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.