---
title: "Hansoh Pharmaceutical Group Company Limited Announces Approval in the European Union as Monotherapy"
description: "Hansoh Pharmaceutical Group Company Limited announced that Aumolertinib Mesylate Tablets, known as Ameile in China, received approval in the European Union as a monotherapy for treating advanced non-s"
type: "news"
locale: "en"
url: "https://longbridge.com/en/news/276480305.md"
published_at: "2026-02-20T19:39:57.000Z"
---

# Hansoh Pharmaceutical Group Company Limited Announces Approval in the European Union as Monotherapy

> Hansoh Pharmaceutical Group Company Limited announced that Aumolertinib Mesylate Tablets, known as Ameile in China, received approval in the European Union as a monotherapy for treating advanced non-small cell lung cancer (NSCLC). This includes first-line treatment for adult patients with specific EGFR mutations and treatment for those with EGFR T790M mutation-positive NSCLC. The approval follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use.

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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> **Disclaimer**: This article is for reference only and does not constitute any investment advice.