BEIJING--(BUSINESS WIRE)-- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the first patient has been dosed in the Phase III registrational trial of the Company’s novel TYK2 (Tyrosine Kinase 2) inhibitor, ICP-488, for the treatment of moderate-to-severe plaque psoriasis in China.

This is a multicenter, randomized, double-blinded, placebo-controlled Phase III clinical study, designed to evaluate the efficacy and safety of ICP-488 monotherapy in adult patients with moderate-to-severe plaque psoriasis.

ICP-488 is an oral, potent and selective TYK2 allosteric inhibitor. By binding to the JH2 domain, ICP-488 blocks the signal transduction of IL-23, IL-12, type 1 IFN and other inflammatory cytokines, thereby inhibiting the pathological processes of autoimmune and inflammatory diseases.

According to the data presented at the Late-breaking Research session of the 2025 American Academy of Dermatology (AAD) Annual Meeting, the Phase II study results demonstrated that ICP-488 is highly effective in treating psoriasis at both 6 mg QD and 9 mg QD doses. Moreover, ICP-488 exhibited favorable safety and tolerability profiles, reinforcing its potential as a valuable treatment option for patients with moderate-to-severe psoriasis.

Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare, said, "Psoriasis severely affects patients’ quality of life and requires safer, more effective oral medications. We are pleased that ICP-488 has received recognition at international academic conferences for its promising clinical data, and we will accelerate the Phase III clinical program. In addition to psoriasis, InnoCare is rapidly advancing several Phase III registration trials in the field of autoimmune diseases. We look forward to bringing our innovative therapies to more patients around the world.”

Recent data indicates that approximately 8.66 million people in China are currently living with psoriasis¹, and this number is on the rise². Existing treatment options do not fully address the needs of psoriasis patients, with particularly high demand for novel, oral medications.

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 cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.

InnoCare Forward-looking Statements

This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.

¹ Epidemiological Burden Analysis of Psoriasis in China Based on the Global Burden of Disease (GBD) Big Data [J]. Chinese Journal of Dermatovenereology, 2021.

² 2021. Progress in Epidemiological Investigation of Psoriasis, Journal of Diagnostics Concepts & Practice. 2021.

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