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SHANGHAI, October 26, 2026— Hansoh Pharmaceutical Group Co., Ltd. (“Hansoh Pharma,” 03692.HK) today presented the primary results from the Phase 3 HS-10241-301 study of the dalmelitinib-aumolertinib as an oral presentation at the 2026 European Society for Medical Oncology (ESMO) Congress. The study evaluated dalmelitinib-aumolertinib versus platinum-based chemotherapy in patients with NSCLC harboring EGFR mutations and MET amplification after progression on EGFR-TKI therapy. At this final analysis, the study met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant and clinically meaningful improvement in PFS.

Dalmelitinib is an oral, highly selective c-MET tyrosine kinase inhibitor (TKI) independently developed by Hansoh Pharma. Aumolertinib is the first domestically developed third-generation EGFR-TKI in China, with approved indications spanning the full treatment course for EGFR-mutated NSCLC—from early-stage to advanced disease—and is the first Chinese-origin third-generation EGFR-TKI to be approved overseas. On February 27, 2026, the New Drug Application (NDA) for the dalmelitinib-aumolertinib was accepted by China's National Medical Products Administration (NMPA).

Data presented at ESMO 2026 demonstrated that dalmelitinib-aumolertinib showed a statistically significant and clinically meaningful improvement in PFS in patients with NSCLC harboring EGFR mutations and MET amplification after progression on EGFR-TKI therapy. Approximately 95% of the study population had failed on third-generation EGFR-TKI therapy, closely reflecting current clinical practice，in which third-generation EGFR-TKIs are the predominant first-line treatment option. In addition, the study adopted a lower MET amplification threshold (defined as MET GCN≥5 or MET/CEP7 ratio≥2 by FISH). Based on these results, the study is expected to provide high-level, biomarker-guided evidence for the treatment of this MET-amplified patient population.

Hansoh Pharma is accelerating the regulatory review of the dalmelitinib-aumolertinib and looks forward to bringing this new treatment option to patients as soon as possible.

Oral presentation details

● Presentation Title: Dalmelitinib plus aumolertinib versus platinum-based chemotherapy in advanced NSCLC patients with MET amplification post EGFR-TKI therapy: a randomized phase 3 study

● Session: Proffered paper 2: NSCLC, metastatic 

● Abstract No.:2615O

● Date/Time: October 26, 2026, 08:40–08:50 CET

● Presenter: Ziming Li，Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China

About the HS-10241-301 Study:

HS-10241-301 is a randomized, open-label phase 3 study that enrolled 314 patients with locally advanced or metastatic NSCLC harboring EGFR mutations with MET amplification (MET GCN≥5 or MET/CEP7 ratio≥2 by FISH) after progression on EGFR-TKI therapy. Patients were randomized 1:1 to receive oral dalmelitinib (300 mg twice daily) plus aumolertinib (110 mg once daily) or platinum-based doublet chemotherapy. The primary endpoint was PFS as assessed by blinded independent central review (BICR). As of December 10, 2025 (median follow-up: 11.2 months), the study had met its primary endpoint.

Efficay

PFS: Median PFS was 6.2 months versus 4.4 months (HR=0.601; 95% CI: 0.448,0.805; p<0.001), representing a 40% reduction in the risk of disease progression or death. A consistent PFS benefit was observed across all pre-specified subgroups, irrespective of prior EGFR-TKI generation and MET gene copy number (GCN≥10 vs. 5≤GCN<10).

Tumor response: Both the ORR (59.6% vs. 38.6%) and DCR (84.6% vs. 74.1%) were higher with dalmelitinib-aumolertinib than with chemotherapy. The combination also yielded more durable tumor response, with a median duration of response (DoR) of 9.7 months versus 4.4 months.

Overall Survival (OS): OS data remain immature with an overall event rate of 22.9%. Median OS was not reached (NR) versus 19.6 months (HR=0.84; 95% CI: 0.524,1.346), and a trend in favor of the combination. Notably, 74 patients (46.8%) in the chemotherapy arm received dalmelitinib -aumolertinib after disease progression.

Safety

The safety profile of dalmelitinib-aumolertinib was manageable, with no new safety signal. The most common treatment-related adverse events (TRAEs) were elevated liver enzymes, mostly grade 1–2, including alanine aminotransferase increased (62.8%) and aspartate aminotransferase increased (60.3%), with grade ≥3 events in 12.8% and 9.6%, respectively. These events resolved to normal or baseline upon treatment interruption or dose adjustment or symptomatic management.

MET-related adverse events were predominantly grade 1–2, with hypoalbuminemia (36.5%，with no grade ≥3 events) and peripheral edema (25.6%，grade ≥3 incidence 1.7%) , consistent with the known safety profile of MET inhibitors.

Previously, data from the Phase Ib HS-10241-102 study presented at the 2026 European Lung Cancer Congress (ELCC) showed that dalmelitinib-aumolertinib achieved a confirmed ORR of 48.7%, a median PFS of 7.4 months, and a median OS exceeding 25 months among 115 evaluable patients with advanced NSCLC harboring MET amplification (MET GCN ≥ 5 or a MET/CEP7 ratio ≥ 2 by FISH) following EGFR-TKI treatment ^[1] ,with a manageable safety profile. Phase 3 data presented at ESMO 2026 further confirm the clinical value of this combination.

Hansoh Pharma will continue to be patient-centric, deepen its commitment to precision treatment in lung cancer, and advance dalmelitinib plus aumolertinib toward approval, with the goal of bringing a precise and accessible new treatment option to patients with advanced NSCLC with MET amplification following EGFR-TKI resistance.

About Non-small Cell Lung Cancer

Lung cancer is one of the most common and deadliest malignancies worldwide. Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer cases, and EGFR mutations occur in approximately 40–50% of NSCLC patients in China, a markedly higher rate than in Western populations^[2]. Acquired resistance to EGFR-TKIs is inevitable. MET amplification is one of the most common bypass resistance mechanisms to EGFR-TKI therapy, occurring in up to 15%–25% of patients who progress after third-generation EGFR-TKI treatment, and is associated with poor prognosis ^[3].

For this population, effective precision treatment options remain limited, and there is an urgent clinical need for targeted combination strategies to replace conventional chemotherapy. Oral targeted combination regimens hold the promise of balancing efficacy, safety, and convenience, offering a new chemo-free treatment option for NSCLC patients with EGFR mutations and MET amplification after progression on EGFR-TKI therapy.

References

1. Dong X, Yu Y, Chen J, et al. HS-10241 combined with aumolertinib in EGFR-TKIs-pretreated patients with EGFR-mutant and MET-amplified advanced NSCLC: a phase 1b study [poster]. Presented at: European Lung Cancer Congress; March 25-28, 2026.

2. Melosky B, Kambartel K, Häntschel M, et al: Worldwide Prevalence of Epidermal Growth Factor Receptor Mutations in Non-Small Cell Lung Cancer: A Meta-Analysis. Mol Diagn Ther 26:7-18, 2022.

3. Angelopoulos PA, et al. Management of MET-Driven Resistance to Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer. Genes (Basel). 2025 Jun 30;16(7):772.