长春高新(000661.SZ)：金赛药业注射用GenSci143 临床试验申请获得受理

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received a written notification from the U.S. Food and Drug Administration (FDA) regarding the acceptance of the clinical trial application for GenSci143, a dual-target antibody-drug conjugate [1] Group 1: Product Details - GenSci143 is a self-developed dual-specific antibody-drug conjugate targeting B7-H3 and PSMA, which has potential dual therapeutic effects of targeted chemotherapy and tumor immunotherapy [1] - The mechanism of GenSci143 involves internalization into lysosomes upon binding to B7-H3 or PSMA, releasing TOPO-I inhibitor toxins to kill B7-H3 positive, PSMA positive, and dual-positive tumor cells [1] - The dual-target approach of B7-H3 and PSMA can overcome tumor heterogeneity and resistance caused by reduced expression of a single target, thereby covering more patients and producing more durable anti-tumor efficacy [1] Group 2: Technical Advantages - GenSci143 utilizes self-developed linker technology, which features strong toxin activity and high plasma stability of the linker, resulting in enhanced tumor-killing effects and improved safety [1] - The innovative dual-target design, stable linker technology, efficient cell-killing mechanism, and broad anti-tumor spectrum of GenSci143 may provide new treatment directions for various solid tumors expressing B7-H3 and/or PSMA [1]