Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has received FDA approval for JSKN003 to conduct a Phase II clinical study in the U.S., marking a significant milestone in the company's global development of its innovative pipeline [1][2]. Group 1: Clinical Trial Details - JSKN003-202 is a randomized, open-label, multi-center Phase II clinical study aimed at treating platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, collectively referred to as platinum-resistant ovarian cancer (PROC) [1]. - The trial will evaluate the efficacy and safety of JSKN003 in the specified patient population and determine the recommended dose for Phase III trials [1]. Group 2: Product Information - JSKN003 is a targeted HER2 bispecific antibody-drug conjugate (ADC) that connects a topoisomerase I inhibitor to the antibody KN026 using glycosylation site-specific conjugation technology, offering better serum stability compared to traditional conjugation methods [2]. - The bispecific HER2 targeting of JSKN003 enhances its internalization and bystander killing effect, providing strong anti-tumor activity in HER2-expressing tumors [2]. Group 3: Licensing and Ongoing Trials - In September 2024, the company entered into a licensing agreement with Shanghai Jinmant Biotechnology Co., Ltd. for the development and commercialization of JSKN003 in mainland China for tumor-related indications [2]. - Currently, JSKN003 is undergoing three Phase III clinical trials in China for treating HER2-positive breast cancer, HER2-low expressing breast cancer, and platinum-resistant recurrent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer [2].
康宁杰瑞制药-B(09966)：JSKN003获美国FDA批准开展一项治疗不限HER2表达水平的PROC的II期临床研究