Hansoh's Aumseqa Becomes First China-Developed EGFR-TKI Approved in UK​​

On 4 June, Hansoh Pharma announced that UK regulator the Medicines and Healthcare products Regulatory Agency (MHRA) approved its third-generation EGFR-TKI Aumseqa (almonertinib) for first-line treatment of locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) and for T790M mutation-positive NSCLC, making it the first China-developed EGFR-TKI approved overseas. The approval was based on Phase III AENEAS trial data showing superior PFS (19.3 months vs 9.9 months, HR = 0.46) over gefitinib. In China, Aumseqa is approved for four indications, including first- and second-line NSCLC treatment across various mutation profiles.

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