Sinomab's SM17 advances to phase 2 for inflammatory bowel disease

Sinomab Bioscience Limited announced on December 11, 2025, that its investigational new drug (IND) application for SM17, targeting inflammatory bowel disease (IBD), has been accepted by China’s National Medical Products Administration. This acceptance allows the company to leverage existing phase 1 healthy volunteer data to progress SM17 directly to phase 2 clinical development for IBD, including Crohn's disease (CD) and ulcerative colitis (UC).

SM17 is a novel, first-in-class humanized IgG4-κ monoclonal antibody designed to modulate Type II inflammatory responses by targeting the IL-25 receptor. This mechanism blocks IL-25-induced signaling and suppresses downstream cytokines, positioning SM17 as a promising candidate for UC and offering potential benefits in CD through both Th17-driven inflammation modulation and an anti-fibrotic effect.

The company believes this expansion from atopic dermatitis to IBD represents a significant opportunity to address substantial unmet medical needs. The global annual cost of IBD management is estimated to exceed $34bn, with current therapies failing to meet the needs of 20–50% of patients. SM17’s multi-mechanistic profile differentiates it from existing single-pathway therapies.