InnoCare Pharma (HKEX: 09969; SSE: 688428) announced that fadeucravacitinib, its oral TYK2 inhibitor, met the primary endpoint with statistical significance in a registrational Phase III trial in moderate-to-severe plaque psoriasis. The result positions InnoCare to file for regulatory approval in China, where approximately 8.66 million people are estimated to have the condition, and adds a second approved oral mechanism to a market currently served by only one such agent.
The drug binds the pseudokinase JH2 regulatory domain of TYK2, allosterically suppressing downstream signaling from IL-23, IL-12, and type I interferons — the cytokine axes central to psoriatic inflammation. Multiple secondary endpoints were also met, and no new safety signals were identified, consistent with earlier clinical studies. InnoCare did not disclose numerical efficacy or safety data, which will be presented at future scientific congresses.
The only approved oral TYK2 inhibitor for plaque psoriasis is Bristol Myers Squibb's Sotyktu (deucravacitinib), cleared by the FDA in September 2022 and by the EMA in 2023. Johnson & Johnson's Icotyde (icotrokinra), an oral IL-23 receptor antagonist approved by the FDA in March 2026, has also entered the oral systemic space. Fadeucravacitinib shares the same allosteric TYK2 mechanism as deucravacitinib, making differentiation dependent on head-to-head data or a distinct efficacy and tolerability profile — neither of which is yet publicly available.
InnoCare's Phase III multicenter trial is a randomized, double-blind, placebo-controlled study in adults with moderate-to-severe plaque psoriasis, and a second Phase III study remains ongoing. Two completed Phase II studies in the same indication preceded the registrational program. Beyond psoriasis, InnoCare is running Phase II trials of fadeucravacitinib in cutaneous lupus erythematosus and has a Phase II study in primary Sjögren's syndrome not yet recruiting, indicating a broader autoimmune strategy for the molecule.