CCHT(SZ:000661) Ge Long Hui A P P·2025-10-17 09:07Core 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][2] Group 1: Product Development - GenSci143 is a self-developed dual-specificity antibody-drug conjugate targeting B7-H3 and PSMA, which has potential dual therapeutic effects of targeted chemotherapy and tumor immunotherapy [1] - The drug works by binding to B7-H3 or PSMA, internalizing into lysosomes, and releasing TOPO-I inhibitor toxins to kill B7-H3 positive, PSMA positive, and dual positive tumor cells [1] - The dual-target mechanism of B7-H3 and PSMA can overcome tumor heterogeneity and resistance caused by reduced expression of single targets, thereby covering more patients and producing more durable anti-tumor efficacy [1] Group 2: Technological Advantages - GenSci143 utilizes self-developed linker technology, which features strong toxin activity and high plasma stability of the linker, providing enhanced tumor-killing effects while ensuring better safety [2] - The innovative dual-target design, stable linker technology, efficient cell-killing mechanism, and broad anti-tumor spectrum of GenSci143 may offer new treatment directions for various solid tumors expressing B7-H3 and/or PSMA [2]