InnoCare Announces Clearance of Clinical Trial of TYK2 Inhibitor ICP-332 by U.S. FDA

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the Company's novel TYK2 (Tyrosine Kinase 2) inhibitor, ICP-332.

ICP-332 is a potent and selective TYK2 inhibitor. ICP-332 achieved multiple efficacy endpoints in the China Phase II study for the treatment of patients with moderate-to-severe atopic dermatitis (AD), demonstrating an outstanding efficacy and safety profile. ICP-332 showed better efficacy profile across different classes/MoAs of therapies for the treatment of AD patients (not a head-to-head comparison). The detailed data was presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting as a late-breaking oral presentation.

Currently, no TYK2 inhibitors have obtained marketing approval for the treatment of AD anywhere in the world. As a non-receptor tyrosine kinase, TYK2 is a member of the JAK kinase family, which is an important kinase on the JAK-STAT signaling pathway and plays an important role in the pathogenesis of inflammatory diseases.

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, "InnoCare is dedicated to targeting the global frontier in autoimmune therapy by focusing on B-cell and T-cell pathways. We have developed robust pipeline of differentiated therapeutics for autoimmune disease with significant market potential worldwide, including orelabrutinib (BTK inhibitor), ICP-332 (TYK2-JH1 inhibitor), ICP-488 (TYK2-JH2 inhibitor) and ICP-923 (IL-17 small molecule inhibitor). We are committed to accelerating clinical development and look forward to our innovative drugs benefiting patients with autoimmune diseases as early as possible."

About InnoCare

InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States.