On May 9, 2025, Hansoh Pharmaceutical Group Co., Ltd (hereinafter referred to as "Hansoh Pharma”, 03692.HK) announced that a new indication for Ameile (almonertinib mesylate tablets) has been approved for marketing. The new indication is for the 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. Ameile now has four approved indications in China, maintaining its leading position among domestically developed third-generation EGFR-TKIs.
This approval is primarily based on the ARTS study (HS-10296-302), a randomized, double-blind, controlled, multicenter Phase III clinical trial. The study results were presented as an oral report at the 2025 American Association for Cancer Research (AACR) Annual Meeting.
Data from the ARTS study presented at the 2025 AACR Annual Meeting confirmed that for patients with completely resected stage II–IIIB EGFR-mutant NSCLC, adjuvant treatment with Ameile—when applicable—can significantly improve disease-free survival (DFS). The 2-year DFS rate reached 90.2%, with an HR of 0.17, and the overall safety profile was manageable. Notably, the study enrolled only Chinese patients, highlighting the significant efficacy and manageable safety profile of the domestically developed EGFR-TKI in the Chinese population.
As China’s first domestically developed third-generation EGFR-TKI, Ameile has steadily expanded its approved indications over the five years since its launch. In addition to strengthening its position in the treatment of locally advanced and metastatic NSCLC (stage III–IV), the drug successfully extended its use to unresectable locally advanced NSCLC (stage III) in March 2025. With this latest approval, Ameile has extended its application to early- and mid-stage NSCLC (stage II–III), achieving broader coverage across the NSCLC treatment spectrum and offering more therapeutic options for patients in China.
About Ameile
As China's first original third-generation EGFR-TKI, Ameile (Aumolertinib Mesilate 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 pharmaceutical company in Greater China driven by innovation. It is committed to the treatment of major diseases in the areas of oncology, anti-infections, CNS diseases, metabolic diseases, as well as autoimmune diseases, and is dedicated to improving human health through continuous innovation. Hansoh Pharma has been ranked among the top 100 global pharmaceutical companies and the top 3 best industrial enterprises in China in terms of pharmaceutical R&D pipeline for several years, and is a national key high-tech enterprise and a national technology innovation demonstration enterprise. Hansoh Pharma was listed on the Stock Exchange of Hong Kong in June, 2019 (stock code: 03692.HK).
For more information, please visit https://www.hspharm.com/.
Statements
1. This announcement is intended for healthcare professionals only and not for advertising purposes.
2. Hansoh Pharma does not recommend the use of any unapproved drugs or off-label indications, nor does it make recommendations regarding any drug or indication.
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Forward-Looking Statements
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