Mabwell Announces CDE Approval to Initiate Phase III Clinical Trial of 9MW2821 for Urothelial Carcinoma in Combination with a PD-1 Inhibitor

SHANGHAI, 26 August 2024 /PRNewswire/ — Mabwell (688062.SH), an innovative biopharmaceutical company with a full industrial chain, announced that its application to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for “a randomized, controlled, open-label, multicenter Phase III clinical trial of 9MW2821 in combination with toripalimab compared with standard chemotherapy for locally advanced or metastatic urothelial carcinoma as first-line therapy” has been approved. The corresponding Phase III clinical trial has been initiated and is currently in the registration phase. As of the time 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 the first of its kind in China to initiate clinical trials towards the same goal, with more than 400 subjects enrolled in the clinical trials for multiple indications. The results of existing clinical trials have demonstrated excellent therapeutic efficacy and an excellent safety profile. The pivotal Phase III clinical trial, “an open-label, randomized Phase 3 study to evaluate 9MW2821 versus investigator's choice of chemotherapy in subjects with locally advanced or metastatic urothelial cancer who have previously received a PD-(L)1 inhibitor and platinum-containing chemotherapy,” is currently in the recruitment phase.