Hansoh Pharmaceutical (03692.HK) Announces EU Approval of Ameile® (Aumseqa®) as Monotherapy for Advanced NSCLC

Hansoh Pharma (03692) announced that on February 12, 2026, the European Commission (EC) approved the marketing authorization of its innovative drug, Aumseqa® (Chinese trade name: 阿美乐®), a monotherapy with Almonertinib Mesylate Tablets. The approval is for: (i) first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations; and (ii) treatment of adult patients with advanced EGFR T790M mutation-positive NSCLC. This approval was granted by the EC based on the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).