Beijing, July 27, 2026
InnoCare Pharma has announced that its novel TYK2 (Tyrosine Kinase 2) inhibitor fadeucravacitinib (ICP-488) successfully met the primary endpoint in a registrational Phase III clinical trial involving patients with moderate-to-severe plaque psoriasis. The randomized, double-blind, placebo-controlled, multicenter study also achieved multiple key secondary endpoints, demonstrating statistically significant and clinically meaningful improvements in disease outcomes. The positive results reinforce the therapeutic potential of fadeucravacitinib, an investigational oral allosteric TYK2 inhibitor, as a next-generation treatment for autoimmune diseases. With a favorable safety profile and no new safety concerns identified, InnoCare plans to complete the Phase III program and advance regulatory submissions, aiming to deliver a new oral treatment option for millions of patients living with psoriasis and other immune-mediated inflammatory diseases.
Phase III Trial Demonstrates Strong Efficacy and Safety
The registrational Phase III clinical study was designed to evaluate the efficacy, safety, and tolerability of fadeucravacitinib (ICP-488) in adults with moderate-to-severe plaque psoriasis, a chronic autoimmune skin disease characterized by persistent inflammation, erythematous plaques, and scaling. According to the study results, the investigational therapy achieved the primary efficacy endpoint with statistical significance, while also meeting multiple secondary endpoints, confirming consistent clinical benefits across several treatment measures. Importantly, fadeucravacitinib maintained a favorable safety profile that was consistent with previous clinical studies, and investigators reported no new safety signals during the trial. Detailed efficacy and safety findings will be presented at upcoming international scientific conferences and published in peer-reviewed medical journals, providing further insight into the drug’s clinical performance and long-term therapeutic potential.
Novel TYK2 Inhibitor Targets Autoimmune Disease Pathways
Fadeucravacitinib is a potent, selective oral TYK2 allosteric inhibitor that works by binding to the JH2 regulatory domain of the TYK2 enzyme rather than the active catalytic site. This differentiated mechanism enables the therapy to selectively block signaling pathways involving IL-23, IL-12, Type I interferons, and other inflammatory cytokines that play central roles in autoimmune disease progression. By interrupting these signaling pathways, the investigational medicine reduces the abnormal immune responses responsible for chronic inflammatory conditions. Beyond plaque psoriasis, InnoCare is also evaluating fadeucravacitinib for additional autoimmune disorders, including cutaneous lupus erythematosus (CLE) and Sjögren’s syndrome, highlighting the broad therapeutic potential of the TYK2 inhibition platform. The growing demand for effective oral therapies continues to drive innovation in autoimmune disease treatment, particularly for patients seeking alternatives to injectable biologic medicines.
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Positive Results Support Regulatory Advancement and Pipeline Growth
The successful Phase III outcome represents another important milestone for InnoCare Pharma, which continues to expand its portfolio of innovative therapies for cancer and autoimmune diseases. The company believes that existing psoriasis treatments still leave significant unmet medical needs, particularly for patients seeking convenient oral therapies that combine strong efficacy with favorable long-term safety. With psoriasis affecting approximately 8.66 million people in China and the global psoriasis treatment market projected to grow substantially over the coming years, the positive data position fadeucravacitinib as a promising candidate in a rapidly evolving therapeutic landscape. Following completion of the Phase III study, InnoCare intends to move forward with regulatory filing activities, supporting commercialization efforts while further strengthening its pipeline of innovative immunology medicines. If approved, fadeucravacitinib could provide physicians and patients with an important new treatment option for chronic inflammatory skin disease and potentially other autoimmune disorders.
Source: InnoCare Pharma press release
