Hansoh Pharma’s HS-10374 met Phase 3 co-primary endpoints in moderate-to-severe plaque psoriasis, with strong PASI 90 and PASI 100 responses at week 16.
Written By: Kirti Kumbhar, M. Pharm (QA)
Reviewed By: Pharmacally Editorial Team
Hansoh Pharma’s oral TYK2 inhibitor HS-10374 met both co-primary endpoints in a pivotal Phase 3 study in adults with moderate-to-severe plaque psoriasis, with significantly higher PASI 75 and sPGA 0/1 response rates than placebo at week 16. More than half of HS-10374-treated participants achieved PASI 90, while nearly one-third reached PASI 100, according to topline results from the company.
Phase 3 Study Confirms Efficacy at Week 16
The pivotal HS-10374-301 study (NCT06672393) is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial evaluating the efficacy and safety of HS-10374 in adults with moderate-to-severe plaque psoriasis. The registered study includes a 16-week placebo-controlled treatment period followed by longer-term treatment and enrolled an estimated 375 participants.
At week 16, both co-primary endpoints favored HS-10374. The proportion of participants achieving PASI 75, defined as at least a 75% reduction from baseline in the Psoriasis Area and Severity Index, was significantly higher than with placebo.
The study also met its second co-primary endpoint, sPGA 0/1, which measures clear or almost clear skin together with at least a 2-point improvement from baseline.
Hansoh Pharma reported that multiple secondary endpoints were also met. However, the company has not yet disclosed the detailed numerical response rates or statistical values in its topline announcement. Detailed findings are expected at an upcoming dermatology congress.
High-Level Skin Clearance Responses
The study showed deeper clinical responses beyond the PASI 75 threshold.
More than half of participants receiving HS-10374 achieved PASI 90 at week 16, representing at least a 90% reduction in psoriasis severity from baseline. Almost one-third achieved PASI 100, corresponding to complete clearance according to the PASI measure.
These topline findings indicate that a substantial proportion of treated participants reached high levels of skin clearance within 16 weeks. The full dataset will be needed to assess response durability, subgroup outcomes and the detailed statistical magnitude of treatment effects.
Selective Allosteric TYK2 Inhibition
HS-10374 is an orally administered, highly selective allosteric inhibitor of tyrosine kinase 2 (TYK2). The drug inhibits signaling through the IL-12, IL-23 and type I interferon pathways, which are involved in immune regulation and inflammatory disease.
HS-10374 enters an established allosteric TYK2 inhibitor class led by deucravacitinib (Sotyktu), which became the first approved allosteric TYK2 inhibitor in 2022. The class has provided an oral approach to selective TYK2 pathway inhibition in plaque psoriasis.
The comparison is relevant for understanding HS-10374’s development context, but the topline PASI 90 and PASI 100 findings should not be interpreted as a direct efficacy comparison with deucravacitinib because the results come from separate clinical trials and patient populations.
Safety Profile Shows No New Signals
Hansoh Pharma reported a favorable safety and tolerability profile for HS-10374, consistent with the broader TYK2 inhibitor class, with no new safety signals observed during the study.
The topline announcement did not provide detailed rates for adverse events, serious adverse events, treatment discontinuations or laboratory abnormalities. Those findings will be important for a complete assessment of the drug’s clinical profile when the detailed Phase 3 dataset becomes available.
Development Extends into Psoriatic Arthritis
HS-10374 is also being evaluated beyond plaque psoriasis. A separate Phase 2 study (NCT06176508; HS-10374-202) is assessing the drug in adults with active psoriatic arthritis. The randomized, double-blind study includes placebo and tofacitinib comparator arms and evaluates ACR20 response at week 16 as its primary endpoint.
This provides a specific example of Hansoh Pharma’s broader development strategy for HS-10374 in immune-mediated disease without extending the company’s current public development plans to indications for which specific clinical programs have not been disclosed.
Hansoh Prepares for China NDA Discussions
Following the Phase 3 results, Hansoh Pharma plans to initiate communication with the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) to advance preparation of a New Drug Application for HS-10374 in China.
The company has not disclosed a specific NDA submission date. It plans to present detailed results from the pivotal study at an upcoming dermatology academic congress, which should provide additional information on efficacy, safety and the statistical performance of HS-10374.
The Phase 3 readout therefore marks a key development milestone for HS-10374 as Hansoh moves the selective allosteric TYK2 inhibitor toward potential regulatory submission in China while continuing clinical development in other immune-mediated diseases.
Reference
Hansoh Pharma Announces Pivotal Phase 3 Clinical Trial of Hs-10374 In the Treatment of Adults with Moderate-To-Severe Plaque Psoriasis Met the Co-Primary Endpoints, 21 September 2026
A Study to Confirm Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis, ClinicalTrials.gov ID NCT06672393
About the Writer
Kirti Kumbhar (LinkedIn) is an M.Pharm graduate with experience in Quality Assurance at Lupin Limited and a strong interest in clinical research, regulatory affairs, and Trial Master File (TMF) management. She has developed knowledge of regulatory documentation, quality systems, compliance, and healthcare research through her professional experience. Passionate about clinical development and continuous learning, Kirti is committed to supporting high-quality healthcare documentation, regulatory excellence, and research-driven healthcare advancements.