FDA Approves BeOne’s Tevimbra Plus Zanidatamab and Chemotherapy for First‑Line HER2‑Positive Gastroesophageal Adenocarcinoma
BeOne Medicines Ltd. (NASDAQ: ONC; HKG: 6160; SHA: 688235) announced that the US FDA has...
Drug
MHLW Approves Takeda’s First‑in‑Class ORZEYFUL (Oveporexton) for Narcolepsy Type 1 in Japan
Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) announced that the Japanese Ministry of Health,...
EC Approves Gilead’s Trodelvy Plus Keytruda for First‑Line PD‑L1‑Positive Metastatic TNBC – 35% Reduction in Progression Risk
Gilead Sciences (NASDAQ: GILD) announced that the European Commission (EC) has granted marketing authorisation for...
GSK’s Jemperli Wins FDA Priority Review for dMMR/MSI‑H Locally Advanced Rectal Cancer – PDUFA Date Set for February 2027
GlaxoSmithKline Plc (GSK, NYSE: GSK) announced that the US Food and Drug Administration (FDA) has...
Hengrui’s NMPA Accepts NDA for HRG2010, a Novel Levodopa/Carbidopa Combination for Parkinson’s Disease
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that China’s National Medical Products...
Antengene Clears Australian Regulatory Hurdles for Phase I ATTRACT Study of UCB‑Licensed ATG‑201
Antengene Corporation Limited (HKG: 6996) announced that the Phase I ATTRACT study of its proprietary...
Leads Biolabs Files NDA for Opamtistomig in EP-NEC — World’s First 4-1BB Bispecific Nears Potential First Approval
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced that it has submitted a New Drug...
Yipinhong Wins NMPA Clinical Trial Approval for Category 1 URAT1 Inhibitor APH03867 in Gout and Hyperuricemia
Yipinhong Pharmacy Co., Ltd. (SHE: 300723) announced that its Category 1 chemical drug APH03867 Tablets...
ImmuneOnco’s IMM0306 Wins FDA IND Clearance for SLE — World’s First CD47/CD20 Bispecific in Clinic Enters U.S.
ImmuneOnco Biopharmaceuticals (HKG: 1541) announced that its drug IMM0306 has received Investigational New Drug (IND)...
North China Pharma Wins NMPA Clinical Trial Approval for World-First Hexavalent Norovirus Vaccine Candidate
North China Pharmaceutical Co., Ltd. (SHA: 600812) announced that its hexavalent recombinant norovirus vaccine (Hansenula...
Hengrui Pharma Wins NMPA Approval for Three Clinical Trials Led by First‑in‑Class SHR‑7012 for Cutaneous Lupus
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that three investigational drugs —...
CStone’s CS5007 IND Approved by NMPA, Advancing EGFR/HER3 Bispecific ADC for EGFR‑Resistant Tumors
CStone Pharmaceuticals (HKG: 2616) announced that the Investigational New Drug (IND) application for CS5007 has...
LongBio Pharma’s LP‑003 BLA Accepted by NMPA for Seasonal Allergic Rhinitis, Advancing Novel Anti‑IgE Antibody Toward China Approval
LongBio Pharma (Suzhou) Co., Ltd. (HKG: 1779) announced that China’s National Medical Products Administration (NMPA)...
Ultomiris Wins NMPA Approval for PNH in China, Bringing Long‑Acting Ravulizumab C5 Inhibitor to Adult and Pediatric Patients
Ultomiris (ravulizumab injection), a long‑acting C5 complement inhibitor under AstraZeneca’s (NYSE: AZN) Rare Disease business,...
Hengrui Wins NMPA Approval for HRS‑5965 – Complement Factor B Inhibitor for Complement Inhibitor‑Naive PNH Patients
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that China’s National Medical Products...
Abbisko Wins NMPA IND Clearance for Pan‑KRAS Inhibitor ABSK211 in Advanced Solid Tumors, Following FDA Green Light
Abbisko Therapeutics Co., Ltd. (HKG: 2256) announced that China’s National Medical Products Administration (NMPA) has...
Haisco Pharmaceutical Wins NMPA Clinical Approval for Nav1.8 Inhibitor HSK51155 – Pain Drug Licensed to AbbVie in USD 700 Million Deal Advances in China
China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced receiving clinical approval for its pain...
Lepu Medical’s siRNA Drug MWN117 Wins NMPA Clinical Trial Approval for Overweight and Obesity – INHBE‑Targeting Therapy Shows Synergy Potential with GLP‑1 Agonists
Lepu Medical (SHE: 300003) announced that MWN117 injection has received approval from China’s National Medical...
Shanghai Yizhong Pharmaceutical’s YXC‑002 Wins IND Approval – Fourth‑Generation Brain‑Penetrant EGFR‑TKI for Non‑Small Cell Lung Cancer Overcomes C797S Resistance
Shanghai Yizhong Pharmaceutical Co., Ltd (SHA: 688091) announced that the Investigational New Drug (IND) application...
Genrix Bio’s GR2302 Bispecific Antibody Receives NMPA IND Approval for Chronic Hepatitis B – TCR‑Mimic T‑Cell Engager Targets HBV‑Infected Hepatocytes
Chongqing Genrix Bio Pharmaceutical Co., Ltd. (SHA: 688443) announced that its investigational product GR2302 (subcutaneous...