HANSOH PHARMA | AUMOLERTINIB: APPROVED BY UK’S MHRA FOR THE TREATMENT OF NSCLC — MARKING THE FIRST OVERSEAS LAUNCH OF CHINA-DEVELOPED EGFR-TKI
On June 4, 2025, Hansoh Pharmaceutical Group Co., Ltd. (Hansoh Pharma, 03692.HK) announced that its innovative drug Aumolertinib Mesylate Tablets (trade name: Aumseqa in UK) has been granted marketing authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom. Aumseqa, as a monotherapy, is indicated for: the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations, and the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. With this approval, Almonertinib has become the first innovative drug from Hansoh Pharma to be approved for the overseas market, and also the first China-developed EGFR-TKI to be launched overseas.
As the first third-generation EGFR-TKI self-developed by China, Aumolertinib Mesylate Tablets (trade name in China: Ameile) continues to expand its clinical application in the NSCLC therapeutic field. To date, supported by multiple pivotal registered clinical studies, four indications of Ameile has been approved by China’s NMPA, covering locally advanced or metastatic NSCLC (Stage III–IV), unresectable locally advanced NSCLC (Stage III), and early to intermediate-stage NSCLC (Stage II–III). This makes Ameile, the China-developed third-generation EGFR-TKI, with the most approved indications and the broadest therapeutic coverage to date. In addition, the marketing authorization application for Ameile in combination with chemotherapy as a first-line treatment for EGFR-sensitive, locally advanced or metastatic NSCLC was accepted by NMPA in November 2024.
Hansoh Pharma will continue to advance the regulatory submission of Ameile to the European Medicines Agency (EMA), aiming to benefit more patients globally.
About Ameile
As China's first original third-generation EGFR-TKI, Ameile (Aumolertinib Mesylate Tablets) features good liposolubility and stability, allowing it to better penetrate the blood-brain barrier with a low incidence of adverse reactions. Currently, Ameile has been approved for four indications: second-line treatment of patients with locally advanced or metastatic NSCLC with T790M mutation, who have progressed on or after EGFR-TKI therapy; first-line treatment for adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitute mutation positive; treatment of patients with locally advanced, unresectable（Stage III）non-small cell lung cancer ("NSCLC") whose disease has not progressed following definitive platinum-based chemoradiotherapy whose tumors have epidermal growth factor receptor ("EGFR") exon 19 deletions or exon 21 (L858R) substitute mutations; adjuvant treatment of adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) mutations, and who have undergone tumor resection.
About Hansoh Pharma
Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, anti-infectives, central nervous system (CNS), metabolism and immunology. Hansoh Pharma has launched 7 innovative medicines that generate product sales in China, with the revenue from innovative medicines and collaborative products exceeding 80%, forming a rich product pipeline. The company has consistently ranked among the top 100 global pharmaceutical companies and is recognized as one of the top 3 pharmaceutical R&D enterprises in China, and is designated as a National Key High-Tech Enterprise and a National Technology Innovation Demonstration Enterprise. Hansoh Pharma was listed on the Hong Kong Stock Exchange in June 2019 (stock code: 03692.HK).
Statements
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