HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX:13) announces that regulatory filings for ORPATHYS^® (savolitinib) in combination with TAGRISSO^® (osimertinib) have been accepted for review in Europe and Japan.

In Europe, the European Medicines Agency (EMA) has validated and accepted for regulatory review the Marketing Authorization Application (MAA) submitted by AstraZeneca, seeking approval for the combination for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (“NSCLC”) whose tumors have MET overexpression or amplification, and who had disease progression on or after an epidermal growth factor receptor (“EGFR”) tyrosine kinase inhibitor (“TKI”) therapy.

In Japan, AstraZeneca has submitted a New Drug Application (“NDA”) to the Ministry of Health, Labour and Welfare (MHLW), which has also been accepted for review, seeking approval in patients with unresectable, advanced or recurrent NSCLC whose tumors have MET overexpression or amplification, and who had disease progression following EGFR-TKI therapy.

These filings in Europe and Japan follow the submission of an NDA for the same combination to the US Food and Drug Administration (FDA) in September 2026, marking further progress in expanding global access to this innovative targeted combination therapy.

The regulatory filings are supported by positive results from the SAFFRON global Phase III trial. These results have been presented in a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2026 and simultaneously published in The New England Journal of Medicine.  

ORPATHYS^® plus TAGRISSO^® demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival (“PFS”) and overall survival (“OS”) versus doublet platinum-based chemotherapy in patients who progressed on treatment with TAGRISSO^®. ORPATHYS^® plus TAGRISSO^® reduced the risk of disease progression or death by 45% compared to chemotherapy (based on a PFS hazard ratio [“HR”] of 0.55; 95% confidence interval [“CI”] 0.42-0.72; p<0.001). Median PFS as assessed by blinded independent central review (BICR) was 7.6 months for ORPATHYS^® plus TAGRISSO^® versus 5.4 months for the comparator arm. Results for the key secondary endpoint of OS showed ORPATHYS^® plus TAGRISSO^® reduced the risk of death by 32% versus chemotherapy (OS HR 0.68; 95% CI 0.50-0.91; p=0.010). ORPATHYS^® plus TAGRISSO^® extended median OS by 4.9 months versus the comparator arm (17.8 versus 12.9 months). The safety profile was consistent with the known profiles of each medicine, and there were no new safety concerns.

Third-generation EGFR-TKIs have significantly improved outcomes for patients with EGFRm NSCLC. However, MET overexpression or amplification is one of the most common mechanisms of resistance on third-generation EGFR-TKI treatment. MET-driven progression is associated with poor prognosis, and there remains a significant unmet need for effective and well-tolerated treatment options in this setting.