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InnoCare Announces First Patient Dosed in the Phase II/IIII Clinical Trial of TYK2 Inhibitor Soficitinib for Treatment of Vitiligo in China

May 16, 2025 --

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 II/III clinical trial of its novel TYK2 inhibitor, Soficitinib (ICP-332), for the treatment of patients with non-segmental vitiligo in China.

Soficitinib is a potent and selective TYK2 inhibitor that is being developed for the treatment of various T-cell related autoimmune disorders, including vitiligo, atopic dermatitis (AD), prurigo nodularis, etc., with broad market potential. TYK2 is a non-receptor tyrosine kinase and a member of the JAK kinase family. It plays a key role in the JAK-STAT signaling pathway and is critically involved in the pathogenesis of inflammatory diseases.

Vitiligo happens when skin melanocytes are destroyed, leading to loss of pigment, and leaving white patches on the skin. Vitiligo affects approximately 0.5%–2%1 of the global population. It is a chronic condition that requires long-term treatment. The goals of therapy include disease stabilization, repigmentation, and maintenance treatment to prevent recurrence of depigmentation.

Dr. Jasmine Cui, Co-founder, Chairwoman, and CEO of InnoCare, said, “Vitiligo imposes significant psychological and social burdens on patients. Many patients experience decreased self-confidence, social barriers, and other challenges. There remains a lack of effective treatments, highlighting substantial unmet medical needs. We will accelerate the clinical development of soficitinib and look forward to bringing benefits to patients with vitiligo and other autoimmune diseases as early as possible.”

In addition to vitiligo, the clinical development of soficitinib for other autoimmune diseases is also progressing, including the Phase III registrational trial for atopic dermatitis.

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 Shanghai Municipal Health Commission

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