Maiwei Biology-B (02493): The clinical trial application for 9MW5211 injection solution has obtained FDA approval.

Medicilon Biotech-B (02493) announced that recently, the company received a "Study May Proceed Notification" from the United States Food and Drug Administration (FDA). The clinical trial application for the use of 9MW5211 injection for the indication of inflammatory bowel disease (IBD) has been officially granted FDA approval. In addition, the company's clinical trial applications for IBD and multiple sclerosis (MS) and other indications have been accepted by the China National Medical Products Administration, and the company is actively advancing other indications for clinical trial applications. The FDA has completed the safety evaluation of this application and has agreed to the proposed clinical research plan for the study of 9MW5211 in healthy subjects. This study is a randomized, placebo-controlled, single-dose escalation first-in-human study aimed at assessing the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of 9MW5211.