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HANSOH PHARMA ANNOUNCES LATE-BREAKING PRESENTATION OF PHASE 2 STUDY ON HS-20137 (ANTI-IL-23P19 ANTIBODY) IN MODERATE TO SEVERE PSORIASIS AT AAD 2025 ANNUAL MEETING
Release Date：2025/03/09
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- 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.

 

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].//www.accessdata.fda.gov/scripts/cder/daf/index.cfm (Accessed, Dec 18, 2024 ).


About Hansoh Pharma

Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise headquartered in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, anti-infectives, central nervous system (CNS), metabolism and immunology. Hansoh Pharma has launched 7 innovative drugs that generate product sales in China, with the revenue from innovative drugs and collaborative products exceeding 80%, forming a rich product pipeline. The company has consistently ranked among the top 100 global pharmaceutical companies and is recognized as one of the top 3 pharmaceutical R&D enterprises in China and is designated as a National Key High-Tech Enterprise and a National Technology Innovation Demonstration Enterprise. Hansoh Pharma was listed on the Hong Kong Stock Exchange in June 2019 (stock code: 03692.HK).

Statements

1. This announcement is intended for healthcare professionals only and not for advertising purposes.2. Hansoh Pharma does not recommend the use of any unapproved drugs or off-label indications, nor does it make recommendations regarding any drug or indication.3. The information provided in this announcement is for reference only; please follow the advice or guidance of a physician or other healthcare professional. Any treatment-related decisions made by healthcare professionals should be based on the specific circumstances of the patient and should be used in accordance with the instructions for the drug.4. For more detailed information about any company products, medical treatments, or diseases, please consult a healthcare professional.

Forward-Looking Statements

This press release is intended to provide information about Hansoh Pharmaceutical Group Co., Ltd. and its affiliates, including their subsidiaries (collectively referred to as "Hansoh Pharma"). It does not constitute a disclosure of information about Hansoh Pharma or any investment recommendations.The information contained in this release may include forward-looking statements related to Hansoh Pharma's business and product prospects, as well as its plans, beliefs, expectations, and strategies. These statements are predictions based on speculative assumptions and are not guarantees of future performance. They are subject to risks and uncertainties, such as scientific, commercial, political, economic, financial, legal factors as well as competitive environment and social conditions, many of which are beyond Hansoh Pharma's control and difficult to predict, thus actual results may differ significantly from what is stated here, and past securities price trends should not be used as a guide for future market conditions. As such, investors should exercise caution when using this information to make investment decisions. Phrases such as "commit," "expect," "believe," "predict," "anticipate," "forecast," "intent,"“project,” “may,” “will,” “should,” “plan,” “could,” “continue,” “target,” “contemplate,” “estimate,” “guidance,” “possible,” “potential,” “pursue,”“likely,”and words and terms of similar terms substance used in connection with any discussion of future plans, actions or events indicate forward-looking statements.Hansoh Pharma does not commit to or guarantee the accuracy, timeliness, or completeness of forward-looking information and assumes no obligation to update or revise these forward-looking statements. Neither Hansoh Pharma nor any of its directors, employees, or agents will be responsible for any forward-looking statements that prove to be inaccurate or unachievable and any losses or damages incurred by users due to reliance on the information provided herein, including but not limited to direct, incidental, indirect, or punitive damages.All information in this press release is current as of the date of release. Hansoh Pharma assumes no responsibility to update or revise this information in light of new developments, future events, or other circumstances, except as required by law. Additionally, Hansoh Pharma reserves the right to make changes, corrections, or discontinuations to all or part of the content of this press release at any time without notice. For information specifically related to the listed company, investors are encouraged to refer to the announcements and financial reports of Hansoh Pharma (03692.HK).