MSD’s KEYTRUDA Wins NMPA Approval for Perioperative Treatment of Resectable Locally Advanced HNSCC in China
Merck & Co., Inc. (MSD; NYSE: MRK) announced that its PD-1 inhibitor KEYTRUDA (pembrolizumab) has...
Drug
Trinomab’s Retavibart Wins NMPA Priority Approval as RSV Prevention Monoclonal Antibody Xinduotuo
Zhuhai Trinomab Pharmaceutical Co., Ltd. (SHA: 688806) announced that its Category 1 pediatric innovative drug,...
Betta’s Ensartinib Wins NMPA Approval for Third Indication as Adjuvant Therapy in ALK-Positive NSCLC
Betta Pharmaceuticals (SHE: 300558) announced that ensartinib (trade name: Ensacove) has been approved by China’s...
Yipinhong’s AR882 Meets Primary Endpoint in Phase 3 Gout Trial, Outperforming Febuxostat on Uric Acid Reduction
Yipinhong Pharmacy Group Co., Ltd (SHE: 300723) announced that its Phase 3 trial for the...
AbbVie’s Etentamig Delivers Positive Phase III CERVINO Results in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma
AbbVie (NYSE: ABBV) announced positive topline results from the Phase III CERVINO study evaluating etentamig,...
Stoke and Biogen to Present 5-Year Zorevunersen Data in Dravet Syndrome at European Epilepsy Congress
Stoke Therapeutics (NASDAQ: STOK) and Biogen Inc. (NASDAQ: BIIB) announced that they will present clinical...
NMPA Approves Eisai’s Lecanemab Subcutaneous Autoinjector for Early Alzheimer’s Disease in China
Eisai Co., Ltd. (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) announced that China’s National Medical...
Kanghong’s Conbercept Wins NMPA Approval for Fifth Indication in Retinopathy of Prematurity (ROP)
Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) announced that China’s National Medical Products Administration...
Simcere’s Culevibart Wins NMPA Approval as China’s RSV Prevention Monoclonal Antibody Yingmule
Simcere Pharmaceutical Group (HKG: 2096) announced that Culevibart Injection (trade name: Yingmule), a domestic Category...
Sino Biopharmaceutical’s GPC3 ADC TQB6426 Gains FDA IND Approval for Advanced Malignant Tumors
Sino Biopharmaceutical Limited (HKG: 1177) announced that TQB6426, a national Category 1 new drug self-developed...
Fosun Pharma’s luvometinib Wins NMPA Approval for NF1-Associated Plexiform Neurofibromas in Adults
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that its drug luvometinib...
Takeda and Belief BioMed End Xinjiuning Commercialization Partnership; Belief BioMed to Advance Gene Therapy Independently
Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) China and Belief BioMed Inc. issued a...
Hengrui’s drotokibart BLA Accepted by NMPA for Moderate-to-Severe Atopic Dermatitis
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that the National Medical Products...
GanLee’s GZC8072 Wins NMPA IND Approval for Once‑Weekly Oral Type 2 Diabetes Candidate
Gan & Lee Pharmaceuticals (SHA: 603087) announced that its drug candidate GZC8072 has received Investigational...
Hengrui Pharmaceuticals’ Oral GLP‑1R Agonist HRS‑7535 NDA Accepted by NMPA for Type 2 Diabetes, Joining China’s Incretin Race
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its New Drug Application...
Keymed Biosciences Grants Aeira Exclusive Rights to Stapokibart Across 18 Southeast and Central Asia Markets, Securing High Double‑Digit Royalties
Keymed Biosciences Inc. (HKG: 2162) announced that it has entered into an exclusive licensing agreement...
Zhongsheng Files China Trial Application to Expand Onradivir into High‑Risk Influenza A Patients, Broadening Its First‑in‑Class PB2 Inhibitor Franchise
Zhongsheng Pharmaceutical (SHE: 002317) announced that it has submitted a clinical trial application in China...
Cutia Therapeutics’ CU‑20101 BLA Accepted by NMPA for Moderate to Severe Glabellar Lines, Advancing a Safer Botulinum Toxin Type A
Cutia Therapeutics (HKG: 2487) announced that the Biologics License Application (BLA) for CU‑20101 has been...
Haixi Pharma Completes Phase I of Oral HX9428 in nAMD with Visual Gains, Files IND for DME Phase IIa as FDA Fast Track Asset Expands
Fujian Haixi Pharmaceuticals Co., Ltd. (HKG: 2637) announced dual clinical progress updates for HX9428, its...
Hansoh’s HS‑20093 Risvutatug Rezetecan NDA Accepted by NMPA for Small Cell Lung Cancer After First Global Phase III OS Win for a B7‑H3 ADC
Hansoh Pharmaceutical (HKG: 3692) announced that the marketing authorization application for its independently developed HS‑20093...