长春高新:子公司注射用GenSci140注册上市许可申请获受理

Core Viewpoint - Changchun High-tech announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received the acceptance notice from the National Medical Products Administration for the registration application of the injectable GenSci140, a novel targeted antibody-drug conjugate for treating advanced solid tumors [1] Group 1: Product Details - GenSci140 is a new type of dual-target antibody-drug conjugate developed independently by Jinsai Pharmaceutical, targeting the folate receptor alpha (FRα) [1] - The drug consists of Fab fragments binding to different epitopes of FRα and a single-domain heavy chain antibody (VHH), utilizing a cleavable linker and carrying a topoisomerase I (TOPO I) inhibitor payload [1] - GenSci140 can bind to two different epitopes expressed on tumor cells, enhancing antibody binding and internalization, which promotes the cytotoxic payload's entry into cells to directly kill tumor cells [1] Group 2: Mechanism of Action - The drug not only directly kills tumor cells but also enhances the anti-tumor effect through a bystander killing effect [1] - Indicated for the treatment of advanced solid tumors, GenSci140 aims to improve therapeutic outcomes in this challenging patient population [1]