HANSOH PHARMA (03692.HK): Refiles EU Marketing Application for Aumseqa
- The MAA covers first-line treatment of adult patients with advanced NSCLC harbouring EGFR exon 19 deletion or exon 21 (L858R) substitution mutations, and treatment of adult patients with advanced NSCLC positive for the EGFR T790M mutation.
- The Company had published an announcement on 27 September 2026 regarding the update on the EU marketing authorisation status of almonertinib, whose overseas brand name is Aumseqa®.
NewTimeSpace News: On 11 October 2026, Hansoh Pharmaceutical Group Company Limited (stock code: 03692) announced that on 29 September 2026 it refiled a marketing authorisation application (MAA) with the European Medicines Agency (EMA) for its innovative drug almonertinib (overseas brand name: Aumseqa®) in the European Union.
The EMA confirmed acceptance of the new MAA on 7 October 2026 and formally started the centralised review procedure. The application covers two indications: first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring EGFR exon 19 deletion or exon 21 (L858R) substitution mutations, and treatment of adult patients with advanced NSCLC positive for the EGFR T790M mutation.
The Company had published an announcement on 27 September 2026 regarding the update on the EU marketing authorisation status of almonertinib.
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