Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, today announced that the first patient has been dosed in a Phase III clinical trial evaluating its novel Nectin-4-targeting ADC (Bulumtatug Fuvedotin, or BFv, R&D code: 9MW2821) for the treatment of locally advanced or metastatic triple-negative breast cancer (TNBC).

The study (CTR20261518) aims to evaluate the efficacy and safety of BFv compared to chemotherapy in patients with locally advanced or metastatic TNBC who have previously received taxane-based therapy (with or without immunotherapy) and ADCs with topoisomerase inhibitor payloads. Given the high expression of Nectin-4 in TNBC, this study imposes no biomarker screening requirements, holding potential for broad patient coverage. A clinical trial for 9MW2821 in ADC-pretreated patients with TNBC is currently enrolling in the United States, which is expected to provide a new treatment option for TNBC patients worldwide.

About 9MW2821

9MW2821 is a novel Nectin-4-targeting ADC independently developed by Mabwell based on its ADC development platform. Mabwell is currently conducting multiple clinical studies for several indications including urothelial carcinoma, cervical cancer, esophageal cancer and breast cancer. It is the world’s first Nectin-4 ADC to enter Phase III clinical trials for cervical cancer (CC) and triple-negative breast cancer (TNBC). Four pivotal Phase III clinical studies are ongoing. 9MW2821 has obtained FDA Fast Track Designation for three indications, Orphan Drug Designation for one indication, and Breakthrough Therapy Designation from the CDE of NMPA for two indications.