Home Hansoh's Oral IL-23 Inhibitor HS-20118 Nominated for Breakthrough Therapy Designation in Moderate-to-Severe Plaque Psoriasis

Hansoh's Oral IL-23 Inhibitor HS-20118 Nominated for Breakthrough Therapy Designation in Moderate-to-Severe Plaque Psoriasis

Jul 31, 2026 17:14 CST Updated 17:14
Hansoh Pharma

Pharmaceutical Research, Production, and Sales

On July 31, the CDE website showed that Hansoh Pharma's HS-20118 tabletsProposed for Inclusion in the Breakthrough Therapy Program, for the treatment ofSevere Plaque Psoriasis。
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In 2026 At the SID Annual Meeting,Hansoh PharmaIn the form of an oral presentationAnnouncedData from two randomized, double-blind, placebo-controlled Phase I studies (HS-20118-101 and 102) conducted in China, New Zealand, and the United States, which evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of HS-20118 in healthy volunteers and patients with moderate-to-severe psoriasis.

The study results showed:After only 4 weeks of treatment, the relative improvement in PASI score from baseline was significantly superior to that of the placebo group, and the PASI score continued to decline within 6 weeks after discontinuation—100 mg QW dose group: Week 4 -39.1%, Week 10 -58.0%; 25 mg QD dose group: Week 4 -54.5%, Week 10 -90.5%.。At Week 8,HS-20118(100mg,Once weekly) GroupandHS-20118(25mg,Once daily) The proportions of patients achieving PASI-75 in the groups were respectively33.3%and 75.0%.

  • Encouraging Pharmacokinetic Profile: HS-20118 has a terminal half-life of 6–7 days, supporting a once-weekly oral dosing regimen; the pharmacokinetic profiles in Chinese and New Zealand populations are essentially consistent.


  • The drug demonstrated positive efficacy signals and biomarker responses in patients with psoriasis, with therapeutic effects comparable to those of IL-23 monoclonal antibodies.

  • Good safety profile andPotent Pharmacodynamic Characteristics

HS-20118 is a drug developed by Hansoh PharmaOral Peptide with Biological Activity Targeting IL-23R, by inhibiting the binding of IL-23 to IL-23R, thereby blocking IL-23-mediated signal transduction and cytokine cascade.

This productDesigned and modified to enhanceStrong pharmacokinetic properties, including a half-life of approximately 100 hours, enableAdministered orally once weekly.Intended for the treatment of patients with psoriasis, its oral formulation can reduce the pain associated with injections and improve patient compliance, thereby offering a new therapeutic option for psoriasis. The Phase II trial of HS-20118 is currently planned to enroll patients with moderate-to-severe psoriasis globally.

In mid-August, Hansoh Pharma announced that it had entered into an exclusive licensing agreement with Avere Therapeutics for HS-20118 and participated in a strategic investment, with the total potential transaction value reaching up to $2.3 billion!

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