InnoCare's TYK2 Inhibitor ICP-332 Gets U.S. FDA Trial Clearance

InnoCare Pharma, a prominent biopharmaceutical company listed on HKEX and SSE, has secured clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application concerning ICP-332, a novel Tyrosine Kinase 2 (TYK2) inhibitor.

ICP-332 is designed to be a powerful and selective inhibitor of TYK2. The drug achieved significant efficacy milestones during its Phase II clinical study in China for treating patients suffering from moderate-to-severe atopic dermatitis (AD). The study revealed that ICP-332 exhibits a remarkable efficacy and safety profile, surpassing various other therapeutic classes and mechanisms of action for AD treatment. Notably, these findings were showcased as a late-breaking oral presentation at the 2024 American Academy of Dermatology (AAD) Annual Meeting.

Globally, there are currently no TYK2 inhibitors approved for the treatment of AD. TYK2, a non-receptor tyrosine kinase, is part of the JAK kinase family, which is vital in the JAK-STAT signaling pathway. This pathway plays a critical role in the development of inflammatory diseases, making TYK2 a significant target in the treatment of such conditions.

Dr. Jasmine Cui, a Co-founder, Chairwoman, and CEO of InnoCare, expressed the company's dedication to advancing autoimmune therapy by targeting B-cell and T-cell pathways. She highlighted the company's robust pipeline of differentiated therapeutics aimed at autoimmune diseases, which have substantial market potential globally. This pipeline includes drugs like orelabrutinib (BTK inhibitor), ICP-332 (TYK2-JH1 inhibitor), ICP-488 (TYK2-JH2 inhibitor), and ICP-923 (IL-17 small molecule inhibitor). Dr. Cui emphasized InnoCare's commitment to expediting clinical development to ensure that their innovative treatments benefit patients with autoimmune diseases as swiftly as possible.

InnoCare is a commercial-stage biopharmaceutical company that focuses on the discovery, development, and commercialization of first-in-class and best-in-class drugs for cancer and autoimmune diseases, particularly where there are unmet medical needs both in China and globally. The company operates branches in major cities including Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and also has a presence in the United States.