Group 1 - Corning Jereh Pharmaceutical-B (09966.HK) announced that JSKN003 has received Breakthrough Therapy Designation (BTD) 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) in adult patients previously treated with bevacizumab [1] - JSKN003 has previously received FDA approval to conduct a Phase II clinical trial for PROC regardless of HER2 expression levels, and has also been granted BTD by the National Medical Products Administration (NMPA) in China for both PROC and colorectal cancer (CRC) [1] - The BTD designation further underscores the confidence of international regulatory agencies in the clinical potential of JSKN003 and its significance as a novel therapeutic candidate [1] Group 2 - Ovarian cancer is one of the most common malignant tumors of the female reproductive system, with most patients diagnosed at an advanced stage, high recurrence rates, and poor prognosis [2] - For PROC patients, treatment options are limited, with existing non-platinum single-agent chemotherapy regimens showing an overall response rate (ORR) of only 10% to 15%, a median progression-free survival of approximately 3 to 4 months, and a median overall survival of about 12 months, highlighting a significant unmet clinical need [2] - The company believes that the BTD designation will further accelerate the clinical development and regulatory review process for JSKN003, providing new treatment options for PROC patients globally [2]
康宁杰瑞制药-B(09966.HK)：JSKN003用于治疗PROC获得FDA突破性疗法认定