HUTCHMED (China) Limited

HCM · AIM · Health Care · mcap £1,721m · 201.0p 2 open situations →

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2026 ORPATHYS plus TAGRISSO regulatory filings SANOVO first-line China filing

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Project milestones

ORPATHYS plus TAGRISSO regulatory filings

US, EU and Japan filings all under review

SAFFRON global Phase III, first reported positive in August 2026, was presented at ESMO and published in NEJM on 26 Oct 2026 (PFS HR 0.55, OS HR 0.68 vs chemotherapy). A US NDA was submitted in September 2026. On 2 Nov 2026 the EMA validated the MAA and Japan's MHLW accepted the NDA, so all three major filings are now under review.

PFS: Median 7.6 vs 5.4 months; HR 0.55; p<0.001 2 Nov 2026 ↗
OS: Median 17.8 vs 12.9 months; HR 0.68; p=0.010 2 Nov 2026 ↗
US filing: NDA submitted to the FDA in September 2026 2 Nov 2026 ↗
EU and Japan: NDA submissions progressing as planned 26 Oct 2026 ↗
Safety: Manageable; no new safety concerns; grade 3+ events 64% vs 63% 26 Oct 2026 ↗
Commercialisation: Jointly developed with AstraZeneca; commercialised by AstraZeneca 2 Nov 2026 ↗

Next: Regulatory decisions in US, EU and Japan; no dates stated

2 Nov 2026 US, EU and Japan filings all under review
26 Oct 2026 US NDA submitted; EU and Japan progressing

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Project milestones

SANOVO first-line China filing

Positive Phase III data; China filing planned

SANOVO, a China Phase III trial of ORPATHYS plus TAGRISSO in first-line MET-overexpressing, EGFR-mutated NSCLC, was presented at ESMO on 26 Oct 2026. It met its PFS primary endpoint (ITT HR 0.56) with an OS benefit (HR 0.48). HUTCHMED plans a supplemental NDA in China; no date is given.

PFS (ITT): Median 24.9 vs 13.8 months; HR 0.56; p<0.0001 26 Oct 2026 ↗
PFS (high MET): Median 24.8 vs 11.1 months; HR 0.45; p<0.0001 26 Oct 2026 ↗
OS (ITT): Median 44.5 vs 34.9 months; HR 0.48 (secondary endpoint) 26 Oct 2026 ↗
Safety: Manageable, no new concerns; 14.8% discontinued due to adverse events 26 Oct 2026 ↗
Next milestone: Supplemental NDA in China for first-line setting; date not stated 26 Oct 2026 ↗
Commercialisation: Jointly developed with AstraZeneca; commercialised by AstraZeneca 26 Oct 2026 ↗

Next: Submit supplemental NDA in China for first-line use

26 Oct 2026 Positive Phase III data; China filing planned

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Company filings. Not investment advice.