InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application for ICP-B161, a bispecific antibody targeting TL1A and IL-23p19, for the treatment of autoimmune diseases, including inflammatory bowel disease (IBD). ICP-B161 is InnoCare’s fifth novel drug candidate to enter clinical development in 2026.

With its novel molecular design, ICP-B161 delivers an extended half‑life, which allows for less frequent dosing and supports subcutaneous administration, making it a differentiated long-acting bispecific antibody.

By simultaneously targeting TL1A and IL-23p19, ICP-B161 has shown synergistic effects in suppressing cytokine release and mitigating inflammatory responses, with the potential to modulate two key pathways involved in the pathogenesis and progression of IBD. Preclinical studies show that ICP-B161 exhibits dose-dependent activity in animal models and significantly inhibits colitis-related symptoms. In a TNBS-induced mouse colitis model, at equivalent doses, ICP-B161 shows superior in vivo efficacy compared with the corresponding TL1A monoclonal antibody, IL-23p19 monoclonal antibody and peer bispecific antibodies, with favorable tolerability. Currently, no bispecific antibodies targeting TL1A and IL-23p19 have been approved for marketing globally.

Dr. Jasmine Cui, Co-Founder, Chairwoman, and CEO of InnoCare, said, “We are pleased to have another candidate from our large molecule platform enter the clinic. IBD is a progressive, lifelong disease. A large proportion of patients experience severe complications despite existing therapies, with huge unmet medical needs. We will accelerate the development of ICP-B161 to deliver innovative therapies to IBD patients as soon as possible.”

IBD is a chronic, relapsing inflammatory disorder of the intestine affecting an estimated 6.8 million people worldwide¹.