InnoCare Announces Phase II Study Results of TYK2 Inhibitor Soficitinib Meet Primary Endpoint in Patients with Vitiligo

BEIJING, July 16, 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 the Phase II portion of the Phase II/III trial of its TYK2 inhibitor Soficitinib (ICP-332) for non-segmental vitiligo has met the primary endpoint.

The study is a Phase II/III randomized, double-blind, placebo-controlled, parallel-group, adaptive, multicenter clinical trial. The study consists of a Phase II portion followed by a Phase III portion.

Phase II results showed that, at Week 24, treatment with soficitinib resulted in significant improvements from baseline in Facial Vitiligo Area Scoring Index (F-VASI). The least-squares mean percent change from baseline in F-VASI was 38.8% in the 80 mg once-daily group and 41.2% in the 120 mg once-daily group, compared with 2.2% in the placebo group. The two soficitinib dose groups demonstrated statistically significant improvements versus placebo (P<0.0001).

Soficitinib also showed a favorable safety profile, which was consistent with previous clinical studies. The treatment was well tolerated, and no new safety signals were identified. Detailed efficacy and safety results 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, Co-founder, Chairwoman and CEO of InnoCare, said, “We are delighted that the Phase II clinical trial of soficitinib for vitiligo has met the primary endpoint. As a novel oral TYK2 inhibitor, soficitinib is expected to provide an innovative treatment option with superior efficacy, a better safety profile and more convenient administration for patients with vitiligo.”

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

About InnoCare Pharma

InnoCare (HKEX: 09969; 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.

¹Shanghai Municipal Health Commission

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