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    AAN 2026 | HANSOH PHARMA PRESENTED PHASE 1B/2 DATA OF HS-10506 (A SELECTIVE OREXIN-2 RECEPTOR ANTAGONIST) IN INSOMNIA
    Release Date：2026/04/17
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    - HS-10506 has shown significant efficacy in improving sleep onset and maintenance, along with favorable safety and pharmacokinetics profiles.


     

    SHANGHAI, April 17, 2026-Hansoh Pharmaceutical Group Co., Ltd. (“Hansoh Pharma,” 03692.HK) today announced the presentation of study data evaluating HS-10506 at the 2026 American Academy of Neurology Annual Meeting (AAN 2026), held on April 18-22 in Chicago.


    HS-10506 is a selective orexin-2 receptor (OX2R) antagonist under clinical development for sleep disorders. At AAN 2026, data were presented from a multi-center, randomized, double-blind, placebo-controlled, phase 1b/2 study evaluating HS-10506 in patients with insomnia.


    In phase 1b, participants were randomized 3:1 to HS-10506 or placebo at multiple-ascending doses of 10, 20, 40 and 80 mg (n=8 per cohort). In phase 2, participants were equally randomized to receive 20 mg, 40 mg, 60 mg HS-10506, or placebo once-nightly for 28 days. The primary endpoint of phase 2 was the change from baseline in the average of polysomnography-measured latency to persistent sleep (LPS) on Days 13 and 14 (D13/14).


    ● Encouraging Efficacy：In phase 2, LPS changes from baseline to D13/14 versus placebo were -13.7 min (95% CI, -21.0 to -6.4; P<0.001), -16.6 min (95% CI, -23.8 to -9.3; P<0.001), and -18.8 min (95% CI, -26.1 to -11.6; P<0.001) for the HS-10506 20 mg, 40 mg, and 60 mg groups respectively, demonstrating clinically meaningful reductions. HS-10506 also showed sustained and consistent improvements versus placebo in other objective and subjective sleep measures.

     

    ● Favorable Safety Profile: HS-10506 showed favorable safety profiles across all the doses. No negative impact on alertness, cognitive function, depressive symptoms, or anxiety symptoms was observed after HS-10506 treatment. No rebound insomnia occurred following discontinuation of treatment.


    In addition, previously reported data presented at the 37th ECNP Congress showed a favorable safety profile and desired pharmacodynamics effect of HS-10506 in healthy subjects. These findings support advancing HS-10506 to a phase 3 study.


    Details of the poster presentation are as follows:

    ◆ Poster Title: Safety, Efficacy and Pharmacokinetics of H$-10506 in Insomnia Patients: A Randomized, Double-Blind, Placebo Controlled, Phase 1b/2 Study

    ◆ Session: P3: Poster Session 3

    ◆ Abstract No.: 3-011

    ◆ Date/Time: Sunday, April 19, from 5:00 PM to 6:00 PM（CT）

    ◆ Corresponding author: Yuping Wang, Department of Neurology, Xuanwu Hospital, Capital Medical University


    About HS-10506

    HS-10506 is an innovative, highly selective OX2R antagonist discovered and developed by Hansoh Pharma for the treatment of insomnia. Emerging evidence indicates that OX2R-mediated signaling plays a predominant role in promoting wakefulness. As a selective OX2R antagonist, HS-10506 would minimize off-target effects and represents a promising new orexin-targeted therapeutic approach for insomnia management.


    About Insomnia

    Insomnia is a globally prevalent sleep disorder, affecting 3.9% to 22% of the population[1,2]. Its core symptoms encompass difficulties with sleep onset and maintenance, early morning awakening, non-restorative sleep, shortened total sleep time, and significant daytime impairment[3,4]. The utility of contemporary insomnia pharmacotherapy is limited by adverse effects, such as next-day sedation, dizziness, and complex sleep behaviors, highlighting a clear unmet need for therapies that deliver robust efficacy with a more favorable safety profile [5].

     

    References 

    1. Kay-Stacey M, Attarian H. Advances in the management of chronic insomnia. Bmj. Jul 6 2016;354:i2123. doi:10.1136/bmj.i2123 

    2. Morin CM, Jarrin DC. Epidemiology of Insomnia: Prevalence, Course, Risk Factors, and Public Health Burden. Sleep Med Clin. Jun 2022;17(2):173–191. doi:10.1016/j.jsmc.2022.03.003 

    3. Riemann D, Baglioni C, Bassetti C, et al. European guideline for the diagnosis and treatment of insomnia. J Sleep Res. Dec 2017;26(6):675–700. doi:10.1111/jsr.12594 

    4. Edinger JD, Arnedt JT, Bertisch SM, et al. Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. Feb 1 2021;17(2):255–262. doi:10.5664/jcsm.8986 

    5. Schroeck JL, Ford J, Conway EL, et al. Review of Safety and Efficacy of Sleep Medicines in Older Adults. Clin Ther. Nov 2016;38(11):2340–2372. doi:10.1016/j.clinthera.2016.09.010

    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, anti-infectives, central nervous system (CNS), metabolism and immunology. 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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