Maiwei Biology (688062.SH): 9MW5211 injection clinical trial application approved by the State Drug Administration

Zhitong Financial App News, Maiwei Biotech (688062.SH) issued an announcement. Recently, the company received the “Drug Clinical Trial Approval Notice” approved and issued by the State Drug Administration, and the clinical trial application for 9MW5211 injection for vitiligo indications was approved. Previously, its clinical trial application for inflammatory bowel disease (IBD) indications had been approved by the National Drug Administration and FDA approval respectively. Clinical trial applications for multiple sclerosis (MS) and type 1 diabetes (T1DM) indications have been approved by the China Drug Administration .

9MW5211 is a highly specific cleavage innovative antibody independently developed by the company to accurately intervene on key pathological mechanisms mediated by abnormal immune cells in autoimmune diseases. Abnormal activation of immune cells and tissue infiltration are core drivers of the development of various autoimmune diseases. The molecule targeted by 9MW5211 is specifically expressed on the surface of pathogenic immune cells and is an important biological marker of abnormal activation of these cells. By selectively identifying and removing this group of pathogenic cells, 9MW5211 can effectively block immune cascades, thereby mitigating disease progression and improving clinical symptoms.