from the US Food and Drug Administration (FDA) for its first-in-class drug candidate DF-003, which is being investigated as a potential treatment for the ROSAH (retinal malnutrition, optic edema, splenomegaly, anhidrosis, and headache) syndrome.…
-
InnoCare Pharma Receives US FDA IND Approval for BCL2 Inhibitor ICP-248
•
InnoCare Pharma (HKG: 9969; SHA: 688428), a China-based pharmaceutical company, has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its B-cell lymphoma-2 (BCL2) inhibitor, ICP-248. The drug is set to enter a Phase I trial to assess safety, tolerability,…
-
Chipscreen NewWay Biosciences Initiates Phase I Trial for PD-1/CD40 Bispecific Antibody Candidate NWY001
•
China-based Chengdu Chipscreen NewWay Biosciences Co., Ltd has announced that the first patient has been dosed in a Phase I clinical trial for its investigational PD-1/CD40 bispecific antibody (BsAb) candidate, NWY001. The multi-center, non-random, open-label trial is conducted under the leadership of Sun Yat-Sen University Cancer Center, with objectives to…
-
3D Medicines Secures Registration for Envafolimab in Macau for Advanced Solid Tumors
•
3D Medicines (HKG: 1244), a China-based oncology specialist, has announced the registration of its PD-L1 monoclonal antibody (mAb) envafolimab in Macau. The approval designates envafolimab for the treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors. Envafolimab is notable for being the world’s first…
-
Hope Medicine Initiates Phase II Trial for HMI-115 in Endometriosis Treatment
•
Hope Medicine Inc., based in China, has announced the first patient dosing in a global Phase II clinical trial for its monoclonal antibody (mAb) HMI-115, which targets the prolactin receptor (PRL R). The study aims to evaluate HMI-115 as a treatment for endometriosis in Chinese patients. In April 2019, Hope…
-
Neuboron Medtech Secures Clinical Trial Approval for First BNCT Drug in China
•
Neuboron Medtech Ltd., based in China, has received clinical trial approval for its borofalan (10b) injection, as indicated on the website of China’s Center for Drug Evaluation (CDE). This marks the first boron neutron capture therapy (BNCT) to enter regulatory studies in China and the second globally, targeting recurrent malignant…
-
SciClone’s Partner Menarini Files for Elacestrant Approval in Macau for Advanced Breast Cancer
•
SciClone Pharmaceuticals Inc. (HKG: 6600) has announced that its Italian partner, Menarini Group, has submitted a pre-licensing application for the import of Orserdu (elacestrant) in Macau, seeking approval for its use in treating advanced or metastatic breast cancer. Elacestrant, a next-generation selective estrogen receptor degrader (SERD) developed by Eisai (TYO:…
-
Bayer’s Asklepios BioPharmaceutical Launches Phase II Trial for AAV Therapy in Heart Failure
•
Bayer’s (ETR: BAYN) gene therapy subsidiary, Asklepios BioPharmaceutical, has initiated patient recruitment for a Phase II clinical trial of its adeno-associated virus (AAV) therapy AB-1002 targeting congestive heart failure (CHF). This placebo-controlled study aims to assess the safety and efficacy of intracoronary infusion in 90 to 150 adults with non-ischemic…
-
CanSino Biologics Enrolls First Patient in Phase I Trial of Innovative Polio Vaccine
•
CanSino Biologics (SHA: 688185, HKG: 6185), a China-based biotechnology firm, has announced the enrollment of its first patient in a Phase I clinical study for its recombinant polio vaccine in Australia. This candidate vaccine is a non-infectious virus-like particle (VLP) formulation, developed utilizing CanSino’s proprietary protein structure design and VLP…
-
RemeGen Secures Fast-Track Designation for RC88 in Platinum-Resistant Ovarian Cancer
•
China-based biotech RemeGen Co., Ltd (HKG: 9995; SHA: 688331) has received fast-track designation (FTD) from the US FDA for its pipeline candidate RC88, a mesothelin (MSLN)-targeted antibody-drug conjugate (ADC). This designation recognizes RC88’s potential as a treatment for platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancers. Developed in-house,…
-
CSPC Pharmaceutical Secures FDA Approval for Clinical Study of JMT106 in GPC3-Positive Tumors
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has received approval from the US FDA to commence a clinical study for its bispecific fusion protein, JMT106, targeting GPC3-positive solid tumors. JMT106 is designed to target both GPC3 and interferon receptors, aiming to elicit antibody-dependent cellular cytotoxicity (ADCC) while activating the immune…
-
MSD’s Keytruda Gains FDA Approval for Advanced Cervical Cancer Treatment
•
Merck, Sharp & Dohme (MSD; NYSE: MRK) has received regulatory approval from the US Food and Drug Administration (FDA) for the use of its anti-PD-1 drug Keytruda (pembrolizumab) in combination with chemoradiotherapy for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 stage III-IVA cervical cancer. This marks…
-
BMS’s Mavacamten Used to Treat First Patient with Hypertrophic Cardiomyopathy in Hainan
•
Bristol-Myers Squibb (BMS; NYSE: BMY) has announced that the first patient with obstructive hypertrophic cardiomyopathy (oHCM) has been treated using its drug mavacamten at Ruijin Hospital’s Hainan branch. Mavacamten, the world’s first cardiac myosin inhibitor, received approval from the Hainan Medical Products Administration for special entry into the Hainan Bo’ao…
-
CARsgen Therapeutics Gets NMPA Approval for CAR-T Therapy CT011 in Hepatocellular Carcinoma
•
China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its chimeric antigen receptor (CAR)-T therapy, CT011. The study will focus on patients with GPC3 positive stage IIIa hepatocellular carcinoma (HCC) who are…
-
Simcere Pharmaceutical Group Gets NMPA Green Light for USP1 Inhibitor SIM0501
•
Simcere Pharmaceutical Group (HKG: 2096) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its cancer drug candidate SIM0501, intended for the treatment of advanced solid tumors. SIM0501 is a small-molecule inhibitor of ubiquitin specific peptidase 1 (USP1), a protein that is…
-
Huadong Medicine’s Relmapirazin Approval Filing Accepted by NMPA for GFR Measurement
•
Huadong Medicine Co., Ltd (SHE: 000963), based in China, has announced that its market approval filing for relmapirazin, a Category 1 chemical drug and fluorescent tracer for measuring glomerular filtration rate (GFR), has been accepted for review by the National Medical Products Administration (NMPA). This tracer is designed for use…
-
Novo Nordisk’s IcoSema Shows Promise in Late-Stage Trial for Type 2 Diabetes Management
•
Danish pharmaceutical giant Novo Nordisk (CPH: NOVO-B) has announced positive results from a late-stage trial of its antidiabetic combination therapy, IcoSema (insulin icodec + semaglutide), in patients with type 2 diabetes (T2D) inadequately controlled on daily basal insulin. In comparison to insulin glargine plus insulin aspart, once-weekly IcoSema demonstrated non-inferiority,…
-
AbbVie’s Lutikizumab Advances to Phase III for Hidradenitis Suppurativa After Positive Mid-Stage Results
•
AbbVie (NYSE: ABBV) has announced the progression of lutikizumab to Phase III clinical trials following the IL1α/1β antagonist’s successful performance in a mid-stage trial for patients with moderate-to-severe hidradenitis suppurativa (HS) who had failed anti-TNF therapy. The study successfully met its primary endpoint, demonstrating a 35% higher clinical response rate…
-
Bio-Thera Solutions Receives NMPA Approval for Combined Phase Ib/II Study of BAT7104 and BAT4706
•
Bio-Thera Solutions Ltd (SHA: 688177), a Chinese biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a combined Phase Ib/II clinical study for its pipeline drugs BAT7104 and BAT4706 in patients with advanced malignant tumors. BAT7104 is a bispecific antibody (BsAb)…
-
Eisai’s Lemborexant Sleep Aid Lemborexant Filed for NMPA Approval in China
•
The China Center for Drug Evaluation (CDE) website has indicated that Japan-based Eisai (TYO: 4523) has filed lemborexant, marketed under the trade name Dayvigo, for approval with the National Medical Products Administration (NMPA) in China. Lemborexant is a dual orexin receptor antagonist that competitively binds to two types of orexin…
-
Joincare Pharmaceutical’s Partner Fermion Gets NMPA Green Light for Pain Drug Clinical Study
•
Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380), a Chinese pharmaceutical company, has announced that Fermion’s FZ008-145 has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for pain treatment in China. Fermion, which previously granted Joincare exclusive rights to the drug in Greater…
-
GSK Secures Second Indication Approval for Nucala in China for Severe Eosinophilic Asthma
•
GSK plc (NYSE: GSK) has received approval for a second indication in China for its anti-interleukin-15 (IL-15) biologic, Nucala (mepolizumab). The drug is now authorized as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older. Nucala was initially approved in China in…
-
Eli Lilly Secures NMPA Approval for Emgality as Preventive Migraine Treatment in China
•
Eli Lilly (NYSE: LLY) has received marketing approval from the National Medical Products Administration (NMPA) for Emgality (galcanezumab) as a preventive treatment for migraines in adults. Emgality, a monoclonal antibody that selectively targets calcitonin gene-related peptide (CGRP), was initially approved by the U.S. FDA in September 2018 for migraine prevention…
-
GenFleet’s SLS009 Receives Fast-Track and Orphan Drug Designations from U.S. FDA for Lymphoma and Leukemia
•
Shanghai-based biotech GenFleet Therapeutics announced that its CDK9 inhibitor, SLS009 (GFH009), has received fast-track and orphan drug designation (ODD) statuses from the U.S. FDA. These designations highlight the drug’s potential as a treatment for recurrent or refractory peripheral T-cell lymphoma (PTCL) and recurrent or refractory acute myeloid leukemia (AML). In…
-
Novartis’s Cosentyx Secures Additional Indication for Psoriatic Arthritis in China
•
Swiss pharmaceutical giant Novartis (SWX: NOVN) has announced that its drug Cosentyx (secukinumab), which targets IL-17A, has received an additional indication approval from the National Medical Products Administration (NMPA) in China. The drug is now approved for the treatment of active psoriatic arthritis (PsA), adding to its existing indications in…
-
Pfizer and Genmab’s Tivdak Earns Priority Review from FDA for Full Registration
•
The US Food and Drug Administration (FDA) has accepted for priority review a filing from Pfizer (NYSE: PFE) and Genmab (NASDAQ: GMAB) for the full registration of their antibody-drug conjugate (ADC) Tivdak (tisotumab vedotin). Tivdak currently holds an accelerated approval from 2021 for the treatment of recurrent or metastatic cervical…
-
AbbVie Launches Continuous Infusion Therapy for Advanced Parkinson’s Disease in EU
•
AbbVie (NYSE: ABBV) has announced the launch of its dopamine replacement therapy, Produodopa (foslevodopa + foscarbidopa), in the European Union (EU) for the treatment of advanced Parkinson’s disease (PD). The therapy is indicated for patients experiencing severe motor fluctuations, hyperkinesia, or dyskinesia, and when other treatments fail to adequately control…
-
OBI Pharma Gets US FDA Green Light for TROP2 Targeting ADC Cancer Therapy Clinical Study
•
OBI Pharma (4174.TWO), partner to Biosion Inc., has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase I/II study for its novel antibody drug conjugate (ADC) cancer therapy, OBI-992, which targets TROP2. The antibody molecules utilized in the development of…
-
MSD’s Gardasil 9 Receives NMPA Approval for Two-Dose Schedule in Younger Females
•
Merck, Sharp & Dohme (MSD; NYSE: MRK), a prominent pharmaceutical company in the U.S., has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its recombinant human papillomavirus (HPV) 9-valent vaccine, Gardasil 9. The vaccine is now approved for a two-dose vaccination schedule (0,…
-
Astellas’ Zolbetuximab Faces FDA Rejection Due to Manufacturing Facility Deficiencies
•
The US Food and Drug Administration (FDA) has issued a rejection for a filing submitted by Astellas (TYO: 4503), a Japanese pharmaceutical company, for its first-in-class anti-CLDN18.2 biologic zolbetuximab. The drug was under consideration for the treatment of locally advanced unresectable or metastatic HER2-negative CLDN18.2-positive gastric or gastroesophageal junction (GEJ)…
-
3SBio Inc. Receives NMPA Approval for OTC Minoxidil Foam for Male Hair Loss Treatment
•
3SBio Inc., a leading biopharmaceutical company based in China (HKG: 1530), has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its over-the-counter (OTC) drug, a 5% minoxidil foam agent, which is indicated for the treatment of male pattern hair loss and alopecia areata.…
-
Jiangxi Jemincare Group Receives Clinical Trial Approvals for Two Innovative Biologics in the US and China
•
Jiangxi Jemincare Group, a biopharmaceutical company based in China, has announced that it has received clinical trial approvals for two of its Category 1 therapeutic biologics, JMB2004 and JYB1931. JMB2004, a monoclonal antibody (mAb), has been approved for clinical study in the United States for the treatment of sepsis and…
-
Allist Pharmaceuticals’ Furmonertinib and AstraZeneca’s Enhertu Earn Breakthrough Designations in China for NSCLC Treatments
•
The Center for Drug Evaluation (CDE) in China has indicated on its website that Allist Pharmaceuticals Co., Ltd, a Shanghai-based biotech firm, has received breakthrough therapy designations (BTDs) for its epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor (TKI) furmonertinib and for Enhertu (trastuzumab deruxtecan), a HER2-targeted antibody drug conjugate (ADC)…
-
Thederma’s TAP-1503 Cream Receives Priority Review Status for Pediatric Atopic Dermatitis Treatment in China
•
The Center for Drug Evaluation (CDE) website has indicated that China-based Thederma’s TAP-1503 cream is poised to receive priority review status for the local topical treatment of atopic dermatitis (AD) in patients aged two years and above. This priority status is granted due to the drug’s classification under “new varieties,…
-
Innovent Biologics’ Mazdutide Achieves Positive Results in Phase III Clinical Trial for Overweight or Obesity
•
Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that the first Phase III clinical study for mazdutide (IBI362), a dual agonist targeting both the glucagon-like peptide-1 receptor (GLP-1R) and the glucagon receptor (GCGR), has successfully met its primary endpoints and all key secondary endpoints…
-
Abbisko Therapeutics’ Pimicotinib Earns Orphan Drug Designation from EMA for TGCT Treatment
•
Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology company, has announced that it has received orphan drug designation (ODD) from the European Medicines Agency (EMA) for its proprietary colony stimulating factor-1 receptor (CSF-1R) inhibitor, pimicotinib (ABSK021). The drug is under development for the treatment of inoperable tenosynovial giant cell…
-
Gilead’s Descovy Receives Additional Indication Approval from China’s NMPA for HIV-1 PrEP
•
Gilead Sciences, Inc. (NASDAQ: GILD), a major player in the pharmaceutical industry in the U.S., has announced that it has received an additional indication approval from China’s National Medical Products Administration (NMPA) for its anti-viral drug Descovy (emtricitabine, tenofovir alafenamide fumarate). The NMPA has granted approval for the use of…
-
CSBIO’s Multi-Kinase Inhibitor CSCJC3456 Gets Green Light for Clinical Trials in Advanced Solid Tumors
•
Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its small-molecule multi-kinase inhibitor, CSCJC3456. This molecule is now set to be evaluated in the context of general advanced malignant…
-
Aidea Pharmaceutical Receives NMPA Approval to Clinically Test HIV-1 Treatment ACC017
•
Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488), a pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug, ACC017. This molecule is now cleared for assessment as a potential treatment for HIV-1 infection when…
-
Hengrui Medicine Gets NMPA Green Light for Phase Ib/II Study of SHR-A1921 Combo in Advanced Solid Tumors
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate an open, multi-center Phase Ib/II clinical study for its injectable pipeline candidate SHR-A1921. This investigational treatment is to be used in combination with adebrelimab (SHR-1316) and SHR-8068…
-
MSD Advances Four Oncology Candidates to Late-Stage Trials, Including Partnerships with Kelun-Biotech and Orion
•
Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced significant progress in its oncology pipeline with the advancement of four candidates to late-stage trials that are currently enrolling participants. The first molecule is the LSD1 inhibitor bomedemstat, which is being developed for the treatment of essential thrombocythemia (ET). Nemtabrutinib, a…
-
BMS’s Abraxane Approved in China for First-Line Metastatic Pancreatic Cancer Treatment
•
Bristol Myers Squibb (BMS, NYSE: BMY), a leading U.S. pharmaceutical company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its drug Abraxane (paclitaxel, albumin). This approval is for the first-line treatment of metastatic pancreatic cancer in combination with gemcitabine. Since June 2008,…
-
Jiangsu Hengrui Medicine Wins NMPA Nod for SGLT-2 Inhibitor and Metformin Combo for Type 2 Diabetes
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its fixed dose combination (FDC) drug, henagliflozin, metformin sustained-release tablets. This new formulation is designed to enhance blood glucose control in…
-
Genrix Bio Seeks China Approval for New Xeligekimab Use in Axial Spondyloarthritis
•
Chongqing Genrix Bio Pharmaceutical Co., Ltd. (SHA: 688443), a biopharmaceutical company based in China, has submitted a new indication filing for its innovative biologic product xeligekimab, which has now been accepted for review by the National Medical Products Administration (NMPA). This latest filing seeks approval for xeligekimab to treat radiologically…
-
Akeso Biopharma Submits New Indication Application for Cadonilimab in Gastric Cancer Treatment
•
Akeso Biopharma (HKG: 9926), a leading biopharmaceutical company based in China, has announced the submission of a new indication supplementary approval filing for its bispecific antibody (BsAb) drug candidate, cadonilimab (AK104). The company is seeking to expand the use of cadonilimab in combination with chemotherapy as a first-line treatment for…
-
JW Therapeutics Secures NMPA Review for CAR-T Therapy in Mantle Cell Lymphoma
•
JW Therapeutics (HKG: 2126), a Chinese biopharmaceutical company, has announced that it has submitted an additional indication application for its chimeric antigen receptor (CAR) T cell therapy, Carteyva (relmacabtagene autoleucel injection), targeting recurrent or refractory mantle cell lymphoma (r/r MCL). The National Medical Products Administration (NMPA) has accepted the filing…
-
Jiangsu Hengrui Medicine Advances Novel Cancer Therapies with NMPA Clinical Trial Approval
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to conduct an open-label, multi-center Phase Ib/II clinical study. The study will assess the efficacy of three of the company’s novel pipeline candidates in combination regimens against general solid tumors. The drugs in…
-
Jiangsu Vcare PharmaTech Submits NDA to US FDA for Vicagrel, a P2Y12 Receptor Antagonist
•
Jiangsu Vcare PharmaTech Co., Ltd, a Chinese pharmaceutical company, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its vicagrel, a P2Y12 receptor antagonist. The drug is proposed for the treatment of acute coronary syndrome (ACS), ischemic stroke, and thrombotic cardiovascular and diagnosed…
-
BMS’s Sotyktu, First TYK2 Inhibitor, Hits Chinese Market
•
US pharmaceutical giant Bristol Myers Squibb (BMS, NYSE: BMY) has announced the market launch of Sotyktu (deucravacitinib) in China, marking a significant milestone for the treatment of moderate to severe plaque psoriasis. Sotyktu is recognized as the world’s first and only TYK2 allosteric inhibitor, suitable for patients eligible for systemic…
-
Shanghai BDgene Technology’s Thalassemia Gene Therapy BD211 Clears NMPA for Clinical Trials
•
Shanghai BDgene Technology Co., Ltd, a specialist in gene therapy, has received clinical trial approval from the National Medical Products Administration (NMPA) for its therapy BD211. This gene-modified autologous hematopoietic stem cell therapy is designed for the treatment of thalassemia. In a preliminary study, BD211 demonstrated safety and efficacy in…
-
Belief BioMed Group Initiates Clinical Study for Hemophilia A Gene Therapy BBM-H803 in China
•
Belief BioMed Group, a Shanghai-based gene therapy specialist, has announced the first subject dosing in a regulatory clinical study for its in-house developed adeno-associated virus (AAV) gene therapy, BBM-H803, for the treatment of hemophilia A in China. This marks a significant step forward in addressing the unmet medical need for…
-
Jiangsu Hengrui Medicine Secures NMPA Approval for Abiraterone in Prostate Cancer Treatment
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category 2.2 drug abiraterone, a modified androgen synthesis inhibitor. The drug is indicated for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and newly diagnosed high-risk…
-
ImmunoTech Biopharm Commences Patient Enrollment in Phase II Study for CAR-T-19 Injection
•
ImmunoTech Biopharm Ltd, a China-based specialist in chimeric antigen receptor T-cell (CAR-T) therapies (HKG: 6978), has announced the enrollment of the first patient in a Phase II clinical study for its CAR-T-19 injection. The treatment is under development for children and young adults with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL).…
-
Sino Biopharmaceutical Ltd Secures Exclusive Rights for Generic Everolimus in China
•
Sino Biopharmaceutical Ltd (HKG: 1177), a leading pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Novartis AG’s Afinitor (everolimus). This achievement marks a significant milestone as the company’s product is set to enjoy…
-
Sciwind Biosciences’ Ecnolgutide Shows Promising Phase III Results in Type 2 Diabetes Treatment
•
Sciwind Biosciences Co., Ltd, a China-based pharmaceutical company, has released the latest topline Phase III data for its lead anti-obesity candidate, ecnolgutide (XW003), in the treatment of type 2 diabetes mellitus (T2DM), following positive Phase II results for the drug as an obesity treatment released in June 2023. The randomized,…
-
InventisBio’s KRAS G12C Inhibitor Garsorasib NDA Accepted for Review by China’s NMPA
•
InventisBio (Shanghai) Co., Ltd (SHA: 688382), a China-based pharmaceutical company, has announced that the New Drug Application (NDA) for its candidate garsorasib (D-1553) has been accepted for review by China’s National Medical Products Administration (NMPA). The KRAS G12C inhibitor is intended for the treatment of locally advanced or metastatic non-small…
-
AstraZeneca and Sanofi’s RSV Prevention Drug Beyfortus Approved by China’s NMPA
•
AstraZeneca (AZ, NASDAQ: AZN) and Sanofi (NASDAQ: SNY), co-development partners in the pharmaceutical industry, have announced that they have received marketing approval from the National Medical Products Administration (NMPA) for their drug Beyfortus (nirsevimab). The antibody is now approved for use in preventing lower respiratory tract infections caused by respiratory…
-
Ascletis Pharma’s ASC41 Shows Promising Results in Phase II NASH Study
•
Ascletis Pharma Inc. (HKG: 1672), a Chinese pharmaceutical company, has announced positive interim results from a 52-week Phase II study evaluating the efficacy of the thyroid hormone receptor β (THRβ) agonist ASC41 in patients with liver biopsy-proven non-alcoholic steatohepatitis (NASH). The ongoing, randomized, double-blind, placebo-controlled, and multi-center Phase II study…
-
Shanghai Junshi Biosciences’ Toripalimab Gains NMPA Approval for NSCLC Perioperative Treatment
•
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has announced an additional indication approval for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab), from China’s National Medical Products Administration (NMPA). The drug is now approved for use as perioperative treatment in combination with…
-
Roche’s Phesgo and Faricimab Receive NMPA Approvals for Breast Cancer and nAM
•
The National Medical Products Administration (NMPA) has granted separate approvals for two distinct drugs from Swiss pharmaceutical giant Roche (SWX: ROG). The first approval is for Phesgo (trastuzumab, pertuzumab), indicated for the treatment of HER2-positive early and metastatic breast cancer. The second approval is for faricimab, which targets neovascular age-related…
-
BeiGene’s Tislelizumab Secures 12th Indication Approval in China for HCC First-Line Treatment
•
BeiGene (NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has received approval in China for the first-line treatment of irresectable or metastatic hepatocellular carcinoma (HCC), marking the drug’s 12th indication approval in the country. The approval is supported by the RATIONALE 301 study, a randomized, open-label, global…
-
BMS’ Augtyro Receives EMA Review for Advanced Lung Cancer and Solid Tumors Treatments
•
The European Medicines Agency (EMA) has accepted for review a filing submitted by Bristol Myers Squibb (BMS; NYSE: BMY) for its orphan drug, Augtyro (repotrectinib), which targets ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and NTRK-positive locally advanced or metastatic solid tumors. The next-generation tyrosine kinase inhibitor…
-
Jiangsu Recbio’s REC610 Shingles Vaccine Shows Positive Results in First-In-Human Study
•
Jiangsu Recbio Technology Co., Ltd (HKG: 2179), a Chinese biotechnology company, has announced positive results from the first-in-human (FIH) study for its novel adjuvanted recombinant shingles vaccine, REC610, which is being conducted in the Philippines. The study uses GlaxoSmithKline’s Shingrix (recombinant zoster vaccine; RZV), a major UK pharmaceutical company’s shingles…
-
Innovent Biologics Initiates Phase III Trial for Mazdutide in Obesity Treatment
•
Innovent Biologics Inc., a biopharmaceutical company based in China (HKG: 1801), has announced the first patient dosing in the Phase III GLORY-2 study, which is assessing the higher dose 9mg version of mazdutide (IBI362) for the treatment of obesity in Chinese adults. Mazdutide is a dual agonist drug candidate targeting…
-
Hainan Poly Pharm’s Novel Nanomedicine PLAT001 Gets US FDA Approval for Clinical Trials
•
Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its novel injectable PLAT001, intended for the treatment of advanced or metastatic solid tumors, including pancreatic cancer. PLAT001, a groundbreaking nanomedicine,…
-
Boan Biotech Secures FDA Orphan Drug Designations for Pancreatic Cancer Treatments
•
China-based Boan Biotech (HKG: 6955) has announced that its novel antibody BA1105 and antibody-drug conjugate (ADC) BA1301 have received orphan drug designations (ODDs) from the U.S. Food and Drug Administration (FDA). Both therapies target Claudin18.2 (CLDN18.2) for the treatment of pancreatic cancer. BA1105 is being developed for Claudin18.2 positive advanced…
-
Gilead’s Kite Receives FDA Nod to Add Overall Survival Data to Yescarta for Large B-Cell Lymphoma
•
Gilead Sciences Inc. (NASDAQ: GILD) subsidiary Kite has received approval from the U.S. Food and Drug Administration (FDA) to update the label of Yescarta (axicabtagene ciloleucel) to include overall survival (OS) data for its use as a second-line treatment for relapsed or refractory large B-cell lymphoma (r/r LBCL). This new…
-
FDA Prioritizes Roche’s Xolair for Food Allergy Indication Extension Ahead of Q1 Decision
•
The U.S. Food and Drug Administration (FDA) has prioritized Roche’s (SWX: ROG) indication extension filing for Xolair (omalizumab), marking it as the first treatment in the U.S. aimed at reducing allergic reactions associated with accidental food exposure in patients with food allergies. The FDA granted biologic breakthrough therapy designation (BTD)…
-
Lepu Biotechnology Completes Enrollment for Phase IIb Trial of MRG003 in Nasopharyngeal Carcinoma
•
Lepu Biotechnology Co., Ltd (HKG: 2157), based in China, has announced the completion of subject enrollment in its Phase IIb clinical study for MRG003, its flagship product targeting recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). The randomized, open-label, multi-center pivotal study aims to evaluate the efficacy and safety of this epidermal growth…
-
Shanghai Henlius Secures Indonesian Approval for HanSiZhuang in Small-Cell Lung Cancer
•
Shanghai Henlius Biotech Inc. (HKG: 2696) has received market approval from the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan) for its anti-PD-1 monoclonal antibody, HanSiZhuang (serplulimab). This approval allows the drug to be used in the treatment of extensive-stage small-cell lung cancer (ES-SCLC). Henlius is collaborating with…
-
Clover Biopharma’s SCB-219M Shows Promising Phase I Results for Chemotherapy-Induced Thrombocytopenia
•
Clover Biopharmaceuticals Ltd (HKG: 2197), based in China, has announced promising preliminary results from its Phase I clinical study of SCB-219M, an innovative thrombopoietin receptor agonist (TPO-RA) developed in-house. The study, which focused on safety, efficacy, and pharmacokinetics, involved tumor patients undergoing chemotherapy. In the Phase I trial, nine chemotherapy-treated…
-
Fosun’s HLX42 Receives Fast-Track Designation from FDA for NSCLC Treatment
•
Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196; SHA: 600196) has announced that its antibody-drug conjugate (ADC) HLX42 has received fast-track designation from the U.S. Food and Drug Administration (FDA). The drug is being co-developed with its subsidiary Shanghai Henlius Biotech Inc. (HKG: 2696) and Suzhou-based Medilink Therapeutics, specifically targeting advanced…
-
Simcere Secures Approval for Local Manufacturing of Cosela, Boosting Patient Access
•
China-based Simcere Pharmaceutical Group (HKG: 2096) has received supplementary filing approval for its drug Cosela (trilaciclib), enabling the transfer of its manufacturing technology from G1 Therapeutics to Simcere’s facility in Hainan. This transition paves the way for localized production of the CDK4/6 inhibitor, enhancing patient accessibility across the region. Trilaciclib,…
-
Sanofi Gains NMPA Approval for Innovative Rosuvastatin and Ezetimibe Combination Therapy
•
Sanofi (NASDAQ: SNY), the French pharmaceutical giant, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its fixed-dose combination tablets of rosuvastatin and ezetimibe. This therapy is indicated for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH). This product marks the first…
-
AstraZeneca Secures FDA Approval for Self-Administered hATTR-PN Therapy Wainua
•
AstraZeneca (AZ, NASDAQ: AZN), headquartered in the UK, announced last week that the U.S. Food and Drug Administration (FDA) has granted regulatory approval for its ligand-conjugated antisense oligonucleotide (LICA) Wainua (eplontersen) as a treatment for hereditary transthyretin-mediated amyloidosis polyneuropathy (hATTR-PN/ATTRv-PN) in adults. Developed in collaboration with Ionis Pharmaceuticals (NASDAQ: IONS),…
-
Taiwan FDA Reviews Nefecon New Drug Application from Everest Medicines
•
China-based Everest Medicines (HKG: 1952) has announced that the New Drug Application (NDA) for Nefecon (sustained-release budesonide) has been accepted for review by the Taiwan Food and Drug Administration (TFDA). The application seeks approval for the treatment of primary immunoglobulin A nephropathy (IgAN) in adult patients. Nefecon is a patented…
-
Amgen’s Lumakras Faces Full Approval Delay as FDA Requests New Study
•
The US Food and Drug Administration (FDA) has declined to grant full approval for Amgen’s (NASDAQ: AMGN) Lumakras (sotorasib), a first-in-class KRASG12C inhibitor, for the treatment of locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC). The regulator has requested an additional confirmatory study, which Amgen intends to…
-
Guangdong Zhongsheng Pharmaceutical’s ZSP1273 for Influenza A Accepted for Review by NMPA
•
Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a Chinese pharmaceutical company, has announced that China’s National Medical Products Administration (NMPA) has accepted for review its market approval filing for ZSP1273, a Category 1 drug candidate and a potential treatment for influenza A. ZSP1273 is recognized as the first small-molecule RNA…
-
Healthstar Medical Receives NMPA Go-Ahead for KC1036 Esophageal Cancer Study
•
Beijing-based Healthstar Medical Development Co., Ltd (SHA: 603590) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for KC1036 in combination with a programmed-death 1 (PD-1) inhibitor as first-line maintenance therapy for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC). KC1036,…
-
Simcere Affiliate Xianbo Biotech Gets China Nod for CAR-T Therapy SNC109
•
Shanghai Xianbo Biotech Co., Ltd, known as Simnova outside of China and an affiliate of Simcere Investment Group, has received tacit clinical trial approval from Chinese authorities for its SNC109, an in-house developed treatment for recurrent glioblastoma. SNC109 is a dual chimeric antigen receptor (CAR)-T cell therapy designed on Xianbo…
-
FDA Grants Priority Review to MSD and Daiichi Sankyo’s ADC for Lung Cancer
•
The US Food and Drug Administration (FDA) has accepted under priority review a filing from Merck, Sharp & Dohme (MSD; NYSE: MRK) and Daiichi Sankyo (TYO: 4568) for their jointly developed antibody-drug conjugate (ADC) patritumab deruxtecan. The treatment is intended for patients with locally advanced or metastatic EGFR-mutated non-small cell…
-
AbbVie and Alpine Immune Sciences Halt Early Enrollment in Lupus Trial
•
AbbVie (NYSE: ABBV) and Alpine Immune Sciences (SWX: ALPN) have made the decision to prematurely cease enrollment in a Phase II trial for the T-cell stimulatory pathways inhibitor acazicolcept in systemic lupus erythematosus (SEL). This move allows for an early assessment of the trial data and enables Alpine to redirect…
-
J&J’s Rybrevant-Lazertinib Combo Accepted for FDA Review in NSCLC
•
The US Food and Drug Administration (FDA) has accepted for review Johnson & Johnson’s (J&J; NYSE: JNJ) application for Rybrevant (amivantamab), a bispecific antibody, in combination with lazertinib, a tyrosine kinase inhibitor (TKI), for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon…
-
Shanghai Fosun to Exclusively Commercialize Generic Entresto in China
•
Nanjing F&S Pharmatech Co., Ltd has officially launched its generic version of Novartis’s heart failure therapy Entresto (sacubitril, valsartan) in China, with exclusive commercialization rights held by Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196). Entresto, a breakthrough treatment for chronic heart failure, was first approved in China in 2017…
-
Shouyao Holdings Receives Ethical Approval for Phase III Study of ALK Inhibitor SY-3505
•
Beijing-based Shouyao Holdings (Beijing) Co., Ltd (SHA: 688197) has announced that it has received ethical approval to conduct a pivotal Phase III clinical study for its third-generation anaplastic lymphoma kinase (ALK) inhibitor, SY-3505. The study is a randomized, controlled, multi-center trial designed to assess the efficacy and safety of SY-3505…
-
Jiangxi Jemincare Group Secures Clinical Trial Approvals for Six Drugs in China and the US
•
China-based Jiangxi Jemincare Group (SHA: 603222) has announced receiving clinical trial approvals for six of its Category 1 chemical drugs in China and the United States, with indications spanning cancer, kidney diseases, and infectious diseases. JMKX003801, approved for study in China for severe infections caused by Gram-negative bacteria, has demonstrated…
-
Yifan Pharmaceutical’s F-652 Shows Promise in Phase II Clinical Trial for ACLF
•
Yifan Pharmaceutical Co., Ltd (SHE: 002019), a China-based pharmaceutical company, has reported positive outcomes from a Phase II clinical trial for F-652, a product developed by its subsidiary Evive Biotech Ltd, in the treatment of acute-on-chronic liver failure (ACLF). The trial demonstrated that F-652 not only exhibits good safety and…
-
Sanofi Halts Development of Tusamitamab Ravtansine After Missed Trial Endpoints
•
Sanofi (NASDAQ: SNY) has announced the discontinuation of its antibody-drug conjugate (ADC) tusamitamab ravtansine following disappointing results from a Phase III trial in metastatic non-squamous (NSq) non-small cell lung cancer (NSCLC) patients with high CEACAM5 expression. The trial did not meet its dual primary endpoints, as indicated by an interim…
-
Asieris Pharmaceuticals Gets Australian Greenlight for Acinetobacter Infection Drug Trial
•
Asieris Pharmaceuticals (SHA: 688176), a China-based specialist in urogenital cancer treatments, has received approval in Australia to commence a Phase I clinical study for its drug candidate APL-2301 (MET-102, formerly ASN-1733), which targets Acinetobacter baumannii infections. The study will evaluate the safety, tolerability, and pharmacokinetics of APL-2301 in healthy subjects…
-
Sino Biopharmaceutical Completes Enrollment for Phase III Trial of Anlotinib in Soft Tissue Sarcoma
•
Sino Biopharmaceutical Ltd (HKG: 1177), a China-based pharmaceutical giant, has announced the completion of patient enrollment for a Phase III clinical trial of anlotinib, marketed under the trade name FOCUS V, in conjunction with chemotherapy for first-line treatment of advanced soft tissue sarcoma. The trial, conducted by Jiangsu Chia Tai…
-
Jiangsu Nhwa Pharmaceutical Gets NMPA Green Light for Schizophrenia Drug Trial
•
Jiangsu Nhwa Pharmaceutical Co., Ltd. (SHE: 002262), a China-based pharmaceutical company, has announced that it has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for its Category 1 chemical drug, NH300231, which is intended for the treatment of schizophrenia. This next-generation atypical antipsychotic drug is characterized as…
-
Legend Biotech’s Carvykti Therapy to Include Myeloid Neoplasms Warning in Label Update
•
GenScript Biotech Corporation (HKG: 1548), a China-based Contract Research Organization (CRO), has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), will update the warning label for its BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), to account for the potential risk of myeloid neoplasms in patients…
-
Takeda’s Livtencity Receives NMPA Approval, a First in China for CMV Infection Treatment
•
Japanese pharmaceutical company Takeda (TYO: 4502) has received its first market approval from China’s National Medical Products Administration (NMPA) for Livtencity (maribavir), a significant milestone for the treatment of adult patients with cytomegalovirus (CMV) infection/disease following hematopoietic stem cell transplantation or solid organ transplantation. The drug is particularly indicated for…
-
AstraZeneca Advances to Phase III with PD-1xTIGIT BsAb for Biliary Tract Cancer
•
AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical company, is set to initiate a Phase III study for its PD-1xTIGIT bispecific antibody (BsAb) rilvegostomig in combination with chemotherapy for patients with biliary tract cancer (BTC) following surgical resection. The double-blind, placebo-controlled, global trial aims to assess the efficacy and tolerability of…
-
Lee’s Pharmaceutical’s Socazolimab Becomes China’s First PD-L1 mAb for Cervical Cancer
•
Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has secured in-licensed rights for socazolimab, a treatment for recurrent-metastatic cervical cancer, according to the National Medical Products Administration (NMPA) website. This drug marks the first programmed-death ligand 1 (PD-L1) monoclonal antibody (mAb) for cervical cancer in China. Socazolimab, originally developed by US-based Sorrento…
-
FDA Rejects MSD’s Gefapixant for Chronic Cough Treatment Over Efficacy Concerns
•
The US Food and Drug Administration (FDA) has declined to approve a filing from Merck, Sharp & Dohme (MSD; NYSE: MRK) for its P2X3 receptor antagonist, gefapixant, which was being considered as a treatment for refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults. The rejection was due…
-
Jiangsu Hengrui Medicine Wins NMPA Approvals for SLE and Lymphoma Drug Candidates
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that it has received separate clinical trial approvals from China’s National Medical Products Administration (NMPA) for two of its drug candidates, SHR0302 and SHR2554. SHR0302 is anticipated to treat systemic lupus erythematosus (SLE), while SHR2554 is…
-
RemeGen’s Telitacicept Secures FDA Approval for Global Phase III Study in Primary Sjogren’s Syndrome
•
RemeGen (HKG: 9995), a China-based pharmaceutical company, has received approval from the US Food and Drug Administration (FDA) to proceed with a global multi-center Phase III clinical study for its fusion protein drug telitacicept in the treatment of active primary Sjogren’s syndrome (pSS). This 48-week, multi-center, randomized, double-blinded, placebo-controlled Phase…
-
RemeGen Ltd Receives FDA Clearance for MSLN-Targeting ADC RC88 in Gynecological Tumors
•
China-based RemeGen Ltd (SHA: 688331, HKG: 9995) has announced that it has received clinical clearance from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) RC88, which targets mesothelin (MSLN) in gynecological tumors. This approval paves the way for global multi-center Phase II clinical trials to…
-
Healthstar Medical Gets NMPA Approval for KC1036 Clinical Study in Juventus sarcoma
•
Beijing-based Healthstar Medical Development Co., Ltd (SHA: 603590) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its drug candidate KC1036 in advanced Juventus sarcoma for adolescents aged 12 and above. KC1036, a tyrosine kinase inhibitor (TKI) that targets AXL, VEGFR2, and FLT3,…
-
Staidson Pharmaceutical’s BDB-001 Earns Breakthrough Therapy Designation in China for AAV Treatment
•
Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a China-based pharmaceutical company, has announced that its drug candidate BDB-001 has been granted breakthrough therapy designation (BTD) status in China for the treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). Research indicates that the downstream activation of C5a, a product of the…
-
3SBio Subsidiary Gets Green Light for SSGJ-608 Ankylosing Spondylitis Study
•
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (HKG: 1530), has received approval from the US Food and Drug Administration (FDA) to conduct separate Phase II clinical studies for its drug candidate SSGJ-608. The molecule is set to be evaluated as a treatment for ankylosing spondylitis (AS)…
-
Lynk Pharmaceuticals Initiates Phase III Clinical Trial for Rheumatoid Arthritis Drug in China
•
China-based Lynk Pharmaceuticals Co., Ltd has announced that the first patient has been dosed in a Phase III clinical study for its drug candidate LNK01001, which is being developed to treat rheumatoid arthritis (RA). The trial is supported by Lynk’s commercialization partner, Simcere Pharmaceutical Group (HKG: 2096), and is being…
-
European Commission Expands Keytruda Indications for Advanced Cancer Treatments
•
The European Commission (EC) has granted Merck, Sharp & Dohme (MSD; NYSE: MRK) additional indications for its leading anti-PD-1 therapy, Keytruda (pembrolizumab), approving its use as a first-line treatment in combination with chemotherapy for locally advanced unresectable or metastatic biliary tract carcinoma (BTC) and HER2-negative gastric or gastroesophageal junction (GEJ)…
-
HuidaGene Secures Rare Pediatric Disease Designation for CRISPR Therapy HG302 Targeting DMD
•
HuidaGene Therapeutics, based in China, has announced that it has received Rare Pediatric Disease Designation (RPDD) from the U.S. FDA for its CRISPR-Cas12 DNA editing therapy, HG302. This designation highlights the therapy’s potential to treat Duchenne muscular dystrophy (DMD), a severe neuromuscular genetic disorder. HG302 employs high fidelity Cas12 (hfCas12Max)…
-
HighField Biopharmaceutical Doses First Patient in HFK1 Clinical Trial Targeting Solid Tumors
•
Hangzhou-based HighField Biopharmaceutical, a leader in immuno-oncology focused on innovative lipid-based therapies, has announced the initiation of dosing for the first patient in a clinical trial of its candidate HFK1. This investigational drug is an immunoliposome encapsulating doxorubicin, aimed at targeting various solid tumors. The trial is being conducted concurrently…
-
EMA’s CHMP Gives Green Light to Sanofi’s Fexinidazole for Acute Sleeping Sickness Treatment
•
Last week, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on Sanofi’s (NASDAQ: SNY) Fexinidazole Winthrop (fexinidazole) as a 10-day treatment for acute sleeping sickness caused by Trypanosoma brucei (T.b.) rhodesiense in both adults and children. The EMA is…
-
InventisBio’s KRAS G12C Inhibitor D-1553 Advances Toward Priority Review in China
•
According to the China Center for Drug Evaluation (CDE), Shanghai-based InventisBio Co., Ltd. (SHA: 688382) is on track to secure priority review status for its KRAS G12C inhibitor, D-1553, aimed at treating locally advanced or metastatic non-small cell lung cancer (NSCLC) with a confirmed KRAS G12C mutation, particularly in patients…
-
Keytruda Gains 12th Indication Approval in China for HER2-Negative Gastric Cancer
•
US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its immunotherapy drug Keytruda (pembrolizumab) has received approval from the National Medical Products Administration (NMPA) in China for a new indication. The drug is now approved as a first-line treatment for locally advanced unresectable or metastatic HER2-negative…
-
Sirnaomics Ltd Granted FDA Approval for Phase I RSV mRNA Vaccine Study
•
Sirnaomics Ltd (HKG: 2257) has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study for its mRNA vaccine candidate RV-1770, targeting the respiratory syncytial virus (RSV) to prevent infections in adults. The study will involve the administration of three different doses (50mg,…
-
Roche Receives NMPA Approval for Ophthalmology BsAb Vabysmo (Farcimab) for Diabetic Macular Edema
•
Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has obtained marketing approval from China’s National Medical Products Administration (NMPA) for its ophthalmology bispecific antibody (BsAb) Vabysmo (faricimab), which is indicated for the treatment of diabetic macular edema (DME). Vabysmo targets both vascular endothelial growth factor A (VEGF-A) and…
-
Huadong Medicine Gets NMPA Green Light for Clinical Study of Ryzodeg Biosimilar
•
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its biosimilar version of Novo Nordisk’s (NYSE: NVO) Ryzodeg (insulin degludec, insulin aspart), intended for the treatment of adults with type 2 diabetes.…
-
FDA Approves Pfizer-Astellas-MSD Combo Therapy for Advanced Urothelial Cancer
•
Pfizer (NYSE: PFE), Astellas (TYO: 4503), and Merck, Sharp & Dohme (MSD; NYSE: MRK) have secured U.S. Food and Drug Administration (FDA) approval for their combination therapy consisting of Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) for the treatment of locally advanced or metastatic urothelial cancer (la/mUC). The FDA’s decision is…
-
Bio-Thera Solutions Gets NMPA Green Light for PD-1 Inhibitor BAT1308 in Endometrial Cancer
•
Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) in China to initiate a clinical study for its programmed death-1 (PD-1) inhibitor, BAT1308, in the treatment of endometrial cancer. BAT1308 is an internally developed…
-
Sanofi’s Rezurock Secures Marketing Approval in China for Chronic Graft-vs-Host Disease
•
French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that its drug Rezurock (belumosudil), the world’s first and only ROCK2 inhibitor for the treatment of chronic graft-versus-host disease (cGVHD), has received marketing approval in China. Clinical data indicates that Rezurock achieves a 75% overall response rate (ORR), a 75% 6-month failure-free…
-
InnoCare’s TYK2 Inhibitor ICP-332 Shows Positive Results in Atopic Dermatitis Phase II Study
•
Beijing InnoCare Pharma Tech Co., (HKG: 9969), a Chinese biotechnology company specializing in oncology and autoimmune diseases, has reported positive outcomes from a Phase II clinical trial for its tyrosine kinase 2 (TYK2) inhibitor, ICP-332. The randomized, double-blind, placebo-controlled study is investigating the efficacy of ICP-332 in patients with moderate…
-
MSD’s Welireg Gains FDA Approval for Advanced Renal Cell Carcinoma
•
The US Food and Drug Administration (FDA) has granted an indication extension approval for Merck, Sharp & Dohme’s (MSD; NYSE: MRK) oral drug Welireg (belzutifan), expanding its use as a therapy for advanced renal cell carcinoma (RCC) in adults who have previously received a PD-1/L1 inhibitor and a VEGF tyrosine…
-
3D Medicines Initiates Phase III Trial for Envafolimab in NSCLC Patient
•
3D Medicines (HKG: 1244), a China-based oncology specialist, has announced the enrollment of the first patient in a Phase III clinical study for its PD-L1 monoclonal antibody (mAb), envafolimab. The randomized, controlled, double-blinded, multi-center trial will evaluate envafolimab in combination with chemotherapy as a neoadjuvant/adjuvant therapy for patients with resectable…
-
Sino Biopharmaceutical Submits Market Approval Application for Recombinant Coagulation Factor VIIa
•
Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced the submission of a market approval application for its in-house developed recombinant human coagulation factor VIIa. The application has been accepted for review by China’s National Medical Products Administration (NMPA). The drug candidate is being developed…
-
Lepu Biotechnology’s Pancreatic Cancer Drug Earns Orphan Drug Status from FDA
•
Lepu Biotechnology Co., Ltd (HKG: 2157), a Chinese pharmaceutical company, has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its proprietary antibody-drug conjugate (ADC), MRG004A, which is being developed to treat pancreatic cancer. MRG004A is an innovative ADC that targets…
-
AbbVie and Genmab’s Epcoritamab Shows Promising Results in Follicular Lymphoma Study
•
AbbVie (NYSE: ABBV) and Genmab (NASDAQ: GMAB) have presented Phase I/II clinical data for their T-cell engager, Tepkinly/Epkinly (epcoritamab), in patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of therapy. Interim results, with a median follow-up of 17.4 months, showed that the…
-
Amgen’s Tarlatamab Receives FDA Priority Review for Advanced Small Cell Lung Cancer Treatment
•
The US Food and Drug Administration (FDA) has granted priority review status to Amgen (NASDAQ: AMGN) for its potential first-in-class bispecific T-cell engager (BiTE) tarlatamab as a second-line treatment for advanced small cell lung cancer (SCLC). The action date for the review is set for June 12, 2024. This decision…
-
Eisai and BioArctic Set December Launch for Alzheimer’s Drug Leqembi in Japan
•
Eisai (TYO: 4523) and BioArctic (STO: BIOA-B) have announced the launch of Leqembi (lecanemab) in the Japanese market on December 20. The amyloid-beta (Aβ)-targeting drug received its second global approval in Japan earlier this year and has been incorporated into the National Health Insurance (NHI) system. Leqembi is indicated for…
-
Abbisko Therapeutics’ Pimicotinib Earns FDA Fast-Track Status for TGCT Treatment
•
Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology firm, has announced that its colony stimulating factor-1 receptor (CSF-1R) inhibitor, pimicotinib (ABSK021), has received fast-track designation from the US Food and Drug Administration (FDA). The drug is under development for the treatment of inoperable tenosynovial giant cell tumor (TGCT). Pimicotinib,…
-
BMS Presents Promising Golcadomide Trial Results for Non-Hodgkin Lymphomas
•
Bristol Myers Squibb (BMS; NYSE: BMY) has presented results from Phase I and Phase I/II trials for combination therapies with golcadomide, a potential first-in-class drug from the company’s CELMoD line of protein degraders, in the treatment of non-Hodgkin lymphomas. The Phase I study indicated that previously untreated patients with aggressive…
-
J&J’s Carvykti Demonstrates Extended Time to Symptom Worsening in Multiple Myeloma Patients
•
Johnson & Johnson (J&J; NYSE: JNJ) has released data from a Phase III study showing that its CAR-T cell therapy, Carvykti (ciltacabtagene autoleucel), extended the median time until symptom worsening to 23.7 months in patients with relapsed and lenalidomide-refractory multiple myeloma (MM) after one to three prior lines of therapy,…
-
Dizal Pharmaceutical Presents Positive Trial Data for Golidocitinib at ASH Annual Meeting
•
China-based Dizal Pharmaceutical Co., Ltd, (SHA: 688192), a spin-off from AstraZeneca (AZ, NASDAQ: AZN) China established in 2017, has presented robust pivotal trial data for its pipeline candidate golidocitinib at the American Society of Hematology (ASH) Annual Meeting. The data was presented in an oral presentation, showcasing the full analysis…
-
China Medical System Gets NMPA Green Light for Phase III Vitiligo Study with Ruxolitinib Cream
•
China Medical System Holdings (CMS; HKG: 0867) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III clinical study for its Opzelura (ruxolitinib) cream for the treatment of non-segmental vitiligo. Opzelura, a topical Janus kinase (JAK) inhibitor, was approved in the…
-
CARsgen Therapeutics Halts Clinical Studies for Three CAR-T Therapies in the US Following FDA Request
•
China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced that the US Food and Drug Administration (FDA) has requested its US subsidiary, CARsgen Therapeutics Corporation, to place clinical studies for CT053, CT041, and CT071 on hold. These chimeric antigen receptor (CAR)-T therapies are on hold pending the FDA’s conclusion after…
-
Shanghai Henlius Biotech Submits Another Application for Serplulimab in China
•
Shanghai Henlius Biotech Inc., (HKG: 2696) has announced a new market filing for its anti-programmed death-1 (PD-1) drug, HanSiZhuang (serplulimab), seeking approval for use in combination with chemotherapy for first-line non-squamous non-small cell lung cancer (nsqNSCLC). The filing, accepted for review by the National Medical Products Administration (NMPA), marks the…
-
Clover Biopharmaceuticals Commences Phase I Trial for RSV Vaccine in Australia
•
China-based Clover Biopharmaceuticals Ltd., (HKG: 2197) has announced the successful enrollment of the first batch of subjects in a Phase I clinical study in Australia for its pipeline candidate, SCB-1019, a respiratory syncytial virus (RSV) PreF trimeric subunit candidate vaccine. The randomized, placebo-controlled Phase I study aims to assess the…
-
HutchMed’s Elunate-Tyvyt Combination Study for Renal Cell Carcinoma Completes Enrollment
•
China-based HutchMed (NASDAQ: HCM) has announced the completion of patient enrollment in its Phase II/III clinical study for Elunate (fruquintinib) in combination with Tyvyt (sintilimab) for the treatment of second-line locally advanced or metastatic renal cell carcinoma (RCC). The randomized, open-label controlled study aims to compare the efficacy and safety…
-
Luye Pharma’s Lurbinectedin Receives Market Approval in Hong Kong for SCLC Treatment
•
China-based Luye Pharma Group (HKG: 2186) has announced that Hong Kong’s pharmacy and poisons board has approved a market approval filing for the company’s lurbinectedin (LY01017), a drug indicated for metastatic small-cell lung cancer (SCLC) in patients with tumor progression during or after platinum-based chemotherapy. The approval, facilitated by the…
-
Suzhou OSAI Biopharma’s L. crispatus Capsule Meets Phase III Endpoints in Bacterial Vaginosis Study
•
China-based Suzhou OSAI Biopharma Inc., a specialist in live biotherapeutic products (LBPs), has announced that its vaginal L. crispatus live bacteria capsule (Lc262-1) has achieved both primary and secondary endpoints in a Phase III study. The multicenter, randomized, double-blind, placebo-controlled trial involved 320 patients with bacterial vaginosis (BV). Following a…
-
Sanofi Abandons MZE001 Licensing Deal Following FTC Intervention Over Pompe Disease Monopoly Concerns
•
Sanofi (NASDAQ: SNY) has withdrawn from an agreement announced earlier this year to in-license the glycogen synthase 1 (GYS1) inhibitor MZE001 from Maze Therapeutics, following an administrative complaint by the Federal Trade Commission (FTC), the US antitrust agency. The FTC sought a temporary restraining order and preliminary injunction in federal…
-
BMS Advances TIGITxCD96 Bispecific Antibody into Phase II Dose Expansion
•
Bristol Myers Squibb (BMS; NYSE: BMY) has advanced its development program for the TIGITxCD96 bispecific antibody (BsAb) BMS-986442 into a Phase II dose expansion trial. The candidate was licensed from Agenus (NASDAQ: AGEN) in 2021, and as part of the agreement, Agenus will receive a USD 25 million cash payment,…
-
Sisram Medical’s Profhilo Accepted for Review by China’s NMPA
•
Sisram Medical Ltd (HKG: 1696), an Israel-based company within the Fosun Pharmaceutical Group (SHA: 600196), has announced that its licensed injection filler product, Prohiro, has had its market filing accepted for review by China’s National Medical Products Administration (NMPA). Profhilo, an injectable sodium hyaluronate solution, is recognized as one of…
-
Staidson Pharmaceutical Initiates Clinical Study for ARDS Treatment STSA-1002
•
Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a Chinese pharmaceutical company, has announced the dosing of the first patient in a Phase Ib/II clinical study for its injectable STSA-1002, an anti-human complement protein C5a (hC5a) monoclonal antibody (mAb). The drug candidate is under evaluation as a potential treatment for acute…
-
Skyline Therapeutics’ Gene Therapy SKG0201 for SMA Gets Green Light from China’s NMPA
•
Skyline Therapeutics has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its proprietary AAV gene therapy, SKG0201 injection, which is being developed as a treatment for type I spinal muscular atrophy (SMA). SKG0201 is an SMN1 gene replacement therapy that is administered through a single intravenous…
-
Kelun-Biotech’s SKB264 NDA Accepted by NMPA for mTNBC, Poised to Be China’s First TROP2-targeted ADC
•
Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422) announced that its innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990), has had its New Drug Application (NDA) for SKB264 accepted for review by China’s National Medical Products Administration (NMPA). This application is based on results from the OptiTROP-Breast01 study,…
-
Chinese Biotech Precision Biotechnology Gets NMPA Green Light for Advanced Cancer Therapies
•
Chongqing Precision Biotechnology Co., Ltd, a Chinese biopharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for C-13-60 cell preparations as a local treatment in the abdominal cavity for CEA+ advanced malignant tumors, including a range of cancers such as colorectal, esophageal, gastric,…
-
MSD Halts Phase III Trial of Keytruda Combo in NSCLC After Missing Primary Endpoints
•
Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced the discontinuation of a Phase III trial for its anti-PD-1 therapy Keytruda (pembrolizumab) in combination with AstraZeneca’s (AZ; NASDAQ: AZN) co-developed PARP inhibitor Lynparza (olaparib) for metastatic squamous non-small cell lung cancer (NSCLC). The decision follows the trial’s failure to meet…
-
Novartis Reports Kisqali Success in Reducing Recurrence Risk in Early Breast Cancer
•
Novartis (NYSE: NVS) has announced an update on the late-stage trial for its CDK4/6 inhibitor Kisqali (ribociclib) in early breast cancer. Data from 78.3% of patients who completed treatment showed a significant reduction in the risk of recurrence, with 30% and 24.5% decreases for stage II and stage III tumors,…
-
Keymed Biosciences’ Stapokibart Filing Accepted for Priority Review in China for Atopic Dermatitis
•
Keymed Biosciences Inc. (HKG: 2162) has announced that its market filing for stapokibart (CM310), a monoclonal antibody targeting the IL-4 receptor alpha (IL-4Rα), has been accepted for priority review by the National Medical Products Administration (NMPA) for the treatment of moderate to severe atopic dermatitis (AD). The filing is supported…
-
Pfizer and CStone Secure NMPA Approval for Sugemalimab, First PD-L1 Inhibitor for ESCC
•
Pfizer (NYSE: PFE) and CStone Pharmaceuticals (HKG: 2616) have secured market approval from the National Medical Products Administration (NMPA) for sugemalimab, a treatment for first-line irresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) in combination with fluorouracil and platinum. This approval marks sugemalimab as the first programmed…
-
Bio-Thera Secures FDA Approval for Avzivi, a Biosimilar to Roche’s Avastin
•
Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that it has received market approval from the U.S. Food and Drug Administration (FDA) for Avzivi (bevacizumab), a biosimilar version of Roche’s (SWX: ROG) Avastin. The approved indications for Avzivi include non-small cell lung cancer (NSCLC), metastatic colorectal cancer (mCRC), glioblastoma (GBM), renal…
-
Mabwell Secures NMPA Approval for Phase III Study of ADC 9MW2821 in Urothelial Carcinoma
•
Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase III clinical study for its antibody-drug conjugate (ADC), 9MW2821, which targets Nectin-4. The randomized, open-label, controlled, multi-center Phase III trial aims to evaluate the efficacy…
-
HutchMed’s Sovleplenib Set for Priority Review in China for Chronic Immune Thrombocytopenia
•
China’s Center for Drug Evaluation (CDE) has indicated that HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) is on track to receive priority review status for its investigational drug, sovleplenib. This designation is granted due to the drug’s potential to treat adults with primary chronic immune thrombocytopenia (ITP) who are unresponsive…
-
Trinomab’s TNM002 Antitetanus Monoclonal Antibody Filing Accepted for Review in China
•
China’s Center for Drug Evaluation (CDE) has accepted Trinomab Biotech Co., Ltd.’s market approval filing for its antitetanus toxin monoclonal antibody (mAb) injection, TNM002, for review. TNM002, developed using Trinomab’s proprietary HitmAb technology platform, has demonstrated strong drug specificity, favorable safety profiles, and exceptional efficacy in neutralizing tetanus toxin in…
-
Eli Lilly Seeks Approval for Pirtobrutinib in China for Relapsed Mantle Cell Lymphoma
•
Eli Lilly (NYSE: LLY) has submitted a marketing approval application for pirtobrutinib, an oral, non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, according to the China Center for Drug Evaluation (CDE) website. The application targets adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously undergone BTK inhibitor…
-
Shenzhen TargetRx’s TGRX-678 Set to Receive Breakthrough Therapy Designation for CML-AP
•
Shenzhen TargetRx, Inc., a China-based developer of small-molecule kinase inhibitors, is poised to receive breakthrough therapy designation (BTD) for its Bcr-Abl inhibitor, TGRX-678, according to the China Center for Drug Evaluation (CDE) website. This designation recognizes the molecule’s promising potential for treating accelerated chronic myeloid leukemia (CML-AP) in patients who…
-
Changchun BCHT Secures NMPA Approval for Freeze-Dried Human Rabies Vaccine Trials
•
Changchun BCHT Biotechnology Co., Ltd. (SHA: 688276), based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its freeze-dried human rabies vaccine, developed using human diploid/MRC-5 cells. This innovative vaccine utilizes human diploid cells, which are widely recognized in international…
-
Shanghai Pharmaceuticals Gains NMPA Approval for WST04 Clinical Trials in Oncology
•
Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607), a leading pharmaceutical distribution company in China, has received clinical trial approval from the National Medical Products Administration (NMPA) for its oral probiotic preparation, WST04, aimed at treating advanced malignant solid tumors. Preclinical studies indicate that WST04 significantly enhances the anti-tumor efficacy of…
-
Jiangsu Hengrui Seeks NMPA Approval for Camrelizumab-Famitinib Combo in Cervical Cancer
•
Jiangsu Hengrui Medicine Co., Ltd. (SHA: 600276), based in China, has announced that its market approval filing for the programmed death-1 (PD-1) monoclonal antibody camrelizumab, in combination with multi-kinase inhibitor famitinib for recurrent or metastatic cervical cancer, has been accepted for review by the National Medical Products Administration (NMPA). This…
-
Antengene Secures NDA Approval for Xpovio in Macau for Advanced Multiple Myeloma
•
Antengene Corp., Ltd. (HKG: 6996), a biopharmaceutical company based in China, has announced that it has received New Drug Application (NDA) approval from the regulatory authority in Macau for its product Xpovio (selinexor). This approval is specifically for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R…
-
Novartis’ Fabhalta Wins FDA Nod as First-in-Class Treatment for Paroxysmal Nocturnal Hemoglobinuria
•
Swiss pharmaceutical giant Novartis (NYSE: NVS) has secured regulatory approval from the US Food and Drug Administration (FDA) for its first-in-class orphan drug Fabhalta (iptacopan) as an oral monotherapy for adults with paroxysmal nocturnal hemoglobinuria (PNH). The approval was granted based on Phase III clinical data that demonstrated a significant…
-
China Medical System’s Methotrexate Injection Receives NMPA Review for Rheumatoid Arthritis Indication
•
China Medical System Holdings (CMS; HKG: 0867) has announced that the National Medical Products Administration (NMPA) has accepted another indication approval filing for its methotrexate injection. The company is now seeking NMPA approval for the use of the drug in treating active rheumatoid arthritis (RA) in adults. Initially approved for…
-
Huadong Medicine Gets NMPA Green Light for Sirolimus Real-World Study in Pediatric Epilepsy
•
Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct a multi-center, parallel external control, retrospective real-world study. The study will assess the efficacy and safety of its Category 2.4 product, sirolimus, in epilepsy related to nodular sclerosis…
-
Jingxin Pharmaceutical’s Didaxini Gains NMPA Approval as Category 1 Drug
•
Jingxin Pharmaceutical Co., Ltd (SHE: 002020), a Chinese pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its Category 1 drug, Didaxini. This drug is a partial agonist of GABAA (γ-aminobutyric acid A) receptors and selectively targets the α1 subtype of…
-
Biocytogen Pharmaceuticals Secures US Patent for Fully Human Antibody Mice Platform RenMab
•
Biocytogen Pharmaceuticals (Beijing) Co., Ltd (HKG: 2315), a China-based Contract Research Organization (CRO), has announced the receipt of patent approval in the United States for its proprietary core technology, the fully human antibody mice platform RenMab. This U.S. patent award comes on the heels of a similar award in China…
-
China’s Betta Pharmaceuticals Advances CFT8919 for EGFR-Mutated NSCLC After NMPA Approval
•
Betta Pharmaceuticals Co., Ltd (SHE: 300558), a Chinese pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for CFT8919, a metamorphic BiDA degradation agent licensed from U.S. firm C4 Therapeutics, Inc. (NASDAQ: CCCC). The study will focus on…
-
Ascletis Pharma’s Denifanstat Advances to Phase III for Severe Acne Vulgaris Treatment
•
Ascletis Pharma Inc., (HKG: 1672) a China-based biotechnology company, has announced the commencement of a Phase III trial for its drug candidate denifanstat (ASC40), intended to assess its efficacy in treating severe acne vulgaris. The trial, a randomized, double-blind, placebo-controlled, and multi-center study, will be conducted at hospitals across China,…
-
Luye Pharma’s Lurbinectedin for Metastatic SCLC Wins Macau Regulatory Nod
•
Luye Pharma Group (HKG: 2186), a Chinese pharmaceutical company, has announced that Macau’s medical products administration bureau has approved a market approval filing for the firm’s lurbinectedin (LY01017), a drug indicated for metastatic small-cell lung cancer (SCLC) in patients experiencing tumor progression during or after platinum-based chemotherapy. The approval is…
-
Yantai Dongcheng Pharmaceutical Gets NMPA Green Light for FAP-Targeting Radiotherapeutic Drug
•
Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) in China to proceed with a clinical study for its radiotherapeutic drug, 177Lu-LNC1004, which targets advanced solid tumors. The drug is designed to treat fibroblast activation protein (FAP)-positive…
-
Tonghua Dongbao Pharmaceuticals Secures NMPA Approval for Biosimilar Liraglutide
•
Tonghua Dongbao Pharmaceuticals (SHA: 600867), a Chinese pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novo Nordisk’s (NYSE: NVO) GLP-1 receptor agonist Victoza (liraglutide), which is indicated for blood sugar control in type 2 diabetes patients.…
-
Simcere Pharmaceutical’s SIM0501 Receives FDA Approval for Advanced Solid Tumor Clinical Trial
•
Simcere Pharmaceutical Group (HKG: 2096) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its cancer drug candidate SIM0501, which targets advanced solid tumors. The company’s clinical filing was previously accepted for review by China’s National Medical Products Administration (NMPA) in…
-
AstraZeneca Halts Late-Stage Trials for Lokelma in Hyperkalemia Due to Timing and Event Rate Issues
•
AstraZeneca (AZ; NASDAQ: AZN), a leading UK pharmaceutical company, has announced the termination of two late-stage trials for its commercial-stage potassium binder, Lokelma (sodium zirconium cyclosilicate), in hyperkalemia (HK) across the cardiorenal spectrum. The company has clarified that the decision is not due to safety concerns and does not affect…
-
Stem-Cell Startup Xellsmart Earns FDA Orphan Drug Designation for ALS Therapy
•
Xellsmart, a stem-cell startup headquartered in Suzhou, has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its induced pluripotent stem cell (iPSC) derived subtype neural precursor cell therapy, targeting amyotrophic lateral sclerosis (ALS). ALS is a devastating motor neuron disease…
-
Worg Pharmaceuticals Gets FDA Approval for Phase II Graves’ Disease Study
•
Worg Pharmaceuticals, a Hangzhou-based developer of allergic drugs, has received the green light from the US Food and Drug Administration (FDA) to proceed with a Phase II clinical study for its drug candidate WP1302 in the treatment of Graves’ disease. Graves’ disease, a prevalent autoimmune condition, impacts an estimated 10…
-
Nanchang Baiji Pharmaceutical’s Budesonide Nasal Spray Approved by China’s NMPA
•
Nanchang Baiji Pharmaceutical Co. Ltd., a Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) for its generic budesonide nasal spray. The product is indicated for the treatment of seasonal and perennial allergic rhinitis, as well as perennial non-allergic rhinitis, and for the prevention of nasal…
-
Eli Lilly’s Jaypirca Receives FDA Accelerated Approval for Chronic Lymphocytic Leukemia
•
The US Food and Drug Administration (FDA) has granted Eli Lilly (NYSE: LLY) an accelerated approval for its reversible BTK inhibitor Jaypirca (pirtobrutinib) for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have received at least two prior lines of therapy. This regulatory…
-
Ambio Gains FDA Approval for Generic Forteo, Challenging Eli Lilly’s Osteoporosis Market
•
Ambio has secured regulatory approval from the U.S. Food and Drug Administration (FDA) for its generic version of Eli Lilly’s (NYSE: LLY) recombinant peptide Forteo (teriparatide), both of which are indicated for the treatment of osteoporosis. The subcutaneous injection will be marketed in partnership with Apotex. According to the public…
-
Chinese Firms Secure EUAs for Omicron XBB Vaccines Amid Dominant Variant Surge
•
A wave of Chinese pharmaceutical companies has announced the receipt of Emergency Use Authorizations (EUAs) for their COVID-19 vaccines targeting the Omicron XBB variant. Among the notable developments are Lizhu Pharmaceutical’s (HKG: 1513) recombinant bivalent vaccine, which combines the prototype strain with the Omicron XBB variant, and CanSino Biologics’ (SHA:…
-
Pfizer’s Danuglipron Phase IIb Trial Achieves Weight Loss Goals Amid Tolerability Concerns
•
Pfizer (NYSE: PFE) announced last week that its Phase IIb trial evaluating danuglipron, a glucagon-like peptide-1 (GLP-1) receptor agonist, in adults with obesity but without type 2 diabetes (T2D) has successfully met its primary endpoint. The study demonstrated significant reductions in body weight from baseline, with participants achieving placebo-adjusted mean…
-
Everest Medicines Secures IND Review for Zetomipzomib in China
•
Everest Medicines (HKG: 1952) has announced that its Investigational New Drug (IND) application for zetomipzomib has been accepted for review by China’s National Medical Products Administration (NMPA). Zetomipzomib is a first-in-class selective immunoproteasome inhibitor currently under development for a variety of autoimmune diseases, including lupus nephritis and systemic lupus erythematosus…
-
Sunshine Guojian’s SSGJ-608 Meets Phase III Efficacy Endpoints in Psoriasis Trial
•
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., a subsidiary of 3SBio Inc. (HKG: 1530), has announced that its Phase III clinical trial for the anti-IL-17A monoclonal antibody SSGJ-608 in moderate to severe plaque psoriasis has successfully met its primary efficacy endpoints, including PASI 75 and sPGA 0/1, as well as all…
-
Akeso Biopharma Files New Indication for Penpulimab in First-Line NPC Treatment
•
Akeso Biopharma (HKG: 9926) has announced a new indication filing for its programmed death-1 (PD-1) inhibitor, penpulimab (AK105), seeking approval for its use in first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) in combination with chemotherapy. The application is currently under review by China’s Center for Drug Evaluation (CDE).…
-
Shanghai Junshi’s Loqtorzi Enters Australian Market Approval Process for Nasopharyngeal Carcinoma
•
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the Therapeutic Goods Administration (TGA) in Australia has accepted its market approval filing for Loqtorzi (toripalimab), a programmed death-1 (PD-1) inhibitor. The application seeks approval for two indications: as a first-line treatment in combination with cisplatin and gemcitabine…
-
CARsgen Therapeutics Secures U.S. FDA Approval for CT071 Clinical Trials in Multiple Myeloma
•
CARsgen Therapeutics Holdings Ltd (HKG: 2171), based in China, has announced that it has received clinical trial approval from the U.S. FDA for its chimeric antigen receptor (CAR)-T cell product, CT071, aimed at treating recurrent/refractory multiple myeloma (R/R MM) and primary plasma cell leukemia (PCL). CT071 is developed using the…
-
Lepu Biotechnology’s MRG003 Gains Fast-Track Status from U.S. FDA for Nasopharyngeal Carcinoma
•
Lepu Biotechnology Co., Ltd (HKG: 2157), based in China, has announced that its flagship product MRG003 has received fast-track status from the U.S. FDA for the treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). The antibody-drug conjugate (ADC), which targets the epidermal growth factor receptor (EGFR), was previously granted orphan drug…
-
Akeso’s AK111 Achieves Key Efficacy Milestones in Phase III Trial for Plaque Psoriasis
•
Akeso Biopharma (HKG: 9926), based in China, has announced that its pivotal Phase III clinical trial for the interleukin (IL)-17A monoclonal antibody (mAb) AK111 in moderate to severe plaque psoriasis has successfully met all primary efficacy endpoints, including PASI100 and sPGA0/1. This randomized, double-blind, placebo-controlled, multi-center study was designed to…
-
Sichuan Kelun-Biotech to Present Promising Phase II Results for SKB264 in mTNBC at SABCS 2023
•
Sichuan Kelun Pharmaceutical Co., Ltd’s (SHE: 002422) innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), is poised to present updated results from a Phase II study expansion cohort for its antibody-drug conjugate, SKB264, targeting previously treated metastatic triple negative breast cancer (mTNBC) at the upcoming San Antonio…
-
TG ImmunoPharma Secures U.S. FDA IND Approval for Promising mAb TGI-5 Targeting Multiple Cancers
•
TG ImmunoPharma Co., Ltd, based in China, has announced that it has received Investigational New Drug (IND) approval from the U.S. FDA for its proprietary monoclonal antibody (mAb), TGI-5. While the specific target of this molecule remains undisclosed, the company claims it could be a potential global first-in-class treatment. TGI-5…
-
Insilico Medicine Launches Clinical Study for First-in-Class PHD Inhibitor ISM5411 in IBD
•
Insilico Medicine, a China-based biotech leveraging generative artificial intelligence (AI), has announced the initiation of a clinical study for its potential first-in-class PHD inhibitor, ISM5411, targeting inflammatory bowel disease (IBD). ISM5411 is an intestinal-restricted small-molecule inhibitor developed using Insilico’s Pharma.AI platform, featuring a novel molecular framework and a unique binding…
-
Simcere Secures NMPA Approval for Edaravone Sublingual Tablets Targeting Post-Stroke Cognitive Impairment
•
Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has received clinical trial approval from the National Medical Products Administration (NMPA) for its edaravone, borneol sublingual tablets, targeting post-stroke cognitive impairment (PSCI) in patients suffering from acute ischemic stroke (AIS). The edaravone, borneol sublingual tablet is a solid oral formulation designed for…
-
Everest Medicines Reports Positive Phase III Results for Velsipity in Ulcerative Colitis
•
Everest Medicines (HKG: 1952), based in China, has announced positive topline results from a multi-center Phase III clinical trial for Velsipity (etrasimod) in patients with moderate-to-severe active ulcerative colitis (UC). Conducted across various sites in Asia, the trial demonstrated clinically meaningful and statistically significant improvements in the primary endpoint, as…
-
AbbVie’s Telisotuzumab-Vedotin Shows Promising Results in NSCLC Phase 2 Trial
•
AbbVie (NYSE: ABBV) has unveiled data from a Phase 2 trial of its potential first-in-class antibody-drug conjugate (ADC) telisotuzumab-vedotin, which targets c-Met protein-overexpressing, EGFR-wild-type, advanced/metastatic nonsquamous non-small cell lung cancer (NSCLC). The trial results showed an overall response rate (ORR) of 35% in patients with high c-Met levels and 23%…
-
Jiangsu Hengrui Receives NMPA Approval for Esophageal Cancer and Breast Cancer Clinical Trials
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II study for adebrelimab (SHR-1316) in combination with neoadjuvant chemotherapy for locally advanced surgically resectable esophageal squamous cell carcinoma (ESCC) in the perioperative setting. Additionally, the Chinese pharmaceutical company…
-
Asieris Pharmaceuticals’ Hexvix for Bladder Cancer Accepted for Review by China’s NMPA
•
Asieris Pharmaceuticals (SHA: 688176), a specialist in urogenital cancer based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its Hexvix (APL-1706) for the diagnosis and management of bladder cancer. Hexvix stands as the only globally approved agent…
-
Jiangxi Jemincare’s KRAS Inhibitor Earns Breakthrough Designation from China’s CDE for NSCLC
•
The China Center for Drug Evaluation (CDE) website has indicated that Jiangxi Jemincare Group’s proprietary small-molecule KRAS inhibitor, JMKX001899, has been granted breakthrough therapy designation (BTD) status for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation in patients who have previously received…
-
Roche’s Mosunetuzumab and AnHeart’s Taletrectinib Poised for Priority Review in China
•
The China Center for Drug Evaluation (CDE) website has indicated that Roche’s (SWX: ROG) Lunsumio (mosunetuzumab) and AnHeart Therapeutics’ taletrectinib are on track to receive priority review status. Mosunetuzumab, a bispecific antibody targeting CD20 and CD3, has already been approved for the treatment of adult recurrent refractory follicular lymphoma (FL)…
-
Sinocelltech’s PD-1 Inhibitor SCT-I10A for HNSCC Accepted for NMPA Review
•
Sinocelltech Group Ltd (SHA: 688520), a Chinese biopharmaceutical company, has announced that its market approval filing for the investigational product SCT-I10A, a programmed-death 1 (PD-1) monoclonal antibody (mAb), has been accepted for review by the National Medical Products Administration (NMPA). The filed indication is for the treatment of head and…
-
Everest Medicines’ Nefecon NDA for IgAN Accepted for Review in South Korea
•
Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that the New Drug Application (NDA) for Nefecon (sustained-release budesonide) has been accepted for review by South Korea’s Ministry of Food and Drug Safety (MFDS). The therapy is under consideration for approval as a treatment for primary immunoglobulin A nephropathy…
-
Merck’s V116 Pneumococcal Vaccine Shows Promising Data Against Pfizer’s Prevnar 20
•
Merck, Sharp & Dohme (MSD; NYSE: MRK) has unveiled new data from a late-stage trial of its 21-valent pneumococcal conjugate vaccine, V116, confirming earlier topline results. The data, released this week, highlights the vaccine’s immunogenicity, tolerability, and safety in comparison to Pfizer’s (NYSE: PFE) 20-valent Prevnar 20/Apexxnar in unvaccinated adults.…
-
JW Therapeutics Secures Priority Review for Carteyva in Relapsed/Refractory Mantle Cell Lymphoma
•
JW Therapeutics (HKG: 2126), based in China, has announced that its CAR-T cell therapy, Carteyva (relmacabtagene autoleucel injection), has received priority review status for the treatment of relapsed or refractory mantle cell lymphoma (r/r MCL). This designation recognizes the drug’s status as a breakthrough therapy. Relmacabtagene autoleucel is an autologous…
-
Healthstar Medical Launches Phase III Study for KC1036 in Advanced Esophageal Cancer
•
Healthstar Medical Development Co., Ltd (SHA: 603590), based in Beijing, has received approval from China’s Center for Drug Evaluation (CDE) to commence a Phase III clinical study for its investigational drug candidate, KC1036. This randomized, controlled, open-label, multi-center Phase III trial aims to evaluate the efficacy and safety of KC1036…
-
Lee’s Pharmaceutical Secures NMPA Approval for Adasuve, Pioneering Loxapine Inhaler for Agitation
•
Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has secured marketing approval from China’s National Medical Products Administration (NMPA) for Adasuve, a loxapine inhaler designed to treat acute agitation in adults with schizophrenia or bipolar I disorder. This approval is supported by a series of clinical studies conducted across the United States,…
-
Gracell Biotechnologies Gets FDA Green Light for FasTCAR-T Therapy in Systemic Lupus Erythematosus
•
Gracell Biotechnologies Inc., a Suzhou-based biotech company (NASDAQ: GRCL), has received approval from the US Food and Drug Administration (FDA) to initiate a Phase I/II clinical study for its FasTCAR-T GC012F in the United States. The CAR-T therapy is set to be assessed as a treatment for refractory systemic lupus…
-
Dupixent Trial Success Reinforces Potential in Moderate-to-Severe COPD Treatment
•
Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi (NASDAQ: SNY) have announced that a late-stage replicate trial for their interleukin blocker Dupixent (dupilumab) has successfully met its primary endpoint during an interim analysis. The trial demonstrated a significant reduction in exacerbations over 52 weeks in patients with chronic obstructive pulmonary disease (COPD)…
-
AbbVie’s Epcoritamab Earns EMA Review and FDA Breakthrough Designation for Follicular Lymphoma
•
AbbVie’s (NYSE: ABBV) bispecific antibody (BsAb) Tepkinly/Epkinly (epcoritamab) has been accepted for review by the European Medicines Agency (EMA) and granted breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of relapsed or refractory (r/r) follicular lymphoma (FL). These regulatory decisions are backed by…
-
Everest Medicines’ Nefecon for IgAN Receives NMPA Approval in China
•
Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that its New Drug Application (NDA) for Nefecon (targeted-release formulation budesonide) for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression has been approved by the National Medical Products Administration (NMPA). Nefecon is a…
-
Henlius Biotech Gets FDA Clearance for Clinical Study of PD-L1 Targeting ADC HLX43
•
Shanghai Henlius Biotech Inc. (HKG: 2696), a Chinese biopharmaceutical company, has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its antibody drug conjugate (ADC) HLX43, which is co-developed with Suzhou-based Medilink Therapeutics. The molecule is set to be evaluated in patients with…
-
CSPC Pharmaceutical Gets NMPA Green Light for SYH2038 Solid Tumor Study
•
CSPC Pharmaceutical Group Ltd (HKG: 1093), a Chinese pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 chemical drug, SYH2038, in advanced solid tumors. SYH2038 is a highly selective SOS1 inhibitor, with no similar…
-
Abbisko Therapeutics Launches Phase II Trial for Pimocitinib in Advanced Pancreatic Cancer
•
Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology company, has announced the initiation of a Phase II clinical study for its Category 1 innovative drug ABSK021 (pimicotinib) in advanced pancreatic cancer in China, with the first patient now dosed. The multi-center, open-label Phase II study (ABSK021-202) is being conducted…
-
Coherus Biosciences Sets Price for PD-1 Inhibitor Loqtorzi at $8,892.03, Offering 20% Discount Compared to Keytruda
•
Coherus Biosciences Inc. (NASDAQ: CHRS) announced yesterday in an SEC filing the wholesale price for its newly launched PD-1 inhibitor, Loqtorzi (toripalimab), in the U.S. market. The drug, co-developed under license from Shanghai Junshi Biosciences Co., Ltd. (HKG: 1877; SHA: 688180), will retail at $8,892.03 per single-use vial. Loqtorzi received…
-
Takeda’s Takecab Receives NMPA Approval for Helicobacter pylori Eradication in China
•
Takeda (TYO: 4502), a Japan-based pharmaceutical company, has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its drug Takecab (vonoprazan) to eradicate Helicobacter pylori (HP) when combined with appropriate antibiotics. The vonoprazan-based quadruple regimen, which includes bismuth, is the first of its…
-
Fujian Cosunter’s Oral COVID-19 Therapy Receives Conditional Approval in China
•
Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436), a Chinese pharmaceutical company, has announced that its Category 1 product, GST-HG171/ritonavir, an oral COVID-19 therapy, has received conditional marketing approval in China. GST-HG171 is a 3CL protease (3CLpro) inhibitor, characterized as having broad-spectrum anti-COVID-19 activity. 3CL protease is an essential protease for…
-
Sichuan Kelun Pharmaceutical’s RET Inhibitor A400 Earns FDA Orphan Drug Designation
•
Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), a Chinese pharmaceutical company, through its innovative drug development subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its RET inhibitor A400/EP0031 in the treatment…
-
Kintor Pharmaceutical’s KX-826 Shows Promising Results in Phase III AGA Clinical Trial
•
Kintor Pharmaceutical Ltd (HKG: 9939), a China-based pharmaceutical company, has released topline data from a Phase III clinical study for its pipeline candidate KX-826, a potential first-in-class androgen receptor (AR) antagonist for the treatment of androgenetic alopecia (AGA). The multi-center, open-label, long-term safety Phase III clinical trial conducted in China…
-
EirGenix’s Trastuzumab Biosimilar Receives European Commission Marketing Approval
•
EirGenix Inc., (6589.TT) a Taiwan-based pharmaceutical company, has announced that it has received marketing approval from the European Commission (EC) for its biosimilar version of trastuzumab, known as Roche’s Herceptin. The approval is for the 150mg form of the drug intended for intravenous use, indicated for the treatment of HER2-positive…
-
Jiangxi Jemincare Group Secures NMPA Approval for Generic Ibrance Capsules
•
Jiangxi Jemincare Group, a Chinese pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic version of Pfizer’s (NYSE: PFE) Ibrance (palbociclib). This follows the company’s earlier approval for its active pharmaceutical ingredients (APIs) of palbociclib in China. Palbociclib, initially…
-
Novo Nordisk Sets February 2024 Launch for Wegovy in Japan, Expanding into Asia
•
Novo Nordisk (CPH: NOVO-B), headquartered in Denmark, has announced that it will launch its anti-obesity medicine Wegovy (semaglutide) in the Japan market on February 22, 2024, marking the GLP-1 drug’s debut in the Asia region. Wegovy will be priced at JPY 7,504 (USD 50.4) for the starter dose and JPY…
-
Jiangsu Hengrui Medicine Receives NMPA Approval for Phase Ib/II Study of Dalpiciclib and HRS-8080
•
China-based Jiangsu Hengrui Medicine Co., Ltd. (SHA: 600276) has announced that it received approval from the National Medical Products Administration (NMPA) to initiate a Phase Ib/II clinical study. This trial will evaluate the combination of dalpiciclib (SHR6390) and HRS-8080 in patients with ER+/HER2- irresectable or metastatic breast cancer. HRS-8080: A…
-
Pyrotech Biotechnology’s PTT-936 Gets US FDA Clinical Trial Approval
•
Pyrotech (Beijing) Biotechnology Co., Ltd, a China-based biotech firm, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its in-house developed innate immune agonist, PTT-936. The specific targeted indication for this trial remains undisclosed. Mechanism of Action and Preclinical Success PTT-936…
-
Boehringer Ingelheim and Eli Lilly’s Jardiance Receives NMPA Approval for CKD Treatment
•
Boehringer Ingelheim (BI) and Eli Lilly (NYSE: LLY) have announced that their SGLT2 inhibitor, Jardiance (empagliflozin), has received marketing approval from the National Medical Products Administration (NMPA) for the treatment of adult chronic kidney disease (CKD). This development expands the drug’s therapeutic applications in China. EMPA-KIDNEY Study Outcomes The approval…
-
Boehringer Ingelheim and Eli Lilly Secure NMPA Approval for Jardiance in Chronic Kidney Disease
•
Boehringer Ingelheim (BI) and Eli Lilly (NYSE: LLY) have announced the receipt of marketing approval from the National Medical Products Administration (NMPA) for their SGLT2 inhibitor Jardiance (empagliflozin) aimed at treating adult chronic kidney disease (CKD). This pivotal approval marks a significant advancement in the management of CKD, further establishing…
-
MicuRx Pharmaceuticals Secures NMPA Approval for MRX-4 and Contezolid Combination Therapy
•
Sino-US firm MicuRx Pharmaceuticals Inc. has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative anti-microbial agent MRX-4, in combination with contezolid (MRX-I). This novel treatment targets infections caused by drug-resistant Gram-positive bacteria, marking a significant advancement in antibiotic therapy. Overview…
-
C2 Pharma Secures C-DMF Approval for Pilocarpine Nitrate API
•
Ireland-based C2 Pharma has announced the receipt of approval for a C-DMF (drug master file) concerning its pilocarbine nitrate API. This critical active pharmaceutical ingredient (API), produced in collaboration with C2’s Brazilian partner, Anidro do Brasil, plays a vital role in the formulation of ophthalmic medications. Key Features of Pilocarpine…
-
SCG Cell Therapy’s SCG101 Receives Tacit Approval for Cholangiocarcinoma Clinical Trial in China
•
China’s Center for Drug Evaluation (CDE) website has indicated that SCG Cell Therapy Pte. Ltd’s SCG101 autologous T cell therapy has obtained tacit clinical trial approval in China. This marks a world-first clinical indication for the treatment of cholangiocarcinoma. SCG101’s Expanding Clinical IndicationsSCG101, a TCR-T cell therapy, targets specific hepatitis…
-
Akeso Biopharma’s Cadonilimab Meets Primary Endpoint in Phase III Cervical Cancer Study
•
China-based Akeso Biopharma (HKG: 9926) has announced that its Phase III AK104-303 study for cadonilimab (AK104), an innovative bispecific antibody targeting programmed death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), has achieved its primary endpoint. The study combines the antibody with chemotherapy and optional bevacizumab for the first-line treatment of…
-
RemeGen’s Telitacicept Receives Full Approval for Systemic Lupus Erythematosus in China
•
China-based pharmaceutical company RemeGen (HKG: 9995) has announced the conversion of conditional approval to complete approval from the National Medical Products Administration (NMPA) for its fusion protein drug telitacicept, used in the treatment of systemic lupus erythematosus (SLE). This approval follows a multi-center, randomized, double-blind, placebo-controlled Phase III study involving…
-
Bayer Halts Late-Stage Trial for Asundexian After Underperformance
•
Germany-headquartered Bayer (ETR: BAYN) announced the termination of a late-stage trial for its antithrombotic candidate asundexian. Asundexian, once considered a potential blockbuster, was outperformed by the standard of care in preventing stroke and systemic embolism in patients with atrial fibrillation, the most lucrative indication for the drug, with an estimated…
-
Sumitomo Pharma Receives Chinese Approval for Xenleta to Treat Pneumonia
•
Japan-based Sumitomo Pharma Co., Ltd (OTCMKTS: DNPUF) has secured market approval in China for Xenleta (lefamulin acetate), a drug indicated for the treatment of community-acquired pneumonia in adults. The approval was obtained through Sumitomo’s Suzhou-based subsidiary, which already has Mepem (meropenem), a carbapenem antibiotic, in its Chinese market portfolio, and…
-
Gilead Announces Low-Carbon Bronchodilator Study for H1 2024
•
Gilead Sciences Inc. (NASDAQ: GILD) has announced plans for a Phase III study in the first half of 2024 for a new iteration of its bronchodilator Ventolin (salbutamol). This version utilizes a low-carbon propellant, which could potentially reduce the greenhouse gas emissions from the associated metered dose inhaler (MDI) by…
-
Hunan Warrant Pharmaceutical’s ZG-001 Approved for Clinical Trial by NMPA
•
Hunan Warrant Pharmaceutical Co., Ltd (SHA: 688799), a China-based pharmaceutical company, has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug, ZG-001, intended to treat adults with major depressive disorder with acute suicidal ideation or behavior (MDSI). ZG-001’s Mechanism and Pre-Clinical Efficacy…
-
VivaVision Biotech Inc. Receives FDA Approval for VVN461 Phase II Clinical Trial
•
China’s VivaVision Biotech Inc. has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase II clinical trial for its in-house developed drug candidate, VVN461. The trial will assess the efficacy of VVN461 as a treatment for inflammation following cataract surgery. VVN461’s…
-
AnHeart Therapeutics and Innovent Biologics File Taletrectinib for Marketing Approval in China
•
China’s Center for Drug Evaluation (CDE) has indicated on its website that taletrectinib, an ROS1/NTRK inhibitor co-developed by AnHeart Therapeutics and Innovent Biologics Inc. (HKG: 1801), has been filed for marketing approval. The drug is intended to treat ROS1 fusion positive non-small cell lung cancer (NSCLC) in patients who have…
-
Janssen Submits Indication Extension Application to FDA for Rybrevant in NSCLC Treatment
•
The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has filed an indication extension application with the US Food and Drug Administration (FDA) for its bispecific antibody Rybrevant (amivantamab) in combination with chemotherapy. The treatment is intended for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)…
-
Fosun Pharmaceutical’s FCN-437c filing Accepted for Review by China’s NMPA
•
Shanghai-based Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196; SHA: 600196) has announced that the National Medical Products Administration (NMPA) has accepted for review its market approval filing for FCN-437c. The small molecule drug candidate is under development for the treatment of hormone receptor (HR) positive and human epidermal growth factor…
-
CSPC Pharmaceutical’s Glumetinib Earns Breakthrough Therapy Designation in China
•
Glumetinib, a MET targeted tyrosine kinase inhibitor (TKI) co-developed by CSPC Pharmaceutical Group Ltd (HKG: 1093) and Shanghai Haihe Pharmaceutical Co., Ltd, has been granted breakthrough therapy designation (BTD) by the Center for Drug Evaluation (CDE) in China. The drug is indicated for locally advanced or metastatic non-small cell lung…
-
BMS and 2seventy Bio’s Abecma Faces FDA Review Extension
•
The US Food and Drug Administration (FDA) has postponed the target action date for Bristol Myers Squibb (BMS; NYSE: BMY) and 2seventy Bio (NASDAQ: TSVT)’s CAR-T cell therapy Abecma (idecabtagene vicleucel) from December 16. The decision affects the therapy’s filing for earlier lines of triple-class exposed relapsed or refractory multiple…
-
Jiangsu Aidea Pharmaceutical’s AINUOVIRINE Receives Priority Review Status from CDE
•
Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488), a Chinese pharmaceutical company, has announced that its ainuovirine has been granted priority review status by the Center for Drug Evaluation (CDE) for an additional indication. The new indication targets the combination therapy of ainuovirine with nucleoside-based antiretroviral drugs for the treatment of…
-
Medilink Therapeutics’ YL201 Earns Orphan Drug Designation for Esophageal Cancer
•
Suzhou-based Medilink Therapeutics has announced that it has obtained orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its antibody-drug conjugate (ADC) YL201, which is being developed to treat esophageal cancer (EC). YL201, a B7H3-targeted ADC product, is based on Medilink’s Tumor Microenviroment Activable LINker (TMALIN)…
-
BeiGene’s Brukinsa Secures Additional EU Approval for Follicular Lymphoma Treatment
•
BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has achieved its latest global approval for the Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib). The European Commission has approved Brukinsa in combination with obinutuzumab (Roche’s CD20-targeted Gazyva) as a third-line treatment for relapsed or refractory (R/R) follicular lymphoma (FL). This marks…
-
Ascentage Pharma Secures Additional Indication Approval for Olverembatinib from NMPA
•
China-based Ascentage Pharma (HKG: 6855) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Category 1 drug, olverembatinib. This second market-approved indication is for the treatment of adult patients with chronic myeloid leukemia (CML) in the chronic phase (CP) who are resistant and/or intolerant…
-
CSPC Pharmaceutical Group Receives NMPA Approval for Phase II Clinical Study of ALMB-0168
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its pipeline drug candidate, ALMB-0168. The drug is set to be assessed as a treatment for acute ischemic stroke. ALMB-0168: A…
-
Apollomics’ Partner Avistone Wins Conditional Approval for c-Met Inhibitor in China
•
US-based biotech Apollomics Inc., (NASDAQ: APLM) has announced that its Chinese partner, Avistone Biotechnology Co., Ltd, has received conditional market approval for the c-Met inhibitor vebreltinib from the National Medical Products Administration (NMPA). The approval is for the treatment of patients with MET exon 14 skipping non-small cell lung cancer…
-
Fosun Pharmaceutical Secures Clinical Trial Approvals for VT-101 in China and the US
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has announced receiving clinical trial approvals for its VT-101 from both the National Medical Products Administration (NMPA) in China and the US Food and Drug Administration (FDA). VT-101 is a next-generation recombinant oncolytic adenovirus product that features a triple-targeted tumor regulation mechanism,…
-
Pfizer and Astellas Pharma Secure FDA Approval for Xtandi in High-Risk Non-Metastatic Prostate Cancer
•
Partners Pfizer (NYSE: PFE) and Astellas Pharma (TSE: 4503) last week received indication extension approval from the US Food and Drug Administration (FDA) for their androgen receptor signaling inhibitor Xtandi (enzalutamide). The drug is now approved as a treatment for non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high…
-
Yifan Pharmaceutical’s Subsidiary Receives FDA Approval for Ryzneuta (F-627)
•
China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) has announced that its subsidiary, Evive Biotech Ltd., has received Biologic License Application (BLA) approval from the US Food and Drug Administration (FDA) for Ryzneuta (efbemalenograstim alfa, F-627). The drug is indicated to reduce the incidence of infection manifested as febrile neutropenia in…
-
AstraZeneca Receives FDA Approval for Truqap in HR-Positive, HER2-Negative Breast Cancer
•
UK-based pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced last week that it has received regulatory approval from the US Food and Drug Administration (FDA) for its first-in-class AKT inhibitor, Truqap (capivasertib), in combination with fulvestrant. This treatment is indicated for HR-positive, HER2-negative locally advanced or metastatic recurrent or refractory breast…
-
Alphamab Oncology’s JSKN003 ADC: Promising Preliminary Data in Advanced Solid Tumors
•
Alphamab Oncology (HKG: 9966) has released preliminary data from a Phase I clinical study on its JSKN003-KN026 antibody drug conjugate (ADC) in Australia, focusing on advanced solid tumors. This open-label, multi-center, dosage escalation study is designed to evaluate the safety, tolerability, and preliminary efficacy of the molecule in treating these…
-
BMS’s Augtyro Receives FDA Approval for ROS1-Positive NSCLC
•
The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS, NYSE: BMY) registration approval for its next-generation tyrosine kinase inhibitor (TKI) Augtyro (repotrectinib) for the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in adults. This decision follows a priority review of Phase…
-
CDE Releases 76th Batch of Chemical Generic Reference Preparations
•
The Center for Drug Evaluation (CDE) has released the 76th batch of chemical generic reference preparations, which includes 11 new specifications, 16 additional specifications, and updates to 22 previously published specifications. The updates encompass the addition of domestic generic names and Marketing Authorization Holder (MAH) information. Specifications Fail Review for…
-
Yipinhong Pharmacy’s AR882 Shows Promise in Gout Treatment in Phase II Study
•
China-based Yipinhong Pharmacy Co., Ltd (SHE: 300723) has announced positive data from a Phase II clinical study for its pipeline candidate drug AR882, co-developed with Arthrosi Therapeutics Inc., for the treatment of gout. The randomized, placebo-controlled global study involved 42 patients, and after 6 weeks of treatment, results indicated that…
-
Easton Pharmaceutical Receives FDA Approval for Generic Nalmefene
•
Chengdu-based Easton Pharmaceutical Co., Ltd (SHA: 688513) has announced receiving Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its generic version of Hikma Pharma’s (LON: HIK) Revex (nalmefene). Nalmefene is utilized to reverse the effects of opioid drugs, including respiratory suppression caused by…
-
Visen Pharmaceuticals Reports Positive Phase II Results for TransCon CNP in Achondroplasia
•
Visen Pharmaceuticals, a joint venture between Denmark-based Ascendis Pharma A/S (NASDAQ: ASND) and Chinese healthcare investment firm Vivo Capital, has announced topline results from the ACcomplisH China Phase II trial. The study assessed the safety and efficacy of once-weekly TransCon CNP (navepegritide) in children with achondroplasia (ACH) aged 2 to…
-
Vertex Pharmaceuticals and CRISPR Therapeutics Receive Conditional Approval for CRISPR Gene-Editing Therapy
•
Vertex Pharmaceuticals (NASDAQ: VRTX) and CRISPR Therapeutics (NASDAQ: CRSP) have received conditional approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for their jointly developed therapy, Casgevy (exagamglogene autotemcel), a treatment for sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs) and for transfusion-dependent beta thalassemia (TDT) in…
-
SinoMab BioScience’s Suciraslimab IND Accepted for Review by China’s NMPA
•
SinoMab BioScience Ltd (HKG: 3681), a Hong Kong-based biotechnology company, has announced that the National Medical Products Administration (NMPA) in China has accepted its Investigational New Drug (IND) filing for suciraslimab for review. The company anticipates initiating a Phase I clinical study for the drug in the treatment of early…
-
Fujian Cosunter’s COVID-19 Therapy GST-HG171/Ritonavir NDA Accepted by NMPA
•
Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436), a China-based pharmaceutical company, has announced that its New Drug Application (NDA) for the Category 1 product GST-HG171/ritonavir, an oral therapy for COVID-19, has been accepted for review by China’s National Medical Products Administration (NMPA). Therapeutic Profile of GST-HG171/RitonavirGST-HG171 is identified as a…
-
China’s NMPA Accepts EOC Pharma Group’s Filing for Vascepa (Icosapent Ethyl) for Review
•
The China-based EOC Pharma Group has achieved a significant milestone with the National Medical Products Administration (NMPA) accepting its market filing for Vascepa (icosapent ethyl) for review. The drug is targeted for the prevention and reduction of cardiovascular event risks in adult patients with hypertriglyceridemia who are diagnosed with cardiovascular…
-
EMA’s CHMP Issues Positive Opinion for Roche’s Tecentriq SC Subcutaneous Formulation
•
The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has issued a positive opinion regarding the approval of Tecentriq SC (atezolizumab), the subcutaneous version of Roche’s (SWX: ROG) PD-L1 inhibitor Tecentriq. This development is a significant step forward for patients with various types of…
-
Eli Lilly’s Donanemab on Track for Priority Review in China for Early-Stage Alzheimer’s
•
The China’s Center for Drug Evaluation (CDE) website has indicated that Eli Lilly’s (NYSE: LLY) donanemab is set to receive priority review status for the treatment of early-stage Alzheimer’s disease (AD). This development is significant as it pertains to the drug’s potential use in patients with mild cognitive impairment or…
-
Bayer Withdraws Aliqopa FDA Filing Following Missed Phase III Endpoint
•
Germany-based pharmaceutical major Bayer (ETR: BAYN) has announced its decision to withdraw the filing for the kinase inhibitor Aliqopa (copanlisib) with the US Food and Drug Administration (FDA). Aliqopa, which received accelerated approval in 2017 for the treatment of relapsed follicular lymphoma (FL), failed to meet the primary endpoint of…
-
Servier’s Tibsovo Receives FDA Approval for IDH1-Mutated R/R MDS, Expanding Indications
•
France-based pharmaceutical company Servier has announced that the US Food and Drug Administration (FDA) has granted market approval for its drug Tibsovo (ivosidenib) for the treatment of recurrent or refractory (R/R) myelodysplastic syndrome (MDS) with IDH1 mutation. This marks the fifth indication for the drug in the IDH1 mutant cancer…
-
Huadong Medicine’s Arcalyst (Rilonacept) Filing for CAPSs Accepted by China’s NMPA
•
Huadong Medicine Co., Ltd (SHE: 000963), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) in China has accepted its market filing for Arcalyst (rilonacept) for the treatment of cryo-pyrin-associated periodic syndromes (CAPSs). The drug is specifically filed for approval in treating familial cold autoimmune syndrome…
-
Jiangsu Hengrui Pharmaceuticals’ HR20031 Accepted for Review by China’s NMPA for Type 2 Diabetes
•
Jiangsu Hengrui Medicine (SHA: 600276), a leading Chinese pharmaceutical company, has announced that the National Medical Products Administration (NMPA) in China has accepted its market filing for the drug candidate HR20031 for review. The drug is intended for type 2 diabetes patients with poorly controlled blood glucose who have previously…
-
AstraZeneca’s Imfinzi Gains NMPA Approval for First-Line Cholangiocarcinoma Treatment
•
The National Medical Products Administration (NMPA) of China has indicated on its website that it has approved AstraZeneca’s (AZ, NASDAQ: AZN) programmed death-ligand 1 (PD-L1) inhibitor, Imfinzi (durvalumab), for use in combination with chemotherapy for the treatment of first-line locally advanced or metastatic cholangiocarcinoma (BTC). This marks a significant expansion…
-
Hansoh Pharmaceutical’s HS-10511 Tablets for Hypertrophic Cardiomyopathy Cleared for Clinical Trials
•
Hansoh Pharmaceutical (HKG: 3692) has announced that its affiliated company’s self-developed Class 1 new drug, HS-10511 tablets, have received approval for clinical trials from the National Drug Administration. The drug is intended for the treatment of hypertrophic cardiomyopathy, a condition that requires significant medical innovation. Clinical Trial Approval and IndicationThe…
-
Novo Nordisk Commits Over DKK 42 Billion to Expand Chronic Disease Production in Denmark
•
Novo Nordisk (CPH: NOVO-B), a leading pharmaceutical company, last week announced a substantial plan to invest over DKK 42 billion (USD 6.0 billion) into expanding its production capacity for serious chronic diseases in Denmark. This significant investment underscores the company’s commitment to addressing the growing needs of patients with chronic…
-
Clinical Research on rAAV Gene Drug ZS805 for Fabry Disease Launched by Zhishan Weixin
•
Zhishan Weixin Biotechnology Co., Ltd, a China-based biotech company, has announced the launch of the first clinical research project in China focused on a recombinant adeno-associated virus (rAAV) genetic therapy for the treatment of Fabry disease. The study will evaluate the adeno-associated virus vector ZS805 as a potential treatment across…
-
Jiangsu Hengrui Medicine’ Subsidiary Shengdi Pharmaceuticals Receives NMPA Approval for HRS-9057
•
Jiangsu Hengrui Medicine (SHA: 600276), a leading pharmaceutical company in China, has announced that its subsidiary, Shengdi Pharmaceuticals, has received clinical trial approval from the National Medical Product Administration (NMPA) for HRS-9057 tablets. This Class 1 innovative drug will be assessed in clinical trials as a potential treatment for autosomal…
-
Beijing Aosaikang’s Combo Therapy for NSCLC Accepted for Clinical Trial by NMPA
•
Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755), a Chinese pharmaceutical company, has announced that the China National Medical Products Administration (NMPA) has accepted a clinical trial application for the combination of two pipeline candidates, ASKC202 tablets and ASK120067 tablets. The company is seeking to evaluate this combination therapy in adults…
-
China’s NMPA Grants Conditional Approval for Juventas’ CAR-T Therapy Inaticabtagene Autoleucel
•
The National Medical Products Administration (NMPA) has conditionally approved the marketing of inaticabtagene autoleucel (CNCT 19), a chimeric antigen receptor (CAR)-T cell therapy developed by Chinese firm Juventas Cell Therapy Ltd. The drug is indicated for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in China. Inaticabtagene Autoleucel’s…
-
Eli Lilly’s Zepbound Approved by FDA for Chronic Weight Management in Adults
•
Eli Lilly (NYSE: LLY) has received registration approval from the US Food and Drug Administration (FDA) for its once-weekly injection Zepbound (tirzepatide). The drug is indicated as an adjunct to diet and exercise for chronic weight management in adults with obesity or overweight conditions, including those with at least one…
-
Yantai Dongcheng Pharmaceutical Gets Singapore HSA Nod for Phase I Study of 177Lu-LNC1003
•
China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced receiving approval from the Health Sciences Authority (HSA) in Singapore to conduct a Phase I clinical study for its investigational drug, 177Lu-LNC1003. 177Lu-LNC1003: A Radiopharmaceutical for Advanced Prostate Cancer177Lu-LNC1003 is a radioactive in vivo therapeutic drug that targets prostate…
-
Chongqing Lummy Pharmaceutical’s Generic Ramosetron Passes GQCE in China
•
China-based Chongqing Lummy Pharmaceutical Co., Ltd (SHE: 300006) has announced that its generic version of Astellas Pharma’s Nasea (ramosetron) has become the first to pass the generic quality and efficacy consistency evaluation (GQCE) process in China. The product received marketing approval in China in May 2005. Ramosetron’s Indications and Market…
-
Sirius Therapeutics Pursues First-in-Human Trial for SRSD107 in Australia
•
Sino-US biotech Sirius Therapeutics has announced its pursuit of Investigational New Drug (IND) approval in Australia to conduct a first-in-human clinical trial for its pipeline candidate, SRSD107. This next-generation small interfering RNA (siRNA) therapeutic is under development for the treatment of thromboembolic disorders and targets coagulation factor XI (FXI). Notably,…
-
ImmVira’s MVR-T3011 IV Achieves Positive Outcomes in US Phase I Clinical Study
•
Shenzhen-based biotechnology company ImmVira has announced the successful completion of Phase I clinical studies in the United States for its intravenous oncolytic virus product, MVR-T3011 IV. The trial, which focuses on late stage patients with various tumor types, yielded “exceptional” safety results and demonstrated initial efficacy for certain indicationsThe study…
-
Novartis’ Remibrutinib Meets Milestones in Late-Stage Chronic Spontaneous Urticaria Studies
•
Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that two late-stage studies for its Bruton’s tyrosine kinase (BTK) inhibitor, remibrutinib, used in the treatment of chronic spontaneous urticaria (CSU), have successfully met all primary and secondary endpoints at the 12-week mark of a 52-week trial. After three months of treatment…
-
Roche’s Lymphoma Therapy Columvi Receives NMPA Approval for Adult Patients with Relapsed DLBCL
•
Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its novel lymphoma therapy, Columvi (glofitamab). The drug is now approved to treat adult patients with recurrent or refractory diffuse large B-cell lymphoma (DLBCL) who have…
-
Janssen Presents Real-World Data on Tremfya’s Efficacy in Treatment-Resistant Psoriatic Arthritis
•
Johnson & Johnson’s (J&J; NYSE: JNJ) pharmaceutical unit, Janssen, has presented real-world efficacy data for Tremfya (guselkumab), an IL-23p19-subunit inhibitor, in the treatment of treatment-resistant active psoriatic arthritis (PsA). The data provides valuable insights into the drug’s performance in alleviating pain, improving physical function, and reducing fatigue in patients with…
-
ImmuneOnco Biopharmaceuticals’ Timdarpacept (IMM01) Earns Orphan Drug Designation for CMML
•
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its investigational drug timdarpacept (IMM01). This marks a significant milestone for the company’s first SIRPαFc fusion protein targeting CD47, which was designed in China.…
-
Abbisko Therapeutics’ CD73 Inhibitor ABSK051 Clears for Phase I Clinical Trial in China
•
Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its next-generation CD73 inhibitor, ABSK051, in China. This first-in-human (FIH), multi-center, open-label study will evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD),…
-
US FDA Approves HutchMed and Takeda’s Fruzaqla for Metastatic Colorectal Cancer Treatment
•
The US Food and Drug Administration (FDA) has granted approval to HutchMed (NASDAQ: HCM) and its partner Takeda (NYSE: TAK, TYO: 4502) for their oral tyrosine kinase inhibitor Fruzaqla (fruquintinib), marking the second approval this year for a China-developed innovative drug. The drug is indicated for adult patients with previously…
-
Janssen’s Nipocalimab Shows Promising Results in Phase II Rheumatoid Arthritis Trial
•
The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has announced the results of a Phase II trial for nipocalimab, a potential best-in-class anti-neonatal Fc (FcRn) biologic, in patients with moderate-to-severe active rheumatoid arthritis (RA) who have anti-citrullinated protein antibodies (ACPAs) or rheumatoid factor (RF) and are unresponsive to…
-
Abbisko Therapeutics Receives FDA Approval for Phase I Study of FGFR4 Inhibitor ABSK012
•
Shanghai-based biotech company Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received clearance from the US Food and Drug Administration (FDA) to commence a Phase I clinical study of its next-generation FGFR4 mutant inhibitor, ABSK012, for the treatment of advanced solid tumors. Objectives of the Phase I…
-
Chengdu Kanghong Pharmaceutical’s KH629 Receives FDA Approval for NASH Clinical Trial
•
Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its Category 1 chemical drug, KH629, which is intended for the treatment of non-alcoholic steatohepatitis (NASH). KH629’s Profile and Previous…
-
Gilead Sciences and Arcus Biosciences Announce Positive Phase II Data for Domvanalimab Combination Therapy
•
Gilead Sciences (NASDAQ: GILD) and Arcus Biosciences (NYSE: RCUS) have this week released preliminary data from a Phase II study combining Gilead’s anti-TIGIT biologic domvanalimab with Arcus’ anti-PD-1 drug zimberelimab plus chemotherapy for the treatment of locally advanced unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. The study marks…
-
Clover Biopharmaceuticals Submits Market Filing for Seasonal Influenza Vaccine in Brazil
•
China-based Clover Biopharmaceuticals Ltd., (HKG: 2197) has announced the submission of a market filing for its seasonal influenza vaccine in Brazil. This move marks a strategic expansion for the company as it seeks to broaden the reach of its vaccine offerings. Product Details and AdvantagesThe product in question is a…
-
Boehringer Ingelheim’s Aldosterone Synthase Inhibitor BI 690517 Shows Promise in CKD Phase II Trial
•
Germany-based Boehringer Ingelheim (BI) has published the results of a Phase II trial for its aldosterone synthase inhibitor (ASi) BI 690517, used alone or in combination with the antidiabetic Jardiance (empagliflozin), in patients with chronic kidney disease (CKD), with or without type 2 diabetes (T2D). The trial aimed to evaluate…
-
RinuaGene Receives US FDA IND Approval for HPV-Associated Tumor mRNA Vaccine RG002
•
RinuaGene, a leading mRNA specialist headquartered in Suzhou, has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its human papillomavirus (HPV) associated tumor therapeutic mRNA vaccine, RG002. This marks a significant step forward in the development of the vaccine,…
-
Enhertu Receives Priority Review Status for HER2-Positive Gastric Cancer Treatment in China
•
The Center for Drug Evaluation (CDE) website has indicated that Enhertu (trastuzumab deruxtecan), a HER2-targeted antibody drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), is set for priority review status in China. This priority review is specifically for the ADC’s potential use as a…
-
MicuRx Pharmaceuticals Secures Clinical Trial Approvals for MRX-4 and Contezolid in Multiple Countries
•
Sino-US firm MicuRx Pharmaceuticals Inc. (SHA: 688373) has announced that it has received clinical trial approvals for its novel anti-microbial agent MRX-4 in combination with contezolid (MRX-I) as a sequential treatment for diabetic foot infections. The approvals span several countries, including the United Kingdom, Turkey, Georgia, Argentina, and Chile. Both…
-
Bayer Unveils Real-World Insights on Kerendia for CKD and T2D Management
•
Germany-headquartered Bayer (ETR: BAYN) recently published interim insights from a significant real-world observational study focusing on the clinical characteristics and treatment patterns associated with its mineralocorticoid receptor antagonist (MRA), Kerendia (finerenone). This medication has received global approvals aimed at reducing cardiorenal risk in patients suffering from chronic kidney disease (CKD)…
-
Seagen’s Adcetris Combo with Keytruda Shows Promising Results in Phase II Study
•
Seagen (NASDAQ: SGEN), currently in the process of being acquired by Pfizer (NYSE: PFE), has released the results of a Phase II study combining its antibody drug conjugate (ADC) Adcetris (brentuximab vedotin) with Merck, Sharp & Dohme’s (MSD; NYSE: MRK) anti-PD-1 therapy Keytruda (pembrolizumab). The study focused on patients with…
-
AstraZeneca Announces Positive Phase IIb Results for CKD Treatment Combination
•
UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) announced last week that its combination therapy of ETA receptor antagonist zibotentan and SGLT2 inhibitor dapagliflozin achieved dose-dependent reductions in urinary albumin-to-creatinine ratio (UACR) during a Phase IIb trial for chronic kidney disease (CKD). This development marks a significant step forward in the…
-
Dizal Pharmaceutical Presents Updates on DZD8586 and Golidocitinib at ASH Annual Meeting
•
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) provided updates on the clinical development of its drug candidates, DZD8586 and the JAK1 inhibitor golidocitinib (DZD4205), at the 65th American Society of Hematology (ASH) annual meeting. The event showcased the latest findings from the company’s research and development efforts in the field…
-
Zhejiang Huahai Pharmaceutical’s HB0052 Receives US FDA IND Approval for Solid Tumors
•
IntroductionZhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a China-based pharmaceutical company, has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its injectable drug candidate, HB0052. The drug will initially be assessed in general advanced solid tumors, marking a significant…
-
BeiGene’s ZW25 on Track for Priority Review for Cholangiocarcinoma Treatment by CDE
•
The Center for Drug Evaluation (CDE) website has indicated that BeiGene’s (NASDAQ: BGNE) ZW25 (zanidatamab) is set to receive priority review status for the treatment of unresectable locally advanced or metastatic cholangiocarcinoma in patients with high HER2 expression who have previously received systemic treatment. This priority review status is a…
-
Innovent Biologics Presents Positive Clinical Results for Efdamrofusp Alfa and IBI324 at AAO
•
Innovent Biologics, Inc. (HKG: 1801), a China-based biopharmaceutical company, has published the latest clinical results for its two drug candidates, efdamrofusp alfa (IBI302) and IBI324, at the American Association of Ophthalmology (AAO) meeting. IBI302 is a recombinant fully human anti-VEGF and anti-complement bispecific fusion protein, while IBI324 is a bispecific…
-
CSPC Pharmaceutical Group Gets NMPA Approval for SYS6011 Biologic Drug Clinical Study
•
CSPC Pharmaceutical Group Ltd (HKG: 1093), a China-based pharmaceutical company, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 biologic drug candidate, SYS6011. The study will be focused on general solid tumors, marking a significant step…
-
Cutia Therapeutics Achieves Primary Endpoint in Phase I Study of CU-40101 for Androgenic Alopecia
•
Cutia Therapeutics (HKG: 2487), a company specializing in dermatological therapies, has announced that its Phase I clinical study for CU-40101, a small-molecule thyroid hormone receptor agonist liniment for external use in androgenic alopecia in China, has successfully reached its primary endpoint. Study Design and ResultsThe Phase I study was a…
-
Sanofi Regains Exclusive Rights to Rezurock in China, Terminating Agreement with BioNova and BK Pharmaceuticals
•
BioNova Pharmaceuticals, a Shanghai-based oncology-focused biopharmaceutical company founded in 2018, and Sanofi (NASDAQ: SNY), a leading French pharmaceutical company, have announced a significant agreement. Sanofi has reacquired the exclusive development and commercialization rights to Rezurock (belumosudil), the world’s first ROCK2 inhibitor, in mainland China from BK Pharmaceuticals Ltd and BioNova…
-
Innovent Biologics Reports Q3 2023 Sales Exceeding RMB 1.6 Billion with 45% YOY Growth
•
Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company based in China, has announced its product sales for Q3 2023, which exceeded RMB 1.6 billion (USD 219 million), marking a 45% increase year-on-year (YOY). The company’s PD-1 inhibitor, Tyvyt (sintilimab injection), continued to show strong market performance, and there was…
-
Gaush Meditech Ltd Receives NMPA Approval for Rigid Corneal Contact Lens
•
Gaush Meditech Ltd (HKG: 2407), a company based in Suzhou, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its rigid corneal contact lens. This development marks a significant step forward for the company, as it now offers a highly rigid gas permeable…
-
Wuhan Hiteck Biological Pharma Receives NMPA Approval for Aponermin in Multiple Myeloma Treatment
•
Wuhan Hiteck Biological Pharma Co., Ltd (SHE: 300683), a Chinese biopharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Aponermin. This approval is for the treatment of adult patients with recurrent or refractory multiple myeloma who have previously undergone…
-
Abbisko Therapeutics to Present CSF-1R Inhibitor ABSK021 Data at CTOS Annual Meeting
•
Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it will present data from two clinical studies on its next-generation CSF-1R inhibitor, ABSK021 (pimicotinib), at the Connective Tissue Oncology Society (CTOS) annual meeting. The presentations will highlight significant findings from the Phase Ib clinical study and the ongoing…
-
Ascentage Pharma’s Olverembatinib Showcases Promising Results at ASH Annual Meeting
•
Suzhou-based Ascentage Pharma (HKG: 6855) has presented the latest results of multiple studies regarding its innovative drug candidate olverembatinib at the 65th American Society of Hematology (ASH) annual meeting. The data highlights the potential of olverembatinib in treating various hematological malignancies, including chronic myeloid leukemia (CML) and Philadelphia-positive acute lymphoblastic…
-
Shanghai Pharmaceuticals Gets NMPA Approval for Phase I Clinical Study of B019 CAR-T Cell Injection
•
Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607), a leading pharmaceutical distribution company in China, has received approval from the National Medical Products Administration (NMPA) to commence a Phase I clinical study for its proprietary B019 injection. B019 is a chimeric antigen receptor (CAR) autologous T cell injection that targets CD19…
-
I-Mab and HI-Bio’s Felzartamab Earns Breakthrough Therapy Designation from US FDA
•
China-based I-Mab (NASDAQ: IMAB) and its US partner HI-Bio have announced that they have received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for their CD38 monoclonal antibody (mAb), felzartamab. This designation highlights the drug’s potential as a treatment for primary membranous nephropathy (PMN), a rare…
-
Pfizer Inc. Reports Q3 2023 Revenue Contraction and Launches Cost Realignment Program
•
US pharmaceutical giant Pfizer Inc., (NYSE: PFE) has released its financial results for the third quarter of 2023, reporting a contraction of -41% year-on-year (YOY) in operational terms to USD 13.2 billion, excluding foreign currency fluctuations. The quarter was marked by a net loss of USD 2.38 billion, the company’s…
-
EpimAh Biotherapeutics to Present First-in-Human Results for EMB-06 at SITC Annual Meeting
•
Shanghai-based biotechnology company EpimAb Biotherapeutics has announced that it will present first-in-human results for its pipeline candidate EMB-06, a BCMAxCD3 bispecific antibody (BsAb), at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in California. The late-breaker poster presentation will detail initial safety, efficacy, and pharmacokinetic/pharmacodynamic (PK/PD) data from the…
-
Chongqing Precision Biotechnology’s PCAR-19B Receives CDE Nod for Breakthrough Therapy Designation
•
The China’s Center for Drug Evaluation (CDE) website has indicated that Chongqing Precision Biotechnology Co., Ltd’s PCAR-19B cell autologous reinfusion preparation is on track to receive breakthrough therapy designation (BTD). This designation recognizes the potential of PCAR-19B as a treatment for patients aged 3 to 21 years old with CD19-positive…
-
Sichuan Kelun-Biotech’s SKB264 Receives Priority Review Status for TNBC Treatment in China
•
The China’s Center for Drug Evaluation (CDE) website has indicated that Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd’s (HKG: 6990) drug candidate, SKB264, is on track to obtain priority review status for the treatment of unresectable, locally advanced, or metastatic triple negative breast cancer (TNBC) in China. This development is particularly significant…
-
Hinova Pharmaceuticals’ HP518 Receives NMPA Approval for mCRPC Clinical Trial
•
China-based biopharmaceutical company Hinova Pharmaceuticals (SHA: 688302) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) in China for its drug candidate HP518, which is being developed to treat metastatic castration-resistant prostate cancer (mCRPC). The androgen receptor (AR)-targeted PROteolysis TArgeting Chimera (PROTAC) drug…
-
Sino Biopharmaceutical’s TQG3902 Injection Receives NMPA Approval for Septic Shock Clinical Trial
•
Sino Biopharmaceutical Ltd (HKG: 1177), a leading biotech company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its TQG3902 injection, which is under development to increase blood pressure in adults with septic shock or other distributed shock. This…
-
Sirnaomics’ STP705 Demonstrates Positive Results in Phase I Focal Fat Reduction Study
•
Sirnaomics Ltd (HKG: 2257) has announced positive safety and efficacy results from a Phase I clinical study for its investigational product, STP705, which is focused on focal fat reduction (FFR). The study provides valuable insights into the potential of STP705 as a non-invasive treatment for reducing fat accumulation in specific…
-
Hainan Poly Pharm Receives FDA Approval for PL002 in Primary Liver Cancer Surgery
•
China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced that it has received clinical trial approval from the US FDA for its novel injection candidate PL002. This innovative product is indicated for preoperative diagnosis and intraoperative navigation in patients with primary liver cancer. PL002 is an in-house developed bimodal…
-
Changchun BCHT Biotechnology Receives NMPA Approval for Anti-Tetanus Monoclonal Antibody Injection
•
China-based Changchun BCHT Biotechnology Co., Ltd (SHA: 688276) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its human anti-tetanus toxin monoclonal antibody (mAb) A82/B86 injection combination preparation. This innovative treatment is designed as a prophylactic against tetanus. Tetanus, a serious bacterial…
-
Shenzhen Chipscreen Biosciences Gets NMPA Approval for Phase I Study of CS32582 in Psoriasis
•
Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321), a China-based biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its investigational drug CS32582 in patients with psoriasis. This approval marks a significant step forward in the…
-
Shanghai Henlius Biotech’s HanSiZhuang Shows Positive Results in Phase III ASTRUM-002 Study
•
Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company in China, has unveiled positive data from the Phase III ASTRUM-002 study. The study assessed the efficacy of its anti-programmed death-1 (PD-1) drug, HanSiZhuang (serplulimab), in combination with chemotherapy for first-line treatment of non-squamous non-small cell lung cancer (nsqNSCLC). The…
-
Luye Pharma Group’s Rivastigmine Patch LY03013 Approved by China’s NMPA for Alzheimer’s Treatment
•
China-based Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its rivastigmine twice-weekly transdermal patch (LY03013), a treatment for symptoms of mild and moderate Alzheimer’s disease (AD). Product Development and AdvantagesLY03013, a modified version of rivastigmine, was developed…
-
Novartis’ Cosentyx Gains FDA Approval for Hidradenitis Suppurativa Treatment
•
The US Food and Drug Administration (FDA) has issued regulatory approval for Novartis’ (NYSE: NVS) IL-17A-targeting drug Cosentyx (secukinumab) for the treatment of adult patients with moderate-to-severe hidradenitis suppurativa (HS). This approval positions Cosentyx as a new entrant in the HS biologic therapy market, potentially challenging AbbVie’s (NYSE: ABBV) Humira…
-
Roche’s Gene Therapy Elevidys Misses Primary Endpoint in DMD Trial
•
Switzerland-headquartered pharmaceutical giant Roche (SWX: ROG) has announced that a Phase III trial for its gene transfer therapy Elevidys (delandistrogene moxeparvovec) did not meet its primary endpoint in Duchenne muscular dystrophy (DMD) ambulatory patients aged 4 to 7 years. The trial aimed to measure the change from baseline in motor…
-
Amgen Reports Q3 2023 Financials: 5% Growth Driven by Volume Expansion
•
Amgen (NASDAQ: AMGN) has released its Q3 2023 financial results, showcasing a 5% year-on-year (YOY) increase in global sales, reaching USD 6.5 billion. This growth comes despite a 3% decrease in net selling price, primarily fueled by an impressive 11% increase in volume. Notably, this marks the company’s fourth consecutive…
-
Coherus’s Loqtorzi Gains FDA Approval for Nasopharyngeal Carcinoma Treatment
•
Coherus Biosciences (NASDAQ: CHRS) executives held an investor conference call on October 30, 2023, to discuss the recent US FDA approval for Loqtorzi (toripalimab) as both a first- and second-line treatment for nasopharyngeal carcinoma (NPC). This approval, co-developed with Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), marks a…
-
Staidson Receives NMPA Approval for Clinical Trial of STSA-1301 in Primary Immune Thrombocytopenia
•
Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its STSA-1301 subcutaneous injection. The drug is targeted for the treatment of primary immune thrombocytopenia (ITP), a condition characterized by a low…
-
Allist Pharmaceuticals’ Furmonertinib Receives FDA Breakthrough Therapy Designation for NSCLC
•
Shanghai-based biotech Allist Pharmaceuticals Co., Ltd (SHA: 688578) has announced that it has received breakthrough therapy designation (BTD) from the US FDA for its drug candidate furmonertinib. This designation underscores the drug’s potential as a treatment for previously untreated, locally advanced, or metastatic non-small cell lung cancer (NSCLC) with epidermal…
-
Yirui Pharmaceutical’s YR001 Completes Successful Phase I Clinical Study in the US
•
Hangzhou-based Yirui Pharmaceutical Technology Co., Ltd has announced the successful conclusion of a Phase I clinical study for its YR001 external preparation in the United States. The topical ointment, which is a small molecule Kv1.3 inhibitor, showed a good safety and tolerability profile in all subjects tested. YR001: Indications and…
-
CDE Grants Priority Review to LaNova’s LM-302, Roche’s Alectinib, and Alphamab’s KN026
•
China’s Center for Drug Evaluation (CDE) has indicated that LaNova Medicines’ LM-302, Roche’s (SWX: ROG) alectinib, and Alphamab Oncology’s HER2-targeted bispecific antibody (BsAb) KN026 (anbenitamab) are set for priority reviews. This designation is a significant step that could expedite the availability of these drugs to patients in need. LM-302: A…
-
Boan Biotech Enrolls First Patient in Phase III Study for Opdivo Biosimilar BA1104 in China
•
Boan Biotech (HKG: 6955), a biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase III clinical study for its drug candidate BA1104. This marks a significant milestone as BA1104 becomes the first biosimilar to Opdivo (nivolumab) to reach the Phase III stage in…
-
CSPC Pharmaceutical Group Gains NMPA Approval for Bivalent COVID-19 mRNA Vaccine Study
•
CSPC Pharmaceutical Group Ltd (HKG: 1093), a prominent pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its bivalent COVID-19 mRNA vaccine SYS6006.32, targeting the XBB.1.5 and BQ.1 variants. Vaccine Development and ImmunogenicitySYS6006.32 is…
-
GenFleet Therapeutics’ SLS009 Receives FDA Fast-Track Status for PTCL Treatment
•
Shanghai-based biotech GenFleet Therapeutics has announced that its investigational drug SLS009 (GFH009) has received fast-track status from the US FDA for the treatment of recurrent/refractory adult peripheral T-cell lymphoma (PTCL) patients. This CDK9 inhibitor was previously awarded an orphan drug designation (ODD) by the FDA in mid-October, highlighting its potential…
-
CStone Pharmaceuticals Receives NMPA Approval for Sugemalimab in R/R ENKTL
•
CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, has announced that it has received a new indication approval from the National Medical Products Administration (NMPA) for sugemalimab, a programmed death-ligand 1 (PD-L1) inhibitor. The drug is now approved for the treatment of recurrent or refractory extranodal NK/T cell lymphoma (R/R…
-
Simcere Pharmaceutical Group Secures Full Approval for Cosela in China
•
Simcere Pharmaceutical Group (HKG: 2096), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has converted the first conditional approval in China for Cosela (trilaciclib) to full approval. Originally discovered by US biotech G1 Therapeutics Inc, trilaciclib was in-licensed by Simcere in August…
-
Novartis Announces Positive Interim Results for Atrasentan in IgA Nephropathy Phase III Study
•
Novartis (NYSE: NVS), a global healthcare company, has released interim results from an ongoing Phase III study for its endothelin A receptor antagonist (ERA) atrasentan, indicating a significant milestone in the treatment of IgA nephropathy (IgAN), a rare kidney disease. The trial successfully met its primary endpoint, demonstrating a clinically…
-
Roche’s Vabysmo Receives FDA Approval for Macular Edema Treatment Following RVO
•
Swiss pharmaceutical giant Roche (SWX: ROG) announced last week that it has received an indication extension approval from the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb) Vabysmo (faricimab) to treat macular edema following retinal vein occlusion (RVO). This approval broadens the therapeutic applications of Vabysmo, which…
-
Alphamab Oncology and 3D Medicines Gain FDA Approval for Envafolimab Phase III Trial
•
Partners Alphamab Oncology (HKG: 9966) and 3D Medicines (HKG: 1244) have announced that they have received approval from the US Food and Drug Administration (FDA) to conduct a Phase III clinical study for envafolimab (KN035) in proficient mismatch repair (fMMR) advanced or recurrent endometrial cancer combined with lenvatinib. This approval…
-
China Grand Pharma’s Lava Liquid Embolic Agent Officially Commercialized in the US
•
China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced the official commercialization of its subsidiary BlackSwan Vascular, Inc.’s innovative liquid embolic agent, Lava, in the United States. This marks a significant milestone for the company as it expands its presence in the US medical market. US Market…
-
Fosun Pharma Gains NMPA Approval for Clinical Trials of HLX42 and HLX43 ADCs
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has announced that it has received approval from the National Medical Products Administration (NMPA) in China to conduct separate clinical studies for HLX42 and HLX43. These two pipeline candidates are antibody drug conjugates (ADCs) co-developed by subsidiary Shanghai Henlius Biotech Inc., (HKG:…
-
Innovent Biologics’ Mazdutide Shows Promising Weight Loss Results in Phase II Trial
•
China-based Innovent Biologics Inc., (HKG: 1801) has revealed compelling Phase II data for its weight loss drug candidate, mazdutide (IBI362), after 48 weeks of treatment. The higher dose (9mg) of mazdutide demonstrated significant efficacy in achieving weight loss among Chinese subjects with obesity, alongside favorable safety profiles and multiple metabolic…
-
Junshi Biosciences’ PD-1 Inhibitor Loqtorzi Approved by FDA for Nasopharyngeal Carcinoma
•
China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the US FDA has approved its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab), for the treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC). The approval marks a significant milestone as Loqtorzi becomes the first…
-
TG ImmunoPharma’s Bispecific Antibody TGI-6 Approved for Phase I Clinical Study by NMPA
•
China-based TG ImmunoPharma Co., Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its bispecific antibody (BsAb) TGI-6 in China. This approval marks a significant milestone in the development of innovative cancer treatments within the country.…
-
Everest Medicines’ Nefecon Receives First Regional NDA Approval in Macau for IgAN Treatment
•
China-based Everest Medicines (HKG: 1952) has announced that its New Drug Application (NDA) for Nefecon, a treatment for primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression, has been approved by the Pharmaceutical Administration Bureau of the Macao Special Administrative Region, China. This marks the first regional…
-
Wyze Biotech’s RJMty19 Injection Accepted for CDE Review for r/r B-Cell NHL
•
Wyze Biotech Co., Ltd, a Guangdong-based developer of off-the-shelf universal DNT cell therapies, has announced that an investigational new drug (IND) filing for its immune cell product RJMty19 injection has been accepted for review by China’s Center for Drug Evaluation (CDE). The therapy is intended for assessment as a treatment…
-
GSK’s ViiV Healthcare Secures NMPA Approval for Vocabria in HIV-1 Treatment
•
UK pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) has announced that its HIV joint venture, ViiV Healthcare, has received approval from China’s National Medical Products Administration (NMPA) for Vocabria (cabotegravir injection). The drug is approved for use in combination with Johnson & Johnson/Janssen Pharmaceutical’s (J&J, NYSE: JNJ) Rekambys (rilpivirine long-acting injection)…
-
AbbVie’s Rinvoq Gains Two New Indications in China: AxSpA and Ankylosing Spondylitis
•
US-based pharmaceutical company AbbVie (NYSE: ABBV) has announced the receipt of two additional indication approvals from China’s National Medical Products Administration (NMPA) for its drug Rinvoq (upadacitinib). The selective JAK inhibitor is now approved for treating adult patients with active radiologically negative axial spinal arthritis (axSpA) who show a poor…
-
Eli Lilly’s Omvoh Receives FDA Approval for Ulcerative Colitis Treatment
•
The US Food and Drug Administration (FDA) has granted regulatory approval to Eli Lilly (NYSE: LLY) for its interleukin-23p19 antagonist, Omvoh (mirikizumab), as a treatment for moderately to severely active ulcerative colitis (UC) in adults. This approval is a significant milestone for Eli Lilly, expanding its portfolio in the inflammatory…
-
Abbisko Therapeutics Gets NMPA Approval for Phase I Study of ABSK112 in NSCLC
•
Shanghai-based biotechnology firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from China’s National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its investigational drug, ABSK112. This next-generation EGFR inhibitor, which targets the Exon20ins mutation, is set to be evaluated as…
-
Biogen’s BIIB080 Shows Promise in Phase Ib Trial for Mild Alzheimer’s Disease
•
Biogen (NASDAQ: BIIB) has released preliminary findings from a Phase Ib trial for BIIB080, a microtubule-associated protein tau (MAPT)-targeting antisense oligonucleotide (ASO) co-developed with Ionis Pharmaceuticals (NASDAQ: IONS). The trial focused on patients with mild Alzheimer’s disease (AD), showing that high doses of the spinal injection led to improvements in…
-
Huadong Medicine’s Elahere Accepted for NMPA Review in China for Ovarian Cancer Treatment
•
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that the National Medical Products Administration (NMPA) has accepted the market filing for its antibody drug conjugate (ADC) Elahere (mirvetuximab soravtansine), targeting folate receptor α (FRα). This marks a significant step towards making the treatment available for patients in China. Acquisition…
-
MSD Halts Phase II Trials for Glutamate Modulator MK-1942 in Alzheimer’s and Depression
•
Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced the discontinuation of two Phase II trials evaluating the efficacy of its glutamate modulator MK-1942 in patients with mild-to-moderate Alzheimer’s disease (AD) and treatment-resistant major depressive disorder (MDD). The decision comes after an unblinded data analysis indicated potential safety concerns. Trial…
-
Novartis’ Pluvicto Demonstrates Positive Phase III Results in mCRPC Treatment
•
Swiss pharmaceutical giant Novartis (NYSE: NVS) has released encouraging data from a Phase III study for its radioligand therapy (RLT) Pluvicto (177Lu vipivotide tetraxetan). The study focused on patients with prostate-specific membrane antigen (PSMA)-positive progressive metastatic castration-resistant prostate cancer (mCRPC), a challenging form of the disease. Primary Endpoint and Risk…
-
Life Molecular Imaging and Sinotau Pharmaceutical Secure NMPA Approval for Neuraceq in China
•
Germany-headquartered Life Molecular Imaging (LMI) and China-based Sinotau Pharmaceutical Group have announced that Neuraceq (florbetaben F-18 injection) has received regulatory approval from the National Medical Products Administration (NMPA) in China. This marks a significant milestone as Neuraceq becomes the first radiopharmaceutical targeting β-amyloid approved in China to support the diagnosis…
-
Innovent Biologics’ GFH925 on Track for Priority Review Status for NSCLC Treatment
•
The Center for Drug Evaluation (CDE) has indicated that Innovent Biologics’s (HKG: 1801) Category 1 chemical drug, GFH925, is set to receive priority review status for the treatment of advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation in patients who have received at least one systemic treatment. This…
-
Zhejiang Jianfeng Receives FDA Approval for JFAN-1001 Clinical Trial in NSCLC
•
Zhejiang Jianfeng Group Co., Ltd (SHA: 600668), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its Category 1 chemical drug, JFAN-1001. The drug is indicated for the treatment of locally advanced or metastatic…
-
CSPC Pharmaceutical Gains NMPA Approval for Clinical Study of Bispecific Antibody NBL-028
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct a clinical study for its investigational bispecific antibody (BsAb) NBL-028. The drug targets CLDN6 and CD137, focusing initially on advanced tumors with CLDN6 expression, such as testicular…
-
Shanghai Henlius Initiates Global Phase III Study for HanSiZhuang in LS-SCLC
•
China’s Shanghai Henlius Biotech, Inc. (HKG: 2696) has announced the milestone of the first patient dosing in the global multi-center Phase III clinical study for its anti-PD-1 monoclonal antibody (mAb) HanSiZhuang (serplulimab). The study is evaluating the drug in combination with chemotherapy and concurrent radiotherapy for patients with limited-stage small…
-
Qilu Pharmaceutical Unveils Promising Data for QL1706 in Cervical Cancer Treatment at ESMO 2023
•
China’s Qilu Pharmaceutical showcased compelling data for its combination drug QL1706 (iparomlimab and tuvonralimab) as a potential treatment for cervical cancer at the European Society for Medical Oncology (ESMO) Annual Congress 2023. The focus was on a multi-center, single-arm Phase II study conducted in China, evaluating QL1706 in combination with…
-
EC Approves AstraZeneca and Daiichi Sankyo’s Enhertu for Advanced HER2+ NSCLC
•
The European Commission (EC) has granted registration approval for the HER2-directed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) to AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568). This approval is for the treatment of advanced HER2-positive non-small cell lung cancer (NSCLC) in adults who require systemic therapy following chemotherapy. The…
-
Dizal’s Sunvozertinib Shows Promising Efficacy in Advanced NSCLC at ESMO 2023
•
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) presented compelling efficacy and safety data for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib, at the European Society for Medical Oncology (ESMO) Congress 2023. The drug is being evaluated for first-line treatment in advanced non-small cell lung cancer (NSCLC) with EGFR…
-
AbbVie Partners with Lupus Therapeutics to Advance Rinvoq in SLE Treatment
•
AbbVie (NYSE: ABBV) announced this week a strategic collaboration with US-based Lupus Therapeutics aimed at accelerating the late-stage development of the JAK inhibitor Rinvoq (upadacitinib) for the treatment of systemic lupus erythematosus (SLE). This partnership marks a significant step in expanding the therapeutic applications of Rinvoq, which is already approved…
-
BMS’s BMS-986278 Receives FDA Breakthrough Therapy Designation for Pulmonary Fibrosis
•
Bristol-Myers Squibb (BMS; NYSE: BMY) announced this week that it has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for BMS-986278, its potential first-in-class lysophosphatidic acid receptor 1 (LPA1) antagonist. This oral treatment for progressive pulmonary fibrosis (PPF) is now set for expedited development and review,…
-
Fosun Pharma Gains NMPA Approval for Phase I Trial of XS-03 in Advanced Solid Tumors
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196), a leading healthcare conglomerate in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its investigational drug, XS-03. This study will focus on evaluating the drug’s efficacy in…
-
Cutia Therapeutics’ CU-20401 Completes Phase I Study for Obesity Treatment
•
China-based dermatology specialist Cutia Therapeutics (HKG: 2487) has announced the last subject out (LSO) in a Phase I study for its potential Category 1 drug, CU-20401. This recombinant mutant collagenase is being developed for the treatment of obesity and other metabolic diseases related to local fat accumulation, marking a significant…
-
China Grand Pharma Initiates Phase III Trial for GPN00833 in Cataract Surgery Recovery
•
China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced a significant milestone in the clinical development of GPN00833, with the first patient enrolled and dosed in a Phase III study. This multi-center, randomized, double-blinded, placebo-controlled, parallel group study is designed to assess the efficacy and safety of…
-
Sihuan Pharmaceutical Gains NMPA Approval for Innovative Type 2 Diabetes Treatment
•
China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its insulin degludec, liraglutide to treat type 2 diabetes. This marks a significant step forward in the development of novel treatments for diabetes in China.…
-
Jiangsu Aidea’s HIV-1 Drug ACC017 Accepted for NMPA Review in China
•
China-based Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) has announced that the National Medical Products Administration (NMPA) has accepted a clinical trial filing for its Category 1 drug, ACC017, for the treatment of HIV-1 infection in combination with other antiretroviral drugs. Mechanism and Pre-Clinical FindingsACC017 is a human immunodeficiency virus…
-
Shandong Luoxin’s LX-039 Demonstrates Promise in Phase I Oncology Study at ESMO
•
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd (SHE: 002793), a China-based pharmaceutical innovator, has published data from a Phase I clinical study for its novel anti-tumor drug, LX-039. This oral selective estrogen receptor modulator (SERD) was in the spotlight at the European Society for Medical Oncology (ESMO) Congress 2023, where…
-
Kintor’s Proxalutamide Shows Promise in Metastatic Breast Cancer Study at ESMO
•
China-based Kintor Pharmaceutical Ltd (HKG: 9939) has published the latest data from a Phase Ic clinical study evaluating its proxalutamide in combination with endocrine therapies (ETs) for metastatic breast cancer. The findings were presented at the European Society for Medical Oncology (ESMO) Congress 2023, shedding light on the drug’s potential…
-
Walvax Biotechnology Secures BPOM Approval for Weuphoria Pneumococcal Vaccine
•
China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced that it has received market approval from the Indonesian Food and Drug Control Agency (BPOM) for its Weuphoria, a 13-valent pneumococcal polysaccharide conjugate vaccine (PCV-13). This approval is a significant milestone for Walvax as it expands its reach into the Indonesian…
-
Ascentage Pharma’s Pelcitoclax Shows Promise in ESMO Study for NSCLC
•
Suzhou-based pharmaceutical company Ascentage Pharma (HKG: 6855) has published the latest results from a Phase Ib study of its pelcitoclax (APG-1252), a dual inhibitor of BCL-2 and BCL-xL proteins, in combination with AstraZeneca’s Tagrisso (osimertinib) for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC). The findings were presented at…
-
Changchun BCHT Biotechnology Invests in Influenza Vaccine Production Expansion
•
China-based Changchun BCHT Biotechnology Co., Ltd (SHA: 688276) has announced plans to invest RMB 805 million (USD 110 million) in the production of 10 million annual doses of its influenza virus split vaccine (BK-01 adjuvant). This substantial investment includes RMB 659 million for industrialization and RMB 146 million for operational…
-
Yiling Pharmaceutical Gains NMPA Approval for XY0206 in AML Trial
•
China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug, XY0206. The drug is intended for use in treating acute myeloid leukemia (AML) with FLT3-ITD mutation (FMS-like tyrosine kinase 3 internal…
-
Chengdu Kanghong Receives FDA Nod for Clinical Trial of Novel Depression Therapy KH607
•
China-based Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) has announced that it has received approval from the US FDA for a clinical trial of its novel depression therapy, KH607. This marks a significant milestone for the company as it advances its innovative treatment through the regulatory pipeline in the…
-
Transcenta Holdings Unveils Updated Osemitamab Data in Advanced Gastric Cancer at ESMO
•
China-based biotech Transcenta Holdings Ltd (HKG: 6628) has presented updated efficacy data from the expansion cohort of the TranStar102 trial at the ESMO Congress 2023 in Madrid, Spain. The trial assessed osemitamab (TST001), a high affinity humanized anti-CLDN18.2 monoclonal antibody (mAb) with enhanced antibody-dependent cellular cytotoxicity (ADCC), in combination with…
-
Vcanbio Receives NMPA Approval for Clinical Study of VUM02 in SR-aGvHD Treatment
•
China-based biotechnology firm Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its VUM02, a Category 1 therapeutic biologic product. This human umbilical cord-derived mesenchymal stem cell therapy is intended…
-
Alphamab Oncology Presents Promising Data for KN046 and KN026 at ESMO 2023
•
China-based Alphamab Oncology (HKG: 9966) has released data snapshots from clinical studies for two of its pipeline candidates, KN046 and KN026, at the European Society for Medical Oncology (ESMO) Congress 2023. These bispecific antibodies (BsAbs) are being evaluated for their efficacy and safety in treating various types of cancers, with…
-
Janssen’s TAR-200 Shows High Complete Response Rate in Bladder Cancer Study
•
Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has published data from a Phase IIb study demonstrating the efficacy of its intravesical gemcitabine delivery system, TAR-200, in patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC) carcinoma in situ-positive. The study results are a significant step forward in the…
-
Novartis’ Kisqali Plus Endocrine Therapy Shows Improved Survival in Early Breast Cancer Study
•
Switzerland-based pharmaceutical company Novartis (NYSE: NVS) has announced additional results from an ongoing Phase III study evaluating the CDK4/6 inhibitor Kisqali (ribociclib) in combination with endocrine therapy for stage II and III HR+/HER2- early breast cancer (EBC). The findings confirm that the combination therapy significantly improves invasive disease-free survival (iDFS)…
-
Pfizer’s Penbraya Receives FDA Approval for Meningococcal Immunization
•
Pfizer Inc. (NYSE: PFE) announced last week that it has successfully registered its pentavalent meningococcal vaccine, Penbraya, with the US Food and Drug Administration (FDA). The vaccine is designed for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals aged…
-
Health Canada Approves Pfizer and Sumitomo Pharma’s Myfembree for Endometriosis Pain Management
•
Health Canada has granted regulatory approval to Pfizer (NYSE: PFE) and Sumitomo Pharma (TYO: 4506) for their women’s health product Myfembree (relugolix + estradiol + norethindrone acetate). The approval is for the management of moderate-to-severe pain associated with endometriosis in pre-menopausal women, supported by late-stage data from multiple trials. Previous…
-
Shanghai Fudan-Zhangjiang’s ADC FZ-AD005 Accepted for NMPA Review in Advanced Solid Tumors
•
China-based Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd (HKG: 1349; SHA: 688505) has announced that the National Medical Products Administration (NMPA) has accepted a Phase I clinical trial filing for its investigational drug FZ-AD005 in advanced solid tumors. This marks a significant step forward in the development of novel cancer therapies in…
-
BeiGene’s Brukinsa Gains NICE Recommendation for CLL Treatment in the UK
•
China-based biotech BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the National Institute for Health and Care Excellence (NICE) in the UK has issued a final draft guidance (FDG) recommending the company’s Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib) for the treatment of eligible adult patients with…
-
Jacobio Pharma’s Glecirasib Combo Shows Promising Results in ESMO Congress 2023 Presentation
•
China-based Jacobio Pharma (HKG: 1167) has presented clinical data for its KRAS G12C inhibitor glecirasib in combination with its pipeline SHP2 inhibitor JAB-3312 at the European Society for Medical Oncology (ESMO) Congress 2023. The data comes from a Phase I/II study that enrolled 144 patients with KRAS G12C mutated cancers,…
-
InxMed Presents Positive Data for FAK Inhibitor Ifebemtinib at ESMO 2023
•
China-based firm InxMed (Nanjing) Co., Ltd has updated two clinical studies for its first-in-class small-molecule FAK inhibitor ifebemtinib (IN10018) at the European Society for Medical Oncology (ESMO) Congress 2023. The studies evaluated the drug’s efficacy and safety in treating platinum-resistant recurrent ovarian cancer and advanced triple negative breast cancer. Phase…
-
Skyline Therapeutics Gains NMPA Approval for SKG0106 in Neovascular AMD Treatment
•
Skyline Therapeutics has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative drug SKG0106, an intraocular injection solution for the treatment of neovascular age-related macular degeneration (nAMD). Innovative Gene Therapy MechanismSKG0106 is a recombinant adeno-associated virus (rAAV) gene therapy drug, utilizing…
-
Accuredit Therapeutics Initiates First Dosing of Gene Therapy ART001 for ATTR
•
China-based gene therapy start-up Accuredit Therapeutics (Suzhou) Co., Ltd has announced the first dosing of its investigational drug ART001 in seven subjects with transthyretin amyloidosis (ATTR), as part of an investigator-initiated trial (ITT). The drug candidate has demonstrated good safety and achieved a clinically significant decrease in transthyroxine (TTR) protein…
-
BMS’s Sotyktu Receives NMPA Approval for Psoriasis Treatment
•
The National Medical Products Administration (NMPA) has granted regulatory approval to US-based pharmaceutical major Bristol-Myers Squibb (BMS, NYSE: BMY) for its first-in-class selective tyrosine kinase 2 (TYK2) inhibitor, Sotyktu (deucravacitinib). The drug is indicated for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Mechanism of…
-
CDE Grants Priority Review to Pearl Biotech’s Breatinib for Glioblastoma Treatment
•
China’s Center for Drug Evaluation (CDE) has indicated that Beijing Pearl Biotechnology Co., Ltd’s breatinib has obtained priority review status for the treatment of WHO grade 4 astrocytoma with isocitrate dehydrogenase (IDH) mutation and PTPRZ1-MET (ZM) fusion gene, or adult glioblastoma (GBM) patients who have relapsed after, or become intolerant…
-
BMS’s Subcutaneous Opdivo Meets Phase III Study Endpoints in ccRCC
•
Bristol-Myers Squibb (BMS; NYSE: BMY) has announced positive results from a Phase III comparative study of its anti-PD-1 drug Opdivo (nivolumab) formulated as a subcutaneous injection. The study, conducted in pre-treated advanced or metastatic clear cell renal cell carcinoma (ccRCC) patients, utilized Halozyme Therapeutics’ (NASDAQ: HALO) proprietary hyaluronidase (rHuPH20) for…
-
AstraZeneca’s Soliris Gains Approval in China for NMOSD Treatment
•
UK-based pharmaceutical giant AstraZeneca Plc (AZ, NASDAQ: AZN) has announced that its rare disease drug Soliris (eculizumab) has received marketing approval in China for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in AQP4 antibody positive (Ab+) adults. This approval marks a significant expansion of Soliris’s application in the Chinese…
-
Qilu Pharmaceutical Presents Promising Data for QL1706 and QL1209 at ESMO 2023
•
China-based Qilu Pharmaceutical has announced the presentation of clinical data for two of its pipeline candidates, QL1706 and QL1209, at the European Society for Medical Oncology (ESMO) Congress 2023. The data highlights the therapeutic potential of these drugs in treating various forms of cancer, showcasing Qilu’s commitment to innovation in…
-
Guangdong Zhongsheng Launches AI Q&A Bot for Leritrelvir Drug Support
•
China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced the innovative launch of a smart Artificial Intelligence (AI) Q&A bot for its antiviral drug Yueruiling (leritrelvir). This AI-driven platform is designed to enhance patient support by providing smart Q&A services, an offline drug purchase map guide, and a comprehensive…
-
Boehringer Ingelheim’s Vitiligo Drug EI-001 Approved for Clinical Trials by NMPA
•
Germany’s Boehringer Ingelheim (BI) has announced that the National Medical Products Administration (NMPA) has approved an Investigational New Drug (IND) filing for EI-001, a Category 1 vitiligo drug co-developed by Elixiron Immunotherapeutics. This approval marks a significant milestone in the development of new treatment options for vitiligo, a condition that…
-
Haisco Pharmaceutical’s HSK21542 Accepted for NMPA Review in Postoperative Pain Management
•
China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that its clinical trial filing for HSK21542, a Category 1 drug, in postoperative analgesia for abdominal surgery has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step forward in the development of HSK21542,…
-
Roche’s Alecensa Shows Unprecedented 76% Improvement in Disease-Free Survival in NSCLC Trial
•
Roche (SWX: ROG) subsidiary Genentech has revealed preliminary but promising results from a Phase III trial for Alecensa (alectinib) in patients with early-stage resected ALK-positive non-small cell lung cancer (NSCLC). The trial demonstrated that the ALK inhibitor significantly improved disease-free survival (DFS) by an unprecedented 76% compared to chemotherapy, meeting…
-
MicuRx Pharmaceuticals Initiates Phase I Study for MRX-5 in Australia
•
Sino-US firm MicuRx Pharmaceuticals Inc. has announced the approval to conduct a Phase I clinical study in Australia to evaluate the safety, tolerability, and pharmacokinetics of its in-house developed antibiotic, MRX-5. The study will also explore the effects of food on the drug’s pharmacokinetics and is expected to conclude in…
-
GenScript Reports $152 Million in Sales for Carvykti as of September 30, 2023
•
China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), achieved sales of USD 152 million for its BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), as of September 30, 2023. This represents a year-on-year growth rate…
-
Novartis Launches Leqvio in China at RMB 9,988 per Shot
•
Swiss pharmaceutical giant Novartis (NYSE: NVS) has officially launched its cholesterol-lowering drug, Leqvio (inclisiran), in China, priced at RMB 9,988 (approximately USD 1,367) per injection. Each pre-filled syringe contains 1.5ml with an effective content of 284mg. The drug is recommended for subcutaneous administration, with a second dose administered three months…
-
Zhejiang Huahai Pharmaceutical Secures Orphan Drug Designation for HB0034
•
China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced that it has received orphan drug designation (ODD) from the US FDA for its interleukin-36 receptor monoclonal antibody (mAb) HB0034. This designation highlights the drug’s potential as a treatment for generalized pustular psoriasis (GPP). Mechanism of Action and Broader Implications…
-
BeiGene’s Tislelizumab Shows Promising Results in ESMO Presentations for GC/GEJC and NSCLC
•
China-based biotech BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced two late-breaking presentations of Phase III data for its programmed death-1 (PD-1) inhibitor tislelizumab at the European Society for Medical Oncology (ESMO) Congress 2023. The presentations include an oral presentation for tislelizumab in combination with chemotherapy for advanced…
-
BeiGene Submits Supplementary BLA for Tislelizumab in Small Cell Lung Cancer
•
BeiGene (NASDAQ: BGNE) has announced that its supplementary Biologic License Application (sBLA) for the programmed death-1 (PD-1) inhibitor tislelizumab has been accepted for review by the Center for Drug Evaluation (CDE) in China. The application seeks approval for the drug to be used in combination with etoposide and chemotherapy as…
-
Mabwell to Present Promising Clinical Data at 2023 ESMO Congress
•
China-based Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) has announced that it will present the latest clinical data for its investigational drugs 9MW2821 and 8MW0511 at the upcoming 2023 European Society for Medical Oncology (ESMO) Congress. This presentation underscores the company’s commitment to advancing innovative therapies in oncology. 9MW2821: Promising…
-
Asieris Pharma Launches Generic Votrient for Renal Cell Carcinoma in China
•
China-based urogenital cancer specialist Jiangsu Yahong Meditech Co., Ltd, trading as Asieris Pharma (SHA: 688176), has announced the issuance of the first prescription for its generic version of the UK pharmaceutical major GSK’s (NYSE: GSK) Votrient (pazopanib) in China. This milestone not only marks the entry of a new treatment…
-
BeiGene’s Brukinsa Receives Positive CHMP Opinion for Follicular Lymphoma Treatment
•
China-based biotechnology leader BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the receipt of a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending approval for its BTK inhibitor Brukinsa (zanubrutinib) as a treatment for relapsed/refractory follicular lymphoma (r/r FL). This recommendation positions Brukinsa as…
-
Eli Lilly’s Tirzepatide Shows Robust Weight Loss Results in Phase III Study
•
Eli Lilly (NYSE: LLY) has released compelling efficacy results from a Phase III study evaluating its GLP-1 receptor agonist, tirzepatide, in adults with obesity or overweight accompanied by comorbidities, excluding type 2 diabetes (T2D). The study successfully met its two co-primary endpoints, demonstrating superiority over placebo in weight loss after…
-
Simcere’s SIM0237 Receives NMPA Approval for Bladder Cancer Trial
•
China-based pharmaceutical innovator Simcere Pharmaceutical Group (HKG: 2096) has announced the receipt of an additional clinical trial approval from the National Medical Products Administration (NMPA) for its investigational bispecific antibody (BsAb), SIM0237. This molecule, targeting both PD-L1 and IL-15, is set to be evaluated as a novel treatment for non-muscular…
-
Abbisko Therapeutics to Unveil Phase I Data for ABSK011 and ABSK043 at ESMO 2023
•
Shanghai-based biotech powerhouse Abbisko Therapeutics Co., Ltd (HKG: 2256) is preparing to present the results of Phase I clinical studies for two of its pipeline candidates at the 2023 European Society for Medical Oncology (ESMO) Congress. The spotlight will be on ABSK011, a small-molecule FGFR4 inhibitor, and ABSK043, an in-house…
-
CANbridge’s Maralixibat Receives Priority Review for PFIC Treatment in China
•
China-based rare disease specialist CANbridge Pharmaceuticals Inc. (HKG: 1228) has announced that a New Drug Application (NDA) for its maralixibat (CAN108) has been accepted for review by the National Medical Products Administration (NMPA) in China, with the added benefit of priority review status. This marks a significant step forward in…
-
Fosun Pharma Initiates Phase III Trial for ET-26 Anesthetic in China
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196), a leading healthcare conglomerate in China, has announced the commencement of a Phase III clinical study for its drug ET-26 (methoxyethyl etomidate). This marks a significant milestone in the development of new anesthetic solutions, with ET-26 being evaluated as an induction therapy…
-
Kelun-Biotech to Present SKB264 Study Results for Metastatic Breast Cancer at ESMO
•
China-based pharmaceutical innovator Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) and its subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) are preparing to present the results of a Phase I/II basket study for their drug SKB264 (MK-2870) at the 2023 European Society for Medical Oncology (ESMO) Congress. The study focuses…
-
Vcanbio Receives NMPA Approval for Stem Cell Therapy VUM02 Clinical Trial
•
China-based biotechnology firm Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a multi-center, randomized, double-blind, placebo-controlled Phase I/II study. The study will assess the efficacy and safety of its innovative product VUM02, a…
-
SciClone Pharmaceuticals Gains FDA Nod for Thymalfasin COVID-19 Vaccine Booster Study
•
SciClone Pharmaceuticals Inc. (HKG: 6600), formerly a US-based and Nasdaq-listed company, has announced that it has received approval from the US FDA to conduct a clinical study for its drug thymalfasin as a booster for COVID-19 mRNA vaccines. This marks a significant step in exploring new ways to enhance the…
-
Hainan Poly Pharm’s PL002 Accepted for FDA Review for Liver Cancer Surgery
•
China-based pharmaceutical company Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced that the Investigational New Drug (IND) filing for its novel injectable PL002 has been accepted for review by the US Food and Drug Administration (FDA). The drug is indicated for preoperative diagnosis and intraoperative navigation in patients with…
-
Pfizer’s Velsipity Approved by FDA for Ulcerative Colitis Treatment
•
China-based pharmaceutical company Everest Medicines (HKG: 1952) announced that its licensing partner, Pfizer Inc. (NYSE: PFE), has secured market approval from the US FDA for Velsipity (etrasimod). This oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator is indicated for adults with moderately to severely active ulcerative colitis (UC), marking a significant…
-
FDA Approves Pfizer’s Braftovi + Mektovi Combo for BRAF V600E Metastatic NSCLC
•
The US Food and Drug Administration (FDA) has granted Pfizer (NYSE: PFE) regulatory approval for the combination therapy of Braftovi (encorafenib) and Mektovi (binimetinib) for the treatment of metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. This decision is supported by interim results from an ongoing Phase…
-
Roche’s Ocrevus Demonstrates Long-Term Efficacy in Multiple Sclerosis Treatment
•
Swiss pharmaceutical giant Roche (SWX: ROG) has presented compelling long-term efficacy data for its selective immunosuppressant Ocrevus (ocrelizumab) in the treatment of multiple sclerosis (MS). The 10-year results from a Phase III extension study provide significant insights into the drug’s sustained impact on patients with relapsing and primary progressive forms…
-
Sichuan Huiyu Pharmaceutical’s HYP2090PTSA Gains NMPA Approval for KRAS G12C Solid Tumors
•
Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug HYP2090PTSA. This small molecule KRAS G12C/PI3K inhibitor is intended for the treatment of advanced solid tumors with KRAS G12C…
-
AbbVie’s Rinvoq Demonstrates Sustained Efficacy in Late-Stage Atopic Dermatitis Study
•
AbbVie (NYSE: ABBV) has announced late-stage results for its JAK inhibitor Rinvoq (upadacitinib) in the treatment of moderate-to-severe atopic dermatitis, a skin condition characterized by inflammation and itching. The data, released this week, highlights the drug’s performance over an extended period of two years. Sustained Efficacy in Atopic DermatitisThe primary…
-
Lee’s Pharmaceutical’s Subsidiary Announces Positive Results for Myopia Treatment NVK002
•
China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced positive topline results from the Phase III mini CHAMP study for NVK002, an atropine external use eye solution developed to address myopia progression. Study Design and ParticipantsThe Phase III mini CHAMP study was…
-
J&J’s Cetrelimab and TAR-200 Gain Tacit Approvals for Bladder Cancer Trials
•
The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J; NYSE: JNJ) has received two tacit clinical trial approvals for its Category 1 drug cetrelimab combined with TAR-200. The approvals are for the treatment of high-risk non-muscle-invasive bladder cancer (NMIBC) patients not receiving BCG treatment, and…
-
RemeGen Secures NMPA Approval for Phase II Study of Disitamab Vedotin in Breast Cancer
•
China-based biopharma RemeGen Ltd (HKG: 9995) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), in patients with breast cancer. First Home-Grown ADC with Conditional Approvals Disitamab vedotin stands…
-
Ascentage Pharma Initiates Phase III Study for APG-2575 and Calquence in CLL/SLL
•
Suzhou-based Ascentage Pharma (HKG: 6855) has announced the approval to commence a global multi-center, randomized, open-label pivotal Phase III clinical trial evaluating the efficacy and safety of APG-2575 combined with Calquence (acalabrutinib) in untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients. Earlier this year, the drug received clearance for a…
-
Betta Pharmaceuticals Secures NMPA Approval for Befotertinib in NSCLC Treatment
•
China-based Betta Pharmaceuticals Co., Ltd. (SHE: 300558) has officially announced its receipt of market approval from the National Medical Products Administration (NMPA) for befotertinib, a third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). This critical approval allows befotertinib to be used as a first-line treatment for locally advanced or…
-
KPC Pharmaceuticals Secures WHO Prequalification for Dihydroartemisinin/Piperaquine
•
Yunnan-based KPC Pharmaceuticals Inc. (SHA: 600422) has announced that its dihydroartemisinin/piperaquine 40mg/320mg formulation has received Prequalification (PQ) status from the World Health Organization (WHO). This critical milestone allows the anti-malaria drug to be included in the procurement scope of international organizations and public health institutions, enhancing its accessibility in malaria-affected…
-
MSD’s Keytruda Achieves Primary Endpoint in Late-Stage NSCLC Trial
•
Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that a late-stage trial for its anti-PD-1 drug Keytruda (pembrolizumab) has successfully met the primary endpoint of statistically significant and clinically meaningful improvement in overall survival (OS) in patients with resectable non-small cell lung cancer (NSCLC). The trial evaluated Keytruda as…
-
Novo Nordisk Halts Phase III Ozempic Study on Renal Impairment in Diabetes Patients
•
Denmark-based pharmaceutical giant Novo Nordisk (NYSE: NVO) has decided to discontinue a Phase III global study evaluating the impact of the GLP-1 receptor agonist Ozempic (semaglutide) on the progression of renal impairment in individuals with type 2 diabetes (T2D) and chronic kidney disease (CKD). The decision was recommended by an…
-
Henlius Pharmaceutical Secures GMP Compliance for PD-1 Inhibitor Serplulimab in Indonesia
•
Shanghai Henlius Pharmaceutical Co., Ltd (HKG: 2696) has announced that its partner, PT Kalbe Genexine Biologics (KGbio), through its subsidiary PT Kalbio Global Medika, has received a GMP inspection completion letter from the Badan Pengawas Obat dan Makanan (BPOM), a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in Indonesia.…
-
Yiling Pharmaceutical Secures NMPA Approval for Phase I Study of G201-Na in Premenopausal Women
•
China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a single-center, randomized, double-blind, placebo-controlled Phase I clinical study. This trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of G201-Na in premenopausal healthy adult women. G201-Na:…
-
GenFleet Therapeutics’ CDK9 Inhibitor SLS009 Earns Orphan Drug Status for AML
•
Shanghai-based biotechnology company GenFleet Therapeutics has announced that its CDK9 inhibitor, SLS009 (GFH009), has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML). This designation is a significant milestone, recognizing the drug’s potential to address a rare and…
-
Roche’s Forimtamig Receives Tacit Approval for Multiple Myeloma Clinical Trials
•
The Center for Drug Evaluation (CDE) has indicated that Swiss pharmaceutical giant Roche (SWX: ROG) has secured tacit clinical trial approval for its Category 1 biologic product, forimtamig (RG6234), in the treatment of multiple myeloma (MM). Promising Efficacy in Phase I Trials Forimtamig is a bispecific antibody (BsAb) designed to…
-
Janssen Unveils Promising Clinical Data on IL-23 Blockers for Psoriasis
•
The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) is showcasing new clinical data this week from trials assessing the efficacy of IL-23 blockers, Tremfya (guselkumab) and JNJ-2113, in the treatment of psoriasis. The findings, derived from a late-stage study, reveal that Tremfya facilitated clear skin within 28 weeks…
-
AstraZeneca Seeks Approval for Capivasertib in Combination with Faslodex for Breast Cancer Treatment
•
AstraZeneca (AZ, NASDAQ: AZN) has submitted a market approval filing for its Category 1 drug candidate, capivasertib, in combination with Faslodex (fulvestrant), according to the China Center for Drug Evaluation (CDE) website. The filing has been accepted for review, marking a significant step forward in the treatment of hormone receptor…
-
Jiangsu Hengrui Medicine Gets NMPA Approval for Anti-Tumor Drug Candidate SHR-2022
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug candidate, SHR-2022 injection. This marks a significant step forward in the development of a new approach…
-
Atom Bioscience Initiates Global Phase III Clinical Study for Gout Drug ABP-671
•
China-based Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd) has announced the enrollment of the first patient in a global pivotal clinical study for its pipeline candidate, ABP-671. This small molecule inhibitor of the urate transporter 1 (URAT1) protein plays a crucial role in the reabsorption of uric acid…
-
GluBio Pharmaceutical’s GLB-002 Receives NMPA Approval for Clinical Trials in Hematological Tumors
•
GluBio Pharmaceutical Co., Ltd, a specialist in molecular glue targeted protein degradation (TPD) based in Zhejiang, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its molecular glue degrading agent, GLB-002. The drug is indicated for the treatment of non-Hodgkin’s lymphoma (NHL)…
-
Luye Pharma Files NDA for Paliperidone Palmitate Injectable Suspension with US FDA
•
China-based Luye Pharma Group (HKG: 2186) has announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its product, paliperidone palmitate extended-release injectable suspension (LY03010), via the 505(b)(2) regulatory pathway. The drug is under consideration for approval as a treatment for schizophrenia…
-
Shanghai BDgene’s BD112 Earns Orphan Drug Designation from US FDA for Huntington’s Disease
•
Shanghai BDgene Technology Co., Ltd, a specialist in gene therapy, has announced that its drug candidate BD112, which utilizes virus-like particle (VLP) delivery technology for in vivo gene editing, has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA). This follows a previous ODD granted by…
-
J&J’s Janssen Reports Favorable Spravato Data in Late-Stage TRD Trial
•
Johnson & Johnson’s (J&J; NYSE: JNJ) subsidiary, Janssen, has presented tolerability and efficacy data from a late-stage trial comparing its antidepressant Spravato (esketamine nasal spray) with oral quetiapine in the treatment of treatment-resistant major depressive disorder (TRD). The trial evaluated both drugs in combination with serotonin reuptake inhibitors (SRIs). Trial…
-
Eli Lilly Launches Three New Oncology Programs Targeting KRAS and Nectin-4
•
Eli Lilly (NYSE: LLY) has announced the initiation of three innovative oncology programs focusing on KRAS and Nectin-4, all of which are currently in the pre-clinical stage. This strategic move highlights Lilly’s commitment to advancing cancer therapies that target specific oncogenic pathways. Details of the New Oncology Programs The new…
-
FDA Rejects Eli Lilly’s Application for Lebrikizumab in Atopic Dermatitis Treatment
•
The U.S. Food and Drug Administration (FDA) has rejected Eli Lilly’s (NYSE: LLY) application for lebrikizumab, an anti-IL-13 biologic intended for the treatment of moderate-to-severe atopic dermatitis. The company announced the setback this week, highlighting the challenges faced in the regulatory approval process. Background on Lebrikizumab’s Acquisition Eli Lilly acquired…
-
Innovent Biologics Doses First Patient in Phase 3 Study of IBI302 for Neovascular AMD
•
China-based Innovent Biologics, Inc. (HKG: 1801) has announced that the first patient with neovascular age-related macular degeneration (nAMD) has been successfully dosed in the Phase 3 clinical study (STAR) of efdamrofusp alfa (IBI302). This recombinant fully human anti-VEGF and anti-complement bispecific fusion protein aims to address unmet needs in nAMD…
-
HutchMed and Takeda Submit Fruquintinib NDA for Metastatic CRC in Japan
•
China-based HutchMed (HKG: 0013, NASDAQ: HCM) has announced that its partner Takeda (TYO: 4502) has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for the approval of fruquintinib as a treatment for adult patients with previously treated metastatic colorectal cancer (CRC).…
-
Bio-Thera Solutions’ BAT1806 Receives US FDA Approval as Biosimilar to Actemra/RoActemra
•
Bio-Thera Solutions Ltd (SHA: 688177), a China-based biopharmaceutical company, announced that its biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab), known as BAT1806, has passed review by the US FDA. This milestone marks the approval of BAT1806 for use in the US market to treat a range of…
-
Sichuan Biokin’s IZalontamab Gets US FDA Greenlight for NSCLC Clinical Study
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its innovative biologic drug, izalontamab (SI-B001). The trial will focus on assessing the efficacy of izalontamab in combination…
-
Innovent Biologics Withdraws Parsaclisib Filing in China, Halts Development
•
Innovent Biologics Inc., a leading China-based biotech company (HKG: 1801), has announced the voluntary withdrawal of its market approval filing for the drug candidate parsaclisib in China. Furthermore, the company has decided to halt all further development of the molecule, as stated in their press release. Background on Parsaclisib and…
-
Jiangsu Hengrui Licenses Pyrotinib to Dr. Reddy’s for Indian Market
•
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has entered into a licensing agreement with India-headquartered Dr. Reddy’s Laboratories, granting the latter exclusive development and commercialization rights for its HER1/HER2/HER4 inhibitor, pyrotinib, in India. Financial Terms of the Agreement Under the terms of the agreement, Hengrui will receive an upfront…
-
AstraZeneca Reports Positive Phase III Results for Forxiga in Children with Type 2 Diabetes
•
UK-based AstraZeneca (AZ, NASDAQ: AZN) has announced promising results from the Phase III T2NOW study (NCT03199053) for its diabetes medication, Forxiga (dapagliflozin), in adolescents and children aged 10 to 17 with type 2 diabetes (T2D). Enrolling 256 patients, this study stands as one of the largest investigations into type 2…
-
Sanofi’s Nexviazyme Approved in China as Enzyme Replacement Therapy for Pompe Disease
•
Sanofi’s (NASDAQ: SNY) next-generation enzyme replacement therapy (ERT), Nexviazyme (avalglucosidase alfa), has received marketing approval from the National Medical Products Administration (NMPA) as a long-term treatment for Pompe disease. This marks Sanofi’s second drug approved for Pompe disease in China, following the approval of Myozyme (alglucosidase alfa) in October 2015.…
-
Takeda Initiates Global Withdrawal of Exkivity Following Phase III Trial Results
•
Japan-based Takeda (TYO: 4502) has announced the voluntary global withdrawal of its tyrosine kinase inhibitor (TKI) Exkivity (mobocertinib) from the U.S. market. This decision comes after a Phase III confirmatory trial failed to meet its primary efficacy endpoint. Exkivity, a first-in-class therapy, had previously received conditional approvals worldwide as a…
-
Everest Medicines and Calliditas Present New Data on Nefecon for IgA Nephropathy
•
Everest Medicines (HKG: 1952), in partnership with Calliditas Therapeutics AB (Nasdaq: CALT), recently presented new biomarker and subgroup analyses for Nefecon, a targeted oral formulation of budesonide currently under clinical development for the treatment of IgA nephropathy (IgAN). The data was showcased during both poster and oral presentations at the…
-
Zhaoke Ophthalmology Completes Patient Enrollment for Phase III Trials of TAB014 and Epinastine
•
Zhaoke Ophthalmology Ltd (HKG: 6622), a former subsidiary of Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), has announced the successful completion of patient enrollment for two separate Phase III clinical studies: one for TAB014 and another for epinastine, a generic version of Allergan’s Elestat. This milestone underscores Zhaoke’s commitment to advancing…
-
Amicus Therapeutics Secures FDA Approval for Pombiliti and Opfolda Combination Therapy
•
Amicus Therapeutics (NASDAQ: FOLD), headquartered in the United States, has announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for its combination therapy of Pombiliti (cipaglucosidase alfa-atga) and Opfolda (miglustat) 65 mg capsules. This innovative two-component therapy is specifically indicated for adults diagnosed with…
-
Transcenta Secures FDA Approval for Phase III Trial of Osemitamab
•
China-based Transcenta Holding Ltd (HKG: 6628) has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate the global Phase III pivotal TranStar study for its pipeline candidate, osemitamab (TST001). This clinical trial will evaluate the efficacy of osemitamab in combination with nivolumab and…
-
Takeda Receives FDA Approval for Subcutaneous Entyvio as UC Maintenance Therapy
•
The US Food and Drug Administration (FDA) has granted Japan’s Takeda Pharmaceuticals (TYO: 4502) regulatory approval for the subcutaneous version of its alpha4beta7 integrin inhibitor, Entyvio (vedolizumab), as a maintenance therapy for adults with moderately to severely active ulcerative colitis (UC) following induction therapy with intravenous Entyvio. This decision comes…
-
Eli Lilly’s Insulin Biosimilar YouBiAn Approved for Diabetes Treatment in China
•
US pharmaceutical major Eli Lilly (NYSE: LLY) has announced that it has received market approval from the National Medical Products Administration in China for its insulin glargine product, YouBiAn. This treatment is indicated for adults with type 1 or type 2 diabetes requiring insulin therapy, as well as for children…
-
Everest Medicines’ Xerava Receives Marketing Approval from TFDA for cIAI Treatment
•
Everest Medicines (HKG: 1952) has announced that it has received marketing approval for its antibiotic Xerava (eravacycline) from the Taiwan Food and Drug Administration (TFDA). This approval grants the drug permission to be used in the treatment of complicated intra-abdominal infections (cIAI) in Taiwan, expanding the drug’s reach in the…
-
Healthstar Medical’s KC1036 Pediatric Indication Accepted for NMPA Review
•
Beijing-based Healthstar Medical Development Co., Ltd (SHA: 603590) has announced that the National Medical Products Administration (NMPA) has accepted a clinical trial filing for its Category 1 chemical drug, KC1036, for a pediatric indication. This development signifies a significant step forward in the exploration of new treatment options for pediatric…
-
Elpiscience Biopharmaceuticals Initiates Phase I Trial for Anti-LILRB2 Antibody ES009
•
Elpiscience Biopharmaceuticals, a China-based biopharmaceutical company, has announced that the first patient has been dosed in a Phase I clinical trial in Australia for its pipeline candidate, ES009. This investigational drug is an anti-LILRB2 (ILT4) monoclonal antibody developed to target cancers, marking a significant step in the company’s oncology research…
-
Tasly Pharmaceuticals Gets NMPA Approval for B1344 Clinical Study in NASH
•
Tasly Pharmaceuticals (SHA: 600535), a China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its human fibroblast growth factor 21 injection, B1344, in patients with non-alcoholic steatohepatitis (NASH). This development marks a significant step in the…
-
ImmuneOnco Initiates Phase I Trial for CD24-Targeted Monoclonal Antibody IMM47
•
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced the first patient dosing in a Phase I clinical study in Australia for its investigational drug, IMM47, a first-in-class CD24-targeted monoclonal antibody (mAb). This marks a significant step in the development of a novel immunotherapy approach for cancer treatment. IMM47’s Mechanism…
-
Mabwell Bioscience Initiates Phase Ib/II Study for Nectin-4 Targeting ADC 9MW2821
•
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced the first patient dosing in a Phase Ib/II clinical study for its antibody-drug conjugate (ADC) 9MW2821, which targets Nectin-4. The study is designed to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics of 9MW2821 in combination with…
-
LEO Pharma Initiates Phase III Clinical Trial for Delgocitinib in China
•
Denmark-based LEO Pharma A/S has announced the commencement of a China Phase III clinical study with the enrollment and dosing of the first patient for its delgocitinib cream, marking the first clinical study for the product in China. This milestone signifies the company’s efforts to address moderate to severe adult…
-
Coherus Biosciences Awaits FDA Decision on Toripalimab with Year-End Approval Forecast
•
Coherus Biosciences Inc., (NASDAQ: CHRS), a US-based biotechnology company, has provided an update on the progress of its programmed death-1 (PD-1) inhibitor, toripalimab, at the US Food and Drug Administration (FDA). Toripalimab is under license from China’s Junshi Biosciences (HKG: 1877; SHA: 688180). The FDA has completed its clinical study…
-
Cutia Therapeutics Files for Market Approval of CU-10201 with NMPA for Acne Treatment
•
Cutia Therapeutics (HKG: 2487), a developer focused on dermatology therapies, has announced the submission of a market approval filing for its CU-10201 (4% minocycline foam agent for external use) to the National Medical Products Administration (NMPA) in China. The drug, which targets the treatment of non-nodular moderate to severe acne…
-
United Laboratories Receives FDA Approval for Clinical Study of UBT251 for Obesity Treatment
•
United Laboratories International Holdings Ltd (HKG: 3933), a Hong Kong-based pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its Category 1 drug candidate, UBT251, for the treatment of overweight and obesity. UBT251: A Triple Agonist…
-
BioTroy Therapeutics Receives US FDA IND Approval for Anti-Tumor Drug BT02
•
BioTroy Therapeutics, a Shanghai-based developer of cancer immunotherapies, has announced the receipt of Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its innovative anti-tumor drug, BT02. This monoclonal antibody (mAb) targets solid tumors with a novel mechanism, representing a significant step forward in cancer…
-
Sichuan Kelun-Biotech’s KL-A167 and SKB264 Gain Tacit Clinical Trial Approval in China
•
The Center for Drug Evaluation (CDE) website has indicated that Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has received tacit clinical trial approval for its KL-A167 injection and SKB264 injection. These drugs are set to be assessed as a combination treatment for unresectable locally advanced, recurrent, or metastatic HR+/HER2 breast…
-
EC Approves AbbVie’s Tepkinly for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
•
The European Commission (EC) has granted marketing approval to AbbVie (NYSE: ABBV) for its bispecific antibody (BsAb) Tepkinly (epcoritamab), a treatment for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adults who have undergone two or more lines of systemic therapy. This decision comes on the heels of…
-
Sanofi’s Altuviiio Receives Marketing Approval from Japan’s MHLW for Hemophilia A Treatment
•
French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that it has received marketing approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its first-in-class drug Altuviiio (Fc-VWF-XTEN fusion protein). This new treatment is indicated for controlling the bleeding tendency in patients with hemophilia A, a genetic disorder that…
-
Japan’s MHLW Approves Eisai and BioArctic’s Leqembi for Alzheimer’s Treatment
•
The Ministry of Health, Labour and Welfare (MHLW) in Japan has granted approval to Eisai (TYO: 4523) and BioArctic (STO: BIOA-B) for their amyloid-beta (Aβ)-targeting drug, Leqembi (lecanemab), as a treatment for slowing the progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD). This marks…
-
Jiangsu Hengrui Medicine Secures NMPA Approvals for Two Cancer Drug Candidates
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for two of its investigational drug candidates, SHR-A1912 and SHR-1826. These drugs will be assessed for their efficacy in…
-
Novartis’ Lutathera Meets Primary Endpoint in Phase III Trial for GEP-NETs
•
Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that a Phase III trial for its radioligand therapy (RLT) Lutathera (lutetium (177Lu) oxodotreotide) combined with the symptom-control drug octreotide has successfully met its primary endpoint of progression-free survival (PFS) in patients with SSTR-positive, aggressive, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This achievement…
-
AffaMed Therapeutics’ Luminate Receives Clinical Trial Approval for Dry AMD in China
•
AffaMed Therapeutics, a China-based biotech firm, has announced the receipt of its first clinical trial approval in China for its pipeline candidate, Luminate (risuteganib; AM011). This development marks a significant milestone for the company, which acquired the Greater China manufacturing, development, and commercial rights to risuteganib from Hanmi Pharmaceutical, a…
-
Hansoh Pharmaceutical Gets NMPA Approval for HS-20105 Clinical Study in Solid Tumors
•
Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692), a China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) in China to initiate a clinical study of its Category 1 drug candidate, HS-20105, for the treatment of advanced solid tumors. This development marks a…
-
Shanghai Junshi’s Tuoyi Meets Primary Efficacy Endpoint in Phase III Melanoma Study
•
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has announced that the Phase III MELATORCH study (NCT03430297) for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) has successfully reached the progression-free survival (PFS) primary efficacy endpoint. This study evaluates Tuoyi as a first-line…
-
Abbisko Therapeutics Gets NMPA Approval for Irpagratinib Combination Study in HCC
•
Shanghai-based biotechnology company Abbisko Therapeutics Co., Ltd (HKG: 2256) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its pipeline candidate irpagratinib (ABSK121) in combination with lenvatinib for the treatment of advanced or irresectable hepatocellular carcinoma (HCC). This development marks a…
-
Hepagene Therapeutics’ HPG7233 Receives US FDA IND Approval for NASH Treatment
•
Hong Kong-based biopharmaceutical company Hepagene Therapeutics Inc. has announced that the US Food and Drug Administration (FDA) has granted an Investigational New Drug (IND) approval for its drug candidate, HPG7233. This small-molecule thyroid hormone receptor beta (THR-β) agonist is poised for development as a treatment for non-alcoholic steatohepatitis (NASH) and…
-
Abbisko Therapeutics’ Irpagratinib Receives FDA Clearance for Phase I Study in HCC
•
Shanghai-based biotechnology company Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase I clinical study. The study will assess the safety, tolerability, and pharmacokinetics of its pipeline candidate, irpagratinib (ABSK121), a fibroblast growth…
-
Sino Biopharmaceutical Submits IND Application for AT2R Antagonist TRD205 to FDA
•
Sino Biopharmaceutical Ltd (HKG: 1177), a leading China-based biotech company, has announced the filing of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for its AT2R antagonist, TRD205. The drug is intended to address neuropathic pain, a common and debilitating chronic condition that significantly…
-
Fosun Pharma’s Serplulimab Approved for Esophageal Squamous Cell Carcinoma and Grafalon for GvHD Study
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has issued updates on the development statuses of two of its key products. The company’s Programmed-death 1 (PD-1) inhibitor, HaiSiZhuang (serplulimab), has been approved for a new indication in the treatment of first-line PD-L1 positive unresectable locally advanced/recurrent or metastatic esophageal squamous…
-
CDC Provisionally Recommends Pfizer’s Abrysvo for Maternal Immunization Against RSV
•
The US Centers for Disease Control and Prevention (CDC) has issued a provisional recommendation for the use of Pfizer’s (NYSE: PFE) bivalent respiratory syncytial virus (RSV) vaccine, Abrysvo, as a seasonal maternal immunization strategy. This measure aims to prevent RSV lower respiratory tract infection in infants, a significant cause of…
-
Boehringer Ingelheim and Eli Lilly’s Jardiance Wins FDA Approval for CKD Prevention
•
Boehringer Ingelheim (BI) and Eli Lilly (NYSE: LLY) have received regulatory approval from the US Food and Drug Administration (FDA) for their SGLT2 inhibitor, Jardiance (empagliflozin), marking a significant advancement in the treatment of chronic kidney disease (CKD). The drug is now approved for the prevention of kidney function decline,…
-
MSD’s Keytruda Meets Endpoints in Urothelial Carcinoma Trial but Misses in NSCLC Study
•
Merck, Sharp & Dohme (MSD; NYSE: MRK), a leading global pharmaceutical company, last week released clinical data from separate late-stage studies for its anti-PD-1 biologic, Keytruda (pembrolizumab), in combination with other oncology therapies from different partners. The results presented a mixed picture of success and challenges in the field of…
-
Betta Pharmaceuticals’ CFT8919 Accepted for Review by China’s NMPA for EGFR L858R Solid Tumors
•
Betta Pharmaceuticals Co., Ltd (SHE: 300558), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) in China has accepted a clinical trial filing for its Category 1 drug candidate, CFT8919. This development marks a significant step forward in the drug’s journey towards clinical evaluation and potential…
-
CNIPA Upholds Alynlam Pharmaceutical’s PCSK9 siRNA Patent Against Junshi Biosciences Challenge
•
The China National Intellectual Property Administration (CNIPA) has rejected a challenge filed by Junshi Biosciences (SHA: 688180) against a patent held by Alynlam Pharmaceutical (NASDAQ: ALNY), which is related to the development of PCSK9-targeted small-interfering RNA (siRNA) therapies. CNIPA’s decision to fully maintain Patent No. 561449, associated with application number…
-
Sanofi’s Dupixent Secures NMPA Approval for Pruritigo Nodosa Treatment in China
•
France-based pharmaceutical company Sanofi (NASDAQ: SNY) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) in China for its drug Dupixent (dupilumab), which is now approved to treat prurigo nodosa (PN) in adults. This makes Dupixent the first and only drug approved for…
-
Suzhou Zelgen Biopharmaceuticals’ ZG005 Receives NMPA Approval for Solid Tumor Trial
•
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its pipeline drug candidate, ZG005. The trial will evaluate the efficacy of ZG005 in combination with the Category 1 anti-cancer drug donafenib…
-
Antengene’s Anti-CD24 Antibody ATG-031 Gets Green Light for Phase I Study at MD Anderson
•
Antengene Corporation Ltd (HKG: 6996), a China-based biopharmaceutical company, has announced that the Institutional Review Board (IRB) of The University of Texas MD Anderson Cancer Center in Houston, Texas, has approved a Phase I study for its best-in-class anti-CD24 antibody, ATG-031. The clinical study, codenamed the PERFORM trial and led…
-
Mabwell Bioscience’s 9MW3011 Earns US FDA Fast Track Designation for Polycythemia Vera Treatment
•
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced that it has received Fast Track Designation (FTD) from the US Food and Drug Administration (FDA) for its drug candidate 9MW3011 (MWTX-003/DISC-3405) for the treatment of patients with polycythemia vera (PV). This designation underscores the potential impact…
-
Novartis’s Aimovig Approved by China’s NMPA for Preventive Migraines Treatment
•
Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Aimovig (erenumab), a calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb), which can now be used as a preventive treatment for adult migraines in China. Phase III…
-
Organon’s Liptruzet Approved in China for Hypercholesterolemia Treatment
•
US-based Organon (NYSE: OGN) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Liptruzet (ezetimibe, atorvastatin), which is indicated for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH) in China. DYSIS China Study and Liptruzet’s ImpactThe DYSIS China study reveals…
-
Hainan Poly Pharm Submits DMF for Tecovirimat API to US FDA
•
China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced the filing of a Drug Master File (DMF) with the US Food and Drug Administration (FDA) for its tecovirimat active pharmaceutical ingredients (APIs). This move signifies the company’s initiative to bring a potential treatment for poxvirus infections, including smallpox and…
-
Tonghua Golden-Horse’s Octohydroaminoacridine Succinate Meets Phase III Endpoints in Alzheimer’s Disease
•
China-based Tonghua Golden-Horse Pharmaceutical Industry Co., Ltd. (SHE: 000766) has announced positive results from its Phase III clinical study for the in-house developed octohydroaminoacridine succinate, an oral acetylcholinesterase inhibitor designed for the treatment of mild to moderate Alzheimer’s disease (AD). Study Design and OutcomesThe Phase III study was a double-blind,…
-
AIM Vaccine’s Serum-Free Rabies Vaccine Completes Phase III Safety Observation
•
China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced the successful completion of the 7-day safety observation period in a Phase III clinical study for its investigational freeze-dried human rabies vaccine, developed using serum-free Vero cells. The study, which was conducted in a randomized, blinded, and similar vaccine parallel controlled…
-
Jiangsu Yahong’s Cevira Meets Primary Endpoint in Phase III Cervical HSIL Study
•
Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176), a specialist in urogenital cancer treatments, has announced that its Phase III clinical study for Cevira (APL-1702) in high-grade squamous intraepithelial lesions (HSIL) of the cervix has successfully reached its primary endpoint. Study Design and ResultsThe global, multi-center Phase III study was…
-
Hybio Pharmaceutical Gets NMPA Approval for COVID-19 Nasal Spray HY3000
•
China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its Category 1.1 chemical drug, HY3000, a nasal spray designed to target COVID-19. Mechanism of Action and EfficacyHY3000 is a new type of polypeptide membrane…
-
GSK’s Ojjaara Approved by FDA for Anemic Myelofibrosis Patients
•
The US Food and Drug Administration (FDA) has granted regulatory approval to GlaxoSmithKline (GSK; NYSE: GSK), a UK-based pharmaceutical company, for its JAK1/JAK2/ACVR1 inhibitor Ojjaara (momelotinib). The drug is indicated for anemic adults with intermediate or high-risk myelofibrosis, a blood cancer affecting approximately 25,000 people in the United States. This…
-
BeiGene Regains Full Rights to Tislelizumab After Terminating Novartis Deal
•
China-based biotech company BeiGene (NASDAQ: BGNE) has reached a mutual agreement with Novartis (NYSE: NVS) to terminate their licensing deal from January 2021, under which Novartis held co-development and commercial rights to the programmed death-1 (PD-1) inhibitor, tislelizumab, in North America, Japan, the EU, and six other European countries. BeiGene…
-
Jiangsu Hengrui Medicine Wins NMPA Approval for Two Novel Drug Candidates
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced receiving clinical trial approvals from the National Medical Products Administration (NMPA) for two of its investigational drug candidates: the injectable SHR-3032 and HRS-7085 tablets. Details of the Investigational DrugsThe Category 1 drug SHR-3032 is under development…
-
Pfizer’s Cibinqo and Everest Medicines’ Cefepime-Taniborbactam Selected for Priority Reviews by CDE
•
The Center for Drug Evaluation (CDE) has indicated on its website that Pfizer’s (NYSE: PFE) Cibinqo (abrocitinib) and Everest Medicines’ (HKG: 1952) cefepime-taniborbactam are slated for priority reviews. These drugs target specific patient populations: teenage patients aged 12 years and above with refractory, moderate to severe atopic dermatitis (AD) who…
-
EMA’s CHMP Supports Gilead’s Veklury for COVID-19 Patients with Hepatic Impairment
•
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recently endorsed the potential approval of Gilead’s (NASDAQ: GILD) repurposed antiviral Veklury (remdesivir) for the treatment of COVID-19 patients with mild-to-severe hepatic impairment. This milestone could position the nucleotide analog as the first COVID-19 treatment authorized…
-
FDA Grants Priority Review to MSD’s Welireg for Advanced RCC Indication Extension
•
The US Food and Drug Administration (FDA) has granted priority review status to an indication extension application filed by Merck, Sharp & Dohme (MSD; NYSE: MRK) for its oral HIF-2α inhibitor Welireg (belzutifan). The application seeks approval for the treatment of advanced renal cell carcinoma (RCC) in adults who have…
-
Astellas Pharma’s Xtandi NDA for mHSPC Treatment Accepted by China’s CDE
•
Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that the Center for Drug Evaluation (CDE) has accepted for review the New Drug Application (NDA) for its medication Xtandi (enzalutamide), which is intended for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). NDA Basis and Study ResultsThe NDA is…
-
Pfizer’s Litfulo Earns EU Approval as First Treatment for Severe Alopecia Areata in Teens
•
Pfizer (NYSE: PFE) has been granted registration authorization by the European Commission (EC) for Litfulo (ritlecitinib), a JAK3/TEC inhibitor, for the treatment of severe alopecia areata in adults and adolescents. This once-daily drug is the first to be approved in the region for this autoimmune disease, including teenage patients. The…
-
Walvax Biotechnology Receives Indonesian FDA Approval for Phase III Pneumococcal Vaccine Trial
•
China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced that it has received approval from the Food and Drug Supervisory Agency of Indonesia to initiate a Phase III clinical study for its Weuphoria, a 13-valent pneumococcal polysaccharide conjugate vaccine. Study Design and ObjectivesThe Phase III study is a randomized, blinded,…
-
Sunshine Guojian Pharmaceutical Gets NMPA Approval for SSGJ-611 Phase II COPD Study
•
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, (SHA: 688336) a subsidiary of 3SBio Inc. (HKG: 1530), has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study for SSGJ-611, an IL-4Rα monoclonal antibody (mAb), for the treatment of moderate to severe chronic obstructive pulmonary…
-
AbbVie’s Allergan Aesthetics Secures NMPA Approval for Juvéderm VOLUMA with Lidocaine
•
Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for Juvéderm VOLUMA with Lidocaine, expanding its indications to include nose augmentation procedures. Product Description and BenefitsJuvéderm VOLUMA with Lidocaine is a cross-linked sodium hyaluronate gel designed…
-
Caliway Biopharmaceuticals’ CBL-514 Achieves Milestones in Dercum’s Disease Trial
•
Taiwan-based Caliway Biopharmaceuticals, a specialist in medical aesthetics and inflammatory medicine, has announced that its trial assessing the efficacy and safety of CBL-514 in subjects with Dercum’s Disease lipomas has met all primary and secondary efficacy endpoints. CBL-514 is a first-in-class small-molecule injection lipolysis drug designed to induce adipocyte apoptosis…
-
Zhejiang Medicine Gets NMPA Approval for NCB003 Clinical Study for Advanced Solid Tumors
•
Zhejiang Medicine Co., Ltd (SHA: 600216), a China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its investigational injectable drug, NCB003. This next-generation targeted coupling long-acting human interleukin-2 (IL-2) drug is being developed to treat patients…
-
Zelgen Biopharmaceuticals’ rhTSH Achieves Primary Endpoint in Phase III Study
•
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a China-based pharmaceutical company, has announced that its Phase III clinical study for the drug candidate, recombinant human thyroid stimulating hormone for injection (rhTSH), has successfully reached its pre-set primary endpoint. Following this achievement, the company will proceed with a pre-BLA (Biologics License…
-
CSBIO’s Albenatide Shows Positive Results in Two Phase III Diabetes Trials
•
Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255) has announced encouraging results from two Phase III clinical studies for its innovative drug candidate, albenatide (CJC-1134-PC). This Category 1 drug is a long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA), modified with Drug Affinity Complex (DAC) technology based on exenatide. CSCJC DM301…
-
Sandoz Receives Positive CHMP Review for Trastuzumab Biosimilar in HER2-Positive Cancers
•
Sandoz (SWX: SDZ), the generic and biosimilar drug maker set to separate from Novartis (NYSE: NVS) next month, has received a positive review from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its trastuzumab biosimilar. The biosimilar is intended for use in treating HER2-positive…
-
Gilead’s Kite CAR-T Therapy Yescarta Achieves 71% CMR in Phase II Trial for R/R LBCL Patients
•
Gilead’s (NASDAQ: GILD) subsidiary Kite has announced early results from a Phase II trial of its CAR-T therapy, Yescarta (axicabtagene ciloleucel), for patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) who are not eligible for high-dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT). The study achieved a primary endpoint…
-
EMA’s CHMP Backs Enhertu for Advanced NSCLC with HER2 Mutations
•
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the use of Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate (ADC) developed by AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), in the treatment of advanced non-small cell lung…
-
EMA’s CHMP Recommends Approval of Keytruda as Adjuvant NSCLC Treatment
•
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Merck, Sharp & Dohme’s (MSD; NYSE: MRK) anti-PD-1 therapy, Keytruda (pembrolizumab), as an adjuvant treatment for non-small cell lung cancer (NSCLC) in adults who are at a high risk of…
-
Novartis’s Kisqali Reduces Cancer Recurrence Risk in HR+/HER2- Early Breast Cancer: Phase III Results
•
Swiss pharmaceutical giant Novartis (NYSE: NVS) has published results from a Phase III study of its CDK4/6 inhibitor Kisqali (ribociclib) in combination with endocrine therapy (ET) as an adjuvant treatment for HR+/HER2- early breast cancer (EBC). The data, recorded for up to three years, indicated that Kisqali reduced the risk…
-
Akeso Biopharma’s AK132 Receives Green Light for Clinical Trial in Advanced Solid Tumors
•
Akeso Biopharma’s (HKG: 9926) AK132, a bispecific antibody (BsAb) targeting Claudin18.2 and CD47, has received approval from China’s Center for Drug Evaluation to proceed with a clinical study in patients with advanced malignant solid tumors. This marks the sixth in-house developed BsAb from the Chinese firm to enter clinical development.…
-
CSPC Pharmaceutical Group Receives NMPA Approval for Irinotecan Liposome Injection
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its irinotecan liposome injection. The drug is indicated for the treatment of metastatic pancreatic cancer in patients after gemcitabine treatment and is also used in…
-
Japan’s MHLW Reviews GSK’s Momelotinib for Myelofibrosis Treatment
•
The Ministry of Health, Labour and Welfare (MHLW) in Japan has accepted for review a filing by UK-based GlaxoSmithKline (GSK; NYSE: GSK) for its first-in-class candidate, momelotinib, as a potential treatment for the blood cancer myelofibrosis. The submission is supported by Phase III clinical trial results that show significant improvements…
-
AstraZeneca and Daiichi Sankyo Report Positive Results for Datopotamab Deruxtecan Combo in NSCLC
•
UK-based pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced positive data from a Phase Ib study for the antibody-drug conjugate (ADC) datopotamab deruxtecan in combination with checkpoint inhibitor Imfinzi (durvalumab). The study, conducted in partnership with Daiichi Sankyo (TYO: 4568), focused on first-line advanced or metastatic non-small cell lung cancer…
-
Chongqing Lummy Pharmaceutical’s Subsidiary Receives NMPA Approval for CUD002 mRNA Vaccine
•
Chongqing Lummy Pharmaceutical Co., Ltd (SHE: 300006), through its subsidiary Sichuan Cunde Therapeutics Co., Ltd, has received clinical trial approval from the National Medical Products Administration (NMPA) for the CUD002 injection. This mRNA-edited DC (dendritic cell) tumor therapeutic vaccine product is based on patient tumor neoantigens, marking a significant step…
-
Dizal Pharmaceutical’s Golidocitinib NDA Accepted for Review by NMPA
•
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that the National Medical Products Administration (NMPA) has accepted for review its New Drug Application (NDA) for golidocitinib, a first-in-class JAK1 inhibitor. The drug candidate is filed for the initial indication of treating recurrent refractory peripheral T-cell lymphoma (r/r PTCL). Supporting…
-
Grand Pharmaceutical’s GSP301 NS Meets Primary Endpoint in Phase III SAR Study
•
China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that its Phase III study (GSP 301-308) for the Ryaltris compound nasal spray (GSP301 NS) in seasonal allergic rhinitis (SAR) has successfully reached its primary endpoint in China. Study Design and Patient EnrollmentThe randomized, double-blind, double-simulation, three-arm, multi-center, parallel-controlled Phase III…
-
Haisco Pharmaceutical’s HSK16149 for Post-Herpes Neuralgia Accepted for NMPA Review
•
China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that the National Medical Products Administration (NMPA) has accepted for review a market approval filing for its drug candidate HSK16149 as a treatment for post-herpes neuralgia (PHN). This in-house Category 1 drug, an oral gamma-aminobutyric acid (GABA) analogue, is under…
-
Asieris Pharmaceuticals’ APL-1202 Shows Positive Interim Analysis in MIBC Trial with BeiGene’s Tislelizumab
•
China-based urogenital cancer specialist Asieris Pharmaceuticals (SHA: 688176) has revealed positive results from a Phase II interim analysis of its drug candidate APL-1202, combined with BeiGene Ltd’s (NASDAQ: BGNE; HKG: 6160) programmed death-1 (PD-1) inhibitor tislelizumab, as neoadjuvant chemotherapy (NAC) in muscular invasive bladder cancer (MIBC). The trial has demonstrated…
-
AstraZeneca’s Fasenra Shows Non-Inferior Efficacy to Nucala in EGPA: Phase III Results
•
UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has unveiled the results of a Phase III study, demonstrating the non-inferiority of its IL-5 antagonist Fasenra (benralizumab) compared to GlaxoSmithKline’s (GSK; NYSE: GSK) Nucala (mepolizumab) in the treatment of relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The study highlights that Fasenra…
-
InnoCare Pharma and ArriVent Biopharma Partner on Clinical Study for Advanced NSCLC Treatment
•
China-based InnoCare Pharma (HKG: 9969; SHA: 688428) has announced that it has received the green light to conduct a clinical study in China for its drug candidate ICP-189, in combination with ArriVent Biopharma Inc.’s furmonertinib, for the treatment of advanced non-small cell lung cancer (NSCLC). The collaboration between InnoCare and…
-
EMA Approves Astellas’ Xtandi for Non-Metastatic Hormone-Sensitive Prostate Cancer
•
The European Medicines Agency (EMA) has granted Japan-based Astellas (TYO: 4503) an indication extension approval for its androgen receptor inhibitor Xtandi (enzalutamide). This approval expands the use of Xtandi as a treatment for non-metastatic hormone-sensitive prostate cancer (nmHSPC) in patients with high-risk biochemical recurrence (BCR) who are unsuitable for salvage-radiotherapy.…
-
FDA Accepts Takeda’s Filing for Subcutaneous Entyvio as Maintenance Therapy for Crohn’s Disease
•
The US Food and Drug Administration (FDA) has accepted a filing from Japan-based Takeda (TYO: 4502) for a subcutaneous version of the alpha4beta7 integrin inhibitor Entyvio (vedolizumab). This new formulation is intended as a maintenance therapy for adult patients with moderately to severely active Crohn’s disease (CD) who have been…
-
AbbVie’s Skyrizi Outperforms Janssen’s Stelara in Phase III Crohn’s Disease Trial
•
AbbVie (NYSE: ABBV) has announced early data from a Phase III trial that compared the IL-23 inhibitor Skyrizi (risankizumab) with Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen’s Stelara (ustekinumab) in patients with moderate-to-severe Crohn’s disease (CD) unresponsive to anti-TNF therapy. The blinded efficacy assessment revealed that Skyrizi achieved clinical…
-
Boehringer Ingelheim Gets NMPA Approval for Brigimadlin Safety and Efficacy Study in China
•
Germany-based Boehringer Ingelheim (BI) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct the Brightline-2 study in China. The study will assess the safety and efficacy of the company’s MDM2-p53 antagonist, brigimadlin (BI 907828), in patients with locally advanced/metastatic, MDM2 amplification, TP53 wild-type…
-
MSD’s Sotatercept Demonstrates Positive Interim Results in Phase III PAH Studies
•
Merck, Sharp & Dohme (MSD; NYSE: MRK) has presented interim data from Phase III and extension studies for its potential first-in-class biologic sotatercept, which is being investigated for the treatment of pulmonary arterial hypertension (PAH). The late-stage trial indicated that the activin signaling inhibitor led to a reduction in right…
-
AstraZeneca’s Tagrisso Combination Therapy Shows Improved Efficacy in EGFR-mutated NSCLC
•
UK-headquartered AstraZeneca (AZ; NASDAQ: AZN) has announced interim Phase III data demonstrating that the addition of pemetrexed plus cisplatin/carboplatin chemotherapy to tyrosine kinase inhibitor (TKI) Tagrisso (osimertinib) improves therapeutic effects in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). The combination therapy reduced the risk of…
-
Janssen Reports Positive Results from Phase Ib/II Study of Rybrevant Combo in EGFR-mutated NSCLC
•
Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has provided an update on an ongoing Phase Ib/II study cohort assessing the safety and pharmacokinetics of the bispecific antibody (BsAb) Rybrevant (amivantamab) in combination with tyrosine kinase inhibitor (TKI) lazertinib and chemotherapy for the treatment of relapsed/refractory EGFR-mutated non-small cell lung…
-
AstraZeneca’s Enhertu Shows Promising Results in Phase II HER2-mutant NSCLC Trial
•
AstraZeneca (AZ; NASDAQ: AZN) has released early data from a Phase II trial investigating the antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) in patients with HER2-mutant unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC). The trial assessed the efficacy and safety of different dosages of Enhertu, revealing that while a…
-
Gan & Lee Pharmaceuticals Initiates Phase II Clinical Study for Weekly Insulin GZR4
•
Gan & Lee Pharmaceuticals (SHA: 603087), a China-based pharmaceutical company, has announced the dosing of the first patient in a Phase II clinical study for its Category 1 therapeutic biologic product, GZR4. GZR4 is an investigational ultra-long-acting insulin designed for once-per-week subcutaneous injection to treat diabetes. Design and Objectives of…
-
Grand Pharmaceutical Receives NMPA Approval for Generic Carbaglu for Hyperammonemia Treatment
•
China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Italy’s Recordati’s Carbaglu (carglumic acid). This marks the first approval of such a generic drug in China, offering a treatment for hyperammoniaemia caused…
-
Clover Biopharmaceuticals Launches AdimFlu-S, the Only Imported Quadrivalent Influenza Vaccine in China
•
China-based Clover Biopharmaceuticals Ltd., (HKG: 2197) has announced the launch of AdimFlu-S (QIS) in mainland China, marking it as the only imported quadrivalent seasonal influenza vaccine approved for use in individuals aged three years and older. The vaccine has been listed in 26 provinces and municipalities across the country, gearing…
-
HutchMed Advances Tazverik Phase II Trial for Follicular Lymphoma in China
•
China-based HutchMed (HKG: 0013, NASDAQ: HCM) has announced the completion of patient enrollment in a bridging study for Tazverik (tazemetostat) in China. Tazverik, originated by US firm Epizyme Inc., was licensed to HutchMed for development in Greater China in an agreement reached in August 2021. Tazverik’s Background and Previous ApprovalsThe…
-
Hybio Pharmaceutical’s Semaglutide Clinical Trial Filing Accepted by China’s NMPA
•
China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced that the National Medical Products Administration (NMPA) has accepted its clinical trial filing for semaglutide, a Category 2.2 product. Category 2.2 products in China are new formulations of known drugs that aim to offer a demonstrable clinical benefit over the originator…
-
FDA Extends Pfizer’s Comirnaty Vaccine Indication for Omicron XBB.1.5 Variant
•
The US Food and Drug Administration (FDA) has granted Pfizer (NYSE: PFE) an indication extension for its SARS-CoV-2 Omicron XBB.1.5 single-dose monovalent vaccine, Comirnaty. The vaccine is now approved for individuals aged 12 years and older, in addition to receiving an emergency use authorization (EUA) for children between 6 months…
-
Amgen’s Lumakras Combo Shows Promising Results in KRAS-mutated NSCLC Early-Stage Trial
•
Amgen (NASDAQ: AMGN) has announced positive early-stage data for its KRASG12C inhibitor Lumakras (sotorasib) when combined with carboplatin and pemetrexed in the treatment of KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) in adults. The confirmed objective response rate (ORR) and disease control rate (DCR) in treatment-naive patients were 65%…
-
Gilead’s Trodelvy Combo with MSD’s Keytruda Shows Promise in NSCLC Phase II Trial
•
Gilead (NASDAQ: GILD) has announced interim data from a Phase II trial assessing the antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) in combination with Merck, Sharp & Dohme’s (MSD; NYSE: MRK) anti-PD-1 Keytruda (pembrolizumab) for first-line advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations. The interim results…
-
Sinovac Biotech Advances SA55 COVID-19 Neutralizing Antibody into Phase II Trials
•
China-based vaccines firm Sinovac Biotech Ltd (NASDAQ: SVA) has announced the completion of a Phase I trial and the immediate initiation of a Phase II study for its broad-spectrum COVID-19 neutralizing antibody, SA55. The molecule, which was first approved to enter clinical trials in China on May 24 this year,…
-
Jiangsu Hengrui Medicine Gets NMPA Approval for HRS-7450 Acute Ischemic Stroke Study
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its investigational drug HRS-7450 in patients with acute ischemic stroke. HRS-7450: A Next-Generation Thrombolytic DrugHRS-7450 is…
-
SinoMab BioScience Receives NMPA Approval for Phase I Study of Atopic Dermatitis Drug SM17
•
Hong Kong-based biotechnology company SinoMab BioScience Ltd (HKG: 3681) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study in China, assessing the safety of SM17, a first-in-class drug for atopic dermatitis (AD). The study is set to commence in the fourth quarter…
-
Haisco Pharmaceutical Gets NMPA Approval for HSK21542 Chronic Pruritus Clinical Study
•
China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 drug HSK21542, aimed at treating chronic pruritus. Understanding the Impact of Chronic PruritusPruritus, or itching, is an unpleasant sensation…
-
ImmuneOnco’s IMM2510 and IMM27M Achieve Milestones in Phase I Clinical Trials
•
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced the completion of patient enrollment for Phase I dosage escalation studies for both IMM2510 and IMM27M, with the recommended Phase II dosage (RP2D) determined for each. IMM2510: A PD-L1/VEGF Bispecific Antibody for Solid TumorsIMM2510, a PD-L1/VEGF bispecific antibody (BsAb) based on…
-
CDE Indicates BTD Status for Visirna’s VSA001, Sperogenix’s Vamorolone, and Zai Lab’s Efgartigimod
•
The Center for Drug Evaluation (CDE) website has indicated that Visirna Therapeutics’ novel siRNA therapy VSA001, Sperogenix Therapeutics’ vamorolone, and Zai Lab’s (HKG: 9688) efgartigimod are on track for breakthrough therapy designation (BTD) status awards in China. VSA001 for Familial Chylomicronemia Syndrome (FCS)VSA001 is designed to reduce triglyceride levels in…
-
Sichuan Kelun Pharmaceutical Submits Biosimilar Cetuximab for NMPA Approval
•
Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), through its innovative drug development subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has announced a market approval filing for its pipeline candidate A140, a biosimilar version of Merck KGaA/Bristol-Myers Squibb’s (NYSE: MRK/BMS, NYSE: BMY) cetuximab, known under the trade name Erbitux. The…
-
United Laboratories’ UBT251 Receives Tacit Approval for NAFLD Clinical Study in China
•
Hong Kong firm United Laboratories International Holdings Ltd (HKG: 3933) has announced that its Category 1 drug candidate UBT251 has been tacitly approved in China for a clinical study focusing on non-alcoholic fatty liver disease (NAFLD). UBT251: A Triple Agonist for Metabolic ImprovementsUBT251 is a long-acting GLP-1 (glucagon-like peptide-1)/GIP (glucose-dependent…
-
Abbisko Therapeutics Receives EMA Approval for Phase III Study of Pimicotinib for TGCT
•
Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the European Medicines Agency (EMA) to conduct a Phase III clinical study for its Category 1 innovative drug ABSK021 (pimicotinib), which is being assessed as a treatment for tendon sheath giant cell tumor (TGCT).…
-
AriBio Files for Phase III Clinical Trial Approval in China for Alzheimer’s Drug AR1001
•
South Korean clinical-stage biotech AriBio Co. has announced the filing for Phase III clinical trial approval in China for its anti-Alzheimer’s disease (AD) drug candidate, AR1001. The filing is currently under review by the National Medical Products Administration’s Center for Drug Evaluation. Global Phase III Trial Expansion PlansAriBio aims to…
-
Allist Pharmaceuticals and ArriVent Biopharma Release Promising Interim Data on Furmonertinib for NSCLC
•
Shanghai-based biotech Allist Pharmaceuticals Co., Ltd and its US partner ArriVent Biopharma Inc. have jointly released interim data from a Phase Ib trial at the 2023 World Conference on Lung Cancer (WCLC) meeting. The trial assessed the efficacy of furmonertinib as a treatment for non-small cell lung cancer (NSCLC), specifically…
-
BMS Announces Positive Outcomes for BMS-986278 in Progressive Pulmonary Fibrosis Study
•
Bristol-Myers Squibb (BMS; NYSE: BMY) has released the final results from a Phase II trial evaluating the potential first-in-class LPA1 antagonist BMS-986278 in the treatment of progressive pulmonary fibrosis (PPF). The trial’s findings indicate that the twice-daily pill significantly reduced the rate of decline in percent predicted forced vital capacity…
-
EMA Reviews Janssen’s Balversa for Advanced Urothelial Carcinoma with FGFR3 Alterations
•
The European Medicines Agency (EMA) has accepted for review a filing made by the Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) for the tyrosine kinase inhibitor (TKI) Balversa (erdafitinib) as a treatment for locally advanced unresectable or metastatic urothelial carcinoma (UC) in adults with susceptible fibroblast growth factor…
-
United Laboratories Receives Tacit Approval for JAK1 Inhibitor TUL01101 Clinical Trial
•
Hong Kong-listed United Laboratories International Holdings Ltd (HKG: 3933) has announced tacit clinical trial approval for its Category 1 drug TUL01101, a small molecule JAK1 inhibitor. The upcoming trial will evaluate the efficacy of TUL01101 as a treatment for patients suffering from moderate to severe atopic dermatitis (AD). Filling the…
-
Jiangsu Hengrui Medicine Gets NMPA Approval for Phase Ib/III Study of Dalpiciclib in mHSPC
•
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a multi-center, randomized, double-blind Phase Ib/III clinical study. The study will assess the combination of dalpiciclib (SHR6390) with abiraterone plus prednisone in patients with metastatic hormone…
-
Roche and Alnylam’s Zilebesiran Achieves Primary Endpoint in Hypertension Phase II Trial
•
Roche (SWX: ROG) and Alnylam (NASDAQ: ALNY) have announced that a Phase II trial for their RNAi therapeutic, zilebesiran, has successfully met its primary endpoint of significantly reducing 24-hour mean systolic blood pressure (SBP) at month three in patients with mild-to-moderate hypertension. The results also demonstrated reductions in SBP and…
-
Pfizer and Valneva’s Lyme Disease Vaccine VLA15 Shows Promise as Booster in Pediatric Trials
•
Partners Pfizer (NYSE: PFE) and Valneva SE (NASDAQ: VALN) have revealed that their Lyme disease vaccine candidate, VLA15, has demonstrated immunogenicity and safety as a booster shot in individuals aged between 5 and 17 years. The primary scheme resulted in seroconversion rates of 94.6% to 95.3% for all serotypes of…
-
European Commission Approves Pediatric Indication for MSD’s Ervebo Ebola Vaccine
•
The European Commission (EC) has granted Merck, Sharp & Dohme (MSD; NYSE: MRK) approval for a pediatric indication for its vaccine Ervebo, expanding its use as an active immunization for individuals aged 1 year or older against Ebola virus disease (EVD) caused by Zaire ebolavirus. This life-threatening condition has been…
-
Cutia Therapeutics’ CU-40102 Meets Primary Endpoint in Phase III Study for Androgenic Alopecia
•
Dermatology therapy developer Cutia Therapeutics (HKG: 2487) has announced that its Phase III clinical study for CU-40102 (external einasteride spray) in androgenic alopecia in China has successfully reached its primary endpoint. Study Design and Patient EnrollmentThe multi-center, randomized, double-blind, placebo-controlled Phase III regulatory study was designed to assess the efficacy…
-
AstraZeneca’s Ultomiris Faces FDA Rejection for NMOSD Indication Extension
•
UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has received a rejection from the US Food and Drug Administration (FDA) for an indication extension of its complement inhibitor Ultomiris (ravulizumab) to treat neuromyelitis optica spectrum disorder (NMOSD) in AQP4 antibody positive (Ab+) adults. The FDA has requested modifications to the drug’s…
-
Chengdu Kanghua Receives FDA Approval for Clinical Trial of Norovirus Vaccine
•
China-based Chengdu Kanghua Biological Products Co., Ltd (SHE: 300841) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its recombinant hexavalent norovirus vaccine. This development marks a significant step forward in addressing the global health challenge posed by norovirus, which is…
-
Merck’s Keytruda Approved in China for MSI-H/dMMR Advanced Solid Tumors: A Biomarker-Driven Milestone
•
US pharmaceutical major Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its programmed drug Keytruda (pembrolizumab) has been approved in China for the treatment of unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene deficient (dMMR) advanced solid tumors. This includes colorectal cancer patients who have…
-
Immunofoco’s IMC008 Earns Orphan Drug Designation for Pancreatic Cancer from FDA
•
Suzhou-based cell therapy developer Immunofoco has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration for its next-generation autologous CAR-T therapy, IMC008, for the treatment of pancreatic cancer. This follows the company’s first ODD status granted for gastric cancer in the country less…
-
Shanghai Haihe Pharmaceutical’s Glumetinib Filed for Marketing in Japan for NSCLC Treatment
•
Shanghai Haihe Pharmaceutical Co., Ltd has announced the filing for marketing approval in Japan for its Category 1 product, glumetinib, indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET 14 exon mutation. Glumetinib’s Development and EfficacyCo-developed by Haihe Pharma and the Chinese Academy…
-
Luye Pharma’s Botawei Receives NMPA Approval for Breast Cancer Treatment
•
Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its injectable goserelin acetate in microsphere form, trade-named Botawei, for the treatment of breast cancer in premenopausal and perimenopausal women eligible for hormone therapy. Botawei: A Pioneering Treatment for…
-
Janssen’s Rybrevant Combo Meets Primary Endpoint in Advanced NSCLC Study
•
Janssen, a subsidiary of Johnson & Johnson (J&J; NYSE: JNJ), has released an update on a late-stage study for its bispecific antibody (BsAb) Rybrevant (amivantamab). The study investigated the combination of Rybrevant with tyrosine kinase inhibitor (TKI) lazertinib and chemotherapy in treating advanced or metastatic non-small cell lung cancer (NSCLC)…
-
Henan Zhongshuai’s Dexmethylphenidate Hydrochloride Capsules Target Priority Review for Pediatric ADHD
•
Henan Zhongshuai Pharmaceutical Co., Ltd., a China-based pharmaceutical company, is poised to secure priority review status for its dexmethylphenidate hydrochloride sustained release capsules, which are being developed for potential pediatric use. The molecule is intended to treat attention deficit hyperactivity disorder (ADHD) in children. Phase III Clinical Study and EfficacyThe…
-
Amneal Pharmaceuticals Receives China Approval for Sevelamer Carbonate
•
US-based Amneal Pharmaceuticals Inc. (NYSE: AMRX) has announced that it has received approval from the Chinese market for its sevelamer carbonate, marking the company’s inaugural product approval in China. The drug is indicated for the treatment of hyperphosphatemia in patients with chronic kidney disease who are undergoing dialysis. Sevelamer represents…
-
CSPC Pharmaceutical’s Narlumosbart Approved by NMPA for Bone Giant Cell Tumors
•
CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its subsidiary, Shanghai JMT Biotechnology Co., Ltd, has received marketing approval from the National Medical Products Administration (NMPA) for narlumosbart (JMT103), an anti-RANKL monoclonal antibody (mAb), to treat giant cell tumors of bone that are inoperable or may lead to severe…
-
Jiangsu Hengrui’s HER2-Targeted ADC SHR-A1811 Aims for CDE’s BTD Status
•
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its HER2 targeted antibody-drug conjugate (ADC), SHR-A1811, is on track to receive breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. This designation is for the treatment of HER2 positive advanced colorectal cancer, marking…
-
Genentech Files for FDA Approval of Crovalimab for PNH, Challenging Soliris
•
Swiss pharmaceutical giant Roche’s subsidiary, Genentech (SWX: ROG), has submitted its anti-C5 investigational drug, crovalimab, to the US Food and Drug Administration (FDA) for the treatment of the rare disease paroxysmal nocturnal hemoglobinuria (PNH). The filing is bolstered by Phase III clinical data that demonstrates crovalimab’s non-inferiority and a similar…
-
Hainan Haiyao Concludes Phase I Clinical Study for PaiEnJiaBin, a Novel KCNQ Agonist
•
China-based Hainan Haiyao Co., Ltd (SHE: 000566) has announced the conclusion of Phase I clinical studies for PaiEnJiaBin, a Category 1 chemical drug co-developed with the Shanghai Institute of Materia Medica. PaiEnJiaBin is a next-generation KCNQ potassium channel agonist, with no similar products approved globally, and is being developed to…
-
MSD’s Gardasil 9 HPV Vaccine Demonstrates 10-Year Efficacy in Adolescents
•
Merck, Sharp & Dohme (MSD; NYSE: MRK) has released long-term effectiveness data for its recombinant human papillomavirus (HPV) 9-valent vaccine, Gardasil 9, in minors aged between 9 and 15 years old. The results indicate that the immunogenicity generated by the vaccine persisted for 10 years after the third and final…
-
Neurophth Biotechnology’s NFS-05 Gene Therapy Gets Australian Clinical Trial Approval for ADOA
•
China-based gene therapy specialist Neurophth Biotechnology Ltd has announced that it has received clinical trial approval from the Therapeutic Goods Administration of Australia for its candidate drug NFS-05. The therapy is set to be assessed as a treatment for autosomal dominant optic atrophy (ADOA), an inherited optic neuropathy. Understanding Autosomal…
-
Harbin Gloria Pharmaceuticals’ Zimberelimab Receives NMPA Approval for Cervical Cancer Treatment
•
China-based Harbin Gloria Pharmaceuticals Co., Ltd (SHE: 002437) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its programmed cell death-1 (PD-1) monoclonal antibody (mAb) zimberelimab. The drug is indicated for the treatment of recurrent or metastatic cervical cancer patients with positive PD-L1…
-
Seagen and Genmab Announce Positive Phase III Results for Tivdak in Cervical Cancer
•
Seagen (NASDAQ: SGEN), currently in the process of being acquired by Pfizer (NYSE: PFE), and its partner Genmab (NASDAQ: GMAB), have announced the achievement of the primary endpoint in a Phase III trial for their antibody-drug conjugate (ADC) Tivdak (tisotumab vedotin). The trial focuses on patients with recurrent or metastatic…
-
SinoMab BioScience’s Suciraslimab Files for Market Approval in China for Rheumatoid Arthritis
•
Hong Kong-based biotech company SinoMab BioScience Ltd (HKG: 3681) has announced that a market approval filing has been submitted for its suciraslimab (SM03) to the National Medical Products Administration (NMPA) in China. The CD22 monoclonal antibody (mAb) is seeking its first indication approval as a treatment for rheumatoid arthritis (RA).…
-
Columbia University Study Weighs Cost-Effectiveness of Weight-Loss Treatments for Adolescents
•
Researchers at US Columbia University have published the results of a study estimating the cost-effectiveness of Novo Nordisk’s (NYSE: NVO) injections Wegovy (semaglutide) and Saxenda (liraglutide), as well as Vivus’s (NASDAQ: VVUS) pill Qsymia (phentermine + topiramate) for weight-loss interventions in adolescents. The study utilized a simulated cohort of 100,000…
-
BDgene Technology Announces Clinical Milestone for CRISPR-Cas9 Gene Therapy in HSK
•
Gene therapy specialist Shanghai BDgene Technology Co., Ltd has announced the conclusion of three clinical research treatments using its HELP technology, based on the CRISPR-Cas9 gene editing tool, for herpes simplex keratitis (HSK). Preliminary positive results have been published in the journal Molecular Therapy, in an article titled “In Vivo…
-
Sihuan Pharmaceutical’s Birociclib NDA Accepted for Review by China’s NMPA
•
China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for birociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, for review. The drug is intended for the treatment of HR+/HER2- advanced breast cancer in patients who have…
-
Jointown Medical’s COVID-19 Drug Candidate SHEN211 Accepted for Review by NMPA
•
China-based Jointown Medical Devices Group Co., Ltd (SHA: 600998) has announced that its clinical trial filing for the Category 1 COVID-19 drug candidate, SHEN211, has been accepted for review by China’s National Medical Products Administration (NMPA). SHEN211 is an oral broad-spectrum anti-novel coronavirus non-peptide 3CL protease inhibitor, co-developed by a…
-
Hansoh Pharmaceutical Receives NMPA Approval for Generic Ofev (Nintedanib)
•
China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Boehringer-Ingelheim’s Ofev (nintedanib). This development marks a significant step for the company in expanding its portfolio of generic drugs. Nintedanib’s Approval History…
-
Chia Tai Tianqing’s Generic Entresto Approved by NMPA, Launch Expected in 2026
•
The National Medical Products Administration (NMPA) website has indicated that Chia Tai Tianqing’s generic version of Swiss pharmaceutical giant Novartis’s heart failure therapy Entresto (sacubitril, valsartan) has been approved for marketing. However, the generic version will not be launched until 2026 when the originator’s patent expires. This follows the approval…
-
Novo Nordisk’s Esperoct on Track for Priority Review in Hemophilia A Treatment
•
The Center for Drug Evaluation (CDE) website has indicated that Denmark-based Novo Nordisk’s (NYSE: NVO) Esperoct (turoctocog alfa pegol) is on track for priority review for the treatment of hemophilia A in adults and children. The drug is indicated for on-demand treatment and control of bleeding events, perioperative management, and…
-
Bayer Subsidiary’s Parkinson’s Treatment Bemdaneprocel Shows Promise in Phase I
•
Germany-based Bayer (ETR: BAYN) has announced that its subsidiary BlueRock Therapeutics’ open-label Phase I study for cell therapy bemdaneprocel in Parkinson’s disease has successfully met the safety and tolerability primary endpoint. After one year, no bemdaneprocel-related serious adverse events (SAEs) were reported. Additionally, dose-dependent improvement in motor symptoms and evidence…
-
AstraZeneca’s Calquence Approved by NMPA for Chronic Lymphocytic Leukemia Treatment
•
UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its Bruton’s tyrosine kinase (BTK) inhibitor, Calquence (acalabrutinib). The drug is now approved for use in adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic…
-
Roche’s Alecensa Achieves Milestone in Adjuvant Therapy Trial for Early-Stage NSCLC
•
Switzerland-based pharmaceutical giant Roche (SWX: ROG) has released an update from an interim analysis of a late-stage trial for its ALK inhibitor Alecensa (alectinib) as adjuvant therapy in the early setting for resected non-small cell lung cancer (NSCLC) with ALK mutations. These mutations are present in approximately 5% of NSCLC…
-
Japan’s MHLW Reviews GSK’s Nucala for Chronic Rhinosinusitis with Nasal Polyps Indication
•
The Ministry of Health, Labour and Welfare (MHLW) in Japan has begun the review process for an indication extension filing submitted by the UK pharmaceutical company GlaxoSmithKline (GSK; NYSE: GSK). The filing seeks to expand the use of GSK’s anti-IL-5 biologic Nucala (mepolizumab) as a treatment for adults with chronic…
-
Eli Lilly’s Verzenios Receives NMPA Approval for Extended Indication in Early-Stage Breast Cancer
•
US pharmaceutical major Eli Lilly & Co., (NYSE: LLY) has announced that the National Medical Products Administration (NMPA) has approved an indication extension for its Verzenios (abemaciclib). The drug is now indicated as adjuvant therapy for hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, and lymph…
-
Shanghai Junshi Biosciences’ JS207 Bispecific Antibody Receives NMPA Clinical Trial Approval
•
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the National Medical Products Administration (NMPA) in China has approved a clinical trial filing for its bispecific antibody (BsAb) JS207. The drug is under development to target PD-1 and VEGF for the treatment of advanced malignant tumors. Pre-Clinical…
-
United Laboratories’ UBT251 Receives Tacit Approval for Obesity Clinical Study in China
•
Hong Kong-based United Laboratories International Holdings Ltd (HKG: 3933) has announced that its Category 1 drug candidate, UBT251, has been tacitly approved in China for a clinical study to assess its effectiveness against overweight and obesity conditions. UBT251: A Triple Agonist for Metabolic ConditionsUBT251 is a long-acting GLP-1 (glucagon-like peptide-1)/GIP…
-
Zai Lab’s Margenza (Margetuximab) Approved by China’s NMPA for HER2-Positive Breast Cancer
•
The National Medical Products Administration (NMPA) website has indicated that Zai Lab Ltd’s (NASDAQ: ZLAB, HKG: 9688) Margenza (margetuximab), an Fc-engineered monoclonal antibody (mAb) targeting HER2 and developed by MacroGenics Inc., has been approved for the China market. The drug is indicated for the treatment of metastatic HER2-positive breast cancer…
-
MicuRx Pharmaceuticals Initiates Phase III Trial for MRX-4 in Complex Skin Infections
•
Sino-US firm MicuRx Pharmaceuticals Inc. has announced the initiation of a Phase III clinical study for its drug candidate MRX-4, focusing on the treatment of complex skin and soft tissue infections in China. The multi-center, randomized, double-blind, double-simulation Phase III trial aims to assess the safety and efficacy of MRX-4…
-
Genexine’s Eftansomatropin Alfa Achieves Phase III Endpoints in Growth Hormone Deficiency Trial
•
South Korea-based Genexine (KOSDAQ: 095700) has announced that its long-acting growth hormone product candidate, eftansomatropin alfa (GX-H9; TJ101), has achieved Phase III endpoints in a clinical trial conducted in China. The study, CTJ101PGHD301, demonstrated the safety and efficacy of the drug in children with growth hormone deficiency. Eftansomatropin Alfa’s Efficacy…
-
AstraZeneca’s Soliris Gains Approval for Pediatric Generalized Myasthenia Gravis in Japan
•
UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced last week that it has received an indication extension approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its orphan drug Soliris (eculizumab). The drug is now approved as a treatment for generalized myasthenia gravis (gMG) in pediatric patients who…
-
AstraZeneca and Daiichi Sankyo’s Enhertu Earns Two BTDs for HER2+ Malignancies
•
The US Food and Drug Administration (FDA) has granted AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) two breakthrough therapy designations (BTDs) for their co-developed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan). This recognition is for its potential as a therapy for HER2-positive malignancies, including unresectable or metastatic solid tumors…
-
Bayer Funds Landmark Trials for Kerendia in Heart Failure Treatment Expansion
•
Germany-based pharmaceutical company Bayer (ETR: BAYN) has announced funding for three investigator-sponsored collaborative studies aimed at expanding its late-stage clinical development program of the mineralocorticoid receptor antagonist (MRA) Kerendia (finerenone) for heart failure (HF). These new trials will broaden the patient pool to include those with reduced (HfrEF), mildly reduced…
-
EMA and FDA Review AbbVie’s Skyrizi for Ulcerative Colitis Indication Extension
•
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have accepted for review indication extension filings for AbbVie’s (NYSE: ABBV) interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab) for the treatment of moderately to severely active ulcerative colitis (UC). This development marks a further expansion of Skyrizi’s potential applications…
-
Shandong Buchang Pharmaceuticals’ BC001 for mCRC Accepted for Review by NMPA
•
Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted a clinical trial filing for its investigational injectable product BC001. The product is intended for use in first and second-line metastatic colorectal cancer (mCRC) patients who have experienced…
-
Sirnaomics’ STP707 siRNA Drug Shows Promising Results in Phase I Solid Tumor Study
•
Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) has revealed that all patients have been dosed in a Phase I clinical study for its siRNA drug candidate STP707, which targets multiple solid tumors. The study is designed to assess the safety, tolerability, and anti-tumor activity of STP707 in six dose…
-
Servier Group’s Pancreatic Cancer Therapy Onivyde Launches in Major Chinese Cities
•
France-based Servier has announced the first prescriptions for its pancreatic cancer therapy, Onivyde (irinotecan), in 10 hospitals across major cities in China, including Tianjin, Beijing, Shanghai, Nanjing, Fuzhou, and Guangzhou. The drug is used to treat metastatic pancreatic cancer after gemcitabine treatment, in combination with 5-fluorouracil (5-FU) plus leucovorin (LV).…
-
Pfizer and BioNTech Receive Positive CHMP Opinion for Comirnaty Vaccine
•
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on the Omicron XBB.1.5-adapted monovalent version of the SARS-CoV-2 vaccine Comirnaty, developed in partnership by Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX). The vaccine is intended for use in children…
-
Dizal Pharmaceutical’s Golidocitinib Earns Priority Review for r/r PTCL Treatment in China
•
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that its drug golidocitinib has been included in the priority review list for the treatment of recurrent or refractory peripheral T-cell lymphoma (r/r PTCL) in patients who have received at least one standard treatment. The priority status indicates the drug’s filing…
-
AIM Vaccine Co., Ltd Launches Phase III Trial for 23-Valent Pneumococcal Vaccine
•
China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced the commencement of a Phase III clinical study for its 23-valent pneumococcal polysaccharide vaccine. The study is designed as a randomized, blind, similar vaccine-controlled trial, expected to enroll 1920 healthy subjects aged two years and older. Targeting Invasive Pneumococcal DiseasesThe 23-valent…
-
CSPC Pharmaceutical’s Biosimilar Ozempic Equivalent Gets NMPA Clinical Trial Approval
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its biosimilar version of Novo Nordisk’s (NYSE: NVO) GLP-1 analog Ozempic (semaglutide) has obtained clinical trial approval from the National Medical Products Administration (NMPA). The upcoming trial will assess the use of CSPC’s biosimilar in maintaining blood sugar control in…
-
Jiangsu Yahong Meditech Gets NMPA Approval for APL1401 Ulcerative Colitis Trial
•
Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176), a specialist in urogenital cancer based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib clinical study for its drug candidate APL1401. The study, which is set to be a…
-
Roche’s Evrysdi Receives EC Approval for Expanded Indication in Infants with SMA
•
Swiss pharmaceutical giant Roche (SWX: ROG) has received regulatory approval from the European Commission (EC) for an indication extension of its SMN2 splicing modifier Evrysdi (risdiplam). The drug is now approved for infants up to 2 months of age with a clinical diagnosis of spinal muscular atrophy (SMA) type 1,…
-
MSD’s Keytruda Gains EC Approval for First-Line HER2-Positive Gastric Cancer Treatment
•
The European Commission (EC) has granted an additional indication to Merck, Sharp & Dohme (MSD; NYSE: MRK) for its blockbuster drug Keytruda (pembrolizumab). The drug is now approved in combination with trastuzumab, originator Roche’s (SWX: ROG) Herceptin, and chemotherapy as a first-line therapy against locally advanced unresectable or metastatic HER2-positive…
-
BMS’ Reblozyl Expands Indication to Include First-Line MDS-Related Anemia Treatment
•
Bristol-Myers Squibb (BMS; NYSE: BMY) has received an indication extension approval from the US Food and Drug Administration (FDA) for its first-in-class drug Reblozyl (luspatercept). The drug is now approved as a first-line treatment for low- to intermediate-risk myelodysplastic syndromes (MDS)-related anemia in adults who may require regular red blood…
-
Bayer Initiates US Recall of TRK Inhibitor Vitrakvi Due to Mold Contamination
•
Germany-based Bayer (ETR: BAYN) has announced a voluntary recall of a specific lot of its tropomyosin receptor kinase (TRK) inhibitor Vitrakvi (larotrectinib) in the US market following the detection of contamination by the Penicillium brevicompactum mold in the oral solution. While no adverse events have been reported, Bayer has advised…
-
Latin America Accelerates COVID-19 Fight with Vaccine and Treatment Initiatives Across the Region
•
Latin America is ramping up its contributions to the worldwide race for COVID-19 vaccines and treatments. Cuba’s state-owned BioCubaFarma, through its Center for Genetic Engineering and Biotechnology (CIGB), has designed a vaccine candidate and is advancing its development in collaboration with China’s Research and Development Center in Yongzhou, Hunan’s Industrial…
-
Genscript’s CAR-T Therapy JNJ-4528 Demonstrates 100% Effective Rate in Long-Term Myeloma Study
•
Genscript Biotech Corporation (HKG: 1548), a leading China-based Contract Development and Manufacturing Organization (CDMO), has announced the publication of long-term follow-up data from the Phase 1b/2 study, CARTITUDE-1. The study, conducted in partnership with Janssen Pharmaceutical, focuses on the chimeric antigen receptor (CAR)-cell therapy JNJ-4528 for the treatment of recurrent…
-
Innovent Biologics and Eli Lilly & Co.’s Tyvyt Achieves Primary Endpoints in Phase II ESCC Clinical Study
•
Innovent Biologics (HKG: 1801), a prominent biotech firm headquartered in Suzhou, China, and Eli Lilly & Co. (Nasdaq: LLY), a titan of the US pharmaceutical industry, have jointly declared a significant milestone in the Phase II clinical study known as ORIENT-2. The study focuses on the co-developed anti-programmed death-1 (PD-1)…
-
Zai Lab’s Optune Approved by China’s NMPA, Offering New Hope for Glioblastoma Patients
•
Zai Lab Ltd (NASDAQ: ZLAB), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) for its innovative therapeutic device, Optune. This tumor treating fields (TTFields) product is now cleared for use in newly diagnosed glioblastoma in combination with temozolomide, and as a monotherapy…
-
Shanghai Roche Pharmaceuticals Launches Erlotinib for Advanced Non-Small Cell Lung Cancer in China
•
Shanghai Roche Pharmaceuticals Ltd. made headlines in March with the launch of its lung cancer treatment, Erlotinib, in the Chinese market. This targeted therapy is designed for patients with advanced non-small cell lung cancer (NSCLC) that has continued to progress despite standard chemotherapy. Erlotinib’s mechanism of action involves the specific…
