SinoMab BioScience Limited (3681) has announced that on 24 February 2026, its Investigational New Drug application for SM17 in the treatment of inflammatory bowel disease (IBD) received approval from the National Medical Products Administration of China. This development follows a series of studies evaluating SM17 for atopic dermatitis, and it marks a significant step in broadening the therapeutic scope to Crohn’s disease (CD) and ulcerative colitis (UC).

SM17 is a first-in-class humanized IgG4-k monoclonal antibody designed to modulate Type 2 inflammatory responses by targeting the receptor of interleukin-25. Current data indicate that SM17 may offer benefits in both UC and CD by suppressing downstream inflammatory cytokines and potentially addressing complications of transmural inflammation, including strictures and fistulas.

According to the announcement, IBD imposes a high disease burden characterized by severe diarrhea, abdominal pain, and weight loss, and its chronic nature may lead to increased anxiety and other complications. The global annual cost of IBD management is estimated to exceed USD34.00 billion. Existing treatments are often limited by incomplete response rates and the heterogeneity of IBD pathophysiology, creating an unmet need for novel therapies.

The company reports completion of follow-up visits for a Phase I bridging study in healthy volunteers assessing the subcutaneous administration of SM17. Data from this study will support further clinical development in IBD. In parallel, an intravenous-to-subcutaneous formulation bridging study is expected to be completed as early as the first quarter of this year, with a potential Phase II clinical trial for atopic dermatitis to follow in the second quarter.