Roche Secures CE Mark for Elecsys pTau217 Blood Test, First Single-Assay Alzheimer’s Diagnostic with Amyloid Pathology Detection
Roche AG (SWX: ROP, OTCMKTS: RHHBY) announced on May 12, 2026, that it has received...
Alphamab Oncology Initiates Phase II Trial of Subcutaneous Co-Formulation JSKN033 in First-Line Advanced Cervical Cancer
Alphamab Oncology (HKG: 9966) announced the initiation of a Phase II clinical study for its...
Bio-Thera’s CD25-Targeted ADC BAT8013 Receives NMPA Approval for Advanced Solid Tumor Clinical Studies in China
Bio-Thera Solutions Ltd. (SHA: 688177) announced that its CD25-targeted antibody drug conjugate (ADC) BAT8013 has...
Sichuan Biokin’s Bispecific ADC Iza-Bren Receives NMPA Approval for NSCLC Clinical Study in China
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced that its bispecific antibody-drug conjugate (ADC) izalontamab...
Hong Kong to Launch FDA-Style Medical Products Regulation Center by Year-End, Creating Gateway for Chinese Innovative Drugs
Hong Kong’s Centre for Medical Products Regulation (CMPR) is set to be established by the...
Changchun GeneScience Receives NMPA Approval for Firsekibart Phase III Trial in Gout Flare Prevention During Urate-Lowering Therapy
Changchun GeneScience Pharmaceutical Co., Ltd. (SHE: 000661) announced it has received approval from China’s National...
MacroGenics Sells GMP-Compliant API Manufacturing Business to Bora Pharmaceuticals for $122.5 Million
MacroGenics, Inc. (NASDAQ: MGNX) announced an agreement to sell its active pharmaceutical ingredient (API) manufacturing...
Merus’ Bizengri Becomes First FDA-Approved Therapy for NRG1 Fusion-Positive Cholangiocarcinoma
The U.S. Food and Drug Administration (FDA) granted approval to Merus N.V.’s Bizengri (zenocutuzumab-zbco) for...
Zai Lab Secures FDA Fast Track Designation for DLL3-Targeting ADC Zocilurtatug Pelitecan in Extrapulmonary NEC
Zai Lab (NASDAQ: ZLAB, HKG: 9688) announced that the U.S. Food and Drug Administration (FDA)...
Mindray Bio-Medical Re-Files for Hong Kong Listing After Initial Application Expiration
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (SHE: 300760), the globally leading medical device innovator, announced...
Ribo Life Science Files EMA Application for Vortosiran Phase IIb Study in Venous Thromboembolism Prevention
Suzhou Ribo Life Science Co., Ltd. (HKG: 6938) announced it has submitted a clinical trial...
Haisco Pharmaceutical’s Sishujing Seeks Postoperative Pain Indication, Expanding Peripheral Kappa Agonist Franchise
Haisco Pharmaceutical Group Co., Ltd. (SHE: 002653) announced that China’s National Medical Products Administration (NMPA)...
Daiichi Sankyo Unveils Ambitious Five-Year Plan Targeting $19B Revenue and Top-Five Global Oncology Position
Daiichi Sankyo Co., Ltd. (TYO: 4568) unveiled its comprehensive five-year business growth plan, targeting total...
Juventas Cell Therapy’s CAR-T Yuanruida Seeks Pediatric ALL Indication, Expanding China’s Only Dual-Malignancy CAR-T Franchise
Juventas Cell Therapy Ltd., the Chinese cell therapy innovator, announced that China’s National Medical Products...
Hengrui and Braveheart Bio Report Positive Phase 2 Results for Next-Gen Cardiac Myosin Inhibitor HRS-1893 in Non-Obstructive HCM
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) and Braveheart Bio announced positive results...
Akari Therapeutics Partners with WuXi XDC to Advance Novel PH1 Payload Platform for Urothelial Cancer
Akari Therapeutics (NASDAQ: AKTX), the US-UK dual-headquartered biotechnology company, announced a strategic development partnership with...
NMPA Releases 105th Batch of Generic Drug Reference Standards, Adding 37 New Specifications
China’s National Medical Products Administration (NMPA) announced the release of the 105th batch of reference...
China Medical System Secures Exclusive China Rights to Pharmacosmos’ MonoFer and CosmoFer IV Iron Therapies
China Medical System Holdings Limited (CMS, HKG: 0867) announced an exclusive licensing agreement with Denmark-based...
Yifan Pharmaceutical Licenses Ryzneuta to French Distributor Intsel Chimos for Exclusive Commercialization
Yifan Pharmaceutical Co., Ltd. (SHE: 002019) announced a licensing agreement with Intsel Chimos SAS, the...
Hybio Pharmaceutical Expands Torrent Pharma Partnership with Lanreotide Acetate for U.S. Market
Hybio Pharmaceutical Co., Ltd. (SHE: 300199) announced an expanded strategic partnership with Torrent Pharmaceuticals Inc.,...