Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has seen a stock increase of over 6%, currently trading at HKD 11.57, with a transaction volume of HKD 12.83 million. The rise is attributed to the FDA granting breakthrough therapy designation for JSKN003, aimed at treating specific types of advanced ovarian cancer in patients previously treated with bevacizumab [1]. Group 1 - Corning Jereh Pharmaceutical announced that its product JSKN003 has received breakthrough therapy designation from the FDA for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer in adults who have previously been treated with bevacizumab [1]. - JSKN003 is a self-developed HER2 dual antibody ADC, with ongoing Phase III clinical trials in China for multiple indications. The efficacy and safety of JSKN003 have shown superior characteristics compared to Enhertu in the platinum-resistant ovarian cancer population [1]. - The company expects to complete data readout for JSKN003 by 2027 and plans to submit a New Drug Application (NDA) to the CDE for 2L HER2-positive breast cancer in 2026. Additionally, a Phase III clinical trial for HER2-positive metastatic colorectal cancer is set to start in October 2025, with projected sales for JSKN003 estimated at 0.05 billion, 0.57 billion, and 1.08 billion for the years 2027, 2028, and 2029 respectively [1].
港股异动 康宁杰瑞制药-B(09966)再涨超6% JSKN003用于治疗PROC获得FDA突破性疗法认定