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)...
Market approval filings
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...
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...
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...
Broncus Medical Secures NMPA Fast‑Track for BroncTarget COPD System, Targeting 9 Million Refractory Patients in China
Broncus Medical (HKG: 2216) announced that China’s National Medical Products Administration (NMPA) has granted fast‑track designation...
Alphamab Oncology Submits Envafolimab for First‑Line Biliary Tract Cancer (BTC) as World’s First Subcutaneous PD‑L1
Alphamab Oncology (HKG: 9966) announced that China’s National Medical Products Administration (NMPA) has accepted its marketing...
Dongcheng Pharma’s PSMA PET Agent [18F] Spiritide NDA Accepted by NMPA
Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) announced that the New Drug Application (NDA)...
Genrix Bio’s GR1803 NDA Accepted for BCMA-Targeted Multiple Myeloma Therapy
Chongqing Genrix Biopharmaceutical Co., Ltd (SHA: 688443) announced that the conditional New Drug Application (NDA)...
Takeda and Protagonist Submit Rusfertide NDA for Polycythemia Vera
Takeda Pharmaceutical Company Limited (TYO: 4502, NYSE: TAK) and Protagonist Therapeutics, Inc. (NASDAQ: PTGX) announced...
Sanofi’s Tzield Wins FDA Priority Review for Pediatric T1D Expansion
Sanofi (NASDAQ: SNY) announced that the U.S. Food and Drug Administration (FDA) has accepted for...
HutchMed’s Savolitinib NDA Accepted by NMPA for MET-Amplified Gastric Cancer with Priority Review
HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced that China’s National Medical Products Administration (NMPA)...
Recbio’s REC610 Shingles Vaccine NDA Accepted by NMPA, Challenging GSK’s Shingrix
Jiangsu Recbio Technology Co., Ltd. (HKG: 2179) announced that the New Drug Application (NDA) for...
HutchMed’s Fanregratinib Wins NMPA Priority Review for FGFR2+ Cholangiocarcinoma
HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced that China’s National Medical Products Administration (NMPA)...
Jenscare Scientific Submits CE Mark Application for JensClip TMVr System in EU
Jenscare Scientific Co., Ltd. (HKG: 9877) announced that it has submitted the registration application for...
Livzon’s Lecankitug Accepted by NMPA as First Domestic Dual IL‑17A/F Psoriasis Drug
Livzon Pharmaceutical Group Inc. (HKG: 1513) announced that China’s National Medical Products Administration (NMPA) accepted...
TransThera NDA Accepted for Tinengotinib in Cholangiocarcinoma After FGFR Inhibitor
TransThera Sciences (Nanjing), Inc. (HKG: 2617) announced that China’s National Medical Products Administration (NMPA) formally...
Bio‑Thera NDA for VEGF‑A165 Antibody Targets $2B Wet AMD Market in China
Bio‑Thera Solutions (SHA: 688177) submitted a New Drug Application (NDA) to China’s National Medical Products...
Novo Nordisk Submits CagriSema NDA for 20% Weight Loss in Obesity
Novo Nordisk A/S (NYSE: NVO) submitted a New Drug Application (NDA) to the U.S. FDA...
Zhicheng’s TAVR Robotic System Enters NMPA Innovation Pathway
Zhicheng Medical Technology (Jiaxing) Co., Ltd. announced that its self‑developed ReachTact Transcatheter Aortic Valve Replacement...