On February 20, 2026, Hansoh Pharmaceutical Group Company Limited announced that, on February 12, 2026, Aumolertinib Mesylate Tablets, marketed as Ameile (阿美乐®) in China and Aumseqa® outside China, the Group’s innovative drug, was approved in the European Union (the “EU”) 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).
Aumolertinib Mesylate Tablets is the first original third-generation EGFR-TKI innovative drug in China. It has been approved for five indications by the National Medical Products Administration (NMPA), namely: it was approved for the treatment of patients with locally advanced or metastatic NSCLC with T790M mutation, who have progressed on or after EGFR-TKI therapy in 2020; it was approved as the 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 in 2021; it was approved for the treatment of patients with locally advanced, unresectable NSCLC whose disease has not progressed following definitive platinum-based chemoradiotherapy whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitute mutations in 2025; it was approved for the adjuvant treatment of adult patients with stage II to IIIB NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, and who have undergone tumor resection with or without prior adjuvant chemotherapy as determined by their physician in 2025; it was approved that Ameile in combination with pemetrexed and platinum-based chemotherapy to be used as the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) mutations in 2026. Additionally, Aumolertinib Mesylate Tablets was approved by the Medicines and Healthcare Products Regulatory Agency in the United Kingdom (MHRA) for marketing in 2025.
About Hansoh Pharma
Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise headquartered 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 autoimmunity. Hansoh Pharma has launched 7 innovative drugs that generate product sales in China, with the revenue from innovative drugs 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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Forward-Looking Statements
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