Maiwei Bioscience-B (02493): The clinical trial application for 9MW5211 injection has been approved by the National Medical Products Administration.

Maiwei Biology-B (02493) issued an announcement that the company has recently received the "Clinical Trial Approval Notice for Drugs" approved and issued by the National Medical Products Administration. The clinical trial application for the use of 9MW5211 injection for the treatment of multiple sclerosis (MS) has been approved. In addition, the clinical trial applications for its use in the treatment of inflammatory bowel disease (IBD) have been approved by both the National Medical Products Administration and the FDA. The company is also actively advancing clinical trial applications for several other indications, with some applications already accepted by the National Medical Products Administration. 9MW5211 is a highly specific clearance type of innovative antibody developed independently by the company, targeting the key pathological mechanisms mediated by abnormal immune cells in autoimmune diseases for precise intervention. Abnormal activation of immune cells and tissue infiltration are core driving factors in the development of various autoimmune diseases. The molecule targeted by 9MW5211 is specifically expressed on the surface of pathogenic immune cells, serving as an important biological marker for their abnormal activation. By selectively recognizing and clearing these pathogenic cells, 9MW5211 can effectively block the immune cascade reaction, thereby alleviating disease progression and improving clinical symptoms. Through multiple rounds of molecular engineering optimization, 9MW5211 has demonstrated excellent target selectivity, achieving highly effective blockade while significantly reducing the risk of non-specific binding to ensure deep clearance of pathogenic cells expressing high levels of the target protein. This unique mechanism of action not only holds the promise of deeper disease relief but also may support longer dosing intervals, thereby enhancing patient compliance and quality of life. Preclinical study results have shown significant therapeutic potential of 9MW5211 in various mouse models of autoimmune diseases, with future clinical applications expected to cover multiple major indications. As of the date of this announcement, the clinical trial applications for 9MW5211 in MS and IBD indications have been approved by the National Medical Products Administration, and the application for IBD indication has received FDA approval. The company is actively advancing multiple other clinical trial applications for different indications, with some applications already accepted by the National Medical Products Administration. Furthermore, safety assessments conducted in the crab-eating monkey model have shown favorable safety characteristics. As the world's first clinical-stage candidate drug targeting this molecule, 9MW5211 is poised to usher in a new chapter in precision treatment of autoimmune diseases.