On September 30, HUTCHMED rose 5.11% in regular trading, trading at HK$23.4/share, with turnover of HK$141 million. The stock gained momentum following its partner AstraZeneca's submission of a new drug application to the US FDA.
According to a company filing on September 29, AstraZeneca submitted a US NDA for the combination therapy of ORPATHYS (savolitinib) and TAGRISSO (osimertinib), targeting locally advanced or metastatic non-small cell lung cancer patients with MET overexpression or amplification whose disease progressed during or after EGFR tyrosine kinase inhibitor treatment. The filing is supported by data from the global Phase III SAFFRON trial, which demonstrated statistically significant improvements in both progression-free survival and overall survival. The all-oral, chemotherapy-free regimen addresses a critical unmet need in MET-driven resistance, one of the most common mechanisms of resistance to third-generation EGFR TKIs.
This milestone builds on earlier positive clinical readouts, including the SANOVO China Phase III trial reported on August 31 and the SAFFRON global results from August 17, both confirming significant survival benefits for the combination versus TAGRISSO monotherapy.
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