INNOCARE (09969.HK): TYK2 Inhibitor Soficitinib (ICP-332) Meets Primary Endpoint in Phase II for Non-Segmental Vitiligo, 24-Week F-VASI Reduced by Around 39%-41% vs Baseline

NewTimeSpace News: INNOCARE (09969.HK) announced on 16 July that its TYK2 inhibitor Soficitinib (ICP-332) hit the primary endpoint in the Phase II segment of adaptive Phase II/III trial for adult patients with non-segmental vitiligo. F-VASI dropped roughly 39%-41% at Week 24 versus baseline, versus only 2.2% in placebo arm with statistically significant differences. The candidate demonstrated favourable safety profile, and the Company will advance to Phase III and communicate with regulators. Risks associated with clinical development exist.

NewTimeSpace News: On 16 July 2026, Innocare (09969.HK) issued a voluntary announcement. The Phase II portion of adaptive Phase II/III clinical study evaluating Soficitinib (ICP-332), the Company’s self-discovered next-generation oral TYK2 inhibitor, for adult patients with non-segmental vitiligo successfully achieved its primary endpoint.

For the change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24: the 80mg once-daily arm recorded a 38.8% reduction, the 120mg once-daily arm achieved a 41.2% reduction, while the placebo arm only saw a 2.2% decline. Both treatment arms showed statistically significant differences versus placebo (P<0.0001). Consistent therapeutic benefits were observed across multiple secondary endpoints.

In terms of safety, Soficitinib (ICP-332) was well tolerated, consistent with findings from prior clinical trials, with no new safety signals identified. The study will proceed to the Phase III segment per protocol. The Company plans to communicate with regulatory authorities to further push forward clinical development.

Soficitinib (ICP-332) is a next-generation highly selective oral TYK2 inhibitor with approximately 400-fold selectivity over JAK2. It is currently under clinical development across five indications of autoimmune diseases.

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