Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that it has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for its investigational antibody-drug conjugate (ADC), 9MW2821. This candidate is designed to target Nectin-4 and is currently in development for the treatment of locally advanced or metastatic triple negative breast cancer (TNBC) that tests positive for Nectin-4.
9MW2821 is the subject of multiple clinical trials, which span a range of cancer types including esophageal cancer, urothelial carcinoma, and cervical cancer. The drug has previously been granted Fast Track Designations for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma and for previously treated recurrent or metastatic cervical cancer in the U.S. In addition, 9MW2821 has also received an Orphan Drug Designation (ODD) for esophageal cancer from the FDA.- Flcube.com
