Hansoh Pharmaceutical (HKG:3692) said the European Medicines Agency (EMA) has validated its resubmitted marketing authorization application for Aumolertinib, allowing the centralized review process to begin, according to a Sunday Hong Kong bourse filing.

The company resubmitted the application on Sept. 29, and the EMA validated it on Oct. 7.

The application covers first-line treatment of adults with advanced non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, as well as treatment of adults with advanced NSCLC positive for the EGFR T790M mutation.