Mabwell Secures NMPA Approval for Phase III Study of ADC 9MW2821 in Urothelial Carcinoma

Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase III clinical study for its antibody-drug conjugate (ADC), 9MW2821, which targets Nectin-4.

The randomized, open-label, controlled, multi-center Phase III trial aims to evaluate the efficacy and safety of 9MW2821 in patients with locally advanced or metastatic urothelial carcinoma (UC) that is not amenable to surgical intervention and has previously been treated with platinum-based chemotherapy and PD-(L)1 inhibitors.

9MW2821 is currently being investigated across a range of advanced solid tumors, including UC, cervical cancer, prostate cancer, HER2-negative breast cancer, and non-small cell lung cancer, among others.- Flcube.com

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