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...
Drug
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...
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...
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...
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...
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...
Zelgen Biopharmaceuticals Secures NMPA Approval for Zepuping in Severe Alopecia Areata – First Immuno-Inflammatory Indication for Pan-JAK Inhibitor
Suzhou Zelgen Biopharmaceuticals Co., Ltd. (SHA: 688266) announced that the National Medical Products Administration (NMPA)...
Hinova Pharmaceuticals Reports Positive Phase IIa Data for HP515 in MASH – THR-β Agonist Achieves >50% Liver Fat Reduction
Hinova Pharmaceuticals Inc. (SHA: 688302) announced that final analysis results from the Phase IIa clinical...
Chia Tai Tianqing Presents Positive Phase II Data for TQC2938 in Allergic Rhinitis – Novel ST2-Targeting mAb Shows Efficacy Across Inflammatory Pathways
Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd. (CTTQ), a subsidiary of Sino Biopharmaceutical Limited (HKG:...
BMS Secures NMPA Approval for Sotyktu in Psoriatic Arthritis – First Selective TYK2 Inhibitor Expands China Indications
Bristol-Myers Squibb (BMS, NYSE: BMY) announced that China’s National Medical Products Administration (NMPA) has granted...
Gilead Sciences Submits sNDA for Once-Weekly Oral Yeztugo PrEP – Potential First Long-Acting Oral HIV Prevention Option
Gilead Sciences, Inc. (NASDAQ: GILD) announced that the U.S. Food and Drug Administration (FDA) has...
Shanghai Leadingtac Secures NMPA Approval for LT-010391 – China’s First Clinical-Stage Oral KRAS-G12D Degrader
Shanghai Leadingtac Pharmaceutical Co., Ltd. announced that China’s National Medical Products Administration (NMPA) has granted...
Fosun Pharma Secures NMPA Approval for Fumaining in Pediatric Langerhans Cell Histiocytosis – Expands MEK Inhibitor Franchise
Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196; HKG: 2196) announced that China’s National Medical Products...