On February 12, 2026, Hansoh Pharmaceutical Group Company Limited (Hansoh Pharma, 3692) received approval from the European Commission (EC) for Aumolertinib Mesylate Tablets as a monotherapy option. The authorization covers the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, as well as the treatment of adults with advanced EGFR T790M mutation-positive NSCLC. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

Aumolertinib Mesylate Tablets, marketed as Ameile in China and Aumseqa outside the country, is recognized as the first original third-generation EGFR-TKI developed in China. It has secured five indications from the National Medical Products Administration since 2020, covering treatment scenarios ranging from second-line therapy for advanced NSCLC with T790M mutations to first-line applications for tumors with EGFR mutations, as well as post-chemoradiotherapy and post-surgical settings. In 2025, it also received marketing authorization from the Medicines and Healthcare Products Regulatory Agency in the United Kingdom, reflecting momentum in global regulatory approvals.