InnoCare wins China IND approval for TL1A/IL-23p19 bispecific ICP-B161
InnoCare Pharma has secured approval from China's National Medical Products Administration (NMPA) to begin clinical trials of ICP-B161, a bispecific antibody designed to simultaneously block the TL1A and IL-23p19 pathways in patients with autoimmune diseases, including inflammatory bowel disease (IBD). The IND clearance, granted by the Centre for Drug Evaluation, marks the fifth InnoCare candidate to enter clinical development in 2026.
ICP-B161 is engineered with an extended half-life that the company says allows for less frequent dosing and supports subcutaneous administration. In preclinical work using a TNBS-induced mouse colitis model, InnoCare reported that ICP-B161 demonstrated superior in vivo efficacy compared with a TL1A monoclonal antibody, an IL-23p19 monoclonal antibody, and unnamed peer bispecific antibodies at equivalent doses, with what the company described as favourable tolerability. Dose-dependent activity was observed across animal models, and the molecule was reported to significantly inhibit colitis-related symptoms.
Mechanism and differentiation
TL1A and IL-23p19 are well-validated targets in intestinal inflammation. IL-23p19 inhibition already underpins several approved therapies in IBD and psoriasis, including risankizumab and guselkumab. TL1A has attracted significant industry attention following Roche's acquisition of Telavant, which brought the TL1A inhibitor RVT-3101 into a major company's pipeline, and Merck's ozanimod approval has reinforced interest in gut-selective mechanisms. The dual-blockade approach positions ICP-B161 as a single-agent attempt to capture complementary pathway suppression, though clinical proof-of-concept in IBD patients is the critical outstanding question.
InnoCare notes that no bispecific antibody targeting both TL1A and IL-23p19 is currently approved anywhere globally, positioning the programme as a potential first-in-class in this particular combination. That claim is credible given publicly available pipeline databases, though competitors are pursuing analogous dual-target strategies.
Market context
IBD affects an estimated 6.8 million people worldwide, according to a 2020 analysis published in The Lancet Gastroenterology and Hepatology. The addressable market is substantial: existing therapies including anti-TNF agents, anti-integrins and IL-12/23 inhibitors leave a meaningful proportion of patients in inadequate remission or experiencing disease progression, which sustains commercial appetite for next-generation biologics.
The Chinese regulatory environment for novel biologics has accelerated meaningfully in recent years, with the NMPA adopting expedited review pathways for conditions of unmet need. InnoCare, which is dual-listed in Hong Kong and Shanghai, already has three approved drugs on the market, lending it a commercial infrastructure that could support eventual China-first or China-concurrent launches. The company's pipeline breadth, five clinical entrants in a single calendar year, will draw attention from investors tracking pipeline execution risk and resource allocation.
Dr Jasmine Cui, co-founder and chief executive of InnoCare, said the company would "accelerate the development of ICP-B161 to deliver innovative therapies to IBD patients as soon as possible."
The company has not disclosed a trial start date, patient enrolment targets, or primary endpoints for the Phase 1 study. Observers will be watching for early safety and pharmacokinetic data to validate the long-acting formulation hypothesis and confirm whether the synergistic effects observed preclinically translate into the clinic.