Posted by Michael Wonder on 21 Feb 2026
Aumorlertinib mesylate tablets approved in the EU as monotherapy
20 February 2026 - Hansoh Pharmaceutical is pleased to announce that, on 12 February 2026, aumolertinib mesylate tablets have been approved in the European Union as monotherapy for: (i) the first-line treatment of adult patients with advanced non-small cell lung cancer (“NSCLC”) whose tumours have epidermal growth factor receptor (“EGFR”) exon 19 deletions or exon 21 (L858R) substitution mutations; and (ii) the treatment of adult patients with advanced EGFR T790M mutation positive NSCLC.
The approval by the European Commission follows the positive opinion of the CHMP of the EMA.
Aumolertinib mesylate tablets is the first original third generation EGFR-TKI innovative drug in China.
