2nd Nov 2026 14:26
(Alliance News) - Hutchmed China Ltd on Monday said regulatory filings for Orpathys, alias savolitinib, in combination with Tagrisso have been accepted for review in Japan and the EU.
The Hong Kong-based biopharmaceutical company said Japan's Ministry of Health, Labour & Welfare, and the EU's European Medicines Agency, validated and accepted for regulatory review the marketing authorisation application submitted by Cambridge, England-based AstraZeneca PLC, which is behind Tagrisso, and together with Hutchmed China develops Orpathys.
Further, AstraZeneca submitted a new drug application to Japan's health ministry, which has also been accepted for review, seeking approval in patients with unresectable, advanced or recurrent non-small cell lung cancer.
Orpathys is an oral selective mesenchymal-epithelial transition factor tyrosine kinase inhibitor approved in China for adults with some locally advanced or metastatic non-small cell lung cancer.
Tagrisso is approved as monotherapy in over 120 countries for several cancers, including forms of non-small cell lung cancer. It is an epidermal growth factor receptor tyrosine kinase inhibitor.
Hutchmed China shares were 1.0% higher at 199.88 pence each on Monday afternoon in London, while AstraZeneca shares were 1.7% lower at 13,726.00p each.
By Tom Budszus, Alliance News slot editor
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