Core Insights - Corning Jereh Pharmaceutical-B (09966) announced that JSKN003 has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (collectively referred to as PROC) regardless of HER2 expression levels [1] Group 1 - JSKN003 has been approved by the FDA to conduct a Phase II clinical trial for treating PROC with no restrictions on HER2 expression levels [1] - The drug has also received Breakthrough Therapy Designation from the National Medical Products Administration (NMPA) for both PROC and colorectal cancer (CRC) [1] - Additionally, JSKN003 has been granted Orphan Drug Designation by the FDA for gastric/gastroesophageal junction cancer (GC/GEJ) [1] Group 2 - The Phase III clinical trial for JSKN003 in treating PROC is currently progressing smoothly in China [1] - The FTD designation further underscores the confidence of international regulatory bodies in the clinical potential of JSKN003 and its significance as a novel therapeutic candidate [1]
康宁杰瑞制药-B(09966)：JSKN003获美国FDA授予用于治疗PROC的FTD