Mabwell’s Novel Nectin-4 Targeting ADC 9MW2821 Granted Breakthrough Therapy Designation by China’s NMPA

CAR-T Digest - August 2020

12 Aug 2024: Mabwell’s Novel Nectin-4 Targeting ADC 9MW2821 Granted Breakthrough Therapy Designation by China’s NMPA

Mabwell’s novel Nectin-4 targeting antibody-drug conjugate (ADC), 9MW2821, has received Breakthrough Therapy Designation from China’s National Medical Products Administration (NMPA) for treating locally advanced or metastatic urothelial carcinoma that has failed previous treatments
9MW2821 is the first site-specific Nectin-4 targeting ADC developed by Mabwell and has shown clinical efficacy in cervical cancer, esophageal cancer, and breast cancer. It also has Fast Track and Orphan Drug Designations from the FDA
The ADC uses proprietary conjugation technology to bind specifically to Nectin-4 on tumor cells, releasing a cytotoxic drug to induce apoptosis and target cancer cells
Mabwell’s pipeline includes 14 products, which comprises 10 novel drug candidates and 4 biosimilars targeting various diseases. Currently, 3 products are approved and commercialized, 1 is filed for MA approval, and 3 are in pivotal trials