InnoCare Begins Phase III Trial of TYK2 Inhibitor ICP-332 for Atopic Dermatitis in China

BEIJING--InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical firm specializing in cancer and autoimmune disease treatments, has announced the commencement of a Phase III registrational trial for their innovative TYK2 inhibitor, ICP-332, aimed at treating atopic dermatitis (AD) in China.

ICP-332 is a highly effective and selective TYK2 inhibitor developed for various T-cell-related autoimmune conditions, including atopic dermatitis, vitiligo, and inflammatory bowel disease, among others, showcasing significant market potential. TYK2 is a non-receptor tyrosine kinase and a crucial member of the JAK kinase family, integral to the JAK-STAT signaling pathway, which is pivotal in the development of inflammatory diseases.

Currently, no TYK2 inhibitors have received marketing approval globally for treating AD. ICP-332 has demonstrated impressive efficacy and safety, reaching multiple efficacy endpoints in a Phase II study in China for patients with moderate-to-severe atopic dermatitis. It has shown superior efficacy across various therapeutic categories for AD treatment.

According to the World Health Organization's Global Burden of Disease Study, there are approximately 230 million people suffering from atopic dermatitis worldwide, making it the most burdensome nonfatal skin disease. In China, the prevalence of atopic dermatitis continues to rise annually.

Dr. Jasmine Cui, Co-founder, Chairwoman, and CEO of InnoCare, commented, “Autoimmune diseases can impact nearly every organ in the body and can manifest at any age. At InnoCare, we are committed to pioneering advancements in autoimmune therapies by targeting B-cell and T-cell pathways. Our robust pipeline includes differentiated therapeutics for autoimmune diseases with substantial market potential globally, such as orelabrutinib (BTK inhibitor), ICP-332 (TYK2-JH1 inhibitor), ICP-488 (TYK2-JH2 inhibitor), and an innovative small molecule inhibitor of IL-17. We are dedicated to expediting clinical development and anticipate our innovative drugs will significantly benefit patients with autoimmune diseases.”

About InnoCare

InnoCare is a biopharmaceutical company at the commercial stage, focused on the discovery, development, and commercialization of first-in-class and best-in-class drugs for treating cancer and autoimmune diseases with unmet medical needs in China and worldwide. The company has operations in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.