Henlius’s HANBEITAI Bevacizumab Biosimilar BLA Accepted by FDA for Multiple Solid Tumors
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the U.S. Food and Drug Administration (FDA)...
Genhouse Bio Raises RMB 300 Million in Cross‑Over Round Led by Green Pine Capital
Genhouse Bio, a small‑molecule oncology company incubated by Viva Biotech, announced the completion of a...
Haichang Biotech’s HC016 Receives FDA Orphan Drug Designation for Osteosarcoma
Haichang Biotech announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug...
Iktos and Servier Forge EUR 1 Billion+ AI Drug Discovery Collaboration
Iktos and Servier announced a multi‑target collaboration agreement leveraging Iktos’ AI‑orchestrated discovery platform to accelerate...
Sanofi’s Teizeild Wins EU Approval as First Disease‑Modifying Therapy for Type 1 Diabetes
Sanofi (NASDAQ: SNY) announced that the European Commission has approved Teizeild (teplizumab), a CD3‑targeted monoclonal antibody,...
CSPC’s Prusogliptin/Metformin FDC NDA Accepted by NMPA for Type 2 Diabetes, Targeting 60 M Underserved Patients
CSPC Pharmaceutical Group Ltd. (HKG: 1093) announced that China’s National Medical Products Administration (NMPA) has accepted...
Lifetech’s CS Stent System Wins NMPA Fast‑Track for Aortic Arch Aneurysms, Eliminates Cerebral Ischemia Risk
Lifetech Scientific Corporation (HKG: 1302) announced that its Concave Supra (CS) integrated aortic arch triple‑branch reconstruction...
ImmuneOnco’s Timdarpacept Receives NMPA Nod for Atherosclerosis Study, Expanding CD47 Platform
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (HKG: 1541) announced that China’s National Medical Products Administration (NMPA) has...
Hengrui’s SHR‑1826 ADC Earns Breakthrough Therapy Designation for c‑Met Overexpressed NSCLC
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that SHR‑1826, an antibody‑drug conjugate (ADC) targeting...
Hengrui’s HRS-7535 GLP-1R Agonist Cleared for Hypertension with Obesity Study in China
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that China’s National Medical Products Administration (NMPA)...
Merck and Abbisko’s Pimicotinib NDA Accepted by FDA for TGCT, Building on China Approval
Merck KGaA (ETR: MRK) and Abbisko Therapeutics Co., Ltd. (HKG: 2256) announced that the U.S. FDA...
Hisoar Pharma Invests RMB 150 Million in Wanbangde’s WP205 for ALS, Securing 15 % Global Revenue Share
Zhejiang Hisoar Pharmaceutical Co., Ltd. (SHE: 002099) announced a strategic collaboration with Wanbangde New Building...
FDA Approves Zycubo as First Therapy for Pediatric Menkes Disease, Targeting Ultra‑Rare Copper Deficiency Disorder
The U.S. Food and Drug Administration (FDA) has approved Zycubo (copper histidinate) injection, the first...
AbbVie Commits $100 Billion US Investment and TrumpRx Expansion for Tariff Relief
AbbVie Inc. (NYSE: ABBV) announced a voluntary agreement with the Trump administration to advance drug access...
Bayer AG Acquires Cardiac Amyloidosis Imaging Tracers from Attralus, Including Phase III AT‑01 with FDA Breakthrough Designation
Bayer AG (ETR: BAYN) announced an agreement with Attralus, Inc. to acquire two investigational molecular imaging...
BMS’s Camzyos Meets Primary Endpoint in Phase III SCOUT-HCM Study for Adolescent oHCM
Bristol-Myers Squibb (NYSE: BMY) announced that the SCOUT‑HCM Phase III study of Camzyos (mavacamten) met its primary...
NHSA Launches 6th VBP Tender for Medical Consumables in China, Targeting Drug-Coated Balloons
China’s National Healthcare Security Administration (NHSA) conducted the 6th volume-based procurement (VBP) tender for high-value...
Summit Therapeutics Submits Ivonescimab BLA to FDA for EGFR‑Mutated NSCLC Post Third‑Gen TKI
Summit Therapeutics (NASDAQ: SMMT), the US partner of Akeso Inc. (HKG: 9926), announced the submission of...
China’s NHSA Launches Pre‑Communication Pilot for Reference Drugs, Targeting Category 1 Innovative Drugs
China’s National Healthcare Security Administration (NHSA) released the “Measures for Pre‑Communication on Reference Drugs (draft...