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    ELCC 2026 | HANSOH PHARMA PRESENTED RESULTS OF DALMELITINIB (HS-10241, A HIGHLY SELECTIVE MET-TKI) COMBINED WITH AUMOLERTINIB FROM A PHASE IB STUDY IN PATIENTS WITH MET-AMPLIFIED ADVANCED NSCLC POST EGFR TKI
    Release Date：2026/03/27
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    - Dalmelitinib (HS-10241) has demonstrated encouraging anti-tumor activity and a manageable safety profile when combined with Aumotinib in MET-amplified NSCLC patients post EGFR TKI.



    SHANGHAI, March 27, 2026, Hansoh Pharmaceutical Group Co., Ltd. (“Hansoh Pharma,” 03692.HK) today announced the study data of Dalmelitinib Mesylate Tablets (HS-10241, Dalmelitinib in short) combined with Aumolertinib Mesylate Tablets (Aumoloertinib in short), for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET amplification post EGFR TKI treatment, were presented in a poster session at the European Lung Cancer Congress (ELCC) 2026 (March 25-28, Copenhagen).


    Dalmelitinib is an oral, highly selective MET-TKI under clinical development for NSCLC patients. At ELCC 2026, the presented data was generated from HS-10241-102 (NCT05430386), which aimed to evaluate the safety, efficacy and pharmacokinetic (PK) profile of the combination of HS-10241 with Aumolertinib.


    Study results showed:

    Encouraging Efficacy：In 115 efficacy-evaluable NSCLC patients with MET-amplification post EGFR TKI treatment, median PFS was 7.4 months and median OS was 25.4 months. 

     

    Manageable safety profile: Overall, the combination of Dalmelitinib with Aumolertinib in 132 patients showed a manageable safety profile. Most TEAEs were grade 1-2, and were generally reversible.

     

    Conclusions: The combination of Dalmelitinib and Aumolertinib demonstrated encouraging clinical activity in NSCLC with MET amplification post EGFR TKI, where >85% of efficacy evaluable patients had received prior third-generation EGFR-TKI therapy which represented current clinical practice. Notably, this study enrolled patients with a broader MET-amplification threshold (MET gene copy number ≥5 or MET/CEP7 ratio ≥2, regardless any type of prior EGFR TKI) compared to previously reported studies. The safety profile was manageable with reversible AEs, and no new safety signals were identified. A randomized phase 3 study evaluating this combination is currently ongoing; results are anticipated.


    Details of the poster presentation are as follows:

    Poster Title: Dalmelitinib (HS-10241) combined with Aumolertinib in EGFR-TKIs-pretreated patients with EGFR- mutant and MET-amplified advanced NSCLC: a phase 1b study

    Session: Advanced NSCLC

    Abstract No.: FPN.31P

    Date/Time: Friday, 27 March 13:00-14:00 (CET) 

    Presenting author: Prof. Xiaorong Dong/ Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

    Corresponding author: Prof. Shun Lu/ Shanghai Chest Hospital, Jiaotong University, Shanghai, China

     

    About Dalmelitinib (HS-10241)

    Dalmelitinib Mesylate Tablets (HS-10241) is an innovative drug independently developed by the Group with proprietary intellectual property rights. As a small-molecule, highly selective MET receptor tyrosine kinase inhibitor, it can binds to the catalytic domain of the c-MET kinase, inhibiting its activity, thereby inhibiting cellular transformation or cancer cell proliferation. Previously, the New Drug Application (NDA) for Dalmelitinib was accepted by the National Medical Products Administration (NMPA) of China, for the treatment of locally advanced or metastatic NSCLC adult patients with MET amplification post EGFR TKI.

     

    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. c-MET amplification is one of the important mechanisms of AR. Among cases of secondary resistance to EGFR TKIs, the proportion with c-MET amplification is approximately 5% to 22%[2-4]. Studies have also found that in a very small subset of patients, c-MET amplification is detected before the use of EGFR TKIs. Even in the presence of EGFR-sensitive mutations, the therapeutic efficacy of EGFR TKIs is suboptimal, indicating the existence of primary resistance[5-6].


    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. Tartarone A, Lerose R. Clinical approaches to treat patients with non-small cell lung cancer and epidermal growth factor receptor tyrosine kinase inhibitor acquired resistance. Ther Adv Respir Dis. 2015;9(5):242–50.

    3. Juchum M, Gunther M, Laufer SA. Fighting cancer drug resistance: opportunities and challenges for mutation-specific EGFR inhibitors. Drug Resist Updat. 2015;20:10–28.

    4. Remon J, Moran T, Majem M, et al. Acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors in EGFR-mutant non-small cell lung cancer: a new era begins. Cancer Treat Rev. 2014;40:93–101.

    5. Benedettini E, Sholl LM, Peyton M, et al, Yeap BY, Fiorentino M, et al. Met activation in non-small cell lung cancer is associated with de novo resistance to EGFR inhibitors and the development of brain metastasis. Am J Pathol. 2010;177(1):415.

    6. Turke AB, Zejnullahu K, Wu YL, et al. Preexistence and clonal selection of MET amplification in EGFR mutant NSCLC. Cancer Cell. 2010;17(1):77.


    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).



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