Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that its antibody drug conjugate (ADC), 9MW2821, which targets Nectin-4, is on track to receive breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic urothelial carcinoma (UC). This designation is for patients who have not responded to prior platinum-based chemotherapy and PD-(L)1 inhibitor therapy.
9MW2821 is currently the subject of multiple clinical studies, encompassing a range of cancers including esophageal cancer, urothelial carcinoma, and cervical cancer. The drug has previously been granted fast-track designations (FTDs) by the U.S. FDA for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma, previously treated recurrent or metastatic cervical cancer (CC), and locally advanced or metastatic Nectin-4 positive triple negative breast cancer. Additionally, 9MW2821 has received an orphan drug designation (ODD) for esophageal cancer in the U.S.- Flcube.com
