Servier’s B7-H4 ADC Emiltatug Ledadotin Receives FDA Breakthrough Therapy Designation for Advanced Adenoid Cystic Carcinoma
Servier announced on May 12, 2026, that the U.S. Food and Drug Administration (FDA) has...
Drug
ImmuneOnco Receives NMPA Approval for IMM0306 Clinical Study in Primary Sjögren’s Syndrome, Expanding Dual-Target Bispecific Platform
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (HKG: 1541) announced it has received clinical approval from China’s...
Alphamab Oncology Initiates Phase II Trial of Subcutaneous Co-Formulation JSKN033 in First-Line Advanced Cervical Cancer
Alphamab Oncology (HKG: 9966) announced the initiation of a Phase II clinical study for its...
Bio-Thera’s CD25-Targeted ADC BAT8013 Receives NMPA Approval for Advanced Solid Tumor Clinical Studies in China
Bio-Thera Solutions Ltd. (SHA: 688177) announced that its CD25-targeted antibody drug conjugate (ADC) BAT8013 has...
Sichuan Biokin’s Bispecific ADC Iza-Bren Receives NMPA Approval for NSCLC Clinical Study in China
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced that its bispecific antibody-drug conjugate (ADC) izalontamab...
Changchun GeneScience Receives NMPA Approval for Firsekibart Phase III Trial in Gout Flare Prevention During Urate-Lowering Therapy
Changchun GeneScience Pharmaceutical Co., Ltd. (SHE: 000661) announced it has received approval from China’s National...
Merus’ Bizengri Becomes First FDA-Approved Therapy for NRG1 Fusion-Positive Cholangiocarcinoma
The U.S. Food and Drug Administration (FDA) granted approval to Merus N.V.’s Bizengri (zenocutuzumab-zbco) for...
Zai Lab Secures FDA Fast Track Designation for DLL3-Targeting ADC Zocilurtatug Pelitecan in Extrapulmonary NEC
Zai Lab (NASDAQ: ZLAB, HKG: 9688) announced that the U.S. Food and Drug Administration (FDA)...
Ribo Life Science Files EMA Application for Vortosiran Phase IIb Study in Venous Thromboembolism Prevention
Suzhou Ribo Life Science Co., Ltd. (HKG: 6938) announced it has submitted a clinical trial...
Haisco Pharmaceutical’s Sishujing Seeks Postoperative Pain Indication, Expanding Peripheral Kappa Agonist Franchise
Haisco Pharmaceutical Group Co., Ltd. (SHE: 002653) announced that China’s National Medical Products Administration (NMPA)...
Juventas Cell Therapy’s CAR-T Yuanruida Seeks Pediatric ALL Indication, Expanding China’s Only Dual-Malignancy CAR-T Franchise
Juventas Cell Therapy Ltd., the Chinese cell therapy innovator, announced that China’s National Medical Products...
Hengrui and Braveheart Bio Report Positive Phase 2 Results for Next-Gen Cardiac Myosin Inhibitor HRS-1893 in Non-Obstructive HCM
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) and Braveheart Bio announced positive results...
CSPC Pharmaceutical Secures Second Breakthrough Therapy Designation for EGFR-Targeting ADC SYS 6010 in Esophageal Cancer
CSPC Pharmaceutical Group Ltd. (HKG: 1093) announced it has received a second Breakthrough Therapy Designation...
AmoyDx PCR11 Companion Diagnostic Approved in Japan for Johnson & Johnson’s Rybrevant in NSCLC with EGFR Exon 20 Insertions
Amoy Diagnostics Co., Ltd. (SHE: 300685) announced in collaboration with Japanese partners Riken Genesis Co.,...
CanSino Biologics’ Five-Component Pertussis Vaccine Enters NMPA Priority Review for Ages 6+
CanSino Biologics Inc. (HKG: 6185) announced that China’s National Medical Products Administration (NMPA) has included...
Henlius Biotech Expands European Footprint with Two Additional EC Approvals for HanSiZhuang PD-1 Inhibitor
Shanghai Henlius Biotech Inc. (HKG: 2696) announced it has secured two additional indication approvals from...
Henlius Biotech Receives FDA Clearance for Phase I Trial of HLX05-N Cetuximab Biosimilar in Metastatic Colorectal Cancer
Shanghai Henlius Biotech Inc. (HKG: 2696) announced it has received Investigational New Drug (IND) clearance...
Hansoh Pharmaceutical’s B7-H3 ADC HS-20093 Receives Fifth NMPA Breakthrough Therapy Designation for Esophageal Cancer
Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that its B7-H3-targeted antibody-drug conjugate (ADC) HS-20093...
CStone Pharmaceuticals Launches First Commercial Batch of Gavreto in China Following NRDL Inclusion
CStone Pharmaceuticals (HKG: 2616) announced the first batch manufacturing and release of its Gavreto (pralsetinib...
Wenda Pharmaceutical Secures NMPA Breakthrough Therapy Designation for NHWD-870 in Rare NUT Carcinoma
Zhejiang Wenda Pharmaceutical Technology Co., Ltd. announced it has received Breakthrough Therapy Designation (BTD) from...