Hansoh Pharma (03692): Single drug treatment of Alectinib Hydrochloride tablets approved and launched in the European Union.

date
07:01 20/02/2026
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GMT Eight
Hansell Pharmaceuticals (03692) announced that on February 12, 2026, the group's innovative drug Gefitinib Hydrochloride Tablets (Chinese trade name: Amel , overseas trade name: Aumseqa ) has been approved for market in the European Union for the following indications: (i) first-line treatment for adult patients with advanced non-small cell lung cancer (NSCLC) with exon 19 deletion or exon 21 (L858R) substitution mutations in the epidermal growth factor receptor (EGFR), and (ii) treatment for adult patients with advanced EGFR T790M-positive NSCLC. This approval was based on the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
HANSOH PHARMA (03692) announced that on February 12, 2026, the group's innovative drug, Ameitini Hydrochloride Tablet (Chinese trade name: Amele; overseas trade name: Aumseqa), has been approved for marketing in the European Union. It is used for: (i) first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutations, and (ii) treatment of adult patients with advanced NSCLC with EGFR T790M mutation positivity. This approval by the European Commission (EC) was based on the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).