HUTCHMED said regulatory applications for ORPATHYS (savolitinib) combined with TAGRISSO (osimertinib) have been accepted for review in Europe and Japan. The European Medicines Agency validated AstraZeneca's Marketing Authorization Application for patients with locally advanced or metastatic non-small cell lung cancer whose tumors have MET overexpression or amplification and whose disease progressed during or after EGFR tyrosine kinase inhibitor therapy. In Japan, the Ministry of Health, Labour and Welfare accepted AstraZeneca's New Drug Application for patients with unresectable, advanced or recurrent disease after EGFR-TKI treatment. The filings follow a U.S. Food and Drug Administration application submitted in September 2026. They are supported by the global Phase III SAFFRON trial, whose results were presented at the ESMO Congress 2026 Presidential Symposium and published simultaneously in The New England Journal of Medicine. The combination reduced the risk of progression or death by 45% versus doublet platinum-based chemotherapy, with a progression-free-survival hazard ratio of 0.55, and also produced a statistically significant and clinically meaningful overall-survival improvement. ORPATHYS is a selective MET TKI (drug targeting the MET cancer pathway), while TAGRISSO is a third-generation irreversible EGFR-TKI. HUTCHMED said the filings represent further progress toward expanding global access, while cautioning that regulatory approval, further development and commercialization remain subject to clinical, safety, funding and regulatory risks.