HUTCHMED says EMA and Japan's MHLW accepted for review filings for ORPATHYS plus AstraZeneca's TAGRISSO in MET overexpression/amplification EGFR-mutated NSCLC. It follows a US NDA filed in Sept 2026,

What happened: Regulatory filings for ORPATHYS (savolitinib) plus TAGRISSO (osimertinib) were accepted for review in Europe by the EMA and in Japan by the MHLW, for MET-driven EGFR-mutated NSCLC after progression on EGFR-TKI therapy. Key numbers: SAFFRON Phase III enrolled 338 patients across 230 centers in 29 countries. Why it matters: The filings follow the US FDA submission and are supported by SAFFRON data presented at the ESMO 2026 Presidential Symposium and published in The New England Journal of Medicine, extending global regulatory reach for the combination. Market: +7.0% today ($186.65), +3.0% YTD, 1.9x vol — as of 22:46 UTC

Regulatory filings for ORPATHYS (savolitinib) plus TAGRISSO (osimertinib) were accepted for review in Europe by the EMA and in Japan by the MHLW, for MET-driven EGFR-mutated NSCLC after progression on EGFR-TKI therapy.

The filings follow the US FDA submission and are supported by SAFFRON data presented at the ESMO 2026 Presidential Symposium and published in The New England Journal of Medicine, extending global regulatory reach for the combination. Market: +7.0% today ($186.65), +3.0% YTD, 1.9x vol — as of 22:46 UTC