Mabwell  announced that its Nectin-4 targeted ADC (9MW2821) received Breakthrough Therapy Designation (BTD) from the CDE of NMPA in China

The combination therapy with toripalimab is for treatment-naive patients with unresectable, locally advanced or metastatic urothelial carcinoma

Clinical results from 40 patients show an ORR of 87.5% (confirmed ORR of 80%) and a DCR of 92.5%, with median PFS and DoR not yet reached

A Pivotal Phase 3 trial of 9MW2821 with PD-1 is ongoing, showing significant improvement in ORR compared to other ADC and PD-1 combinations

It was also granted Breakthrough Therapy Designation (BTD) by the CDE as a monotherapy for urothelial carcinoma resistant to platinum-based chemotherapy and PD-(L)1 inhibitors

Mabwell continues to lead in developing innovative ADCs, with 9MW2821 positioned as a potential breakthrough for urothelial carcinoma treatment