Mabwell (688062.SH), an innovative biopharmaceutical company with the whole industry chain layout, announced that the clinical trial application in advanced solid tumors for its innovative antibody-drug conjugate (ADC) 7MW3711, developed based on its novel ADC platform IDDC™ (Interchain-Disulfide Drug Conjugate), was accepted by National Medical Products Administration (NMPA). 

7MW3711 is a novel antibody-drug conjugate targeting B7-H3, which is a member of the B7 ligand family and is overexpressed in most cancer types but expressed at a low level in normal tissues. In malignant tissues, B7-H3 inhibits tumor antigen-specific immune responses, resulting in a protumorigenic effect. Additionally, B7-H3 promotes migration and invasion, angiogenesis, chemotherapy resistance, endothelial-to-mesenchymal transition, and affects tumor cell metabolism.

The new generation antibody-drug conjugate molecule 7MW3711 with fully autonomous intellectual property right, developed based on Mabwell's novel Antibody Drug Conjugate platform IDDC™, is composed of innovative antibody molecule, novel linker, and novel payload (topoisomerase I inhibitor). When 7MW3711 enters into human body, it can specifically bind to antigens on the tumor cell membrane surface, be internalized and trafficked to the lysosome, release cytotoxic drug and induce the apoptosis of tumor cells. 

7MW3711 is pharmaceutical characterized as stable structure, homogeneous composition, high purity, and it is suitable for industrial scale-up. Compared with similar drugs at home and abroad, 7MW3711 has shown better tumor killing effects in multiple animal tumor models. In the safety evaluation model of animals including cynomolgus monkeys, the on-target and off-target toxicities of 7MW3711 are effectively controlled, showing its good drug safety and pharmacokinetic properties. The above research results indicate that 7MW3711 has clinical differentiation characteristics and a promising future of clinical development.