Hansoh Pharma's First-in-Class Chinese-Originated Third-Generation EGFR-TKI Ameile (Aumolertinib) Gains National Reimbursement, Enhancing Accessibility for Lung Cancer Patients

On March 1, 2023, with the official implementation of the "National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug Catalog (2022)" across China, the first-line treatment indication of Hansoh Pharma's first China-developed third-generation EGFR-TKI, Almonertinib Mesylate Tablets (brand name: Amelie), began to be prescribed for the first time under medical insurance at major hospitals and grassroots medical institutions nationwide.

According to the national medical insurance administration's requirements for the supply and security of negotiated drugs, Almonertinib has been quickly included in the "dual-channel management" across China, and can be reimbursed through medical insurance at designated pharmacies, making it convenient for patients to purchase the drug.

Almonertinib is a Class 1 innovative drug independently developed by Hansoh Pharma, and also the first China-originated third-generation EGFR-TKI. In March 2020, the first indication of Almonertinib was approved for marketing, filling the gap in China’s self-developed third-generation EGFR-TKI. In December 2021, the first-line treatment indication of Almonertinib was approved for marketing, indicated for 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. On January 18, 2023, Almonertinib was included in the new edition of the National Reimbursement Drug List (NRDL), benefiting more patients with lung cancer.

Lung cancer is the malignant tumor with the highest incidence and mortality rate worldwide. It is estimated that nearly one-third of global non-small cell lung cancer patients (approximately 85% of lung cancer patients) have EGFR mutations. Almonertinib (Amelie) can irreversibly and highly selectively inhibit both EGFR-sensitive mutations and T790M resistance mutations, demonstrating good efficacy and safety. Over 30 studies on Almonertinib were presented at prestigious global oncology conferences, receiving broad and authoritative recognition. In May 2022, the results of the AENEAS study on Almonertinib were published in the renowned oncology journal, Journal of Clinical Oncology, and the latest brain metastasis subgroup data was also showcased at the American Society of Clinical Oncology (ASCO) Annual Meeting.

Professor Lu Shun from the Thoracic Hospital affiliated with Shanghai Jiao Tong University introduced that Aumetinib is the first third-generation EGFR-TKI in China and the second globally to achieve positive results in clinical research. The previous FLAURA study of Osimertinib included fewer Asian participants, and its results were slightly less favorable. In reality, the EGFR mutation rate in East Asian populations is higher than in Caucasians from Europe and America. By comparison, the frontline AENEAS study of Aumetinib was mainly conducted among the Chinese population and achieved excellent results.

Since its approval for marketing, Amelo has quickly entered medical institutions and pharmacies at all levels across China and has been widely used in clinical practice, benefiting more than 200,000 patients with NSCLC. With its excellent efficacy and safety, it has won unanimous praise from both doctors and patients. As China's indigenous R&D capabilities rise, the latest targeted drugs have become an important part of the national medical insurance catalog, greatly improving drug accessibility and allowing more patients to benefit from the health outcomes brought about by technological advancements in Chinese enterprises.

Reportedly, to explore the treatment potential of Almonertinib in the field of lung cancer subtypes, Hansoh Pharma is conducting multiple registrational clinical studies. These include first-line treatment of Almonertinib combined with platinum-based doublet chemotherapy for NSCLC with sensitive mutations, adjuvant therapy for NSCLC, and other indications across various clinical trials. This will provide comprehensive and multidimensional medication solutions for more NSCLC patients, ranging from early to advanced stages, including perioperative adjuvant therapy, first-line and second-line treatments, as well as later-line therapies, bringing more hope to lung cancer patients. (Zhu Wen)