Hansoh Pharma Announces Positive Phase III Data for Ameile (Aumolertinib) in Two NSCLC Indications at AACR 2025

On April 29, Hansoh Pharmaceutical Group Company Limited (hereinafter referred to as "Hansoh Pharma") announced that the Phase III study data of innovative drug Almonertinib Mesylate Tablets (Almonertinib) combined with chemotherapy for first-line treatment of advanced non-small cell lung cancer was presented for the first time in an oral plenary session by Professor Shun Lu from Shanghai Chest Hospital at the 2025 American Association for Cancer Research (AACR) Annual Meeting.

Data show that in patients with EGFR-sensitive mutations in locally advanced or metastatic non-small cell lung cancer (NSCLC), first-line treatment with Almonertinib (Ameile) combined with chemotherapy significantly prolongs progression-free survival (PFS) compared to monotherapy, with an HR of 0.47. This indicates that, compared to monotherapy, the combination of Almonertinib and chemotherapy can reduce the risk of disease progression or death by 53%. The median progression-free survival (mPFS) was extended to 28.9 months, with an objective response rate (ORR) as high as 93.2%, and no new safety risks were identified. The study included only Chinese patients, demonstrating the significant efficacy and manageable safety of the domestically developed EGFR-TKI for patients in China.

At the same time, the Phase III study data of Ameile for adjuvant treatment of non-small cell lung cancer (NSCLC) after surgery was orally presented by Professor Cheng Ying from Jilin Province Cancer Hospital in a symposium. This marks the global debut of the results of this Phase III clinical trial. The data confirmed that for patients with completely resected Stage II-IIIB NSCLC carrying EGFR mutations, adjuvant treatment with Ameile, where applicable, significantly improved disease-free survival (DFS), with an HR of 0.17 and a 2-year DFS rate as high as 90.2%. The safety profile was generally manageable. Notably, all patients included in the study were Chinese, demonstrating the significant efficacy and controllable safety of the China-developed EGFR-TKI for patients in China.