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阿美乐第五项适应症「靶化联合」获批上市,引领中国原研三代EGFR-TKI全病程覆盖
Zhong Guo Jing Ji Wang· 2026-01-09 11:34
Group 1 - The core point of the news is that Hansoh Pharmaceutical announced the approval of a fifth indication for Amelot (Ametinib Mesylate Tablets) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations [1] - The approval is based on the AENEAS2 Phase III clinical study, which demonstrated that Amelot combined with chemotherapy significantly extends progression-free survival (PFS) compared to monotherapy, with a hazard ratio (HR) of 0.47, indicating a 53% reduction in the risk of disease progression or death [1] - The median PFS was extended to 28.9 months, with an objective response rate (ORR) of 93.2%, and no new safety risks were identified in the study, which included only Chinese patients [1] Group 2 - Since its initial approval in March 2020, Amelot has expanded from a single indication to five, with all previous indications included in the national medical insurance catalog, enhancing its clinical position and providing high-level evidence for the treatment of lung cancer in China [2] - The previously approved indications include postoperative adjuvant therapy for EGFR-mutant NSCLC, maintenance therapy after chemoradiotherapy for unresectable locally advanced NSCLC, and first-line and second-line treatments for advanced NSCLC [2]