Core Viewpoint - 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, marking a significant milestone in the global development of JSKN003 [1] Group 1 - JSKN003 has been granted FTD by the FDA for treating platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, indicating its clinical potential [1] - The FDA has also approved a Phase II clinical trial for JSKN003 targeting platinum-resistant recurrent epithelial ovarian cancer with no restrictions on HER2 expression levels [1] - JSKN003 has received breakthrough therapy designation from the National Medical Products Administration (NMPA) for both PROC and colorectal cancer (CRC), and orphan drug designation from the FDA for gastric/gastroesophageal junction cancer (GC/GEJ) [1] Group 2 - The Phase III clinical trial for JSKN003 in treating platinum-resistant recurrent epithelial ovarian cancer is currently progressing smoothly in China [1] - The FTD designation further underscores the confidence of international regulatory bodies in the clinical potential and importance of JSKN003 as a novel therapeutic candidate [1]
康宁杰瑞制药-B：JSKN003获美国FDA授予用于治疗PROC的FTD