Hansoh Pharma's Ameile (Almonertinib) Gains Two New Indications in China's 2025 National Reimbursement Drug List, Enabling Full-Course Coverage for NSCLC Patients

China Finance and Economics News, December 10th: Recently, the National Healthcare Security Administration announced the "National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug Catalog (2025)" ("Medical Insurance Catalog").

Among them, two indications of Hansoh Pharma's third-generation EGFR-TKI inhibitor Almonertinib (Almety) for adjuvant treatment after surgery and treatment of unresectable locally advanced cases have been included in the new edition of the national medical insurance catalog. It is used for adjuvant treatment in adult patients with non-small cell lung cancer (NSCLC) who are positive for epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation after tumor resection, as well as for the treatment of patients with unresectable locally advanced NSCLC with EGFR exon 19 deletion or exon 21 (L858R) mutation who have not experienced disease progression after platinum-based radical chemoradiotherapy.

It is reported that the two indications of Aumetinib for first-line and second-line treatment in advanced stages have also been successfully renewed and included in the new version of the medical insurance directory. Currently, all four approved indications of Aumetinib have been included in the medical insurance directory. This means that Aumetinib has become the first China-developed third-generation EGFR-TKI to achieve medical insurance coverage for postoperative adjuvant treatment, locally advanced disease, as well as first-line and second-line treatment in advanced stages, comprehensively covering the entire treatment process for EGFR-mutated NSCLC from early to advanced stages, which is expected to further reduce the economic burden on lung cancer patients in China.

Data shows that lung cancer is the malignant tumor with the highest incidence and mortality rate in China, with 1.0606 million new cases and 733,000 deaths annually. Among these, non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer cases. About 30% of patients are diagnosed at an early stage where surgery is possible, but they still face risks of recurrence and metastasis post-surgery, impacting long-term survival. Meanwhile, locally advanced patients often have more complex conditions, most of which are inoperable, and traditional radiotherapy and chemotherapy have limited efficacy, creating an urgent need for more precise treatment options.

In recent years, with the deepening of clinical research, third-generation EGFR-targeted drugs represented by Aumolertinib have demonstrated significant advantages in the treatment of NSCLC. Their application has gradually expanded from advanced stages to earlier stages, achieving comprehensive coverage of critical treatment phases for lung cancer. In the field of postoperative adjuvant therapy, a Phase III ARTS clinical study conducted on Chinese patients confirmed that Aumolertinib used as adjuvant therapy for EGFR-mutated NSCLC patients after surgery can provide long-lasting benefits, significantly reducing the risk of disease recurrence or death by 83% (HR=0.17), with a two-year disease-free survival rate (DFS) as high as 90.2%. Meanwhile, the safety profile during treatment was favorable, with only a 0.9% incidence of adverse reactions leading to discontinuation, offering important assurance for patients' long-term treatment and improvement in quality of life.

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, hence there is a need for safer and more effective adjuvant treatment options. "Based on the robust evidence from the ARTS study, which involved 100% Chinese participants, Aumolertinib has become one of the standard options for adjuvant treatment in early-stage NSCLC patients with EGFR mutations after surgery. Its inclusion in the National Reimbursement Drug List (NRDL) will help optimize clinical decision-making pathways, strengthen treatment confidence, and allow more patients to benefit."

"The inclusion of the adjuvant treatment indication for Aumetinib post-surgery into the medical insurance will greatly improve drug accessibility, enabling doctors at all levels of medical institutions to follow the latest authoritative guidelines and provide standard adjuvant treatment options for eligible patients," said Professor Zhou Qinghua from West China Hospital of Sichuan University. He added that this would strongly promote the standardization and normalization of postoperative 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 hospitals of various levels, benefiting a wide range of patients in grassroots and remote areas.

Another indication simultaneously included in the medical insurance directory this time also provides a new option for precise targeted therapy for patients with locally advanced (Stage III) unresectable NSCLC. The previously announced Phase III POLESTAR study showed that, compared with traditional regimens, the use of Aumetinib as maintenance therapy following chemoradiotherapy for Stage III unresectable NSCLC patients extended the median progression-free survival to 30.4 months and reduced the risk of disease progression by more than 80%, achieving sustained disease control.