Hanson Pharmaceuticals (03692): Ametinib re-submitted the EU marketing license application and was confirmed and accepted by the European Medicines Agency

Zhitongcaijing · 2d ago

Zhitong Financial App News, Hanson Pharmaceuticals (03692) issued an announcement. On September 29, 2026, the Group re-submitted a marketing license application (MAA) for the innovative drug ametinib in the European Union (EMA), and on October 7, 2026, the EMA confirmed acceptance of the new MAA and officially initiated a centralized approval process. The indications are: (i) advanced non-small cell lung cancer (NSCL) with loss of EGFR exon 19 or exon 21 (L858R) replacement mutation C) Frontline for adult patients treatment, and (ii) treatment of adult patients with advanced NSCLC who are positive for the EGFR T790M mutation.