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Apeiron Therapeutics Initiates Phase Ia/B Study for GTA182 in Solid Tumors with MTAP Deficiency
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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…
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Epigenic Therapeutics Receives Approval for EPI-003 Clinical Study in New Zealand
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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,…
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Betta Pharmaceuticals’ MCLA-129 Approved for Clinical Trial in Advanced Solid Tumors
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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,…
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Xeltis AG Enrolls First Patient in US Pivotal Trial for aXess with FDA BTD Status
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Holland-based Xeltis AG has announced the enrollment of the first patient in a US-staged pivotal trial for its flagship product, aXess, which has been granted Breakthrough Device Designation (BTD) status by the US FDA. This marks a significant milestone in the development and potential approval of aXess, a novel medical…
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Huadong Medicine’s DR10624 Receives NMPA Approval for MAFLD and MASH Clinical Trials
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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…
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Huadong Medicine’s HDM1005 Receives FDA Approval for MASH Clinical Study
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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…
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Beijing Wantai Receives NMPA Clearance for Nine-Valent HPV Vaccine Targeting Male Population
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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…
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Hasten Biopharmaceutical Initiates Phase III Clinical Trial for Lerodalcibep in China
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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…
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CanSino Biologics Initiates Phase I Clinical Trial for Freeze-Dried Hib Conjugate Vaccine
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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,…
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Sichuan Kelun-Biotech Secures NMPA Approval for Two Antibody Drug Conjugates
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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…
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Suzhou Ribo Life Science Receives EU Approval for Phase II Trial of RBD5044
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Suzhou Ribo Life Science Co., Ltd. and its subsidiary Ribocure Pharmaceuticals AB have announced that their novel siRNA drug, RBD5044, has received approval to commence Phase II clinical trials in the European Union. This represents a significant step forward in the development of RNA interference therapies targeting lipid metabolism. RBD5044:…
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Jiangsu Hengrui Receives NMPA Approval for SHR-2173 Clinical Trial in ITP
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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…
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Sino Biopharmaceutical’s TQB3002 Receives FDA Clearance for Phase I Study
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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…
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Mabwell Bioscience Receives NMPA Approval for 9MW2821 Clinical Trials
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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)…
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Jiangxi Jemincare’s JMX-2002 Liposome Injection Gets NMPA Clinical Clearance
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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…
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Lion TCR Gains NMPA Approval for mRNA TCR-T Therapy GZL-016 in HCC
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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…
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ImmuneOnco Initiates Phase II Study for IMM27M in ER+ Advanced Breast Cancer
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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…
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J&J MedTech Receives FDA IDE for OTTAVA Robotic Surgical System Trials
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US-based Johnson & Johnson MedTech (J&J, NYSE: JNJ) has announced that it has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA), allowing its OTTAVA robotic surgical system to commence clinical trials at various sites across the United States. This approval marks a significant step…
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CSPC Pharmaceutical Gains NMPA Approval for Clinical Trial of mRNA Vaccine SYS6026
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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…
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Frontera Therapeutics Receives FDA Approval for Phase II Study of FT-003 in nAMD
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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…
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Jiangsu Kanion Pharmaceutical Gets FDA Approval to Test KYS202004A for Psoriasis
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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…
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Jiangsu Hengrui Medicine Receives NMPA Clearance for Multiple Clinical Trials of Oncology Drugs
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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…
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Sichuan Biokin Pharmaceutical Gets FDA Approval for Phase I Study of BL-M17D1 in Solid Tumors
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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…
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Sichuan Huiyu Pharmaceutical’s HYP-6589 Receives NMPA Approval for Solid Tumor Clinical Trial
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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…
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Frontier Biotechnologies Inc. Gets NMPA Approval for Phase II Study of Albuvirtide as HIV Therapy
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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…
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HuidaGene Receives FDA Clinical Clearance for HG202 in Neovascular AMD Treatment
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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…
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Isap Biotech Secures FDA IND Approval for iSAP-0909 for Bladder Cancer Imaging
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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).…
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Jiuzhitang Co., Ltd Announces Clinical Clearance for Volagidemab in Type 1 Diabetes
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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.…
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Shenzhen Chipscreen Biosciences Receives NMPA Approval for Chiauranib Clinical Study
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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…
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Novartis’ Trispecific Antibody PIT565 Secures NMPA Approval for Clinical Trial
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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…
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Shenzhen Chipscreen Biosciences’ Tivozanib Secures NMPA Approval for ES-SCLC Phase III Trial
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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…
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Tasly Pharmaceuticals Gets FDA Approval for Acute Ischemic Stroke Cell Therapy Clinical Study
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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…
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Zhejiang Huahai Pharmaceutical Gets New Zealand Approval for Asthma Bispecific Antibody Trial
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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…
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Youcare Pharmaceutical Group Gets NMPA Approval for YKYY015 Phase I Study
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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…
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Akeso Biopharma Initiates Phase III Clinical Trial for PD-1/VEGF Bispecific Antibody Combination
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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…
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AIM Vaccine Secures NMPA Approval for mRNA Vaccine Targeting RSV
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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…
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Sunshine Guojian Pharmaceutical Secures NMPA Approval for Clinical Trials of SSGJ-626 in Lupus Indications
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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…
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Sun-Novo Pharmaceuticals Gets Green Light for CAR-T Therapy Clinical Trial in Lupus Treatment
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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…
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CSPC Pharmaceutical’s SYS6020 Receives NMPA Approval for Myasthenia Gravis Clinical Trial
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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,…
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Humanwell Healthcare Receives NMPA Approval for Chemically Synthesized Semaglutide Clinical Trial
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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…
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RiboX Therapeutics’ Circular RNA Therapy RXRG001 Gets FDA Green Light for Dry Mouth Clinical Trial
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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…
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Shanghai MicroPort Initiates Pre-Marketing Clinical Study for Embolic Microspheres in Liver Cancer Treatment
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), a Chinese medical technology company, has announced the commencement of a pre-marketing clinical study for its polyvinyl alcohol embolic microspheres. The company has completed the first pre-marketing clinical implantation in transcatheter arterial chemoembolization (TACE) surgery for left lobe lesions in patients with…
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Asieris Pharmaceuticals Gets FDA Green Light for USP1 Inhibitor APL-2302 in Advanced Solid Tumors
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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…
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Henlius Biotech Commences Global Phase III Trial for Serplulimab in First-Line Metastatic Colorectal Cancer
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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…
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ImmuneOnco Biopharmaceuticals Initiates Phase Ib Study for Dual-Target Therapy in Systemic Lupus Erythematosus
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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…
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Gan & Lee Pharmaceuticals Initiates Phase I Clinical Trial for Biosimilar Secukinumab
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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…
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Kanghong Pharmaceutical’s NASH Drug KH629 Approved for Clinical Trials in China
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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…
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Huadong Medicine Gets Green Light for HPK1 PROTAC Drug HDM2006 in Advanced Solid Tumors
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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…
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Jiangsu Hengrui Medicine Initiates Phase III Clinical Trial for SHR-A1904 in Gastric Cancer
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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…
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Westgene Biopharma’s Pioneering mRNA Vaccine for EBV-Related Tumors Clears IND Hurdle in China
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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…
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Kanghong Pharmaceutical’s NASH Drug KH629 Receives Clinical Trial Implicit Approval in China
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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).…
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Akeso Biopharma Launches Phase Ib/II Trial for Cadonilimab and AK112 in Pancreatic Cancer
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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,…
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Shenzhen Chipscreen Advances CS231295 for Cancer Treatment as IND Accepted by NMPA
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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:…
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Laekna Advances Obesity Treatment Candidate LAE102 with Subcutaneous Dosing in Phase I Study
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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…
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Alphamab Oncology and CSPC Pharma’s KN026 Phase III Trial for Breast Cancer Gets NMPA Approval
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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…
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Innovec Pharma’s IVB103 Gene Therapy for nAMD Receives Clinical Trial Approval from China’s CDE
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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…
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Hinova Pharmaceuticals Gets NMPA Green Light for HP568 Clinical Study in Breast Cancer
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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…
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Huadong Medicine Gets NMPA Green Light for BCMA-Targeted ADC HDM2027 Phase I/IIa Study
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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…
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Changchun High & New Technology Industries Receives FDA Tacit Approval for GenSci122 Clinical Study
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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…
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Humanwell Healthcare Secures NMPA Approval for Clinical Trial of HW211026 to Treat Actinic Keratosis
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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…
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United Laboratories’ TUL12101 Eye Drops Enter Phase IIa Clinical Trial for Dry Eye Syndrome
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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.…
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Sichuan Biokin Pharmaceutical Gets FDA Approval for CD33-Targeting ADC in Acute Myeloid Leukemia
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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…
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Reforgene Medicine’s Gene Editing Therapy RM-101 Clears IND Hurdle for Usher Syndrome Treatment
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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…
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Jiangsu Hengrui’s RGL-193 Receives NMPA Greenlight for Parkinson’s Disease Clinical Study
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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…
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CSPC Pharma Initiates Phase III Trial for JMT101 in First-Line EGFR-Positive NSCLC Treatment
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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…
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KangaBio’s KGX101 Receives NMPA Approval for Clinical Trial in China
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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…
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Juventas Cell Therapy’s CAR-T Therapy Clears for SLE-ITP Study in China
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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…
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Immupeutics Medicine Secures NMPA Approval for Personalized Liver Cancer Immunotherapy IPM001
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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…
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Huadong Medicine Secures NMPA Approval for Semaglutide Biosimilar, Aims to Capture Weight Loss Market
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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…
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Doma Biopharmaceutical Receives Green Light for Clinical Trial of Novel ADC DM001 Targeting Solid Tumors
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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…
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Boehringer Ingelheim’s Survodutide Earns FDA Breakthrough Therapy Designation for MASH Treatment
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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…
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Ascentage Pharma Receives Approval for Two Phase III Trials of APG-2449 in NSCLC
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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)…
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Unixell Advances in Cell Therapy with CDE IND Acceptance
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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…
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Duality Biotherapeutics’ BDCA2 ADC DB-2304 Phase I Trial Registered on ClinicalTrials.gov
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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…
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BeiGene’s FGFR2b ADC BG-C137 Enters Phase I Clinical Trial for Advanced Solid Tumors
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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…
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FRα ADC Rina-S by Genmab Enters Late-Stage Clinical Trial Following ProfoundBio Acquisition
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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…
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NMPA Clears AbbVie’s ABBV-706 for Clinical Trials Targeting SCLC and Neuroendocrine Tumors
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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…
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CStone Pharmaceuticals’ Partner HengRui Medicine Launches Phase III Trial for CTLA-4 Antibody in HCC
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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).…
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Sichuan Biokin’s Partner Bristol-Myers Squibb Gets FDA Nod for Bispecific ADC Study
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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…
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Yabao Pharmaceutical’s SY-009 Receives NMPA Approval for Phase II Clinical Trial in Constipation
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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…
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Jiangsu Hengrui Medicine Gets NMPA Green Light for Clinical Trial of TSLP-Targeted Asthma Treatment
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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…
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Huadong Medicine Gets NMPA Green Light for Clinical Trials of Roflumilast Cream
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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…
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Shanghai Fosun Pharmaceutical Gets NMPA Clinical Clearance for Lymphoma Drug XS-04
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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…
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Jacobio Pharma Receives NMPA Approval for Pan-KRAS Inhibitor JAB-23E73 Clinical Trial
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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…
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Zelgen Biopharmaceuticals Receives NMPA Approval for ZG005 Clinical Trial in Advanced Solid Tumors
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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…
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Jiangsu Hengrui Medicine Gets NMPA Green Light for Generic Vizamyl Clinical Trial
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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)…
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Allist Pharma’s Partner Abbisko Receives NMPA Green Light for NSCLC Drug Trial
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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…
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HBOW Bio’s First-in-Class Tumor Imaging Drug NC527-X Receives NMPA Clinical Trial Approval
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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…
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Shanghai Fudan-Zhangjiang Enrolls First Patient in U.S. Phase II Study for Port Wine Stain Treatment
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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),…
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Allist Pharmaceuticals’ EGFR Inhibitor AST2303 Approved for Clinical Trial in NSCLC by NMPA
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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…
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Sichuan Biokin’s Multi-Specific Antibody GNC-077 Gets NMPA Nod for Advanced Solid Tumor Clinical Trial
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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…
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SciClone Pharmaceuticals Gets NMPA Approval for Phase III Study of First-in-Class SERD Orserdu
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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,…
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ApolloBio’s HPV Therapeutic Vaccine VGX-3100 Gets NMPA Green Light for Clinical Trial
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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…
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Jacobio Pharma’s Pan-KRAS Inhibitor JAB-23E73 Clears FDA Hurdle for Clinical Trials
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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…
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Hybribio’s Chloroquine Phosphate Gel Cleared for Clinical Trial on High-Risk HPV Infections
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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…
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Yantai Dongcheng Pharmaceutical’s 18F-LNC1007 Receives Clinical Clearance for Solid Tumor Diagnostics
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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…
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Beijing’s Apollobio Receives NMPA Approval for HPV Therapeutic Vaccine VGX-3100
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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…
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Ascletis Pharma Initiates Phase I Trials for Monthly Subcutaneous and Daily Oral Obesity Treatment ASC30 in the US
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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…
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Shanghai Pharmaceuticals’ Dual-Targeting CAR-T Therapy Advances with IND Re-Acceptance
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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…
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Innovent Biologics Launches Phase I Clinical Trial for IBR822 Cell Injection Solution in Solid Tumors
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Innovent Biologics (Hangzhou) Co., Ltd (HKG: 1801, OTCMKTS: IVBXF), a biopharmaceutical company based in China, has announced the successful initiation of a Phase I clinical trial for its proprietary IBR822 cell injection solution at Zhejiang Cancer Hospital. The trial, led by Professor Song Zhengbo from Zhejiang Cancer Hospital, is conducted…
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Suzhou GenAssist Launches First-of-Its-Kind Base Editing Drug Trial for Duchenne Muscular Dystrophy
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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…
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Nuance Pharma Completes Enrollment for Phase III COPD Trial of Ohtuvayre in China
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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…
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Duality Biotherapeutics Initiates Global Clinical Trial for DB-1419 in Advanced Solid Tumors
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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…
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Vcanbio’s Stem Cell Therapy VUM02 Gets NMPA Approval for Systemic Sclerosis Clinical Trial
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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…
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Akeso’s Ivonescimab Shows Promising Results in Phase III Clinical Trial for Hepatocellular Carcinoma
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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…
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Sinocelltech’s Herpes Zoster Vaccine SCTV04C Clears NMPA for Clinical Trial
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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…
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Jiangsu Kanion Pharmaceutical Gets NMPA Go-Ahead for Psoriasis Drug Clinical Trial
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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…
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Venus Medtech Initiates Global Study with Venus Vitae TAVR System Implantations
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Venus Medtech (Hangzhou) Inc., listed on the Hong Kong Stock Exchange as HKG: 2500, has reached a significant milestone with the implantation of its next-generation transcatheter aortic valve replacement (TAVR) system, Venus Vitae, in two patients as part of the global, multi-center pivotal SMART-ALIGN study. This prospective, randomized, interventional study…
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Humanwell Healthcare’s Innovative Drug for Solid Tumors Gets Green Light from NMPA
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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…
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Henlius Biotech’s HLX17 Biosimilar to MSD’s Keytruda Wins NMPA Clinical Trial Approval
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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…
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GeneQuantum Healthcare’s GQ1005 ADC Receives CDE Clearance for Phase III Breast Cancer Trial
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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…
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Sinocelltech’s Anti-Angiogenic Biologic SCT520FF Gets NMPA Green Light for Neovascular AMD Clinical Study
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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…
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AccurEdit Therapeutics’ Gene-Editing Drug ART001 Clears FDA Hurdle for US Clinical Trials
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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…
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Bio-Thera Solutions’ BAT2406 Biosimilar Gets Green Light for Clinical Trials in China
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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…
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Doma Biopharmaceutical Receives FDA Clearance for Phase I Trial of EGFR-MET Targeting ADC, DM005
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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…
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Jiyuan Biotechnology’s Stem Cell Therapy for Type 2 Diabetes Gains NMPA Tacit Approval for Clinical Trials
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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…
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Jiangsu Simcere and AnDiConBio’s Anti-Influenza Drug ADC189 Doses First Patient in Phase III Study
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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…
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Shanghai-Based ANEXT Commences Clinical Trials for Exosome Product ANEXT FIT CELL in Respiratory Conditions
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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…
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Hinova Pharmaceuticals’ HP515 Receives NMPA Approval for NASH Clinical Study
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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…
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Bio-Thera Solutions’ BAT8006 Receives NMPA Approval for Clinical Trial in Recurrent Ovarian Cancer Maintenance Therapy
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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…
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Shanghai Fudan-Zhangjiang Enrolls First Patient in Phase III Trial for TROP2 ADC FDA018 in TNBC
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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…
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China’s Guilin Sanjin Pharmaceutical Advances BC011 with NMPA Approval for Phase I Clinical Trial
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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,…
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Changchun High & New Technology Industries Receives FDA Approval for GenSci098 Clinical Trial in Thyroid Eye Disease
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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)…
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China’s CDE Approves Multitude Therapeutics’ AMT-676 for Clinical Study in Solid Tumors
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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…
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Mabwell Bioscience Initiates Phase III Trial for 9MW2821 Combo in Urothelial Carcinoma Following NMPA Clearance
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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…
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Jiangsu Simcere Pharmaceutical Gets NMPA Green Light for SIM0508 Clinical Trial in Advanced Solid Tumors
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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…
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Mabwell Bioscience Receives Approval for Phase III Trial of 9MW2821 in Cervical Cancer from China’s CDE
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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…
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Gene Cradle Initiates First Regulatory Gene Therapy Study in China for Late-Onset Pompe Disease
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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…
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Phase I Success for Shandong Xinhua’s OAB-14, Advancing to Phase IIa in Alzheimer’s Therapy
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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…
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Hunan Warrant Pharmaceutical’s ZG-002 Receives NMPA Approval for Clinical Trials in Plaque Psoriasis
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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…
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Everest Medicines Launches Trial for Personalized mRNA Cancer Vaccine EVM16 in Solid Tumors
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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…
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Sichuan Biokin Launches Phase III Trial for Bispecific ADC BL-B01D1 in Lung Cancer
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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…
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Staidson Launches Phase Ia Trial for STSP-0902 Injection in Oligoasthenozoospermia
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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…
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Jiangsu Hengrui Secures NMPA Approval for Clinical Trials of SHR-2106 in Primary Sjögren’s Syndrome
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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…
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Vimgreen Pharma Launches Phase II Trial for A2AR Antagonist VG081821AC in Parkinson’s Disease
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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…
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Ascentage Pharma Secures NMPA Approval for Phase III Trial of Lisaftoclax in MDS
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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…
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Hengrui Medicine Launches Phase II Trial for SHR7280 to Treat Uterine Fibroids
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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…
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GSK Initiates Phase III Study for RSV Vaccine in China Following U.S. Approval
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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.…
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IASO Biotechnology’s CAR-T Therapy Fucaso Gets FDA Green Light for Lupus Treatment
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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…
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CSPC Pharmaceutical’s SYS6020 Receives NMPA Approval for Clinical Trials in Systemic Lupus Erythematosus
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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),…
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Lee’s Pharma Subsidiary Receives Green Light for Phase III Dry Eye Study and Completes Myopia Trial
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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…
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Jiangsu Hengrui Medicine Gains NMPA Approval for Five Drug Candidates, Including IL-17A mAb for Psoriasis
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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…
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WestGene Biopharma’s EB Virus-Targeting mRNA Vaccine WGc-043 Clears for Clinical Trials in China
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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…
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Insilico Medicine’s ISM6331 Earns FDA Orphan Drug Designation for Mesothelioma Treatment
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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…
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Haisco Pharmaceutical’s PDE4B Inhibitor HSK44459 Gets NMPA Green Light for Interstitial Lung Disease Clinical Trial
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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…
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Akeso Biopharma Initiates Phase III Clinical Trial for Cadonilimab in Hepatocellular Carcinoma
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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…
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Hotgen Biotech’s SGC001 Receives NMPA Approval for Clinical Trials in Myocardial Infarction
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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…
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Suzhou Zelgen Biopharmaceuticals’ ZG005 Receives NMPA Approval for Clinical Trials in Solid Tumors
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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…
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Gan & Lee Pharmaceuticals Gets FDA Green Light for Phase I Clinical Trial of Insulin Aspart Biosimilar
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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…
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Luye Pharma’s LY03020 Receives NMPA Approval for Schizophrenia and Alzheimer’s Psychosis Treatment
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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…
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Degen Biopharmaceutical’s DG01 PROTAC Drug Receives NMPA Clearance for Solid Tumor Studies
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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…
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Yantai Dongcheng Pharmaceutical Secures NMPA Nod for PSMA-Targeted Radiotherapeutic Drug
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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…
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Innovent Biologics and Sanegene Bio Commence Phase I Clinical Trial for Hypertension siRNA Drug
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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…
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Akeso Biopharma Initiates Phase II Global Study for Ligafulimab in High-Risk MDS
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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…
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Lee’s Pharmaceutical Commences Phase I Clinical Trial for AI-Discovered HCC Drug AU409
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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…
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Tonghua Dongbao Pharmaceuticals Launches Phase III Clinical Trial for Semaglutide Biosimilar in China
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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,…
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Jiangsu Hengrui Medicine Receives NMPA Approval for SHR-A1921 Clinical Study in Advanced Solid Tumors
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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…
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Sinqi Pharmaceutical Gets NMPA Green Light for SQ-22031 Eye Drops to Treat Dry Eye Syndrome and Neurotrophic Keratitis
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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…
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China’s NMPA Gives Tacit Nod to IASO Biotechnology’s IASO-782 for SLE Clinical Trials
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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…
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Luye Pharma’s Subsidiary Gets NMPA Go-Ahead for First CD228-Targeted ADC BA1302
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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…
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Hainan Poly Pharm’s Novel Nanomedicine PLAT001 Cleared for Clinical Trial by NMPA
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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.…
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Hinova Pharmaceuticals Receives NMPA Approval to Test Myelofibrosis Drug Candidate HP560
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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,…
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IASO Biotechnology’s CAR-T Therapy Fucaso Receives FDA IND Approval for Multiple Sclerosis
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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…
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ST Phi Therapeutics’ Universal Cell Therapy for Solid Tumors Gets Green Light for Clinical Trial in China
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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…
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Innorna’s Herpes Zoster mRNA Vaccine IN001 Receives Clinical Trial Approval in China
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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…
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Bayer’s BAY 3375968 Receives NMPA Approval for Clinical Trial in Advanced Solid Tumors
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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…
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Chipscreen’s HDAC Inhibitor Chidamide to be Tested in Combination Therapy for CRC by NMPA
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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…
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RemeGen’s Telitacicept Earns Full NMPA Approval for RA Treatment and PMN Clinical Study Green Light
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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…
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AccurEdit Therapeutics Receives CDE Approval for Gene Editing Drug ART001 Targeting Amyloidosis
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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…
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Jiangsu Hengrui Receives NMPA Approval to Study CDK 4/6 Inhibitor Dalpiciclib in Combination with HRS-1358 for Breast Cancer
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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…
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Anhui Anke Biotechnology Receives NMPA Clearance for Clinical Trial of mRNA Drug AFN0328 for HPV-Related Cancers
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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…
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Consun Pharmaceutical Gets NMPA Go-Ahead for CKD Drug Clinical Trial
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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…
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BeiGene Receives NMPA Greenlight for BG-C9074 Clinical Trial in Advanced Solid Tumors
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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…
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Celling Biotechnology’s CEL001 Earns Tacit Approval for Clinical Trials in China
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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…
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Betta Pharmaceuticals’ EYP-1901 Implant Secures NMPA Clinical Trial Nod for Wet AMD
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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…
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Shenzhen Tyercan Bio-Pharma’s TYE1001 Earns Tacit IND Approval from FDA for Advanced Solid Tumors
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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…
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Mabwell Bioscience Receives NMPA Approval for Phase II TNBC Clinical Trial of 9MW2821
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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…
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Eisai’s Next-Gen SERD, Orserdu, Begins Real-World Study in Shanghai Ruijin Hospital’s Hainan Subsidiary
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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…
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Jiangsu Hengrui’s Subsidiary Conducts First Surgical Dosing in Parkinson’s Gene Therapy Clinical Trial
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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…
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Shanghai Escugen Initiates Phase III Clinical Trial for Breast Cancer Drug Candidate ESG401
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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-)…
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Sichuan Biokin Pharmaceutical Gets NMPA Approval for BL-M14D1 Clinical Trial in Solid Tumors
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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…
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Beijing Sun-Novo Gets NMPA Green Light for STC008 Clinical Trial in Tumor Cachexia
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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…
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Shanghai Vitalgen BioPharma Launches Phase I/II Gene Therapy Trial for Parkinson’s Disease
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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…
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Suzhou Sanegene Bio Receives NMPA Approval for Clinical Trial of Antihypertensive siRNA Drug
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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,…
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Staidson Pharmaceutical Gets NMPA Green Light for Neurotrophic Keratitis Eye Drop Clinical Trial
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Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a biopharmaceutical company based in China, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its investigational STSP-0902 eye drops, which are intended for the treatment of neurotrophic keratitis (NK). Neurotrophic keratitis, also referred to as…
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Shandong Buchang Pharmaceuticals Receives NMPA Approval for BC008-1A Biologic Product Clinical Trial
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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…
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HOB Biotech Receives NMPA Approval for Clinical Trials of MM09 Sublingual Spray
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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…
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Shanghai Fosun Pharmaceutical Gets NMPA Green Light for FH-2001 and Serplulimab Combo Clinical Trial
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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…
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CSPC Pharmaceutical’s SYS6023 Receives FDA Approval for Clinical Study in Advanced Solid Tumors
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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.…
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Immorna Therapeutics Earns FDA Approval for Phase I/II Clinical Trial of Self-Replicating RNA Cancer Therapy
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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…
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Hinova Pharmaceuticals’ HP537 Receives FDA Approval for Phase I/II Clinical Trial in Hematologic Malignancies
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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…
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Amoytop Biotech’s Peginterferon α-2b Receives NMPA Approval for Primary Thrombocytosis Clinical Trial
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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…
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Doma Biopharmaceutical’s Bispecific ADC DM001 Receives FDA Clearance for Clinical Trial
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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…
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Jiangsu Hengrui Medicine Gets NMPA Green Light for HRS-9813 IPF Clinical Trial
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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…
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Shanghai Henlius Biotech Advances Serplulimab Phase III Trial for First-Line Metastatic Colorectal Cancer
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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…
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Yantai Dongcheng Pharmaceutical’s 177LuLNC1011 Gets FDA Green Light for Prostate Cancer Clinical Trial
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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…
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SCG Cell Therapy Receives FDA Approval for HPV-Targeted SCG142 Clinical Trial
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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…
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Huadong Medicine’s ROR1-Targeting ADC HDM2005 Receives FDA Clinical Trial Approval
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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…
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IASO Biotherapeutics’ RD118 CAR-T Therapy Receives Clinical Trial Approval for Multiple Myeloma
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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…
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HighTide Therapeutics Completes Enrollment for Two Phase III Trials of T2DM Drug Candidate HTD1801
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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…
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CSPC Pharmaceutical’s BCMA-Targeted CAR-T Therapy SYS6020 Receives NMPA Clinical Trial Approval
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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…
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Staidson Pharmaceutical Gets FDA Clearance for TNFR2-Targeted mAb SBT-1901
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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…
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Asieris Pharmaceuticals Gets NMPA Green Light for APL-1202 Clinical Trial in FLA Infections
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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…
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ImmuneOnco Biopharmaceuticals Receives NMPA Approval for CD47 and CD20 Dual-Targeted BsAb in SLE
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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…
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Sichuan Biokin Pharmaceutical Gets NMPA Go-Ahead for BL-M17D1 Solid Tumor Clinical Study
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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.…
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StarryGene Initiates Phase I Clinical Trial for XMVA09 Gene Therapy in wAMD
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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…
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Zhangzhou Pien Tze Huang’s PZH2113 Receives NMPA Clinical Trial Approval for Lymphoma Treatment
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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…
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Tonghua Dongbao Pharmaceuticals’ THDBH120 Receives NMPA Approval for Phase II Clinical Trial
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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…
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Fudan-Zhangjiang Bio-Pharmaceutical Advances Aminolevulinic Acid Study for Glioma Visualization
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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…
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AstraZeneca’s AKT Inhibitor Truqap Misses Primary Endpoints in Phase III TNBC Trial
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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…
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Kintor Pharmaceutical Initiates Phase II Clinical Trial for Acne Treatment GT20029 in China
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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,…
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RemeGen’s Telitacicept Receives NMPA Approval for Clinical Trial in IgG4 Related Diseases
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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…
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Jiangsu Hengrui Medicine Gets NMPA Green Light for Breast Cancer Drug Combo
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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…
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Shenzhen Chipscreen Biosciences Receives NMPA Approval for Chiauranib Phase II Trial in Pancreatic Cancer
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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…
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Sichuan Kelun-Biotech Receives NMPA Clearance for SKB518 Clinical Trial in Solid Tumors
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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…
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Haisco Pharmaceutical’s BRAF Inhibitor HSK42360 Gains NMPA Approval for Clinical Trials
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653), a leading pharmaceutical company based in China, has announced that it has secured another clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug HSK42360. This BRAF V600 inhibitor is now poised to be evaluated in clinical trials for…
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AbbVie-Calico Partnership Advances with FDA Approval for Fosigotifator Trial in Rare Brain Disorder
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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)…
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SinoMab BioScience’s SM17 Atopic Dermatitis Drug Reaches First Patient Milestone in Phase Ib Trial
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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,…
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Ascentage Pharma Gets Green Light for Global Phase III Trial of Olverembatinib in SDH-Deficient GIST
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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…
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InnoCare Pharma’s TYK2 Inhibitor ICP-332 Receives FDA IND Approval for Atopic Dermatitis
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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…
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AI-Powered Biotech Insilico Medicine Initiates Phase I Clinical Trial for Inflammatory Bowel Disease Drug
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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…
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HutchMed Initiates Phase I Clinical Trial for HMPL-506 in Hematologic Malignancies
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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…
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Jiangsu Hengrui Receives NMPA Approval to Begin Clinical Trials for New Anticancer Biologic
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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,…
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Olymvax Bio Receives Ethical Approval for Oral Helicobacter pylori Vaccine Trial in Australia
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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.…
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Sanofi Receives NMPA Approval for Phase III Clinical Trial of RSV Vaccine SP0125
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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…
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Huadong Medicine’s ROR1-Targeting ADC HDM2005 Cleared for Clinical Trials by China’s NMPA
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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…
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ImmuneOnco Receives NMPA Approval for Phase III Clinical Trial of Timdarpacept in CMML
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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…
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Hengrui Medicine Advances Two Drug Candidates Following NMPA Clinical Trial Green Lights
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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…
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Laekna Therapeutics Initiates Phase III Trial for Breast Cancer Candidate LAE002 in Combination with Fulvestrant
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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,…
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Jiangsu QYuns Therapeutics Initiates Phase III Trial for Skin Disease Candidate QX005N
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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…
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Zelgen Biopharmaceuticals Gets NMPA Approval for Jacktinib Vitiligo Trial in Adolescents and Adults
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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.…
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Hengrui Medicine’s Vitiligo Treatment SHR0302 and Diabetes Drug HRS9531 Get Green Light from China’s NMPA
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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…
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Full-Life Technologies Receives FDA Green Light for ²²⁵Ac-FL-020 Clinical Study in mCRPC
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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…
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Hotgen Biotech Receives FDA Approval to Begin Clinical Trials for Acute Myocardial Infarction Drug
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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…
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Hotgen Biotech Receives FDA Clearance to Initiate Clinical Trials for SGC001
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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…
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Yantai Dongcheng Pharmaceutical Receives NMPA Approval for SSTR2 Targeted Radioactive Drug
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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…
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Kexing Pharmaceutical Secures NMPA Approval for Childhood Growth Hormone Deficiency Study
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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…
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Bio-Thera Solutions Receives NMPA Approval for BAT6005 and BAT1308 Combination Therapy Trial
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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…
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Roche’s Genentech Gets Green Light for Vixarelimab UC Clinical Trial in China
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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…
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NK CellTech’s NK-Cell Therapy Gets Green Light from China’s NMPA for Solid Tumor Treatment
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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…
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Laekna Therapeutics’ mCRPC Drug Combo Advances to Phase III with FDA Approval
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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…
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Changchun High & New Technology Industries Gets Green Light for Jinnamab Clinical Trial
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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…
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Sichuan Biokin’s BL-B01D1 Advances to Phase III for HR+/HER2- Breast Cancer
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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…
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Alphamab Oncology’s JSKN016 Begins Phase I Clinical Trial for Solid Tumor Treatment
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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…
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Jiangsu Hengrui’s SHR1905 Anti-TSLP mAb Gets Green Light for COPD Clinical Trial
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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…
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ImmuneOnco Biopharmaceuticals’ CD47 Inhibitor Receives NMPA Go-Ahead for Phase III Trial
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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…
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Bayer’s 225Ac-PSMA-Trillium Therapy Begins Early-Stage Clinical Trial for mCRPC
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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…
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Olymvax Biopharmaceuticals Gets Green Light for Tetravalent Influenza Vaccine Clinical Trial
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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…
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Insilico Medicine’s ISM8207 Enters Phase I Clinical Trial for Lymphoma and Solid Tumors
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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…
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Fosun Pharmaceutical Advances Lasofocine Clinical Trials for Breast Cancer after NMPA Nod
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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…
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Jiangsu Hengrui’s SHR-2173 Gets Green Light for Clinical Trial in IgA Nephropathy
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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…
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Tonghua Dongbao Pharmaceuticals Begins Clinical Trial for Xultophy Biosimilar
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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…
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RemeGen’s Telitacicept Achieves Full Enrollment in Phase III Primary Sjogren’s Syndrome Trial
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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…
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Roche and Genprex Initiate Phase I Trial Combining Tecentriq and Reqorsa for ES-SCLC
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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…
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HutchMed’s HMPL-306 Advances to Phase III Trial in R/R AML Patients
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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…
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Yunnan Baiyao’s Radiopharmaceutical INR101 Advances to Clinical Trial Stage with NMPA Approval
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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…
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Jacobio Pharma’s KRAS G12C Inhibitor Gains NMPA Approval for Phase III CRC Study
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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…
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WestGene Biopharma’s Groundbreaking mRNA Vaccine for EB Virus Tumors Gets FDA Green Light
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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…
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ReJuKon Biopharm’s RJK002 Earns Tacit Approval for Amyotrophic Lateral Sclerosis Clinical Trial
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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…
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Sichuan Biokin Pharmaceutical Advances BL-B16D1 to Clinical Trial for Advanced Solid Tumors
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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,…
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Jiangsu QYuns Therapeutics Gets NMPA Green Light for CSU Treatment QX013N
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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…
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Laekna’s ActRIIA Monoclonal Antibody LAE102 Gets Green Light from China’s CDE for Obesity Treatment
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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…
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Jiangsu Hengrui Medicine Advances HRS-5965 with NMPA Clinical Trial Approval for Glomerular Diseases
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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…
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Yantai Dongcheng Pharmaceutical’s Radiopharmaceutical 18F-LNC1007 Cleared for Australian Phase I Trial
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a Chinese pharmaceutical company, has announced that its radioactive diagnostic drug, 18F-LNC1007 injection, has successfully passed a safety review conducted by the US Food and Drug Administration (FDA). This clearance paves the way for the drug to commence a Phase I clinical…
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Sichuan Biokin’s EGFR/HER3 ADC Expands Phase II Clinical Program with NMPA Approval
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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…
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Tonghua Dongbao Pharmaceuticals Commences Phase IIa Trial for Dual-Targeted Gout Drug Candidate
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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…
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China’s CDE Gives Tacit Approval to Keymed Biosciences’ Alzheimer’s Drug CM383 for Clinical Trials
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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…
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Kelun-Biotech’s RET Inhibitor A400 Advances to Phase II Trial with FDA Approval
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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…
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Zhejiang Huahai Pharmaceutical Wins IND Approval for Antibody-Drug Conjugate from China’s NMPA
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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.…
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iRegene’s Pioneering Cell Therapy NouvNeu001 Administered in Wuhan for Parkinson’s Disease
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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…
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Chengdu Kanghong Pharmaceutical Gets US FDA Nod for Clinical Trial of KH658 for Wet AMD
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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…
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Yantai Dongcheng Pharmaceutical Receives NMPA Approval for Advanced Solid Tumor Therapy
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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…
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AbelZeta Pharma’s CAR-T Therapy C-CAR031 Receives Implicit Approval for Clinical Study in China
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Sino-US biotechnology company AbelZeta Pharma Inc., operating in Rockville, Maryland, and Shanghai, China, has received implicit approval for its autologous armored GPC3-targeted chimeric antigen receptor (CAR) T cell therapy, C-CAR031, developed by its subsidiary, Shanghai Cellular Biopharmaceutical Group Ltd. The therapy is intended for the treatment of GPC3+ advanced or…
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Wuhan Bio-Raid Biotechnology Secures NMPA Approval for First-in-Class CD99-Targeted CAR-T Therapy
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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…
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Shanghai Henlius Biotech Achieves First Patient Dosing in Phase I Trial for Fibrosis Treatment HLX6018
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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…
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Huadong Medicine’s HDM1005 Receives US FDA Clinical Trial Approval for Weight Management
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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…
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Jiangsu Hengrui Medicine Gets NMPA Go-Ahead for Camrelizumab Combination Therapy Study in Pancreatic Cancer
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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)…
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CanSino Biologics Receives NMPA Approval for Haemophilus influenzae type B (Hib) Conjugate Vaccine Clinical Trial
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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.…
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Hengrui Medicine Gets Green Light from NMPA for Two Anti-Cancer Drugs
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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…
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Sichuan Biokin Gets NMPA Green Light for BL-B01D1 ADC in NSCLC Clinical Trial
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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…
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ImmuneOnco Receives NMPA Approval for Phase III Clinical Trial of CD47 Inhibitor TIMDARPACEPT
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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.…
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Shanghai Henlius Biotech Advances TIGIT-Targeting HLX53 to Phase II Clinical Trial for Hepatocellular Carcinoma
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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…
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Innovent Biologics’ IBI133 Receives Tacit Approval for Clinical Trial from China’s CDE
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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…
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Kangtai Biological Receives NMPA Approval for 20-Valent Pneumococcal Vaccine Clinical Trial
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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…
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Sirnaomics Receives FDA Feedback on STP705 Development Plan for isSCC Treatment
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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…
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Sanofi Advances Phase I/II Trial of Trifunctional NK Cell Engager in Blood Cancers
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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…
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Keymed Biosciences Achieves First Dosing in Global Phase III Trial for Claudin 18.2 Targeting ADC
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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…
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Hengrui Medicine Gets NMPA Approval for Clinical Study of CDK 4/6 Inhibitor Combo in Breast Cancer
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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…
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Laekna’s Anti-ActRIIA Antibody LAE102 Clears FDA Hurdle for Obesity Treatment Trial
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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…
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Suzhou Zelgen Receives NMPA Approval for Jacktinib Cream Trial in Vitiligo Patients
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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…
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Haisco Pharmaceutical Gets NMPA Green Light for HSK31858 COPD Trial
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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…
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Yantai Dongcheng Secures Approval for Phase I Study of 68Ga-LNC1007 in Singapor
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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…
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Jiangsu Hengrui Secures NMPA Approval for Clinical Study of SHR-A2102 and SHR-8068 in Advanced Tumors
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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…
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Sichuan Biokin Pharmaceuticals Initiates Phase III Trial for BL-M05D1 in Esophageal Cancer
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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…
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Jiangsu Hengrui Medicine Advances Pipeline with NMPA Approvals for Three Drugs
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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…
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Jiangsu Hengrui Medicine Gains NMPA Approval for HRS-4642 Clinical Trial in KRAS G12D Mutated Tumors
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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…
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Gan & Lee Pharmaceuticals Commences Clinical Trial for Innovative GLP-1 Agonist GZR18
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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…
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Jiangsu Hengrui Medicine Secures IND Approvals for Two Drug Candidates from China’s NMPA
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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)…
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Abbisko Therapeutics Achieves Milestone in Global Phase III Trial for Pimicotinib in Tendon Sheath Giant Cell Tumor
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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…
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Huadong Medicine Gets NMPA Approval for Clinical Trial of FRα-Targeting ADC Elahere
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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…
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Hinova Pharmaceuticals Receives NMPA Greenlight for HP501 Clinical Trial in Gout Patients
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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…
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IASO Biotherapeutics Gains FDA Nod for Fucaso CAR-T Study in Myasthenia Gravis
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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.…
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Sichuan Biokin Secures NMPA Approval for Phase II Study of BL-M07D1 in Advanced Solid Tumors
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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…
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Shanghai Fosun Pharma and Meiji Seika Pharma Launch Phase III Studies for Anti-Infective Nacubactam
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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…
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Junshi Biosciences Gets Green Light for Global Phase III Study of Tifcemalimab Combination Therapy in LS-SCLC
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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…
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Novatim Immune Therapeutics’ KQ-2003 Gains Tacit Approval for POEMS Syndrome Clinical Trial in China
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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…
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IASO Biotherapeutics Gets NMPA Go-Ahead for BCMA-Targeted CAR-T Therapy Clinical Trial
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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…
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BeiGene and GenFleet Join Forces for DLBCL Trial Combining Brukinsa and GFH009
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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…
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Jiangsu Hengrui Receives NMPA Approval for SHR-7631 ADC Clinical Study in Solid Tumors
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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…
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Wuhan YZY Biopharma Initiates Phase II Study for M701 in Malignant Pleural Effusion Treatment
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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…
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Innovent Biologics Initiates Phase III Neoshot Study for MSI-H/dMMR Colon Cancer Treatment
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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…
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CanSino Biologics Launches Phase III Study for Menhycia Vaccine in Indonesia
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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…
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Grand Pharma Receives NMPA Approval for Global Phase III Study of RDC ITM-11 in GEP-NETs
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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,…
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Jenscare Scientific Completes Enrollment in Clinical Study for Mitral Valve Repair System
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Jenscare Scientific Co., Ltd (HKG: 9877), a leading structural heart disease device manufacturer headquartered in Ningbo, has announced the successful completion of patient enrollment in a confirmatory study for its flagship product, the JensClip transcatheter mitral valve repair and clamping system. The system is designed to address severe mitral regurgitation,…
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Lynk Pharmaceuticals Doses First Patient in Phase III Trial for Atopic Dermatitis Treatment
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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…
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HutchMed Launches Phase II/III Study for Sovleplenib in Autoimmune Hemolytic Anemia
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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…
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Antengene’s ATG-022 Advances to Dose Expansion Phase in Phase II CLINCH Study for Solid Tumors
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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…
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CSPC Pharmaceutical Secures NMPA Approval for Clinical Study of SYS6023 in Advanced Solid Tumors
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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…
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Jiangsu Hengrui Receives NMPA Approval for Phase Ib/II Study of HRS2398 in Advanced Solid Tumors
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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…
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CSPC Pharmaceutical Gets NMPA Greenlight for SYH2039 Clinical Study in Advanced Malignant Tumors
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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…
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China Medical System Gets Green Light for Phase III Clinical Trial of Opzelura in Atopic Dermatitis
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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…
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Sino Biopharmaceutical Advances Lanifibranor and TQA2225 into Late-Stage Clinical Trials for MASH
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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…
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Shanghai Henlius Initiates Phase I Trial for HLX42, an Innovative ADC Targeting EGFR
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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…
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Merck Plans Broader HPV Vaccine Development, Targeting African and Asian Populations
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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,…
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Allist Pharmaceuticals Secures NMPA Approval for Phase I Study of AST2169 Liposome in KRAS G12D Tumors
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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…
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Sichuan Biokin Gains NMPA Approval for Phase I Study of BL-M05D1 in Advanced Solid Tumors
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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…
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Bio-Thera Solutions Gets Green Light for Phase Ib/II Study of ADC BAT8008 in Advanced Solid Tumors
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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…
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Ji Xing Pharmaceuticals Gets CDE Green Light for Phase III Aficamten Study in nHCM
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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…
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Simcere Pharmaceutical Gets NMPA Approval for Clinical Study of Trispecific Antibody SIM0500
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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…
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Fosun Pharmaceutical Gets NMPA Green Light for Phase I Study of Fibrosis Drug HLX6018
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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…
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Sinocelltech Gains NMPA Approval for Clinical Study of SCTB35 in B-Cell Non-Hodgkin’s Lymphoma
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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…
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Huadong Medicine Secures NMPA Approval for HDM1005, Targeting Type 2 Diabetes and Obesity
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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…
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Simcere Secures FDA Approval for Clinical Study of Trispecific Antibody SIM0500 in Multiple Myeloma
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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…
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Shanghai Fosun Pharma Gets NMPA Green Light for Universal NK Cell Therapy GCK-01 Clinical Study
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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…
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Shanghai Fosun Pharma Gets NMPA Green Light for XS-02 Solid Tumor Clinical Study
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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…
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Shanghai RAAS Receives NMPA Approval to Initiate Clinical Trial for Hemophilia Preventive Treatment
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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…
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Bio-Thera Solutions Receives NMPA Approval for Three Cancer Treatments Including a Novel ADC
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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…
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Luye Pharma Initiates Phase III Clinical Trial for Irinotecan Liposome Injection in Small-Cell Lung Cancer
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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…
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Hengrui Medicine Gets NMPA Green Light for KRAS G12C Inhibitor Clinical Trial in Advanced Solid Tumors
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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…
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HitGen Secures CDE Approval for Lipisense IND Filing, Advancing Development for Dyslipidemia Treatment
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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…
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AIM Vaccine Advances Pneumococcal Vaccine and Initiates Phase II Meningococcal Study
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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…
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Shanghai Fosun Pharma’s GCK-01 CAR-NK Cell Therapy Gets Tacit Clinical Approval from China’s CDE
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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…
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Astellas Launches Late-Stage Trial in Japan for Nonhormonal Menopause Treatment
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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…
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Fosun Pharmaceutical Secures NMPA Approval for Phase II Study of FCN-338 and FCN-647 in Chronic Lymphocytic Leukemia
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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…
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Jiangsu Hengrui Receives NMPA Approval for HRS-1167 Clinical Trials in Advanced Solid Tumors
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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…
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Jenscare Scientific Achieves Milestone with First LuX-Valve Plus Implantation in Brazil
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Jenscare Scientific Co., Ltd (HKG: 9877), a leading structural heart disease device manufacturer headquartered in Ningbo, China, has announced the successful completion of the first clinical implantation surgery using its transjugular tricuspid valve replacement product, LuX-Valve Plus, in Brazil. This milestone marks a significant advancement for the company in the…
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AstraZeneca’s AZD0486 Receives NMPA Greenlight for Clinical Study in B-Cell Leukemia
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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…
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Shandong Buchang Pharmaceuticals Gets NMPA Greenlight for Phase I Study of BC001 in Solid Tumors
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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…
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Haisco Pharmaceutical Gets NMPA Greenlight for HSK39775 Solid Tumor Drug Candidate
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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…
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Everest Medicines Gets CDE Approval for Global Phase IIb Study of Zetomipzomib in Lupus Nephritis
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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).…
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Kelun-Biotech Launches Clinical Trials for SKB264, Triggering $75 Million Milestone Payment from MSD
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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…
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AstraZeneca Launches Phase I Trial for siRNA Therapy in Collaboration with Silence Therapeutics
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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,…
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Jiangsu Hengrui Receives NMPA Approval for Adjuvant Therapy Clinical Study of Adebrelimab in NSCLC
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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…
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Livzon Pharmaceutical Gets CDE Green Light for JP-1366 Reflux Esophagitis Clinical Study
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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…
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Hinova Pharmaceuticals’ HP537 Receives CDE Approval for Clinical Study in Hematologic Malignancies
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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…
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Zhongsheng Pharmaceutical Initiates Phase II Trials for Polypeptide Drug RAY1225 in Diabetes and Obesity
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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…
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Bayer Advances BAY3018250 into Phase II Trial Following Successful Phase I Completion
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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…
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Mabwell Bioscience Receives FDA Green Light for B7-H3 Targeting ADC 7MW3711
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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…
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Jacobio Pharma Gets CDE Green Light for Phase III Study Combining Gleevec Inhibitors in NSCLC
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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…
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Phanes Therapeutics’ PT886 Receives CDE Approval for Clinical Trials in Advanced Solid Tumors
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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…
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ImmunoTech Biopharm Gets NMPA Green Light for Clinical Study of aT19 Injection for B-ALL
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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…
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CMS Secures NMPA Approval for Clinical Trials of TYK2 Inhibitor CMS-D001 and GnRH Antagonist CMS-D002
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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…
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Sinovent Enrolls First Patient in Phase III Trial for Gout Drug XNW3009
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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…
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ChinaGene Secures CDE Approval for ZVS101e Gene Therapy Targeting Retinitis Pigmentosa
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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…
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Jiangsu Hengrui Receives NMPA Approval for Phase II Study of GLP-1 Agonist for Weight Loss
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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…
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Healthstar Medical Commences Phase III Clinical Trial for KC1036 in Esophageal Cancer
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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…
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Joincare Pharmaceuticals Gets Green Light for Semaglutide Biosimilar Clinical Trial
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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,…
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Chongqing Genrix Bio Pharmaceutical Gets NMPA Clearance for IL-4Rα mAb Candidate GR1802
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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…
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Sichuan’s Ancocare Gets FDA Green Light for Phase I/III Study of Oncolytic Virus in Neuroblastoma
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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…
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Yantai Dongcheng’s Radiopharmaceutical 68GaLNC1007 Gets FDA Nod for Diagnostic Use in Solid Tumors
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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…
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Shanghai Fosun Pharmaceutical Receives NMPA Approval for Phase II Study of FCN-338 for Light Chain Amyloidosis
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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…
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Roche Commences Phase II Trial of Repare Therapeutics’ ATR Inhibitor, Camonsertib, in Solid Tumors
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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…
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Biosion’s SIRPα-Targeting Monoclonal Antibody BSI-082 Clears US FDA Clinical Trial Hurdle
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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…
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IASO Biotechnology Secures NMPA Approval for Fucaso in Refractory Myasthenia Gravis
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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…
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MSD’s Keytruda Combines with PharmAbcine’s PMC-309 in Phase Ia/b Solid Tumor Trial
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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,…
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China Grand Pharmaceutical Gets NMPA Green Light for mRNA Cancer Vaccine ARC01 Phase I Study
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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…
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Lingyi Biotechnology’s Gene Therapy Candidate LY-M001 Gets FDA Green Light for Gaucher’s Disease
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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…
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Zhaoke Ophthalmology Secures NMPA Approval for Presbyopia Treatments Brimochol PF and CarbacholPF
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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…
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Harbour BioMed Gets FDA Green Light for Phase I Study of BsAb Targeting PD-L1 and CD40
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Harbour BioMed (HKG: 2142), a biotechnology company with operations in Suzhou, China, Cambridge in the US, and the Netherlands, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I study. The study will assess the safety, tolerability, pharmacokinetics, and anti-tumor…
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BriSTAR Immunotech’s LILRB4-Targeted Cell Therapy YTS104 Gets Tacit Approval for Clinical Trial in China
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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…
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Hansoh Pharmaceutical Gets NMPA Approval for Type 2 Diabetes and Obesity Drug Trial
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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…
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Abbott Initiates Clinical Study for Volt PFA System in Australia for Cardiac Arrhythmias
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Abbott (NYSE: ABT) has announced that the first patients have been treated with its Volt pulsed field ablation (PFA) system as part of a clinical study in Australia. The study is designed to evaluate the safety and effectiveness of the device in treating common cardiac arrhythmias such as atrial fibrillation…
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Tasly Pharmaceuticals Gets NMPA Go-Ahead for Clinical Trial of Stem Cell Therapy in Heart Failure
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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…
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Sinocelltech Granted NMPA Approval for Phase I Clinical Trial in Hematological Malignancies
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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…
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Luzhu Biotechnology’s LZ901 Herpes Zoster Vaccine Trial Fully Enrolls 26,000 Participants
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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…
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Beijing Aosaikang Initiates Phase III Trial for Advanced Gastric Cancer Treatment
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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…
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Shanghai-Based NK CellTech Earns FDA IND Clearance for Non-Genetically Modified NK Cell Therapy
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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…
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Hansoh Pharmaceutical Advances Schizophrenia Treatment with HS-10509 Clinical Trial Approval
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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
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Changchun High & New Technology Industries to Launch GenSci125 Phase I Trial in US
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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…
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Hengrui Medicine Receives NMPA Approval for Phase II Cervical Cancer Study
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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…
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Sino Biopharmaceutical Commences Phase III Trial for Semaglutide Biosimilar in China
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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…
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RemeGen’s MSLN-Targeted ADC RC88 Clears to Begin Phase I/IIa Study in China
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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…
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Hope Medicine Initiates Phase II Trial for HMI-115 in Endometriosis Treatment
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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…
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Neuboron Medtech Secures Clinical Trial Approval for First BNCT Drug in China
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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…
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Bayer’s Asklepios BioPharmaceutical Launches Phase II Trial for AAV Therapy in Heart Failure
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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…
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CanSino Biologics Enrolls First Patient in Phase I Trial of Innovative Polio Vaccine
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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…
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CSPC Pharmaceutical Secures FDA Approval for Clinical Study of JMT106 in GPC3-Positive Tumors
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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…
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CARsgen Therapeutics Gets NMPA Approval for CAR-T Therapy CT011 in Hepatocellular Carcinoma
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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…
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Simcere Pharmaceutical Group Gets NMPA Green Light for USP1 Inhibitor SIM0501
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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…
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Joincare Pharmaceutical’s Partner Fermion Gets NMPA Green Light for Pain Drug Clinical Study
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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…
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OBI Pharma Gets US FDA Green Light for TROP2 Targeting ADC Cancer Therapy Clinical Study
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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…
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Jiangxi Jemincare Group Receives Clinical Trial Approvals for Two Innovative Biologics in the US and China
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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…
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CSBIO’s Multi-Kinase Inhibitor CSCJC3456 Gets Green Light for Clinical Trials in Advanced Solid Tumors
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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…
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Aidea Pharmaceutical Receives NMPA Approval to Clinically Test HIV-1 Treatment ACC017
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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…
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Hengrui Medicine Gets NMPA Green Light for Phase Ib/II Study of SHR-A1921 Combo in Advanced Solid Tumors
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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…
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Jiangsu Hengrui Medicine Advances Novel Cancer Therapies with NMPA Clinical Trial Approval
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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…
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Shanghai BDgene Technology’s Thalassemia Gene Therapy BD211 Clears NMPA for Clinical Trials
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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…
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Belief BioMed Group Initiates Clinical Study for Hemophilia A Gene Therapy BBM-H803 in China
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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…
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ImmunoTech Biopharm Commences Patient Enrollment in Phase II Study for CAR-T-19 Injection
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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).…
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Innovent Biologics Initiates Phase III Trial for Mazdutide in Obesity Treatment
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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…
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Hainan Poly Pharm’s Novel Nanomedicine PLAT001 Gets US FDA Approval for Clinical Trials
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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,…
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Lepu Biotechnology Completes Enrollment for Phase IIb Trial of MRG003 in Nasopharyngeal Carcinoma
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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…
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Healthstar Medical Receives NMPA Go-Ahead for KC1036 Esophageal Cancer Study
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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,…
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Simcere Affiliate Xianbo Biotech Gets China Nod for CAR-T Therapy SNC109
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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…
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Shouyao Holdings Receives Ethical Approval for Phase III Study of ALK Inhibitor SY-3505
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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…
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Jiangxi Jemincare Group Secures Clinical Trial Approvals for Six Drugs in China and the US
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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…
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Asieris Pharmaceuticals Gets Australian Greenlight for Acinetobacter Infection Drug Trial
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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…
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Sino Biopharmaceutical Completes Enrollment for Phase III Trial of Anlotinib in Soft Tissue Sarcoma
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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…
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Jiangsu Nhwa Pharmaceutical Gets NMPA Green Light for Schizophrenia Drug Trial
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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…
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AstraZeneca Advances to Phase III with PD-1xTIGIT BsAb for Biliary Tract Cancer
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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…
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Jiangsu Hengrui Medicine Wins NMPA Approvals for SLE and Lymphoma Drug Candidates
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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…
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RemeGen’s Telitacicept Secures FDA Approval for Global Phase III Study in Primary Sjogren’s Syndrome
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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…
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RemeGen Ltd Receives FDA Clearance for MSLN-Targeting ADC RC88 in Gynecological Tumors
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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…
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Healthstar Medical Gets NMPA Approval for KC1036 Clinical Study in Juventus sarcoma
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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,…
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3SBio Subsidiary Gets Green Light for SSGJ-608 Ankylosing Spondylitis Study
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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)…
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Lynk Pharmaceuticals Initiates Phase III Clinical Trial for Rheumatoid Arthritis Drug in China
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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…
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Sirnaomics Ltd Granted FDA Approval for Phase I RSV mRNA Vaccine Study
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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,…
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Huadong Medicine Gets NMPA Green Light for Clinical Study of Ryzodeg Biosimilar
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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.…
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Bio-Thera Solutions Gets NMPA Green Light for PD-1 Inhibitor BAT1308 in Endometrial Cancer
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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…
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3D Medicines Initiates Phase III Trial for Envafolimab in NSCLC Patient
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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…
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China Medical System Gets NMPA Green Light for Phase III Vitiligo Study with Ruxolitinib Cream
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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…
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Clover Biopharmaceuticals Commences Phase I Trial for RSV Vaccine in Australia
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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…
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HutchMed’s Elunate-Tyvyt Combination Study for Renal Cell Carcinoma Completes Enrollment
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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…
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BMS Advances TIGITxCD96 Bispecific Antibody into Phase II Dose Expansion
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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,…
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Staidson Pharmaceutical Initiates Clinical Study for ARDS Treatment STSA-1002
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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…
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Skyline Therapeutics’ Gene Therapy SKG0201 for SMA Gets Green Light from China’s NMPA
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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…
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Chinese Biotech Precision Biotechnology Gets NMPA Green Light for Advanced Cancer Therapies
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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,…
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Mabwell Secures NMPA Approval for Phase III Study of ADC 9MW2821 in Urothelial Carcinoma
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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…
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Changchun BCHT Secures NMPA Approval for Freeze-Dried Human Rabies Vaccine Trials
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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…
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Shanghai Pharmaceuticals Gains NMPA Approval for WST04 Clinical Trials in Oncology
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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…
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Ascletis Pharma’s Denifanstat Advances to Phase III for Severe Acne Vulgaris Treatment
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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,…
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Yantai Dongcheng Pharmaceutical Gets NMPA Green Light for FAP-Targeting Radiotherapeutic Drug
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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…
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Simcere Pharmaceutical’s SIM0501 Receives FDA Approval for Advanced Solid Tumor Clinical Trial
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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…
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Worg Pharmaceuticals Gets FDA Approval for Phase II Graves’ Disease Study
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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…
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CARsgen Therapeutics Secures U.S. FDA Approval for CT071 Clinical Trials in Multiple Myeloma
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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…
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TG ImmunoPharma Secures U.S. FDA IND Approval for Promising mAb TGI-5 Targeting Multiple Cancers
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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…
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Insilico Medicine Launches Clinical Study for First-in-Class PHD Inhibitor ISM5411 in IBD
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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…
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Simcere Secures NMPA Approval for Edaravone Sublingual Tablets Targeting Post-Stroke Cognitive Impairment
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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…
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Jiangsu Hengrui Receives NMPA Approval for Esophageal Cancer and Breast Cancer Clinical Trials
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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…
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Healthstar Medical Launches Phase III Study for KC1036 in Advanced Esophageal Cancer
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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…
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Henlius Biotech Gets FDA Clearance for Clinical Study of PD-L1 Targeting ADC HLX43
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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…
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CSPC Pharmaceutical Gets NMPA Green Light for SYH2038 Solid Tumor Study
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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…
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Abbisko Therapeutics Launches Phase II Trial for Pimocitinib in Advanced Pancreatic Cancer
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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…
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Yantai Dongcheng Pharmaceutical Gets Green Light for Prostate Cancer Diagnostic Drug Trial
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a Chinese pharmaceutical company, has announced that it has received ethical approval from Beijing Hospital to conduct a Phase III clinical study. The study will assess the diagnostic efficacy of a radionuclide candidate, intended for use with positron emission tomography (PET) imaging,…
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Kintor Pharmaceutical’s KX-826 Shows Promising Results in Phase III AGA Clinical Trial
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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…
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Jiangsu Hengrui Medicine Receives NMPA Approval for Phase Ib/II Study of Dalpiciclib and HRS-8080
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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…
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Pyrotech Biotechnology’s PTT-936 Gets US FDA Clinical Trial Approval
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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…
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MicuRx Pharmaceuticals Secures NMPA Approval for MRX-4 and Contezolid Combination Therapy
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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…
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SCG Cell Therapy’s SCG101 Receives Tacit Approval for Cholangiocarcinoma Clinical Trial in China
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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…
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Hunan Warrant Pharmaceutical’s ZG-001 Approved for Clinical Trial by NMPA
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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…
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VivaVision Biotech Inc. Receives FDA Approval for VVN461 Phase II Clinical Trial
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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…
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CSPC Pharmaceutical Group Receives NMPA Approval for Phase II Clinical Study of ALMB-0168
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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…
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Fosun Pharmaceutical Secures Clinical Trial Approvals for VT-101 in China and the US
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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,…
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Hansoh Pharmaceutical’s HS-10511 Tablets for Hypertrophic Cardiomyopathy Cleared for Clinical Trials
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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…
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Clinical Research on rAAV Gene Drug ZS805 for Fabry Disease Launched by Zhishan Weixin
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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…
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Jiangsu Hengrui Medicine’ Subsidiary Shengdi Pharmaceuticals Receives NMPA Approval for HRS-9057
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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…
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Yantai Dongcheng Pharmaceutical Gets Singapore HSA Nod for Phase I Study of 177Lu-LNC1003
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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…
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Abbisko Therapeutics’ CD73 Inhibitor ABSK051 Clears for Phase I Clinical Trial in China
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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),…
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Abbisko Therapeutics Receives FDA Approval for Phase I Study of FGFR4 Inhibitor ABSK012
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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…
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Chengdu Kanghong Pharmaceutical’s KH629 Receives FDA Approval for NASH Clinical Trial
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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…
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RinuaGene Receives US FDA IND Approval for HPV-Associated Tumor mRNA Vaccine RG002
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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,…
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MicuRx Pharmaceuticals Secures Clinical Trial Approvals for MRX-4 and Contezolid in Multiple Countries
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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…
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Zhejiang Huahai Pharmaceutical’s HB0052 Receives US FDA IND Approval for Solid Tumors
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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…
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CSPC Pharmaceutical Group Gets NMPA Approval for SYS6011 Biologic Drug Clinical Study
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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…
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Shanghai Pharmaceuticals Gets NMPA Approval for Phase I Clinical Study of B019 CAR-T Cell Injection
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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…
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Hinova Pharmaceuticals’ HP518 Receives NMPA Approval for mCRPC Clinical Trial
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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…
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Sino Biopharmaceutical’s TQG3902 Injection Receives NMPA Approval for Septic Shock Clinical Trial
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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…
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Hainan Poly Pharm Receives FDA Approval for PL002 in Primary Liver Cancer Surgery
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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…
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Changchun BCHT Biotechnology Receives NMPA Approval for Anti-Tetanus Monoclonal Antibody Injection
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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…
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Shenzhen Chipscreen Biosciences Gets NMPA Approval for Phase I Study of CS32582 in Psoriasis
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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…
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Staidson Receives NMPA Approval for Clinical Trial of STSA-1301 in Primary Immune Thrombocytopenia
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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…
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Boan Biotech Enrolls First Patient in Phase III Study for Opdivo Biosimilar BA1104 in China
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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…
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CSPC Pharmaceutical Group Gains NMPA Approval for Bivalent COVID-19 mRNA Vaccine Study
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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…
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Alphamab Oncology and 3D Medicines Gain FDA Approval for Envafolimab Phase III Trial
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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…
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Fosun Pharma Gains NMPA Approval for Clinical Trials of HLX42 and HLX43 ADCs
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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:…
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TG ImmunoPharma’s Bispecific Antibody TGI-6 Approved for Phase I Clinical Study by NMPA
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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.…
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Abbisko Therapeutics Gets NMPA Approval for Phase I Study of ABSK112 in NSCLC
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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…
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Zhejiang Jianfeng Receives FDA Approval for JFAN-1001 Clinical Trial in NSCLC
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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…
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MicroPort CardioFlow Medtech Completes Clinical Implantations of Second-Generation TAVI Device
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MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), a spin-off of China-based MicroPort Scientific Corp (HKG: 0853), has announced the successful completion of seven clinical implantations of its second-generation transcatheter aortic valve implantation (TAVI) product, VitaFlow Liberty. The surgeries were performed in Denmark and Ireland, with all patients recovering well post-operation.…
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CSPC Pharmaceutical Gains NMPA Approval for Clinical Study of Bispecific Antibody NBL-028
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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…
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Shanghai Henlius Initiates Global Phase III Study for HanSiZhuang in LS-SCLC
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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…
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Fosun Pharma Gains NMPA Approval for Phase I Trial of XS-03 in Advanced Solid Tumors
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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…
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Cutia Therapeutics’ CU-20401 Completes Phase I Study for Obesity Treatment
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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…
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China Grand Pharma Initiates Phase III Trial for GPN00833 in Cataract Surgery Recovery
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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…
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Sihuan Pharmaceutical Gains NMPA Approval for Innovative Type 2 Diabetes Treatment
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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.…
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Yiling Pharmaceutical Gains NMPA Approval for XY0206 in AML Trial
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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…
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Chengdu Kanghong Receives FDA Nod for Clinical Trial of Novel Depression Therapy KH607
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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…
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Blue Sail Medical Enrolls First Patient in Study for Rapamycin-Coated Balloon Catheter
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China’s Blue Sail Medical Co., Ltd (SHE: 002382) has announced a significant milestone with the enrollment of the first patient in a prospective, multi-center, randomized controlled clinical study. The study is designed to assess the efficacy and safety of Blue Sail Medical’s rapamycin-coated balloon dilation catheter for arteriovenous fistula in…
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Vcanbio Receives NMPA Approval for Clinical Study of VUM02 in SR-aGvHD Treatment
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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…
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Skyline Therapeutics Gains NMPA Approval for SKG0106 in Neovascular AMD Treatment
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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…
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Boehringer Ingelheim’s Vitiligo Drug EI-001 Approved for Clinical Trials by NMPA
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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…
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MicuRx Pharmaceuticals Initiates Phase I Study for MRX-5 in Australia
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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…
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Simcere’s SIM0237 Receives NMPA Approval for Bladder Cancer Trial
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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…
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MicroPort CardioFlow Medtech’s Third-Generation TAVI Product Achieves Initial Clinical Success
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MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), a spin-off from China-based MicroPort Scientific Corp (HKG: 0853), has announced the successful completion of the first two clinical applications of its third-generation transcatheter aortic valve implantation (TAVI) product. This advanced medical device features a recyclable and controllable bend delivery system, which was…
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Fosun Pharma Initiates Phase III Trial for ET-26 Anesthetic in China
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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…
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Vcanbio Receives NMPA Approval for Stem Cell Therapy VUM02 Clinical Trial
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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…
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SciClone Pharmaceuticals Gains FDA Nod for Thymalfasin COVID-19 Vaccine Booster Study
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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…
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Sichuan Huiyu Pharmaceutical’s HYP2090PTSA Gains NMPA Approval for KRAS G12C Solid Tumors
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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…
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RemeGen Secures NMPA Approval for Phase II Study of Disitamab Vedotin in Breast Cancer
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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…
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Ascentage Pharma Initiates Phase III Study for APG-2575 and Calquence in CLL/SLL
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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…
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Kintor Pharmaceutical Secures NMPA Approval for Phase II Study of GT1708F in Idiopathic Pulmonary Fibrosis
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its Hedgehog/SMO inhibitor, GT1708F, targeting idiopathic pulmonary fibrosis (IPF). Understanding the Role of Hedgehog Signaling in IPF Recent research has highlighted the…
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Yiling Pharmaceutical Secures NMPA Approval for Phase I Study of G201-Na in Premenopausal Women
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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:…
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Roche’s Forimtamig Receives Tacit Approval for Multiple Myeloma Clinical Trials
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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…
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Jiangsu Hengrui Medicine Gets NMPA Approval for Anti-Tumor Drug Candidate SHR-2022
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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…
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Atom Bioscience Initiates Global Phase III Clinical Study for Gout Drug ABP-671
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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…
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GluBio Pharmaceutical’s GLB-002 Receives NMPA Approval for Clinical Trials in Hematological Tumors
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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)…
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Sichuan Biokin’s IZalontamab Gets US FDA Greenlight for NSCLC Clinical Study
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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…
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Transcenta Secures FDA Approval for Phase III Trial of Osemitamab
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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…
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Elpiscience Biopharmaceuticals Initiates Phase I Trial for Anti-LILRB2 Antibody ES009
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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…
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Tasly Pharmaceuticals Gets NMPA Approval for B1344 Clinical Study in NASH
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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…
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ImmuneOnco Initiates Phase I Trial for CD24-Targeted Monoclonal Antibody IMM47
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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…
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Mabwell Bioscience Initiates Phase Ib/II Study for Nectin-4 Targeting ADC 9MW2821
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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…
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LEO Pharma Initiates Phase III Clinical Trial for Delgocitinib in China
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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…
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United Laboratories Receives FDA Approval for Clinical Study of UBT251 for Obesity Treatment
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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…
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BioTroy Therapeutics Receives US FDA IND Approval for Anti-Tumor Drug BT02
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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…
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Sichuan Kelun-Biotech’s KL-A167 and SKB264 Gain Tacit Clinical Trial Approval in China
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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…
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Jiangsu Hengrui Medicine Secures NMPA Approvals for Two Cancer Drug Candidates
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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…
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AffaMed Therapeutics’ Luminate Receives Clinical Trial Approval for Dry AMD in China
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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…
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Hansoh Pharmaceutical Gets NMPA Approval for HS-20105 Clinical Study in Solid Tumors
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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…
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Hepagene Therapeutics’ HPG7233 Receives US FDA IND Approval for NASH Treatment
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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…
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Fosun Pharma’s Serplulimab Approved for Esophageal Squamous Cell Carcinoma and Grafalon for GvHD Study
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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…
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Suzhou Zelgen Biopharmaceuticals’ ZG005 Receives NMPA Approval for Solid Tumor Trial
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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…
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Hybio Pharmaceutical Gets NMPA Approval for COVID-19 Nasal Spray HY3000
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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…
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Jiangsu Hengrui Medicine Wins NMPA Approval for Two Novel Drug Candidates
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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…
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Eli Lilly Partners with Boundless Bio to Develop CHK1 Inhibitor for Solid Tumors
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Eli Lilly (NYSE: LLY) has announced a partnership with precision oncology specialist Boundless Bio to clinically develop Boundless’s CHK1-targeting small-molecule inhibitor (SMI) BBI-355 in combination with Lilly’s CDK4/6 inhibitor Verzenio (abemaciclib). This collaboration aims to target locally advanced or metastatic solid tumors with oncogene amplifications, with Boundless highlighting its candidate…
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Walvax Biotechnology Receives Indonesian FDA Approval for Phase III Pneumococcal Vaccine Trial
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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,…
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Sunshine Guojian Pharmaceutical Gets NMPA Approval for SSGJ-611 Phase II COPD Study
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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…
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Zhejiang Medicine Gets NMPA Approval for NCB003 Clinical Study for Advanced Solid Tumors
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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…
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Akeso Biopharma’s AK132 Receives Green Light for Clinical Trial in Advanced Solid Tumors
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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.…
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Chongqing Lummy Pharmaceutical’s Subsidiary Receives NMPA Approval for CUD002 mRNA Vaccine
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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…
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InnoCare Pharma and ArriVent Biopharma Partner on Clinical Study for Advanced NSCLC Treatment
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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…
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Boehringer Ingelheim Gets NMPA Approval for Brigimadlin Safety and Efficacy Study in China
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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…
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Gan & Lee Pharmaceuticals Initiates Phase II Clinical Study for Weekly Insulin GZR4
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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…
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HutchMed Advances Tazverik Phase II Trial for Follicular Lymphoma in China
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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…
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Jiangsu Hengrui Medicine Gets NMPA Approval for HRS-7450 Acute Ischemic Stroke Study
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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…
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SinoMab BioScience Receives NMPA Approval for Phase I Study of Atopic Dermatitis Drug SM17
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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…
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Haisco Pharmaceutical Gets NMPA Approval for HSK21542 Chronic Pruritus Clinical Study
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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…
