Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced a significant milestone for its proprietary Nectin-4 targeted ADC (9MW2821). On January 8, 2025, 9MW2821 was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. 9MW2821 is given in combination with toripalimab, an anti-PD-1 monoclonal antibody, for treatment-naïve, unresectable, locally advanced or metastatic urothelial carcinoma(la/mUC). Up to now, 40 treatment-naïve patients with la/mUC were enrolled and received the combination therapy. ORR was 87.5% (comfirmed ORR was 80%) and DCR was 92.5%. Median PFS and DoR were not reached.

A pivotal Phase III study of 9MW2821 in combination with PD-1 is ongoing. Compared with similar ADC and PD-1 combos, 9MW2821 has shown significant increase in ORR. Previously, 9MW2821 had been granted BTD by the CDE as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma that has failed to platinum-based chemotherapy and PD-(L)1 inhibitor therapy.

The BTD is a recognition aimed at expediting the development of new medicines for serious diseases. It is awarded to therapies that have shown significant efficacy or safety advantages over existing treatments in early-stage clinical trials. For drugs included in the BTD list, the CDE prioritizes resource allocation to facilitate communication and provide guidance, thereby accelerating both clinical development progress and speeding up market review and approval processes.