Mabwell (Shanghai) Bioscience Co., Ltd, a biopharmaceutical company listed in China (SHA: 688062), has received approval from the Center for Drug Evaluation (CDE) in China to proceed with a Phase III clinical trial for its pipeline candidate, 9MW2821. The study is designed as a randomized, open, controlled, multi-center trial, comparing 9MW2821 against chemotherapy selected by the investigator for the treatment of patients with recurrent or metastatic cervical cancer who have failed platinum-based chemotherapy.
9MW2821 is an antibody-drug conjugate (ADC) that targets Nectin-4 and is currently under investigation in multiple clinical studies for various cancers, including esophageal cancer and urothelial carcinoma (UC). The drug has previously been granted fast-track designations (FTDs) by the US for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma, as well as for patients with previously treated recurrent or metastatic cervical cancer 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 US. In the latest development, the drug earned a breakthrough therapy designation in China for the treatment of locally advanced or metastatic UC in patients who have failed previous platinum-based chemotherapy and PD-(L)1 inhibitor therapy.- Flcube.com
