Mawell Biotech (688062.SH): The clinical trial application for 9MW5211 injection has been approved by the National Medical Products Administration.

Maiwei Biotech (688062.SH) announced that it recently received the Clinical Trial Approval Notice approved by the National Medical Products Administration (NMPA) for the clinical trial application of 9MW5211 injection for the indication of primary biliary cholangitis (PBC). Previously, its clinical trial application for inflammatory bowel disease (IBD) had been approved by the NMPA and licensed by the FDA. Clinical trial applications for multiple sclerosis (MS), type 1 diabetes (T1DM), and vitiligo have also been approved by the NMPA. The company is also actively advancing the application work for clinical trials of other indications. 9MW5211 is a highly specific clearing-type innovative antibody independently developed by the company, targeting the key pathological mechanisms mediated by abnormal immune cells in autoimmune diseases for precise intervention. The abnormal activation and tissue infiltration of immune cells are core driving factors in the occurrence and development of various autoimmune diseases. The molecules targeted by 9MW5211 are specifically expressed on the surface of pathogenic immune cells, serving as important biological markers for their abnormal activation. By selectively recognizing and clearing this group of pathogenic cells, 9MW5211 can effectively block the immune cascade response, thereby alleviating disease progression and improving clinical symptoms.