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Jiangsu Hengrui Pharmaceuticals Receives NMPA Clearance for HRS-4729 Peptide Drug
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced the receipt of clinical clearance from China’s National Medical Products Administration (NMPA) for its peptide drug HRS-4729. This development marks a significant step forward in the company’s pipeline of innovative drugs. HRS-4729: A Triple Agonist for Diabetes TreatmentHRS-4729 is a triple…
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AstraZeneca’s Lynparza Shows Sustained Improvements in OlympiA Phase III Study
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UK pharmaceutical major AstraZeneca (AZ; NASDAQ: AZN) has updated data from the Phase III OlympiA study for its PARP inhibitor Lynparza (olaparib) at the San Antonio Breast Cancer Symposium 2024 (SABCS). The study provides significant insights into the efficacy and safety of Lynparza in patients with germline BRCA-mutated (gBRCAm) HER2-negative…
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Sanofi Receives FDA Fast-Track Designation for Influenza and COVID-19 Combo Vaccine Candidates
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Sanofi (NASDAQ: SNY) has announced that it has received Fast-Track Designations from the US Food and Drug Administration (FDA) for its combination vaccine candidates aimed at preventing influenza and COVID-19 infections in individuals aged 50 and older. Details of the Combination Vaccine CandidatesOne of the combination vaccine candidates (NCT06695117) pairs…
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Eli Lilly’s Imlunestrant Reduces Disease Progression in ER+/HER2- Advanced Breast Cancer: EMBER-3 Study
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US pharmaceutical major Eli Lilly and Company (NYSE: LLY) has published results from the Phase III EMBER-3 study for its drug imlunestrant in patients with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (ABC). The study focused on patients whose disease progressed on…
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Arvinas and Pfizer Present Positive TACTIVE-U Sub-Study Data at SABCS 2024
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Partners Arvinas, Inc. (NASDAQ: ARVN) and Pfizer Inc. (NYSE: PFE) have jointly presented preliminary data from the ongoing Phase Ib portion of the TACTIVE-U sub-study at the 2024 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas. The study assesses vepdegestrant in combination with Verzenios (abemaciclib) in patients with…
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Novartis’ Kisqali Shows Sustained Efficacy in NATALEE Study at SABCS 2024
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Swiss pharmaceutical giant Novartis (NYSE: NVS) presented updated results from the pivotal Phase III NATALEE study for its Kisqali (ribociclib) at the 2024 San Antonio Breast Cancer Symposium (SABCS). The study provides significant insights into the efficacy of Kisqali in combination with endocrine therapy (ET) for patients with receptor-positive/human epidermal…
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Legend Biotech’s Carvykti Demonstrates High MRD Negativity Rates in Phase III CARTITUDE-4 Trial
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China-based Legend Biotech Corporation (NASDAQ: LEGN) has released new data on minimal residual disease (MRD) negativity rates from the Phase III CARTITUDE-4 trial at the 66th Annual American Society of Hematology (ASH) Annual Meeting. The trial compared Carvykti (ciltacabtagene autoleucel; cilta-cel) with the standard of care (SoC) in treating multiple…
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Huadong Medicine’s Arcalyst Receives NMPA Approval for Recurrent Pericarditis Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Arcalyst (rilonacept), a treatment for recurrent pericarditis (RP). This marks an expansion of the drug’s application in addressing autoimmune diseases. Rilonacept’s Mechanism and Global ApprovalsRilonacept is a recombinant…
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IMEIK Technology Receives NMPA Approval for Recombinant Human Hyaluronidase Clinical Study
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China-based IMEIK Technology Development Co., Ltd (SHE: 300896) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its recombinant human hyaluronidase for injection. The study aims to explore the use of the drug to promote the diffusion of subcutaneous infusion as an…
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Patronus Biotech’s RSV Vaccine LYB005 Receives NMPA Approval for Clinical Study
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Guangzhou Patronus Biotech Co., Ltd., a vaccine start-up specializing in respiratory and infectious diseases, has received approval from China’s National Medical Products Administration (NMPA) to initiate a clinical study for its recombinant respiratory syncytial virus (RSV) vaccine (CHO cells), LYB005. LYB005’s U-VLP Technology and Clinical ProgressLYB005 is an RSV vaccine…
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Shanghai Pharmaceuticals’ SRD4610 Receives FDA Orphan Drug Designation for ALS Treatment
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China’s Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607) has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its SRD4610, an in-house developed compound Chinese medicine, for the treatment of amyotrophic lateral sclerosis (ALS). This designation highlights the potential impact of SRD4610 in…
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Sperogenix Therapeutics’ Agamree Receives NMPA Approval for Duchenne Muscular Dystrophy Treatment
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China-based rare disease specialist Sperogenix Therapeutics Limited has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its drug Agamree (vamorolone), which is used to treat patients with Duchenne muscular dystrophy (DMD). This marks a significant milestone as Agamree becomes the first DMD drug approved in China,…
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Jiangsu Hengrui Pharmaceuticals Secures NMPA Approvals for SHR-4394 and HRS-3802 Clinical Trials
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving separate clinical trial approvals from China’s National Medical Products Administration (NMPA) for its two drug candidates, SHR-4394 and HRS-3802. SHR-4394: A Novel Therapeutic Biologic for Prostate CancerSHR-4394 is an in-house developed therapeutic biologic product, with its target undisclosed, currently under…
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Merck’s PD-1 Inhibitor Keytruda Approved by NMPA for Cervical Cancer Treatment in China
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US-based Merck, Sharp & Dohme Inc., (MSD, NYSE: MRK) has announced receiving marketing approval from China’s National Medical Products Administration (NMPA) for its PD-1 inhibitor Keytruda (pembrolizumab). The approval allows the use of Keytruda in combination with chemotherapy for International Federation of Obstetrics and Gynecology (FIGO) 2014 stage III-IVA cervical…
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MSD’s Noxafil Receives NMPA Approval for Pediatric Use in Antifungal Treatment
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US-based Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has announced that China’s National Medical Products Administration (NMPA) has approved an extended indication for its antifungal agent Noxafil (posaconazole) to include pediatric patients in the prevention and treatment of fungal infections. This approval covers two dosage forms: enteric-coated tablets and…
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NMPA Approves Zynlonta for Relapsed or Refractory Large B-Cell Lymphoma Treatment
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The website of China’s National Medical Products Administration (NMPA) has indicated that the marketing filing for Zynlonta (loncastuximab tesirine), a collaboration between China’s Overland Pharmaceuticals and Swiss firm ADC Therapeutics SA (NYSE: ADCT), has been approved. This approval allows the CD19-targeted antibody-drug conjugate (ADC) to be used for treating adult…
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Wuhan YZY Biopharma’s M701 Shows Promise in Phase II Study for Malignant Pleural Effusion at ESMO ASIA 2024
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China-based Wuhan YZY Biopharma Co., Ltd (HKG: 2496) has announced the presentation of results from a Phase II clinical study for its M701, a recombinant anti-EpCAM and CD3 human murine chimeric bispecific antibody (BsAb) injection, at the ESMO ASIA Congress 2024. The study focused on patients with malignant pleural effusion…
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Immunofoco’s IMC002 Earns FDA Fast-Track Designation for CLDN 18.2-Positive Gastric Cancer
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Immunofoco, a leading developer in tumor immunotherapy based in Suzhou, has announced that it has received Fast-Track Designation (FTD) from the US Food and Drug Administration (FDA) for its IMC002. This chimeric antigen receptor (CAR)-T therapy targets CLDN 18.2 and is intended for the treatment of patients with unresectable locally…
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InnoVec Biotherapeutics’ IVB102 Receives FDA IND Approval for X-Linked Retinoschisis Treatment
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Beijing-based gene therapy specialist InnoVec Biotherapeutics Inc. has announced receiving Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its IVB102. This development follows the completion of enrollment in the investigator-initiated trial (ITT) at Peking Union Medical College Hospital. The FDA clearance was granted based…
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Eisai’s Urece (Dotinurad) Approved by China’s NMPA for Gout Treatment with Hyperuricemia
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Eisai’s (TYO: 4523) China unit has announced that it has received marketing approval from the National Medical Products Administration (NMPA) of China for its Urece (dotinurad), a uric acid excretion promoting drug. This approval allows the use of Urece to treat gout patients with hyperuricemia in China. Phase III Study…
