Group 1 - Corning Jereh Pharmaceutical-B (09966) announced that JSKN003 has received Breakthrough Therapy Designation (BTD) from the 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 been granted FDA approval to conduct a Phase II clinical trial for PROC regardless of HER2 expression levels, and has also received BTD from the National Medical Products Administration (NMPA) for PROC and colorectal cancer (CRC) [1] - The BTD designation further underscores the confidence of international regulatory agencies in the clinical potential of JSKN003 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)：JSKN003用于治疗PROC获得FDA突破性疗法认定