BeOne’s Zanidatamab Achieves PFS & OS Wins in HERIZON-GEA-01 Phase 3 HER2-Positive Cancer Trial
BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced its HER2‑targeted bispecific antibody zanidatamab (Ziihera)...
Biokin’s iza-bren ADC Achieves Dual PFS & OS Endpoints in Phase 3 Esophageal Cancer, a Global First
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced its antibody-drug conjugate iza-bren (izalontamab brengitecan, BL‑B01D1)...
Resight Therapeutics Secures Tens‑Millions RMB Angel Round to Accelerate iPSC‑Derived Corneal Endothelial Cell Therapy
Resight Therapeutics, a China‑based cell‑therapy pioneer founded in September 2024, announced the close of an Angel‑stage...
BMS and J&J Halt Phase III Milvexian Anticoagulant Trial for Acute Coronary Syndrome Patients
Bristol‑Myers Squibb (BMS, NYSE: BMY) and Johnson & Johnson (J&J, NYSE: JNJ) announced the premature...
Jiangsu Hengrui Secures NMPA Approval for Tegileridine in Mechanically Ventilated ICU Patients
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that its μ‑opioid receptor (MOR)‑biased...
Johnson & Johnson to Acquire Halda Therapeutics for $3.05 B – Deal Highlights First‑in‑Class Oral RIPTAC HLD‑0915
Johnson & Johnson (J&J, NYSE: JNJ) announced a definitive agreement to acquire Halda Therapeutics in an all‑cash...
Lundbeck’s Vyepti Secures Chinese NDA, Expands Asian Footprint
Lundbeck A/S (OTCMKTS: HLUBF) announced that the Center for Drug Evaluation (CDE) of China’s National...
Suzhou Zelgen Biopharma to Deregister U.S. Subsidiary Gensun to Sharpen R&D Focus
Suzhou Zelgen Biopharmaceuticals Co., Ltd. (SHA: 688266) announced plans to de‑register and cancel its U.S. subsidiary,...
Akeso Secures NMPA Approval for AK152 – First Bispecific Antibody Targeting Alzheimer’s in China
Akeso Inc. (HKG: 9926) announced that its self‑developed bispecific antibody AK152 has received regulatory approval...
MSD Acquires Cidara Therapeutics in $9.2‑Billion Deal to Expand Antiviral Portfolio
Merck Sharp & Dohme Inc. (MSD, NYSE: MRK) disclosed a definitive acquisition agreement with Cidara Therapeutics, Inc....
Abbisko Therapeutics Reports Durable Response in Phase 3 MANEUVER Study for Pimicotinib (ABSK021) in TGCT
Abbisko Therapeutics Co., Ltd. (HKG: 2256) released long‑term efficacy, safety and patient‑reported outcome data from its...
Zhejiang Jianfeng Group Secures NMPA Approval for JFAN‑1001/ Vinorelbine Combination in Advanced NSCLC
Zhejiang Jianfeng Group Co., Ltd. (SHA: 600668) announced that its subsidiary Jianfeng Yien Biotechnology has obtained...
Servier’s Vorasidenib Enters China’s SPARK Program – First Dual IDH Inhibitor for IDH‑Mutant Glioma
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) issued a...
PegBio’s PB‑119 (Paidakang) Wins NMPA Approval for Type 2 Diabetes Treatment
PegBio Co., Ltd. (HKG: 2565) announced that its next‑generation GLP‑1 receptor agonist PB‑119, marketed under...
Henlius’ POHERDY (HLX11) Receives Full FDA Approval for All Pertuzumab Indications
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that its pertuzumab biosimilar POHERDY (clinical name HLX11)...
Hangzhou Bio‑Sincerity Pharma‑Tech Secures NMPA Approval for BIOS2242 Oral Solution in Acute Ischemic Stroke
Hangzhou Bio‑Sincerity Pharma‑Tech Corp., Ltd. (SHE: 301096) announced that its BIOS2242 oral solution has received...
NMPA Launches Pilot Program to Cut Review Time for Overseas‑Manufactured Drug Supplementary Applications
The National Medical Products Administration (NMPA) issued a formal notice today announcing a pilot program...
FDA Issues Boxed Warning on Elevidys (delandistrogene moxeparvovec‑rokl) – Use Limited to Ambulatory DMD Patients Aged 4+
The U.S. Food and Drug Administration (FDA) announced a Boxed Warning for Elevidys, Sarepta Therapeutics’...
Zelgen Biopharma’s ZG006 (Alveltamig) Receives FDA Orphan‑Drug Designation for Neuroendocrine Carcinomas
Suzhou Zelgen Biopharmaceuticals Co., Ltd. (SHA: 688266) announced that its trispecific antibody ZG006 (alveltamig) has been...
WestVac BioPharma & West China Hospital Secure NMPA Clearance for China’s First Acne Therapeutic Vaccine
WestVac BioPharma Co., Ltd. announced that the National Medical Products Administration (NMPA) has granted clinical‑trial...