HUTCHMED (00013.HK): savolitinib+osimertinib filings accepted in Europe, Japan
NewTimeSpace News: On 2 November 2026, HUTCHMED (China) Limited (HUTCHMED, 00013.HK) disclosed that regulatory filings for savolitinib (ORPATHYS®) in combination with osimertinib (TAGRISSO®) to treat MET-driven EGFR-mutated lung cancer have been accepted in Europe and Japan.
In Europe, the European Medicines Agency (EMA) has validated and accepted the marketing authorisation application submitted by AstraZeneca; in Japan, AstraZeneca has submitted a new drug application to the Ministry of Health, Labour and Welfare. Following the US FDA submission in September 2026, the acceptances mark further progress in the global registration of this targeted combination.
The filings are supported by positive data from the global Phase III SAFFRON study. Compared with platinum-based doublet chemotherapy, the combination reduced the risk of disease progression or death by 45% (PFS HR 0.55, p<0.001), with median PFS of 7.6 versus 5.4 months, and reduced the risk of death by 32% (OS HR 0.68, p=0.010), with median OS of 17.8 versus 12.9 months. The results were featured in the Presidential Symposium of ESMO 2026 and published in The New England Journal of Medicine. Savolitinib is co-developed by AstraZeneca and HUTCHMED and commercialised by AstraZeneca.
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