Hansoh Pharmaceutical has received marketing authorisation in the European Union (EU) for its third-generation EGFR tyrosine kinase inhibitor (TKI), Ameile/Aumseqa (aumolertinib). The drug is approved for two adult indications: the first-line treatment of advanced non-small cell lung cancer (NSCLC) harbouring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, and for the treatment of advanced EGFR T790M mutation-positive NSCLC. Aumolertinib is the first China-developed third-generation EGFR-TKI to gain EU approval.
The drug is already approved in China for five indications, covering a broad range of treatment settings from adjuvant therapy to first and second-line treatment for advanced disease. This EU approval follows the drug's authorisation in the United Kingdom in June 2025. In a further move to expand its global footprint, Hansoh granted Glenmark Pharmaceuticals exclusive multi-region commercial rights to aumolertinib in December 2025.

According to PharmCube's NextBiopharm® database, Hansoh has three products approved in the EU, namely aumolertinib, XPO1 inhibitor selinexor, and anti-CD19 biologic inebilizumab. Click here to request a free trial for NextBiopharm®.