Just now, Hansoh Pharmaceutical announced that its innovative drug, Ametinib Mesylate Tablets (Chinese trade name: Ameile® , overseas trade name: Aumseqa® ) , has been officially approved by the European Commission ( EC ) for marketing in the European Union for the treatment of:

First-line treatment for adult patients with advanced non-small cell lung cancer ( NSCLC ) with epidermal growth factor receptor ( EGFR ) exon 19 deletion or exon 21 ( L858R ) substitution mutation ;

Treatment of adult patients with advanced EGFR T790M mutation-positive NSCLC .

This approval came after the European Medicines Agency ( EMA ) Committee for Medicinal Products for Human Use ( CHMP ) issued a positive opinion. Ametinib thus becomes the first Chinese-developed EGFR-TKI drug to receive EU approval, marking another breakthrough for domestically produced targeted innovative lung cancer drugs in the European market.
Ametinib mesylate tablets (Aumseqa® ) are China's first original third-generation EGFR-TKI , exhibiting good lipid solubility and stability, better crossing the blood-brain barrier, and a low incidence of adverse reactions. Currently, ametinib has been approved for marketing in five indications by the NMPA :

Second-line treatment for patients with locally advanced or metastatic NSCLC who have progressed on previous EGFR-TKI therapy and are T790M mutation positive ;

First-line treatment for adult patients with locally advanced or metastatic NSCLC who are positive for EGFR exon 19 deletion or exon 21 ( L858R ) substitution mutation ;

Treatment of unresectable locally advanced NSCLC patients with EGFR exon 19 deletion or exon 21 ( L858R ) substitution mutation who have not experienced disease progression after platinum-based radical chemoradiotherapy ;

For the treatment of adult NSCLC patients with stage II-IIIB EGFR exon 19 deletion or exon 21 ( L858R ) substitution mutation , the patient must have previously undergone surgical resection and the physician shall decide whether to receive adjuvant chemotherapy;

The combination of pemetrexed and platinum-based chemotherapy is indicated for first-line treatment of adult patients with locally advanced or metastatic NSCLC who have EGFR exon 19 deletions or exon 21 ( L858R ) substitution mutations .

On June 4 , 2025 , amitinib monotherapy for two indications was approved for marketing in the UK. On December 16 , 2025 , Hansoh Pharmaceutical announced that it had granted Glenmark multi-regional exclusive rights to amitinib. On February 12 , 2026 , amitinib monotherapy for two indications was approved for marketing in the EU.

https://mp.weixin.qq.com/s/Je36H7yQKBMcQUIyXh7ZUg