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Mabwell’s 9MW2821 Receives Breakthrough Therapy Designation in China for Urothelial Cancer

Demonstrates an 87.5% overall response rate in a clinical study.

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By: Charlie Sternberg

Associate Editor

Biopharmaceutical company Mabwell has 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 no...

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