On September 21, Hansoh Pharma announced that its self-developed selective allosteric inhibitor of tyrosine kinase 2 (TYK2), HS-10374, achieved the co-primary endpoints and multiple secondary endpoints in a pivotal Phase 3 clinical trial for the treatment of adults with moderate-to-severe plaque psoriasis. This was a randomized, double-blind, placebo-controlled, multicenter Phase 3 study designed to evaluate the efficacy and safety of HS-10374 in adult patients with moderate-to-severe plaque psoriasis.
The trial has enrolled 503 subjects, who were randomly assigned to receive either HS-10374 or a placebo. Results showed the study met its co-primary endpoints. At week 16 of treatment, the proportion of patients in the HS-10374 group achieving at least a 75% reduction from baseline in the Psoriasis Area and Severity Index (PASI 75), as well as the proportion achieving a static Physician's Global Assessment (sPGA) score of 0 or 1 with at least a 2-point reduction from baseline (sPGA 0/1), were both significantly higher than in the placebo group.
For secondary endpoints, at week 16, more than half of patients treated with HS-10374 achieved a PASI 90 response, and nearly one-third achieved a PASI 100 response. In terms of safety, HS-10374 demonstrated a favorable safety and tolerability profile, consistent with the safety characteristics of other TYK2 inhibitors in its class, with no new safety signals observed.
According to the press release, Hansoh Pharma plans to initiate communication with regulatory authorities in the near term to advance preparations for the New Drug Application (NDA) submission of HS-10374. Detailed data from the study will be presented at an upcoming dermatology academic conference. HS-10374 is an oral, highly selective TYK2 allosteric inhibitor independently developed by Hansoh Pharma. It inhibits signal transduction of the cytokine interleukin-12 (IL-12), IL-23, and type I interferon (IFN) pathways, offering potential therapeutic effects in multiple autoimmune diseases.
According to the Insight database, beyond plaque psoriasis, Hansoh Pharma is also conducting clinical studies of HS-10374 for indications such as psoriatic arthritis and alopecia areata. The TYK2 allosteric inhibitor space is seeing mounting competition, with multiple products under development globally. Bristol Myers Squibb's deucravacitinib is the first approved TYK2 allosteric inhibitor worldwide, having secured approval for moderate-to-severe plaque psoriasis. Several other candidates targeting the same mechanism are in various stages of clinical development, including selective TYK2 allosteric inhibitors in pipelines for autoimmune conditions like psoriasis and psoriatic arthritis.
Domestically, besides Hansoh Pharma's HS-10374, several other local biopharmaceutical companies are advancing clinical development of TYK2 allosteric inhibitors for plaque psoriasis and other indications, intensifying competition in the sector.
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