-HS-20137 demonstrated strong efficacy and a favorable safety profile in plaque psoriasis patients treated for 28 weeks.
-Up to 76.9% of patients achieved a PASI 90 response by week 16, increasing to 89.7% by week 24.
-The findings were presented in a late-breaking session at the AAD 2025 Annual Meeting.
On March 9 ,2025, Hansoh Pharmaceutical Group Co., Ltd (Hansoh Pharma, 03692.HK)) announces that the results from the phase 2 study of HS-20137 Injection (humanized IgG1 monoclonal antibody targeting IL-23), which was developed by the Company in collaboration with Qyuns Therapeutics Co., Ltd. ( Qyuns, 02509.HK), has been presented in Session 2 of Late-Breaking Research at the 2025 AAD Annual Meeting.
The study was designed as a randomized, double-blinded, placebo-controlled, phase 2 study to evaluate the efficacy, safety, and pharmacokinetic profile of HS-20137 in adults with moderate-to-severe plaque psoriasis for 52 weeks, including a 28-week double-blind treatment period (placebo-controlled in the first 16 weeks), a 16-week extended open-label period, and an 8-week follow-up period. Subjects were randomly assigned to treatment groups (i.e. HS-20137 100mg Q8W, 200mg Q8W, and 200mg Q12W) and the placebo group. The primary endpoint was the proportion of subjects who attained PASI 90 at Week 16. After 16 weeks, subjects in the placebo group received 200 mg of the trial drug as treatment.
Study results showed:
A total of 159 subjects were enrolled in this study, and 156 completed the primary endpoint assessment.
Eye-catching primary results: At week 16, PASI 75 and PASI 90 were achieved in 92.3% and 76.9% participants of 200mg Q8W group (NRI fill), respectively, and the proportion of participants achieving PASI 100 was up to 40% in the 200mg Q12W group.After week 16, proportion of patients achieved PASI 90 increased to 84.6%,89.7% and 87.2% at week 20,24 and 28 in 200mg Q8W group.
Rapid response after first injection: HS-20137 had a rapid response, with PASI scores reduced from the baseline after the first injection, by more than 40% at week 4 and 70% by week 8.The mean PASI score decreased to below 3.3 by week 16 and continued to decline steadily, reaching below 3.0 by week 28.
Stable improvement in quality of life: The Dermatology Life Quality Index (DLQI) of subjects were improved significantly as treatment progressed, the mean DLQI score averaged decreased to below 5 from weeks 16 to 28 across the trial drug groups.
About HS-20137
HS-20137 Injection, a recombinant humanized IgG1 monoclonal antibody, specifically binds to human IL-23, and is categorized as a Class 1 innovative biological drug for therapeutic use. HS-20137 is used to treat psoriasis by specifically binding to the p19 subunit of human IL-23, blocking binding of the extracellular IL-23 to IL-23 receptor on the surface of cells, and inhibiting the IL-23-mediated release of pro-inflammatory cytokines and chemokines.
The results of phase 2 study further demonstrated the efficacy of HS-20137 for its treatment of psoriasis, and further supported the results observed in the Phase I study published in JAMA Dermatology[1].
In April 2024, Hansoh Pharma entered into a license agreement with Qyuns , pursuant to which, the Group obtained an exclusive license from Qyuns to develop and commercialize monoclonal antibody HS-20137 (license-in as QX004N) within China (including Hong Kong, Macau and Taiwan).
About Psoriasis
Psoriasis is a chronic, immune-mediated disease that effects 0.09%~3.34% of the global population[2] and imposes significant physical and mental burdens on patients.
Guidelines recommend biologic agents for the treatment of patients with moderate-to-severe psoriasis, citing a high benefit-to-risk ratio[3,4].
Meta-analysis has shown that anti-IL-17 and anti-IL-23 treatments ranked highest in achieving PASI 90 compared with other classes of systemic drugs[5].
While current FDA-approved IL-23 inhibitors offer a more convenient dosage compared to the class of anti-IL-17 drugs[6], they present a promising management option for psoriasis.
About AAD Annual Meeting
The American Academy of Dermatology (AAD) Annual Meeting is a premier dermatology event that attracts dermatology experts worldwide every year. At this event the latest research advances in dermatology are shared, and the impact on the industry is far reaching.
About Hansoh Pharma
Hansoh Pharma is a leading pharmaceutical company in Greater China driven by innovation. It is committed to the treatment of major diseases in the areas of oncology, anti-infections, CNS diseases, metabolic diseases, as well as autoimmune diseases, and is dedicated to improving human health through continuous innovation. Hansoh Pharma has been ranked among the top 100 global pharmaceutical companies and the top 3 best industrial enterprises in China in terms of pharmaceutical R&D pipeline for several years, and is a national key high-tech enterprise and a national technology innovation demonstration enterprise. Hansoh Pharma was listed on the Stock Exchange of Hong Kong in June, 2019 (stock code: 03692.HK). For more information, please visit www.hspharm.com.
References
[1]Li X., Li B., Yang D., et al. JAMA Dermatol. 2024;161(2):1-9.
[2].Vos T., Lim S. S., Abbafati C., et al. The Lancet. 2020;396(10258):1204–1222.
[3].Menter A., Strober B.E., Kaplan D.H., et al. J Am Acad Dermatol. 2019;80(4):1029-1072.
[4].Nast A., Smith C., Spuls P.I., et al. J Eur Acad Dermatol Venereol. 2020;34(11):2461-2498.
[5].Sbidian E., Chaimani A., Guelimi R., et al. Cochrane Database Syst Rev. 2023; 12;7(7):CD011535.
[6].https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm (Accessed, Dec 18, 2024 ).
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