长春高新:注射用GenSci140境内生产药品注册临床试验申请获受理

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received the acceptance notice from the National Medical Products Administration for the clinical trial application of GenSci140, a novel targeted dual-epitope antibody-drug conjugate [1] Group 1: Product Development - GenSci140 is independently developed by Jinsai Pharmaceutical and is designed as a dual-epitope antibody-drug conjugate targeting the folate receptor alpha (FRα) [1] - The drug consists of Fab fragments that bind to different epitopes of FRα and a single-domain heavy chain antibody (VHH), utilizing a cleavable linker and carrying a topoisomerase I (TOPOI) inhibitor payload [1] - GenSci140 can bind to two different epitopes expressed on tumor cells, enhancing antibody binding and internalization, which promotes the delivery of the TOPOI inhibitor cytotoxic payload into the cells [1] Group 2: Mechanism of Action - The mechanism of GenSci140 involves direct cytotoxicity against tumor cells and an enhanced anti-tumor effect through a bystander killing effect [1]