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翰森制药阿美乐第四项适应症获批 用于EGFR突变阳性NSCLC术后辅助治疗
03692HANSOH PHARMA(03692) 中国经济网·2025-05-13 08:22

Core Viewpoint - Hansoh Pharmaceutical Group announced the approval of Amelot (Ametinib Mesylate Tablets) for a new indication, expanding its application to treat adult non-small cell lung cancer (NSCLC) patients with specific EGFR mutations [1][2] Group 1: Product Approval and Clinical Research - The new indication is for patients with stage II-III B NSCLC who have previously undergone surgical resection and may or may not receive adjuvant chemotherapy [1] - The approval is based on the ARTS (HS-10296-302) Phase III clinical study, which was presented at the 2025 American Association for Cancer Research (AACR) annual meeting [1] - The ARTS study demonstrated a significant improvement in disease-free survival (DFS) for patients receiving Amelot as adjuvant therapy, with a 2-year DFS rate of 90.2% [1] Group 2: Market Position and Expansion - Amelot, as China's first original third-generation EGFR-TKI, has been expanding its treatment areas since its launch five years ago [2] - The recent approval allows Amelot to cover early to mid-stage NSCLC (II-III stage), providing more treatment options for lung cancer patients in China [2]