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...
BrightGene Boosts Stake in Geek Gene to 12.8% with RMB 50 M Injection – Expanding Cell‑Therapy Portfolio
BrightGene BrightGene Bio-Medical Techonology (Suzhou) Co., Ltd. (SHA: 688166) disclosed a RMB 50 million (≈ US$7.2 million) capital increase...
Changchun GeneScience Secures NMPA Approval for GS3‑007a Dry Suspension & Green‑lights GenSci140 ADC Trials
Changchun GeneScience Pharmaceutical Co., Ltd. announced two pivotal regulatory milestones from the China National Medical...
BrightGene Secures NMPA Nod for BGM1812 Obesity Trial, FDA Grants Trial Clearance
BrightGene Bio-Medical Techonology Co., Ltd. (SHA: 688166) disclosed that China’s National Medical Products Administration (NMPA) has...
Changchun GeneScience Secures FDA Approval for GenSci143 – Bispecific ADC Targeting B7‑H3 & PSMA in Advanced Solid Tumors
Changchun GeneScience Pharmaceutical Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted...
Qyuns Therapeutics Receives NMPA Trial Approvals for QX027N – Long‑Acting Bispecific Antibody Targeting Asthma and Atopic Dermatitis
Qyuns Therapeutics Co., Ltd. (HKG: 2509) announced that China’s National Medical Products Administration (NMPA) has...
Suzhou Zelgen Secures NMPA Trial Approval for ZG006 (Alveltamig) – First‑In‑Class Trispecific Antibody for Advanced Neuroendocrine Carcinoma
Suzhou Zelgen Biopharmaceuticals Co., Ltd. (SHA: 688266) announced that China’s National Medical Products Administration (NMPA)...
Adagene Licenses SAFEbody Platform to Third Arc Bio for Masked CD3 T‑Cell Engagers
Adagene Inc. (NASDAQ: ADAG) and Third Arc Bio, Inc. announced today that they have signed...
Gan & Lee’s Ondibta Receives Positive CHMP Opinion – EU Biosimilar Pathway Opened
Gan & Lee Pharmaceuticals Co., Ltd. (SHA: 603087) announced that the European Medicines Agency (EMA) has...
Corxel Secures FDA IND Clearance for CX11 Phase 2 Trial in Type 2 Diabetes
Corxel Pharmaceuticals Limited announced today that the U.S. Food and Drug Administration (FDA) has cleared...
Pfizer Reduces BioNTech Holding by 54.7% While Collaboration Remains Intact
Pfizer Inc. (NYSE: PFE) disclosed on November 13, 2025 that it has sold a portion of its...
Jiangsu Hengrui’s Rezvilutamide Clears NMPA Hurdle, Moves Into Phase III Prostate‑Cancer Trial
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) announced today that its second‑generation androgen‑receptor inhibitor...
Legend Biotech Reports $524 M CARVYKTI Sales, FDA Updates & Q3 Loss
Legend Biotech (NASDAQ: LEGN) published the unaudited financial results for fiscal Quarter 3 2025 (2025Q3) on 12 Nov 2025. The flagship...