Ameile (Almonertinib) Granted Dual New Indications in China's 2025 National Reimbursement Drug List for Adjuvant and Unresectable Locally Advanced NSCLC

Source: Global Times

On December 7, the National Healthcare Security Administration announced the "National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug Catalog (2025)" (referred to as the "Medical Insurance Catalog"). Two indications for Hansoh Pharma's third-generation EGFR-TKI inhibitor, Aumolertinib (Ameile), were included in the new edition of the Medical Insurance Catalog: adjuvant treatment post-surgery and treatment for unresectable locally advanced cases. It is indicated for adult patients with non-small cell lung cancer (NSCLC) who have tumors with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, for adjuvant treatment following tumor resection, and for treating unresectable locally advanced NSCLC patients with EGFR exon 19 deletions or exon 21 (L858R) mutations who have not experienced disease progression after platinum-based radical chemoradiotherapy. The inclusion of these two indications in the Medical Insurance Catalog means that Aumolertinib has become the first China-developed third-generation EGFR-TKI to achieve medical insurance coverage across four major indications: adjuvant treatment post-surgery, locally advanced, first-line advanced, and second-line advanced treatments. This provides more affordable innovative treatment options for the comprehensive management of NSCLC patients with EGFR mutations.

Professor Gao Shugeng from the Cancer Hospital of the Chinese Academy of Medical Sciences stated that postoperative recurrence may lead to shorter expected survival for patients, especially for those with driver gene-positive conditions such as EGFR mutations, who face a higher risk of recurrence. The survival benefits brought by previous adjuvant chemotherapy have been relatively limited, so we need safer and more effective adjuvant treatment options. Based on the solid evidence from the ARTS study, which involved 100% Chinese population, Aumolertinib has become one of the standard choices for adjuvant treatment after surgery for early-stage NSCLC patients with EGFR mutation positivity. The inclusion of Aumolertinib in the National Reimbursement Drug List (NRDL) this time will help optimize clinical decision-making pathways, strengthen treatment confidence, and allow more patients to benefit.

Professor Zhou Qinghua from West China Hospital of Sichuan University believes that the inclusion of adjuvant treatment indications for Aumetinib after surgery in the medical insurance will greatly improve the accessibility of the drug, enabling doctors at all levels of medical institutions to follow the latest authoritative guidelines and provide eligible patients with standard adjuvant treatment options. This will strongly promote the standardization and normalization of post-surgical adjuvant treatment for NSCLC patients with EGFR mutations in China, thereby narrowing the gap in lung cancer diagnosis and treatment levels between different regions and different levels of hospitals, benefiting a wide range of patients in grassroots and remote areas.