HANSOH PHARMA(03692): Almonertinib Marketing Authorization Application Resubmitted to the EU and Confirmed for Acceptance by the European Medicines Agency
HANSOH PHARMA (03692) announced that on September 29, 2026, the Group resubmitted a Marketing Authorization 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 the indications being: (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.
HANSOH PHARMA (03692) announced that on September 29, 2026, the Group resubmitted the Marketing Authorization Application (MAA) in the European Union for its innovative drug almonertinib to the European Medicines Agency (EMA), and on October 7, 2026, the EMA confirmed acceptance of the new MAA and officially initiated the centralized review procedure, for the indications of: (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.
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