Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) experienced a nearly 5% increase in stock price, reaching HKD 11.19 with a trading volume of HKD 8.53 million, following the announcement of breakthrough therapy designation (BTD) for JSKN003 by the FDA [1] Group 1: FDA Designation - JSKN003 has been granted breakthrough therapy designation (BTD) by 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 who have previously received bevacizumab treatment [1] - Prior to this, JSKN003 had already received FDA approval to conduct a Phase II clinical trial for PROC regardless of HER2 expression levels, and it has also been granted BTD by the National Medical Products Administration (NMPA) 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]
康宁杰瑞制药-B再涨近5% JSKN003已获FDA授予突破性疗法认定