On January 6, 2026, Hansoh Pharmaceutical Group Co., Ltd. ("Hansoh Pharma," 03692.HK) announced that a new indication of Ameile (Aumolertinib Mesylate Tablets) has been approved for marketing. The approved indication is 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 non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. With this approval, the number of approved indications for Ameile in China has reached five, achieving full-course treatment coverage from early-stage to advanced EGFR-mutated NSCLC.
This approval is primarily based on a Phase III clinical study named AENEAS 2, the results of which were first released globally as an oral presentation at a plenary session of the 2025 Annual Meeting of the American Association for Cancer Research (AACR).
Data from the AENEAS 2 study presented at AACR 2025 confirm that in patients with locally advanced or metastatic NSCLC harboring EGFR-sensitizing mutations, first-line treatment with Ameile in combination with chemotherapy significantly prolonged progression-free survival (PFS) compared with Ameile monotherapy, with a HR of 0.47, indicating that Ameile in combination with chemotherapy reduces the risk of disease progression or death by 53% compared to monotherapy. The median progression-free survival (mPFS) was extended to 28.9 months, the objective response rate (ORR) reached 93.2%, and no new safety signals were observed. All patients enrolled in the study were Chinese, demonstrating the significant efficacy and manageable safety profile of this original EGFR-TKI in the Chinese patient population.
Ameile is the first original third-generation EGFR-TKI innovative drug in China. Since its initial approval in March 2020, Ameile has expanded from a single indication to full-course coverage, including adjuvant treatment after surgical resection, maintenance treatment following definitive chemoradiotherapy for unresectable locally advanced NSCLC, as well as first-line and second-line treatment for advanced NSCLC, totaling five approved indications. By providing high-level evidence-based medical support for the treatment of lung cancer patients in China with an original third-generation EGFR-TKI, Ameile has further strengthened its clinical positioning, enabling more lung cancer patients to achieve survival benefits from China’s innovative therapeutic solutions.
About Ameile
Ameile (Aumolertinib Mesylate Tablets) is the first original third-generation EGFRTKI innovative drug in China. It has been approved for four indications in China, namely: it wasapproved 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. Additionally, Aumolertinib Mesylate Tablets (trade name in the United Kingdom: Aumseqa®) was approved by the Medicines and Healthcare Products Regulatory Agency in the United Kingdom (MHRA) formarketing in 2025. On December 16, 2025, Hansoh Pharma grants Glenmark exclusive multi-regional rights regarding Ameile.
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).
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