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...
Drug
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...
Gritpharma Secures NMPA Approval for Doxylamine as China’s First Novel Short-Term Insomnia Treatment
Nanjing Gritpharma Co., Ltd. announced it has received marketing approval from China’s National Medical Products...
Sichuan Biokin’s Iza-Bren Becomes World’s First EGFR×HER3 Bispecific ADC with NDA Accepted by China’s NMPA
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced that the new drug application (NDA) for...
Novo Nordisk to Fully Launch Sogroya in China This Summer for Pediatric Growth Hormone Deficiency
Novo Nordisk (NYSE: NVO) announced that its long-acting growth hormone injection Sogroya (somapacitan) will be...
Sanofi’s Tzield Receives FDA Approval to Preserve Insulin Production in Recently Diagnosed Type 1 Diabetes
Sanofi (NASDAQ: SNY) announced that the U.S. Food and Drug Administration (FDA) has granted accelerated...
Jazz Pharmaceuticals Reports Phase 3 LAGOON Trial Misses Primary Endpoint for Zepzelca in Relapsed Small Cell Lung Cancer
Jazz Pharmaceuticals (NASDAQ: JAZZ) announced on June 12, 2026 that the Phase 3 LAGOON trial,...
AstraZeneca’s Truqap Receives FDA Approval as First Targeted Therapy for PTEN-Deficient Prostate Cancer
AstraZeneca plc (NYSE: AZN) announced that the U.S. Food and Drug Administration (FDA) has approved...
Merck Secures FDA Approval for Keytruda-Welireg Combination as Adjuvant Therapy in High-Risk Kidney Cancer
Merck & Co., Inc. (MSD; NYSE: MRK) announced that the U.S. Food and Drug Administration...