Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has received Breakthrough Therapy Designation (BTD) from the FDA for JSKN003, aimed at treating platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer in adult patients previously treated with bevacizumab [1][2] Group 1: Drug Development and Regulatory Approvals - JSKN003 has previously been approved by the FDA to conduct a Phase II clinical trial for treating PROC regardless of HER2 expression levels [1] - The drug has also received BTD from the National Medical Products Administration (NMPA) in China for both PROC and colorectal cancer (CRC) [1] - JSKN003 has been granted Fast Track designation by the FDA for PROC and orphan drug designation for gastric/gastroesophageal junction cancer (GC/GEJ) [1] Group 2: Clinical Need and Market Potential - Ovarian cancer is one of the most common malignant tumors of the female reproductive system, with most patients diagnosed at an advanced stage and a high recurrence rate [2] - Current treatment options for PROC patients are limited, with existing non-platinum single-agent chemotherapy regimens showing an overall response rate (ORR) of only 10% to 15% and a median progression-free survival of approximately 3 to 4 months [2] - The median overall survival for these patients is about 12 months, highlighting a significant unmet clinical need [2] - The company believes that the BTD designation will accelerate the clinical development and regulatory review process for JSKN003, providing new treatment options for global PROC patients [2]
康宁杰瑞制药-B：JSKN003用于治疗PROC获得FDA突破性疗法认定