CCHT(SZ:000661) Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2025-10-19 06:25Core Viewpoint - Changchun High-tech Industry (Group) Co., Ltd. announced that its subsidiary, Changchun JinSai Pharmaceutical Co., Ltd., received written notification from the FDA regarding the acceptance of the clinical trial application for the injectable GenSci143, a dual-target antibody-drug conjugate aimed at treating advanced solid tumors [1][2]. Group 1: Drug Information - Product Name: Injectable GenSci143 [1] - Indication: Advanced solid tumors [2] - Application Details: The clinical trial application has been accepted by the FDA with acceptance number 177763 [1]. Group 2: Mechanism and Technology - GenSci143 targets B7-H3 and PSMA, which are highly expressed in various malignancies, including non-small cell lung cancer, pancreatic cancer, and prostate cancer [2]. - The drug utilizes a proprietary linker technology that enhances the potency and stability of the toxin, aiming to provide a new treatment avenue for tumors expressing B7-H3 and/or PSMA [3]. Group 3: Development Timeline - The clinical trial application for GenSci143 is also set to be accepted in China by the National Medical Products Administration by August 2025 [3]. Group 4: Company Commitment - The company will actively advance the research and development of GenSci143 and will fulfill its information disclosure obligations regarding the project's progress [5].