Hansoh Pharmaceutical's Almonertinib Receives MHRA Approval in the UK for Non-Small Cell Lung Cancer Treatment

Recently,Hansoh Pharmaceutical Group Company LimitedHansoh Pharma (hereinafter referred to as "Hansoh Pharma") announced that the company's innovative drug, Aumseqa® (Mesylate Almonertinib Tablets), has been approved for marketing by the UK Medicines and Healthcare products Regulatory Agency (MHRA). It is indicated as monotherapy for: first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating epidermal growth factor receptor (EGFR) mutations, and for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. Mesylate Almonertinib Tablets have become the first innovative drug of Hansoh Pharma to be approved for entry into overseas markets, and also the first China-originated EGFR-TKI to be launched overseas.

As China’s first domestically developed third-generation EGFR-TKI, Osimertinib Mesylate Tablets (Chinese trade name: Amelie®) continue to expand their application in the field of NSCLC treatment. To date, based on several pivotal registration clinical studies, Amelie® has been approved for four indications in China, covering the treatment of locally advanced or metastatic NSCLC (Stage III-IV), unresectable locally advanced NSCLC (Stage III), and early to intermediate-stage NSCLC (Stage II-III). Additionally, the marketing authorization application for Amelie® in combination with chemotherapy for first-line treatment of EGFR-sensitive mutation-positive locally advanced or metastatic NSCLC was accepted by the NMPA in November 2024.

In the future, Hansoh Pharma will continue to advance the overseas regulatory approval of Almonertinib (Ameile®) at the European Medicines Agency (EMA) to benefit more patients.