Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has seen a stock increase of over 6% following the announcement that its drug JSKN003 has received breakthrough therapy designation from the FDA for treating advanced or metastatic ovarian cancer, primary peritoneal cancer, or fallopian tube cancer in patients previously treated with bevacizumab [1] Group 1 - JSKN003 is a self-developed HER2 dual antibody ADC by the company, currently undergoing orderly Phase III clinical trials in China for multiple indications [1] - The efficacy and safety of JSKN003 in platinum-resistant ovarian cancer have shown characteristics superior to Enhertu, with data readout expected in 2027 and a New Drug Application (NDA) submission to the CDE for 2L HER2-positive breast cancer anticipated in 2026 [1] - The company plans to initiate Phase III clinical trials for HER2-positive metastatic colorectal cancer in China by October 2025, with projected sales for JSKN003 expected to be 0.05 billion, 0.57 billion, and 1.08 billion in 2027, 2028, and 2029 respectively [1]
康宁杰瑞制药-B再涨超6% JSKN003用于治疗PROC获得FDA突破性疗法认定