Hansoh Pharmaceutical Group (HKEX: 3692) said the European Medicines Agency (EMA) validated its resubmitted marketing authorization application (MAA) for aumolertinib (Aumseqa), restarting regulatory review for two non-small cell lung cancer (NSCLC) indications. The resubmission follows the European Commission's September 2026 revocation of the drug's previous authorization after determining that the original application improperly referenced clinical data for AstraZeneca's Tagrisso (osimertinib) that remained under EU regulatory data protection at the time of submission.
The application, resubmitted on September 29 and validated on October 7, seeks approval of aumolertinib as monotherapy for first-line treatment of adults with advanced NSCLC harboring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, and for advanced EGFR T790M mutation-positive NSCLC. The third-generation EGFR tyrosine kinase inhibitor targets both activating EGFR mutations and the T790M resistance mutation.
In the Phase III AENEAStrial involving 429 patients with previously untreated EGFR-mutated NSCLC, aumolertinib significantly improved median progression-free survival to 19.3 months versus 9.9 months with gefitinib (HR 0.46; P<0.0001). The findings established clinical efficacy for aumolertinib monotherapy in the first-line setting and supported its original regulatory development.