China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced it has received approval from the U.S. Food and Drug Administration (FDA) to conduct a clinical study of its antibody drug conjugate (ADC) 9MW2821, targeting Nectin-4, in solid tumors. The drug is the first of its kind to enter clinical trials in China.
Drug Profile
9MW2821 binds to Nectin-4 on tumor cells, releasing cytotoxins to precisely kill cancer cells. The ADC leverages Mabwell’s proprietary linker technology for site-specific antibody modification, resulting in uniform components, high purity, and easy industrialization. Non-clinical studies demonstrated significant tumor suppression in multiple models and a favorable therapeutic window in animal safety studies.
Company Background
Founded in 2017, Mabwell has a pipeline of 12 novel drugs and 4 biosimilars targeting autoimmunity, oncology, metabolism, ophthalmology, infection, and other therapeutic areas.-Fineline Info & Tech
