Hansoh Pharmaceutical Group (HKEX: 3692) has reported that HS-10374, its oral selective allosteric tyrosine kinase 2 (TYK2) inhibitor, met co-primary endpoints in a pivotal Phase III trial for adults with moderate-to-severe plaque psoriasis. The company said it plans to begin discussions with China's NMPA regarding a new drug application.
In the multicenter, randomized, double-blind, placebo-controlled Phase III study, both the proportion of participants achieving PASI 75 (at least a 75% reduction from baseline in the Psoriasis Area and Severity Index) and the proportion achieving sPGA 0/1 (static Physician's Global Assessment score of 0 or 1 with at least a 2-point improvement from baseline) at week 16 were significantly higher in the HS-10374 group versus placebo. The trial also met multiple secondary endpoints. Hansoh reported that more than half of treated participants achieved PASI 90 and almost one-third achieved PASI 100 at week 16. No numerical data were disclosed; detailed results are expected at an upcoming dermatology conference. The safety profile was described as consistent with other TYK2 inhibitors, with no new safety signals observed.
HS-10374 selectively binds the pseudokinase regulatory domain of TYK2, blocking downstream signaling of interleukin-12 and interleukin-23, cytokines central to psoriasis pathogenesis. Hansoh said it will initiate communications with China's National Medical Products Administration (NMPA) to prepare a new drug application.
The Phase III result follows positive Phase II data presented at CDA 2024, where HS-10374 at 6 mg and 12 mg once daily demonstrated statistically significant PASI 75 and sPGA 0/1 response rates versus placebo in 125 patients over 12 weeks.