---
title: "翰森制药集团有限公司宣布其单药疗法在欧盟获得批准"
description: "汉森制药集团有限公司宣布，阿莫雷替尼美克沙片（在中国称为 Ameile）获得欧盟批准，作为单药治疗用于治疗晚期非小细胞肺癌（NSCLC）。这包括针对特定 EGFR 突变的成人患者的首选治疗，以及针对 EGFR T790M 突变阳性 NSCLC 患者的治疗。该批准是在欧洲药品管理局人用药品委员会给予积极意见后获得的"
type: "news"
locale: "zh-CN"
url: "https://longbridge.com/zh-CN/news/276480305.md"
published_at: "2026-02-20T19:39:57.000Z"
---

# 翰森制药集团有限公司宣布其单药疗法在欧盟获得批准

> 汉森制药集团有限公司宣布，阿莫雷替尼美克沙片（在中国称为 Ameile）获得欧盟批准，作为单药治疗用于治疗晚期非小细胞肺癌（NSCLC）。这包括针对特定 EGFR 突变的成人患者的首选治疗，以及针对 EGFR T790M 突变阳性 NSCLC 患者的治疗。该批准是在欧洲药品管理局人用药品委员会给予积极意见后获得的

The board of directors of Hansoh Pharmaceutical Group Company Limited announced that, on February 12, 2026, Aumolertinib Mesylate Tablets, marketed as Ameile in China and Aumseqa outside China, the Group's innovative drug, has been approved in the European Union as monotherapy for: (i) the first-line treatment of adult patients with advanced non-small cell lung cancer ("NSCLC") whose tumours have epidermal growth factor receptor ("EGFR") exon 19 deletions or exon 21 (L858R) substitution mutations; and (ii) the treatment of adult patients with advanced EGFR T790M mutation-positive NSCLC. The approval by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

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