Hansoh Pharmaceutical's Ameile® (Almonertinib Mesilate Tablets) Granted Fourth Indication by China's NMPA for Adjuvant Treatment of Resected EGFR-Mutated NSCLC

Hansoh Pharma (03692) announced that the group's innovative drug, Almonertinib Mesylate Tablets (brand name: Amelie®), has been granted a drug registration certificate by the China National Medical Products Administration (NMPA). The approval adds a new indication for "the treatment of adult patients with Stage II-IIIB non-small cell lung cancer (NSCLC) who have epidermal growth factor receptor ('EGFR') exon 19 deletions or exon 21 (L858R) substitution mutations, and who have previously undergone surgical resection, with adjuvant chemotherapy at the discretion of the physician." This is the fourth approved indication for Amelie®.