Mabwell (Shanghai) Bioscience Co., Ltd. (688062.SH) has announced that it has received a "Drug Clinical Trial Approval Notice" from the National Medical Products Administration (NMPA). The approval covers the clinical trial application for 9MW5211 injection for the treatment of primary biliary cholangitis (PBC).

Previously, clinical trial applications for 9MW5211 injection for inflammatory bowel disease (IBD) were approved by both the NMPA and the FDA. Additionally, approvals for indications including multiple sclerosis (MS), type 1 diabetes mellitus (T1DM), and vitiligo have been obtained from the NMPA. The company is also actively advancing clinical trial applications for other indications.

9MW5211 is a novel, highly specific, depleting antibody developed independently by Mabwell. It targets a key pathological mechanism driven by abnormal immune cells in autoimmune diseases. The abnormal activation and tissue infiltration of immune cells are core drivers in the development of various autoimmune conditions. The molecule targeted by 9MW5211 is specifically expressed on the surface of pathogenic immune cells, serving as a crucial biological marker of their abnormal activation. By selectively recognizing and eliminating these pathogenic cells, 9MW5211 effectively blocks the immune cascade, thus alleviating disease progression and improving clinical symptoms.