Hansoh Pharma’s Ameile Gains Approval for New Indication in Early-Stage EGFR-Mutant NSCLC
Hansoh Pharmaceutical Group Co., Ltd (03692.HK), hereafter referred to as Hansoh Pharma, announced that its innovative product Ameile (almonertinib mesylate tablets) has received approval in China for a new clinical indication. The drug is now approved as adjuvant therapy for adult patients with non-small cell lung cancer (NSCLC) whose tumors harbor epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations and who have undergone tumor resection. This marks the fourth approved indication for Ameile in China, reinforcing its leadership position among domestically developed third-generation EGFR tyrosine kinase inhibitors (EGFR-TKIs).
The approval is based primarily on results from the ARTS study (HS-10296-302), a randomized, double-blind, controlled, multicenter Phase III clinical trial. The study’s findings were presented as an oral report at the 2025 American Association for Cancer Research (AACR) Annual Meeting.
Data from the ARTS trial showed that adjuvant treatment with Ameile significantly improved disease-free survival (DFS) in patients with completely resected stage II–IIIB EGFR-mutant NSCLC. Specifically, the two-year DFS rate reached an impressive 90.2%, with a hazard ratio (HR) of 0.17, indicating a substantial reduction in the risk of disease recurrence. The safety profile was reported as manageable. Notably, the study exclusively enrolled Chinese patients, underscoring the strong efficacy and favorable safety of this domestically developed EGFR-TKI within the Chinese population.
As China’s first domestically developed third-generation EGFR-TKI, Ameile has steadily expanded its clinical footprint since its launch five years ago. Initially approved for locally advanced and metastatic NSCLC (stage III–IV), the drug further extended its indication to unresectable locally advanced NSCLC (stage III) in March 2025. With this latest approval, Ameile broadens its reach to include early- and mid-stage NSCLC (stage II–III), offering more comprehensive treatment options across the NSCLC disease spectrum and bringing new hope to patients across China.
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).
