29th Sep 2026 10:20
(Alliance News) - Hutchmed China Ltd on Tuesday said AstraZeneca PLC submitted a new drug application to the US Food & Drug Administration for Orpathys, or savolitinib, in combination with Tagrisso for patients with non-small cell lung cancer.
Shares in Hutchmed were up 2.9% at 215.00 pence, while AstraZeneca shares were up 1.6% at 12,696.00 pence on Tuesday morning in London.
Orpathys is being jointly developed by the two pharmaceutical companies and is being commercialised by AstraZeneca.
The application was supported by the phase 3 Saffron trial, in which the combination of Orpathys and Taggrisso demonstrated statistically significant and clinically meaningful improvements in overall survival and progression-free survival compared with doublet platinum-based chemotherapy.
The trial involved 338 patients globally with locally advanced or metastatic non-small cell lung cancer. The patients had an epidermal growth factor receptor mutation and had previously been treated with an EGFR tyrosine kinase inhibitor, including Tagrisso. Their disease subsequently progressed, with their tumours showing MET overexpression or amplification.
Hutchmed Acting Chief Executive Officer & Chief Financial Officer Johnny Cheng said: "This filing is an important step toward potentially bringing Orpathys plus Tagrisso to patients in the US, after its approval in China based on the Sachi Phase 3 trial. The success of the global Saffron phase 3 trial reflects the long-standing collaboration between Hutchmed and AstraZeneca in addressing MET-driven progression in EGFR-mutated lung cancer."
By Camilla Borri, Alliance News reporter
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