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    AACR 2026 | HANSOH PHARMA PRESENTED RESULTS OF HS-10504 (A NOVEL, POTENT, HIGHLY SELECTIVE, FOURTH-GENERATION EGFR TKI) FROM A FIRST IN HUMAN PHASE 1 STUDY IN PATIENTS WITH ADVANCED NSCLC
    Release Date：2026/04/22
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    - HS-10504 has demonstrated a promising anti-tumor activity in advanced NSCLC harboring EGFR C797S mutation with the ORR 52.9% and mPFS 9.6 months at the RP2D of 400 mg QD.

    - Given its quick and durable response, HS-10504 is expected to provide a novel treatment option for these patients with poor prognostic and currently having no targeted treatment option.



    SHANGHAI, April 22, 2026-Hansoh Pharmaceutical Group Co., Ltd. (“Hansoh Pharma,” 03692.HK) today announced that the encouraging results of HS-10504 for the treatment of advanced non-small cell lung cancer (NSCLC) post Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR TKI) therapy  were presented in an oral session at AACR 2026 (April 17-22, San Diego, California).


    HS-10504 is a novel, potent, highly selective, fourth-generation EGFR TKI under clinical development for NSCLC patients. At AACR 2026, the presented data was generated from HS-10504-101 (NCT06461156), which aimed to evaluate the safety, efficacy and pharmacokinetic (PK) profile of orally administered HS-10504. The leading principal investigator of this study is Professor Jianxing He (Department of Thoracic Surgery, Phase I Clinical Research Center, The First Affiliated Hospital of Guangzhou Medical University).


    Study results showed:

    • Promising Efficacy：In 34 efficacy-evaluable advanced NSCLC patients harboring EGFR C797S with or without T790M resistance mutations who received 400 mg once daily (QD), Objective Response Rate (ORR) was 52.9% and median Progression-Free Survival (PFS) was 9.6 months.

     

    • Manageable safety profile: Overall, HS-10504 demonstrated a favorable and manageable safety profile, with most Treatment-Related Adverse Events (TRAEs) being Grade 1-2. The most common Grade ≥3 TRAEs were primarily hematological abnormalities, including decreased lymphocyte count and anemia, which were clinically manageable.


    Details of the oral presentation are as follows:

    Presentation Title: The tolerability and efficacy of HS-10504 in patients with EGFR mutation-positive advanced NSCLC: Initial results from a first-in-human phase 1 study

    Session: Advances in Precision Oncology

    Date/Time: 4/21/2026 2:30:00 to 4:30:00 PM（ET） 

    Presenting author: Prof. Zhanhong, Xie/ Department of Respiratory and Critical Care Medicine and Department of Oncology, The First AffiliatedHospital of Guangzhou Medical University, Guangzhou, China


    About HS-10504

    HS-10504 is an innovative drug independently developed by Hansoh Group with proprietary intellectual property rights, targeting EGFR-sensitive mutations and drug-resistant mutations. This compound specifically overcomes the steric hindrance effect caused by the serine residue at C797S on third-generation EGFR TKIs, as well as the steric hindrance effect induced by the T790M mutation on first- and second-generation TKIs.


    About NSCLC

    EGFR TKI had been widely used as first line treatment of EGFR-mutant advanced non-small cell lung cancer (NSCLC). After treatment with EGFR TKIs, most patients develop acquired resistance (AR)[1], leading to disease progression. The mechanism of resistance is complicated especially post third generation TKI. The C797S mutation is one of the main mechanisms leading to acquired resistance due to EGFR mutations. The EGFR C797S mutation accounts for approximately 7% of resistance mutations in the first-line treatment with osimertinib and approximately 14% of resistance mutations in the second-line treatment with osimertinib[2] and also reported in other third-generation EGFR TKIs (including aumolertinib and furmonertinib)[3].


    References

    1. Mok TS, Wu Y-L, Ahn M-J, et al; AURA3 Investigators. Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer. N Engl J Med. 2017 Feb 16;376(7):629-640.

    2. Alessandro Leonetti, Sugandhi Sharma, Roberta Minari. et al. Resistance mechanisms to osimertinib in EGFR-mutated non-small cell lung cancer. British Journal of Cancer, 2019, 121: 725-737.

    3. He J, Huang Z, Han L, Gong Y, Xie C. Mechanisms and management of 3rd‑generation EGFR‑TKI resistance in advanced non‑small cell lung cancer (Review). Int J Oncol. 2021;59(5):90.

    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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