CCHT(SZ:000661) Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2025-11-13 23:20Core Viewpoint - Changchun High-tech Industry (Group) Co., Ltd. announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received FDA approval for the clinical trial application of GenSci143, a dual-target antibody-drug conjugate for treating advanced solid tumors [1][2]. Group 1: Drug Information - Product Name: GenSci143 - Application: Clinical trial in the United States - Acceptance Number: 177763 - Applicant: Changchun Jinsai Pharmaceutical Co., Ltd. - Approval Conclusion: Clinical trial permitted in the U.S. - Indication: Advanced solid tumors [1]. Group 2: Drug Mechanism and Innovation - GenSci143 targets B7-H3 and PSMA, internalizing into lysosomes to release TOPO-I inhibitor toxins, effectively killing B7-H3 positive, PSMA positive, and dual-positive tumor cells [2]. - The dual-target mechanism helps overcome tumor heterogeneity and resistance due to reduced expression of single targets, potentially benefiting a broader patient population [2]. Group 3: Company Impact - Successful progress in clinical trials could enhance the company's business structure, optimize product offerings, and strengthen its core competitiveness [3]. - The company is committed to advancing the research project and will fulfill its information disclosure obligations regarding subsequent developments [4].