Ascentage’s PROTAC BTK Degrader APG-3288 Wins FDA IND for B-Cell Malignancies
Ascentage Pharma (NASDAQ: AAPG, HKG: 6855) announced that the U.S. Food and Drug Administration (FDA)...
Drug
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...
Novo Nordisk, Lilly Cut China Prices for Wegovy, Mounjaro by Up to 80%
Novo Nordisk (NYSE: NVO) and Eli Lilly (NYSE: LLY) have lowered list prices for their...
Yifan Pharmaceutical’s F-652 Wins NMPA IND for GVHD Therapy
Yifan Pharmaceutical Co., Ltd (SHE: 002019) announced that its Recombinant Human Interleukin‑22‑Fc Fusion Protein for...
Ark Biopharma’s Azstarys Approved in China for ADHD, First New Methylphenidate in 20 Years
Shanghai Ark Biopharmaceutical Co., Ltd. announced that Azstarys (serdexmethylphenidate, dexmethylphenidate) has been approved by China’s...
Hengrui’s HRS9531 and AR‑PROTAC Win NMPA IND Approval for Clinical Trials
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276, HKG: 1276) announced that four drug candidates—HRS9531 (GLP‑1R/GIPR...
Genhouse Bio’s MAT2A Inhibitor GH31 Wins NMPA and FDA Clinical Trial Approvals
Genhouse Bio (Suzhou) Co., Ltd. (invested in and incubated by Viva Biotech) announced that China’s...
Yifan Pharmaceutical Licenses ACT001 for SCLC Brain Metastases Across 12 Asian Markets
Yifan Pharmaceutical Co., Ltd. (SHE: 002019) announced exclusive commercial cooperation and cornerstone investment agreements with...
Humanwell Healthcare’s HW221043 Receives NMPA Approval for Advanced Solid Tumor Trials
Humanwell Healthcare (Group) Co., Ltd. (SHA: 600079) announced that its independently developed HW221043 tablets have...
Frontier Biotech’s FB7013 Wins NMPA IND for MASP‑2 siRNA in IgA Nephropathy
Frontier Biotechnologies Inc. (SHA: 688221) announced that it has submitted an Investigational New Drug (IND)...
Kelun-Biotech’s sac-TMT Wins Breakthrough Therapy Designation for First‑Line NSCLC
Sichuan Kelun‑Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced that sacituzumab tirumotecan (sac‑TMT, SKB264/MK‑2870), its TROP2‑directed...
Kelun-Biotech’s ITGB6 ADC SKB105 Wins NMPA IND Approval
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced that its Investigational New Drug (IND) application...
GenEditBio’s GEB-101 Wins FDA IND Approval as World’s First Corneal Gene Therapy
GenEditBio announced that GEB-101, its self‑developed in vivo genome editing investigational drug, has received Investigational...
Merck’s Winrevair Wins China NMPA Approval for Pulmonary Arterial Hypertension
Merck Sharp & Dohme Inc. (MSD, NYSE: MRK) announced that Winrevair (sotatercept for injection), the world’s...
China Approves Record 76 Innovative Drugs in 2025 as Out‑Licensing Hits $130 Billion
The National Medical Products Administration (NMPA) announced that China approved 76 innovative drugs for marketing...
China Supreme Court Upholds Novo Nordisk Semaglutide Patent Validity
Novo Nordisk (NYSE: NVO) announced that China’s Supreme People’s Court upheld the Beijing IP Court ruling,...
Genmab Discontinues Acasunlimab to Focus on Late‑Stage Portfolio
Genmab A/S (NASDAQ: GMAB) announced it will discontinue clinical development of acasunlimab, a PD‑L1 x...
Tarlatamab Enters China via Hainan Pilot Zone as First SCLC Immunotherapy
Ruijin Hospital Hainan Boao Research Hospital (Ruijin Hainan Hospital) successfully introduced Tarlatamab for Injection, making...
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)...