Oct. 19, 2021, Shanghai - Mabwell, an innovative biopharmaceutical company with the whole industrial chain, announced today that its IND application for 9MW2821, an anti-Nectin-4 ADC drug candidate (R&D code: 9MW2821), has been formally approved by the Center for Drug Evaluation (CDE) of China National Medical Products Administration. The clinical trials will be conducted for solid tumors including urothelial carcinoma, breast cancer, lung cancer. This is China's first drug candidate that has been approved to clinical study among its domestic counterparts using the same target. And it will be the second Nectin-4 targeted ADC drug candidate approved to initiate clinical studies in the world.

9MW2821, categorized as a Class I innovative drug, is a novel anti-Nectin-4 ADC drug candidate developed by world-class ADC drug development platform and automated high-throughput antibody discovery platform of Mabwell. This drug candidate has achieved site-specific modification based on the ADC conjugate technology jointly developed by Mabwell and Shanghai Institute of Materia Medica.

9MW2821 boasts the advantages of homogenous structure, high purity and being easy production. It has also demonstrated favorable druggability properties in binding affinity, endocytosis, preliminary in vivo and in vitro pharmacodynamic activities, drug metabolism properties and preliminary safety. Results from preclinical pharmacological and toxicological studies showed that this drug candidate has favorable anti-tumor effects in a variety of animal tumor models. In addition, its safety in cynomolgus monkeys and rats indicated a superior safety margin, which indicates its potential in future trials.