Trinity Delta Orpathys/Tagrisso combination approved in China

Orpathys/Tagrisso combination approved in China

Lighthouse | 1 July 2025

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China’s NMPA has approved Orpathys (savolitinib) in combination with AstraZeneca’s Tagrisso (osimertinib) for treating locally advanced or metastatic EGFR (epidermal growth factor receptor) mutation-positive NSCLC (non-small cell lung cancer) with MET amplification after disease progression on first-line EGFR TKI therapy. The approval triggers a $11m milestone from partner AstraZeneca (who are responsible for marketing both Orpathys and Tagrisso in China), and the timing means this new indication is eligible for NRDL negotiations this year, with the potential for inclusion in government insurance coverage from January 2026, if successful.
The approval in China was based on the highly positive Phase III SACHI study, which had been stopped early for efficacy at the interim analysis. Detailed SACHI data were recently presented at ASCO 2025 (June 2025 Lighthouse), with significant improvements in PFS (progression free survival), and other key outcome measures (objective response rate, disease control rate, median duration of response). Importantly, the all-oral combination of savolitinib + osimertinib is well tolerated and adverse events are manageable.
MET amplification leads to a poorer prognosis, with 15-50% of NSCLC patients who progress on a 1L EGFR experiencing MET aberration, a critical resistance mechanism. Hence the approval of savolitinib + osimertinib brings an important biomarker-specific treatment option for this poorly served group. MET amplification is underdiagnosed by liquid biopsies compared to tissue re-biopsy, hence a precision diagnostic to appropriately treat patients will be key and is part of partner AstraZeneca’s commercial plan.
Outside of China, the global Phase III SAFFRON study is ongoing in patients who have progressed with Tagrisso, a third-generation EGFR TKI (note that SACHI included patients who had progressed on 1^st, 2^nd and 3^rd gen EGFR TKIs). In a predefined subset of patients from SACHI that had received prior Tagrisso treatment (ie a population similar to the SAFFRON study) significant PFS benefits were observed, helping to de-risk this study for global approvals. As Tagrisso is increasingly recognised as standard of care in EGFRm NSCLC, this population is representative of the real-world setting.

Trinity Delta view: The approval of the Orpathys/Tagrisso combination in China is an important element for revenue growth and sustained profitability. The smooth China approval, and near-term launch, in this broader NSCLC patient group should mean that Orpathys makes an increasingly meaningful contribution to domestic sales. This NSCLC indication also underpins the major global commercial opportunity for savolitinib, and recent data support the view that similar approvals will happen in global (ex-China) markets. Yet this is only one of many components supporting HUTCHMED’s investment case. In the near-term, the novel ATTC platform could be a significant new opportunity, with further details expected by early-2026, and surufatinib in pancreatic cancer could also provide a “wildcard” upside. Our valuation is $5.86bn/£4.69bn/HK$45.74bn, or $33.64/ADS and 538p/HK$52.48 per share.

Lighthouse

1 July 2025


Price (US ADS) (UK share) (SEHK share)	$15.05 227.0p HK$23.55
Market Cap	$2.62bn £1.98bn HK$20.54bn
Exchanges	NASDAQ AIM London SEHK
Sector	Healthcare
Company Codes	HCM HCM.L 0013.HK

Corporate client	Yes

Company description

HUTCHMED is a Hong Kong headquartered biopharma focused on discovering, developing and commercialising innovative targeted therapeutics and immunotherapies to treat cancer and immunological diseases for the China and global markets.

Analysts

Lala Gregorek
lgregorek@trinitydelta.org
+44 (0) 20 3637 5043

Philippa Gardner
pgardner@trinitydelta.org
+44 (0) 20 3637 5042

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