InnoCare Pharma Receives China Clearance for Autoimmune Drug ICP-B161
Chinese regulators at the Center for Drug Evaluation have approved the Investigational New Drug application for ICP-B161 from InnoCare Pharma Ltd. (SSE:688428). The decision allows the drug candidate to advance into human clinical trials. ICP-B161 is a long-acting bispecific antibody administered subcutaneously to target both TL1A and IL-23p19 for the treatment of autoimmune conditions, including inflammatory bowel disease.
The approval marks InnoCare Pharma's fifth novel therapeutic candidate to gain clinical trial clearance in 2026. By addressing two disease pathways simultaneously, the therapy aims to differentiate itself from existing single-target treatments. No bispecific antibody targeting both TL1A and IL-23 has been approved to date, giving the treatment potential first-mover positioning in a competitive therapeutic market. Shares of InnoCare Pharma rose 4.03% to 28.12 CNY following the decision.
Development now moves to initial Phase 1 clinical testing to evaluate safety, pharmacokinetics, and preliminary therapeutic activity. Clinical progress, key safety findings, and eventual progression into Phase 2 clinical trials for inflammatory bowel disease will serve as primary milestones for the program.
Key points
- China's CDE approved the Investigational New Drug application for InnoCare Pharma's ICP-B161 candidate.
- ICP-B161 targets both TL1A and IL-23p19 pathways using a long-acting, subcutaneous design for autoimmune diseases.
- This approval represents the company's fifth novel drug program to enter clinical testing in 2026.
- InnoCare Pharma shares gained 4.03% to 28.12 CNY following the regulatory approval.
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How we writeDisclaimerQuestions and answers
What regulatory approval did InnoCare Pharma receive?
China's Center for Drug Evaluation approved the Investigational New Drug application for ICP-B161, permitting the company to begin human clinical trials for the treatment.
What is ICP-B161 designed to treat?
ICP-B161 is a long-acting bispecific antibody designed for autoimmune diseases, including inflammatory bowel disease, targeting the TL1A and IL-23p19 pathways.
How did InnoCare Pharma stock respond to the news?
InnoCare Pharma Class A shares increased by 4.03% to 28.12 CNY.