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    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
    Release Date：2026/09/21
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    - Pivotal Phase 3 clinical trial of HS-10374 met co-primary endpoints in adults with moderate-to-severe plaque psoriasis, with both PASI 75 and sPGA 0/1 response rates significantly higher than those in the placebo group at week 16.

    - More than half of HS-10374-treated participants achieved PASI 90, and almost one third achieved PASI 100 at week 16.

    - Hansoh Pharma will soon initiate communications with regulatory authority to advance the New Drug Application preparation for HS-10374 in China.Hansoh Pharma intends to present the detailed data from this study at upcoming dermatology academic congress.




    SHANGHAI, September 21, 2026— Hansoh Pharmaceutical Group Co., Ltd. (“Hansoh Pharma”, 03692.HK) today announced that HS-10374, a selective allosteric inhibitor of tyrosine kinase 2 (TYK2) self-developed by Hansoh Pharma, met the co-primary endpoints in the pivotal Phase 3 clinical trial for adult patients with moderate-to-severe plaque psoriasis. At week 16 of treatment, the proportion of participants in the HS-10374 group achieving at least a 75% reduction (PASI 75) from baseline in the Psoriasis Area and Severity Index (PASI) and the proportion achieving a static Physician's Global Assessment (sPGA) score of 0 or 1 with at least a 2-point improvement from baseline (sPGA 0/1) were both significantly higher than those in the placebo group. The trial also met multiple secondary endpoints. More than half of HS-10374-treated participants achieved PASI 90, and almost one-third achieved PASI 100 at week 16. Meanwhile, HS-10374 demonstrated a favorable safety and tolerability profile, which was consistent with that of other TYK2 inhibitors, and no new safety signals were observed.

     

    Based on these positive results, Hansoh Pharma will initiate communications with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to advance preparations for New Drug Application in China. The results are scheduled to be presented at an upcoming congress in the dermatology therapeutic area.

     

    About HS-10374

    HS-10374 is an orally administered, highly selective allosteric TYK2 inhibitor self-developed by Hansoh Pharma. It inhibits signaling through the cytokine pathways of interleukin-12 (IL-12), IL-23, and type I interferon (IFN), with potential therapeutic effects in multiple autoimmune diseases [1]. The positive results of this pivotal Phase 3 clinical trial demonstrate the clinical efficacy of HS-10374, and Hansoh Pharma will further explore its therapeutic potential in other autoimmune diseases.

     

    About Plaque Psoriasis

    Psoriasis is an immune-mediated chronic, relapsing, inflammatory, and systemic disease triggered by the interplay of genetic and environmental factors. Plaque psoriasis is the most common form, accounting for approximately 80%~90% of cases, and is characterized by scaly erythema or plaques that may be localized or widespread. Psoriasis can be accompanied by systemic comorbidities and significantly impairs patients' quality of life [2]. The prevalence of psoriasis is approximately 0.5%~3.15% in the United States, 0.75%~2.9% in Europe [3, 4], and approximately 0.47%~0.5% in China [5, 6]. Psoriasis is difficult to treat, often persists for life, and compromises patients' quality of life and work capacity; severe cases can lead to disability, imposing a substantial burden on patients, their families, and society.

     

    References

    1. Baker KF, Isaacs JD. Novel therapies for immune-mediated inflammatory diseases: What can we learn from their use in rheumatoid arthritis, spondyloarthritis, systemic lupus erythematosus, psoriasis, Crohn's disease and ulcerative colitis?. Ann Rheum Dis. 2018;77(2):175-187.

    2. Committee on Psoriasis, Chinese Society of Dermatology. Guideline for the diagnosis and treatment of psoriasis in China (2023 edition). Chin J Dermatol. 2023, 56(7): 573-625.

    3. Helmick CG, Lee-Han H, Hirsch SC, et al. Prevalence of psoriasis among adults in the U.S.: 2003-2006 and 2009-2010 National Health and Nutrition Examination Surveys. Am J Prev Med. 2014, 47(1): 37-45.

    4. Wu C, Jin HZ. Epidemiology of psoriasis: An update. Int J Dermatol Venereol. 2013, 39(02): 97-100.

    5. Ding XL, Wang TL, Sheng YW, et al. Prevalence of psoriasis in China: An epidemiological survey in six province. Chin J Derm Venereol. 2010, 24(7): 598-603.

    6. Wang XH. Epidemiologic study of psoriasis of four provinces in southwest China. Harbin medical jorunal. 2017, 37(5): 426-427.

    About Hansoh Pharma

    Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, metabolism, immunology, central nervous system (CNS) and anti-infectives. Hansoh Pharma has launched 7 innovative medicines that generate product sales in China, with the revenue from innovative medicines 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).


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