InnoCare Announces Phase III Study Results of TYK2 Inhibitor Soficitinib Meet Primary Endpoint in Patients with Atomic Dermatitis

BEIJING, July 15, 2026 (GLOBE NEWSWIRE) — InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that registrational phase III clinical study results of novel TYK2 (Tyrosine Kinase 2) inhibitor soficitinib (ICP-332) met the primary endpoint in patients with moderate-to-severe atopic dermatitis (AD).

The Phase III study is a randomized, double-blind, placebo-controlled, multicenter registrational clinical trial designed to evaluate the efficacy, safety and tolerability of soficitinib in patients with moderate-to-severe AD.

The study demonstrated that soficitinib achieved the primary endpoint with statistical significance and clinically meaningful improvement. In addition, multiple secondary endpoints were successfully met, demonstrating a consistent treatment effect across efficacy measures.

Soficitinib also showed a good safety profile, which was consistent with previous clinical studies, and no new safety signals were identified. Detailed efficacy and safety data from the study will be presented at upcoming international scientific congresses and/or academic journal.

Soficitinib is a potent and selective oral TYK2 inhibitor that is being developed for the treatment of various T-cell related autoimmune disorders. The current indications under development are strategically positioned within the vast dermatology market, including AD, vitiligo, psoriasis, nodular prurigo and chronic spontaneous urticaria, etc. TYK2 plays a key role in the JAK-STAT signaling pathway and is critical in the pathogenesis of inflammatory diseases.

Dr. Jasmine Cui, the Co-founder, Chairwoman and CEO of InnoCare, said, “We are happy to see that soficitinib has met the primary endpoint in the Phase III studies in atopic dermatitis with excellent clinical results. AD is a chronic, relapsing inflammatory skin disease characterized by intense pruritus, eczema and substantial impairment in patients’ quality of life. We will continue to complete the Phase III study, and plan to advance the regulatory filing to bring better treatment option to patients with atopic dermatitis and other autoimmune diseases.”

According to the WHO Global Burden of Disease study, AD affects as many as 230 million people globally, ranking first in disease burden among non-fatal diseases worldwide¹. In China, the number of patients with AD is nearly 70 million, and the prevalence is increasing year by year².

About InnoCare Pharma

InnoCare (HKEX: 9969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing innovative drugs for the treatment of cancers and autoimmune diseases, two therapeutic areas with unmet medical needs worldwide. InnoCare has established comprehensive innovation platforms for drug discovery. To date, the Company has developed a robust product pipeline comprising three approved drugs (orelabrutinib, tafasitamab and zurletrectinib), more than ten innovative drug candidates in clinical development, and multiple programs in preclinical stages. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. For more information about InnoCare, please visit https://www.innocarepharma.com/en and follow us on LinkedIn.

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1 Jiefang Daily
2 People’s Daily Overseas Edition