Hansoh Pharma (03692): Aumolertinib Marketing Authorization Application Resubmitted to the EU and Accepted for Review by the European Medicines Agency

Zhito Finance APP News, Hansoh Pharmaceutical (03692) announced that on September 29, 2026, the Group resubmitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for its innovative drug almonertinib in the European Union, and on October 7, 2026, the EMA confirmed acceptance of the new MAA and officially initiated the centralized review procedure, with indications for: (i) first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutations, and (ii) treatment of adult patients with advanced NSCLC positive for the EGFR T790M mutation.