---
title: "翰森製藥集團有限公司宣佈其單藥療法在歐盟獲得批准"
description: "漢森製藥集團有限公司宣佈，阿莫雷替尼美克沙片（在中國稱為 Ameile）獲得歐盟批准，作為單藥治療用於治療晚期非小細胞肺癌（NSCLC）。這包括針對特定 EGFR 突變的成人患者的首選治療，以及針對 EGFR T790M 突變陽性 NSCLC 患者的治療。該批准是在歐洲藥品管理局人用藥品委員會給予積極意見後獲得的"
type: "news"
locale: "zh-HK"
url: "https://longbridge.com/zh-HK/news/276480305.md"
published_at: "2026-02-20T19:39:57.000Z"
---

# 翰森製藥集團有限公司宣佈其單藥療法在歐盟獲得批准

> 漢森製藥集團有限公司宣佈，阿莫雷替尼美克沙片（在中國稱為 Ameile）獲得歐盟批准，作為單藥治療用於治療晚期非小細胞肺癌（NSCLC）。這包括針對特定 EGFR 突變的成人患者的首選治療，以及針對 EGFR T790M 突變陽性 NSCLC 患者的治療。該批准是在歐洲藥品管理局人用藥品委員會給予積極意見後獲得的

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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|-------|-------------|-----|
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