ImmuneOnco’s IMM2510 Advances to Phase II/III in Endometrial Cancer After Axion Bio Deal Termination
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (HKG: 1541) announced that China’s National Medical Products Administration (NMPA) has...
Drug
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)...
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...
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...
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...
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...
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...
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...
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...
Pfizer’s BRAFTOVI Trio Achieves 64 % Response Rate in BREAKWATER Cohort 3 for BRAF V600E Metastatic Colorectal Cancer
Pfizer Inc. (NYSE: PFE) announced that Cohort 3 of the pivotal Phase 3 BREAKWATER trial met its primary...
Insilico Medicine Doses First Patient in Phase IIa Study of AI‑Designed ISM5411 for Inflammatory Bowel Disease
Insilico Medicine (HKG: 3696) announced that the first patient has been dosed in the BETHESDA...
Lynk Pharmaceuticals Reports Positive Phase III Data for Zemprocitinib in Rheumatoid Arthritis – Best‑in‑Class JAK1 Inhibitor Shows 79 % ACR20 Response
Lynk Pharmaceuticals Co., Ltd. announced positive topline results from a pivotal Phase III trial of zemprocitinib...
Santen’s UPNEEQ Wins Japan Approval for Acquired Ptosis
Santen Pharmaceutical Co., Ltd. announced that UPNEEQ Mini 0.1% oxymetazoline solution (STN1013800) has been approved...
Hengrui’s Quadruple Prostate Cancer Combo Wins NMPA IND for Phase 2 Study
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276, HKG: 1276) announced that the National Medical Products...
Shanghai Pharma Receives NMPA Approval for Myasthenia Gravis Oral Solution
Shanghai Pharmaceuticals Holding Co., Ltd (SHA: 601607) announced that its subsidiary, Shanghai SPH Zhongxi Pharmaceutical...