Mabwell has announced that its submission to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for a randomized, controlled, open-label, multicenter Phase III clinical study of 9MW2821 in combination with Toripalimab versus standard chemotherapy in first-line locally advanced or metastatic urothelial cancer, has been approved.

The corresponding Phase III clinical study has been initiated and is currently in the enrollment stage. As of the announcement, 9MW2821 has been approved for three pivotal clinical trials.

9MW2821 is a novel Nectin-4-targeting ADC independently developed by Mabwell, and it is the first of its kind in China to initiate clinical trials on the same target, with more than 400 subjects enrolled in the clinical studies for multiple indications. The results of existing clinical studies have demonstrated outstanding therapeutic efficacy and safety profile.

The pivotal Phase III clinical study, 'an open-label, randomized Phase 3 study to evaluate 9MW2821 vs investigator's choice of chemotherapy in subjects with locally advanced or metastatic urothelial cancer who have previously received PD-(L)1 inhibitor and platinum-containing chemotherapy', is currently in the enrollment stage.

Mabwell is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system that covers target discovery, early discovery, preclinical, clinical research and manufacturing transformation was established.

Mabwell has 14 pipeline products in different stages based on a world-class and state-of-the-art R&D engine, including 10 novel drug candidates and 4 biosimilars.