GSK and Spero Therapeutics Secure FDA Approval for Utebzi, First Oral Carbapenem Antibiotic for Complicated UTIs
GlaxoSmithKline plc (GSK) (NYSE: GSK) and Spero Therapeutics (NASDAQ: SPRO) announced that the U.S. Food...
Alebund Pharmaceuticals Raises $163M in Hong Kong IPO to Advance Kidney Disease Pipeline
Alebund Pharmaceuticals (Jiangsu) Limited (HKG: 9637) successfully completed its initial public offering (IPO) on the...
Shanghai Henlius Biotech Secures NMPA Approval for Phase I Trial of HLX3902 Trispecific Antibody in Advanced Solid Tumors
Shanghai Henlius Biotech Inc. (HKG: 2696) announced that China’s National Medical Products Administration (NMPA) has...
Biogen to Acquire Immunology Specialist RayThera in $1 Billion Deal Targeting Anti-Inflammatory Pipeline
Biogen Inc. (NASDAQ: BIIB) announced a definitive agreement to acquire RayThera, a private biotechnology company...
Hopstem Biotechnology Secures FDA Clearance for hNPC01 Neural Progenitor Cell Therapy in Hemorrhagic Stroke Motor Dysfunction
Hopstem Biotechnology Co., Ltd., a neural stem cell specialist founded by neuroscientists and stem-cell biologists...
Bayer AG Completes $2.45 Billion Acquisition of Perfuse Therapeutics for PER-001 Glaucoma Implant
Bayer AG (ETR: BAYN) announced the completion of its acquisition of Perfuse Therapeutics, Inc., securing...
Walvax Biotechnology’s 13-Valent Pneumococcal Vaccine Weuphoria Meets All Endpoints in Indonesian Phase III Trial
Walvax Biotechnology Co., Ltd (SHE: 300142) announced that its Phase III clinical study for Weuphoria,...
Insilico Medicine’s NLRP3 Inhibitor ISM8969 Achieves First-in-Human Milestone in Phase I Trial for CNS Disorders
Insilico Medicine (HKG: 3696) announced that ISM8969, jointly developed with Hygtia Therapeutics Co., Ltd., has...
Hengrui Pharmaceuticals Expands Dalpiciclib Label with NMPA Approval for Early Breast Cancer Adjuvant Therapy
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced it has received additional indication...
WuXi XDC Partners with BioDlink International for Monoclonal Antibody Intermediate Manufacturing in RMB 19.0 Million CRDMO Agreement
WuXi XDC (HKG: 2268), a leading global end-to-end CRDMO (Contract Research, Development and Manufacturing Organization),...
Hengrui Pharmaceuticals Receives NMPA Clinical Approvals for Two Novel Anti-Tumor Candidates SHR-6914 and HRS-7525, Addressing Unmet Needs in Prostate Cancer and Solid Tumors
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced it has received separate clinical...
Zai Lab’s DLL3-Targeting ADC Zocilurtatug Pelitecan Receives EMA Orphan Drug Designation for Pulmonary Neuroendocrine Carcinomas
Zai Lab Limited (NASDAQ: ZLAB; HKG: 9688) announced that the European Medicines Agency (EMA) has...
Luye Pharma’s Dual-Target Candidate LY03015 Achieves Breakthrough Phase II Results in Tardive Dyskinesia with 76.5% Response Rate
Luye Pharma Group Limited (HKG: 2186) announced that its Category 1 candidate drug LY03015 has...
GSK’s Momelotinib Receives Orphan Drug Designation from FDA and EMA for VEXAS Syndrome, Addressing Critical Unmet Need in Rare Myeloid Disorder
GlaxoSmithKline plc (GSK) (NYSE: GSK) announced that momelotinib has received Orphan Drug Designation (ODD) from...
Regent Pacific’s Senstend Receives NMPA Approval with Four-Year Data Protection, Triggering $5M Milestone Payment from Wanbang
Regent Pacific Group Limited (HKG: 0575) announced that the New Drug Application (NDA) for its...
Bayer AG Inaugurates Second Consumer Health Innovation Center in China, Expanding Skin and Digestive Health Partnerships
Bayer AG (ETR: BAYN) announced the inauguration of its second Bayer Consumer Health China Center...
Shanghai Henlius Biotech Receives Australian Clearance for Phase II Study of PD-L1 ADC HLX43 Combined with Hansizhuang in NSCLC Neoadjuvant Therapy
Shanghai Henlius Biotech Inc. (HKG: 2696) announced it has received regulatory clearance in Australia to...
Shanghai Henlius Biotech’s HLX04-O Meets Primary Endpoints in Phase III Trial for Wet AMD, Demonstrating Non-Inferiority to Ranibizumab
Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the Phase III international multicenter clinical study...
NMPA Releases 106th Batch of Reference Drugs for Generic Quality Consistency Evaluation, Including BeOne Medicines’ Brukinsa (zanubrutinib)
The National Medical Products Administration (NMPA) announced the 106th batch of reference drugs designated for...
China’s CDE Proposes Framework for Reference Listed Drug Selection Following Marketing Authorization Holder Changes for Foreign-Originator Drugs Manufactured Locally
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released two...