Chinese biopharmaceutical company Mabwell (SH:688062) (HK:02493) announced on Friday that the Investigational New Drug (IND) application for 9MW5211, its independently developed novel antibody, has received clearance from the US Food and Drug Administration (FDA) to conduct clinical studies for the treatment of inflammatory bowel disease (IBD).

Clinical trial applications for multiple indications including IBD and multiple sclerosis (MS) have been accepted for review by the National Medical Products Administration (NMPA) of China.

9MW5211 is a highly specific, depleting, and innovative antibody independently developed by Mabwell, designed to precisely intervene in the key pathological mechanisms mediated by abnormal immune cells in autoimmune diseases. According to Mabwell, 9MW5211 is the world's first clinical-stage drug candidate for its target.

Preclinical study results have demonstrated that 9MW5211 exhibits significant therapeutic potential in various mouse models of autoimmune diseases, suggesting its future clinical application may cover multiple major indications. Safety evaluations conducted in cynomolgus monkey models have shown a favourable safety profile. Clinical trial applications for other indications are also being actively advanced.