China-based biopharmaceutical company Mabwell (688062.SH) announced on Monday that it has received approval from China's Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for a randomised, controlled, open-label, multicentre Phase III clinical study of 9MW2821 in combination with Toripalimab compared to standard chemotherapy in first-line locally advanced or metastatic urothelial cancer.

The corresponding Phase III clinical study has been initiated and is currently in the enrolment 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 company says that the results of existing clinical studies have demonstrated outstanding therapeutic efficacy and safety profile.