Ameile's Fifth Indication 'Targeted-Chemo Combination' Approved, Enabling Full-Course Coverage for China's Homegrown Third-Generation EGFR-TKI

1On the 8th, Hansoh Pharmaceutical Group Company Limited (hereinafter referred to as "Hansoh Pharma") announced that the fifth indication of Almonertinib Mesylate Tablets (Almonertinib) has been approved for marketing: in combination with pemetrexed and platinum-based chemotherapy drugs for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. This approval marks that Almonertinib has achieved full-course treatment coverage from early to late-stage EGFR-mutated NSCLC patients.

This approval is mainly based on the AENEAS 2 Phase III clinical study, the results of which were globally premiered in an oral presentation at the plenary session of the 2025 American Association for Cancer Research (AACR) Annual Meeting.

AENEAS 2Study data confirmed that, in patients with EGFR-sensitive mutations in locally advanced or metastatic NSCLC, first-line treatment with Almonertinib (Ameile) combined with chemotherapy significantly prolonged progression-free survival (PFS) compared to monotherapy, with an HR of 0.47, indicating that the combination can reduce the risk of disease progression or death by 53% compared to monotherapy. 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 produced EGFR-TKI for patients in China.

As China’s first domestically developed third-generation EGFR-TKI, Almonertinib (brand name: Amelie) has expanded from a single indication to five since its initial approval for marketing in March 2020. The previously approved four indications have all been included in the National Medical Insurance Catalog, including: adjuvant treatment for NSCLC patients with EGFR mutations after surgery, maintenance therapy following chemoradiotherapy for unresectable locally advanced NSCLC, and first-line and second-line treatments for advanced NSCLC. While providing high-level evidence-based medical proof for the efficacy of original third-generation EGFR-TKI in treating Chinese lung cancer patients, it also solidifies its clinical status, allowing more lung cancer patients to benefit in terms of survival from innovative Chinese solutions.