InnoCare Announces First Subject Dosed in the Phase III Registrational Trial of TYK2 Inhibitor ICP-332 for the Treatment of Atopic Dermatitis in China

Nov.15, 2024，InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, today announced that the first subject has been dosed in the Phase III registrational trial of the Company's novel TYK2 (Tyrosine Kinase 2) inhibitor ICP-332 for the treatment of atopic dermatitis (AD) in China.

ICP-332 is a potent and selective TYK2 inhibitor that is being developed for the treatment of various T-cell related autoimmune disorders, including atopic dermatitis (AD), vitiligo, inflammatory bowel disease, etc., with broad market prospects. 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.

Currently, no TYK2inhibitors have obtained marketing approval for the treatment of AD anywhere in the world. 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 a better efficacy profile across different classes/MoAs of therapies for the treatment of AD patients (not a head-to-head comparison).

According to the Global Burden of Disease Study by WHO, the number of patients with atopic dermatitis is as high as 230 million, making it the skin disease with the highest disease burden among nonfatal diseases. In China, the number of patients with atopic dermatitis continues to increase year by year.

Dr. Jasmine Cui, Co-founder, Chairwoman, and CEO of InnoCare, said, “Autoimmune diseases can affect almost every organ in the body and can occur at any age. InnoCare is dedicated advancing the global frontier in autoimmune therapy by focusing on B-cell and T-cell pathways. We have developed a 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 the novel small molecule inhibitor of IL-17. We are committed to accelerating clinical development and look forward to our innovative drugs benefiting patients with autoimmune diseases.”

About InnoCare

InnoCare 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.