Enhertu Gains Conditional Approval in China for Advanced HER2-Positive Gastric Cancer
Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody-drug conjugate co-developed by AstraZeneca (NASDAQ: AZN, LON: AZN) and...
Product approvals
Lepu Medical’s PeakHeat Vascular Sheath Gains Regulatory Green Light for Market Launch
Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a leading provider of cardiovascular disease solutions...
Sihuan Pharmaceutical Secures NMPA Approval for First Biosimilars of Novo Nordisk’s Diabetes Drugs
Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has secured separate marketing approvals from China’s National...
Ascendis Pharma’s Hypoparathyroidism Therapy Yorvipath Wins FDA Nod, Fills Market Gap
This week, the U.S. Food and Drug Administration (FDA) granted market approval to Ascendis Pharma...
Artech Medical’s Balloon Cryoablation Catheter Wins NMPA Nod for Atrial Fibrillation Treatment
Shanghai Artech Medical Technology Co., Ltd., a company known for its innovation in the medical...
Chinese NMPA Approves Hengrui Pharmaceuticals’ Generic Abraxane for Metastatic Pancreatic Cancer Treatment
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced...
Guangdong Zhongsheng Pharmaceutical’s COVID-19 Drug Leritrelvir Approved in Macau
Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a pharmaceutical company based in China, has announced...
Sansure Biotech’s MTHFR Gene Detection Kit Receives NMPA Approval, Aids in Pregnancy Health Management
Sansure Biotech Inc. (SHA: 688289), a specialist in molecular diagnostics based in China, has achieved...
Huadong Medicine Expands Global Footprint with Launch of Aesthetic Injection MaiLi in Singapore
Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has announced the international expansion...
Changshan Biochemical Gets Marketing Nod for Enoxaparin in Kyrgyzstan for Venous Thromboembolic Diseases
Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255), a Chinese pharmaceutical company, has announced...
Vazyme Biotech Secures NMPA Nod for Two RSV Antigen Detection Kits
Vazyme Biotech Co., Ltd (SHA: 688105), a biotechnology company based in China, has announced that...
Antengene’s Xpovio Receives NDA Approval in Malaysia for Multiple Myeloma Treatment
Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced the approval...
CMS’s Methotrexate Injection Gains NMPA Approval for Active Rheumatoid Arthritis Treatment
China Medical System Holdings (CMS; HKG: 0867) has received approval from the National Medical Products...
Takeda’s Vonicog Alfa Receives NMPA Approval for Von Willebrand Disease Treatment in China
Takeda Pharmaceutical Company Limited (TYO: 4502 / NYSE: TAK), a leading Japanese pharmaceutical company, has...
Sino Medical Sciences’ HT Supreme Drug-Eluting Stent System Gains Market Approval in Mexico
Sino Medical Sciences Technology Inc. (SHA: 688108), a prominent player in the medical device industry...
Roche’s Alzheimer’s Disease Diagnostic Kits Gain Approval in Hainan, Set for Use in Shanghai Ruijin Hospital
Swiss pharmaceutical and diagnostics giant Roche (SWX: ROG) has received approval from the Hainan Medical...
AbbVie’s Allergan Aesthetics Wins NMPA Approval for Juvéderm Dermal Filler in China
Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), has secured marketing approval from China’s National...
GSK’s Jemperli Receives EC Approval for Endometrial Cancer Treatment in Combination Therapy
GSK plc (NYSE: GSK), a leading UK pharmaceutical company, has announced that the European Commission...
MicroPort Scientific’s Bioabsorbable Stent System Gains NMPA Nod for Ischemic Heart Disease Treatment
Shanghai-based medical device conglomerate MicroPort Scientific Corp. (HKG: 0853) has announced that it has received...
Bio-Thera Solutions’ Bevacizumab Biosimilar Avzivi Receives European Commission Approval
Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that its biosimilar version of Roche’s Avastin, Avzivi...