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ICP-B161 is a novel, long-acting bispecific monoclonal antibody developed by InnoCare Pharma for the treatment of autoimmune diseases, particularly inflammatory bowel disease (IBD). It is designed to simultaneously target and inhibit tumor necrosis factor ligand superfamily member 15 (TL1A) and interleukin-23 subunit alpha (IL-23p19), thereby blocking two key inflammatory pathways involved in the pathogenesis of IBD. Preclinical studies have demonstrated that ICP-B161 exhibits synergistic suppression of cytokine release and inflammatory responses, with superior in vivo efficacy in animal colitis models compared to single-target monoclonal antibodies. Engineered with an extended half-life, ICP-B161 is formulated for subcutaneous administration to allow for less frequent dosing. In October 2026, the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) approved the Investigational New Drug (IND) application for ICP-B161, marking its entry into clinical development.
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