Gilead’s Yeytuo Gains EU Marketing Authorization for Twice‑Yearly HIV‑1 PrEP
European Commission Grant – On 26 Aug 2025 Gilead Sciences (NASDAQ: GILD) announced that the European Commission...
Drug
Innogen Commences Phase II Trial of Efsubaglutide Alfa for Obesity in Australia
Shanghai Innogen Pharmaceutical Technology Co., Ltd. (HKG: 2591) announced on 26 August, 2025 that the first...
Humanwell Secures NMPA Approval for Remimazolam ICU Sedation
China‑based Humanwell Healthcare (Group) Co., Ltd. (SHA: 600079) announced that the National Medical Products Administration...
Eisai & Biogen Launch Lecanemab in Austria & Germany – First Cause‑Based Alzheimer’s Therapy
Japan-based Eisai (TYO: 4523) and US-based Biogen (NASDAQ: BIIB) have officially launched Lecanemab (LEQEMBI)—the first...
Anke Biotech Secures Long‑Acting FSH‑CTP Approval in China
Shanghai Bao Pharmaceuticals Co., Ltd. has received official marketing authorization from China’s National Medical Products Administration (NMPA)...
Hengrui Pharmaceuticals Secures NMPA Approval for HRS‑2162 and HRS‑6093 Clinical Trials
China‑based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) announced that its two investigational...
Wusheng Erlunbao: Sinopharm’s First‑of‑Its‑Kind Hexavalent Rotavirus Vaccine Receives NMPA Approval
The Wuhan Institute of Biological Products Co., Ltd., a subsidiary of Sinopharm Group Co., Ltd....
Chengdu Ucello’s UC101 CAR‑T Gains NMPA Approval
China‑based Chengdu Ucello Biotechnology Co., Ltd. announced that its Investigational New Drug (IND) application for...
Daiichi Sankyo’s Enhertu Submitted for Priority Review in China for HER2-Positive Breast Cancer
On August 22, 2025, Daiichi Sankyo (TYO: 4568) submitted a marketing authorization application for Enhertu...
Yantai Dongcheng’s 225Ac-LNC1011 Injection Gains FDA Approval for Prostate Cancer Trial
Yantai Dongcheng Pharmaceutical Group Co., Ltd. (SHE: 002675), a China-based company, announced that its 225Ac-LNC1011...
Ocumension’s OT-301 Meets Primary Endpoint in Denali Phase III Trial
Chinese ophthalmology specialist Ocumension Therapeutics (HKG: 1477) , a China-based pharmaceutical company, announced on August 21,...
Zhejiang Medicine Receives NMPA Approval for Phase 1 Trial of XC2309 Injection
Zhejiang Medicine Co., Ltd. (SHA: 600216), a China-based pharmaceutical company, announced that it has received...
Zhongsheng Pharma’s Onradivir Granted Drug Registration in Macau
Guangdong Zhongsheng Pharmaceutical Co., Ltd. (SHE: 002317) announced that its onradivir tablets have received a...
Jazz Pharmaceuticals Secures Global Rights to Saniona’s Epilepsy Drug SAN2355
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) and Saniona (STO: SANION) announced today that they have entered...
Ionis Pharmaceuticals’ DAWNZERA Approved by FDA for HAE Prevention
Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced on August 22, 2025, that the U.S. Food and...
InnoCare Pharma’s ICP-723 Joins China’s SPARK Project for Pediatric Solid Tumors
China’s Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) has announced...
Bio-Thera Adjusts BAT3306 Clinical Study to Meet Regulatory Standards
On August 21, 2025, China-based Bio-Thera Solutions, Ltd. (SHA: 688177) announced a strategic adjustment to...
Novartis’ Atrasentan Approved in China for IgAN Proteinuria Reduction
Switzerland-based Novartis (NYSE: NVS) has received approval from China’s National Medical Products Administration (NMPA) for...
Suzhou Zelgen’s ZG005 and Gecacitinib Win NMPA Approval for Advanced Solid Tumors
On August 21, 2025, Suzhou Zelgen Biopharmaceuticals Co., Ltd. (SHA: 688266), a China-based company, announced...
Sino Biopharma’s Zongertinib Receives Second Breakthrough Designation for NSCLC
On August 20, 2025, Sino Biopharmaceutical Limited (HKG: 1177) announced that its selective HER2 tyrosine...