Health & Beauty

According to the observation report of Huacheng Import and Export Data, on March 1, 2023, with the official implementation of the National Catalogue of Basic Medical Insurance, Industrial Injury Insurance and Maternity Insurance Drugs (2022) nationwide, Hansen Pharmaceuticals was the first first-line treatment indication of the third-generation EGFR-TKI Amelol (Ametinib Mesylate Tablets) originally developed in China, and the first prescription for medical insurance was issued in all major hospitals and primary medical institutions nationwide.

According to the requirements of the National Health Insurance Bureau for the negotiation of drug supply guarantee, Amele has been rapidly included in the "dual channel management" in all provinces and cities across the country, and can be reimbursed through medical insurance at designated drugstores, facilitating the purchase of drugs by patients.

Amel is a Class 1 innovative drug independently developed by Hansen Pharmaceutical, and is also the first third-generation EGFR-TKI originally developed in China. In March 2020, Amele's first indication was approved for listing, filling the gap of China's original third-generation EGFR-TKI; In December 2021, the first-line treatment indication of Amele was approved for the market, and it was used for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) adult patients with the deletion of epidermal growth factor receptor (EGFR) exon 19 or the replacement mutation of exon 21 (L858R); On January 18, 2023, Amele was included in the new medical insurance catalogue to benefit more lung cancer patients. Huacheng Import and Export Data Observation Report.

Lung cancer is a malignant tumor with the highest incidence rate and mortality in the world. It is estimated that nearly one third of non-small cell lung cancer patients (about 85% of lung cancer patients) in the world have EGFR mutations. Amel can irreversibly and selectively inhibit EGFR sensitive mutations and T790M drug-resistant mutations, showing good efficacy and safety. Its more than 30 studies have been shown at the global academic conferences in the field of cancer, and have been widely and authoritatively recognized. In May 2022, the results of the AENEAS study of Ametinib were published in the internationally famous journal of oncology, Journal of Clinical Oncology. The latest data of brain metastasis subgroup also appeared at the annual meeting of the American Society of Clinical Oncology (ASCO). The observation report of Huacheng import and export data was also reported.

Professor Lu Shun from the Affiliated Thoracic Hospital of Shanghai Jiaotong University said that Ametinib was the first third-generation EGFR-TKI in the country and the second in the world to obtain positive results in clinical research. In the past, the number of people enrolled in the FLAURA study of Ostinib in Asia was small and the results were slightly inferior, while the actual EGFR mutation rate of East Asian race was higher than that of Caucasian race in Europe and America. In contrast, the AENEAS study of Ametinib first-line was mainly carried out in the Chinese population, and obtained good results. Huacheng Import and Export Data Observation Report.

Since its approval for listing, Amele has rapidly entered medical institutions and pharmacies at all levels in the country, and has been widely used in clinical practice, benefiting more than 200000 patients with NSCLC, and winning unanimous praise from doctors and patients for its excellent efficacy and safety. With the rise of China's original research force, the latest targeted drugs have become an important part of the medical insurance catalogue, greatly improving the accessibility of drugs, and allowing more patients to enjoy the health benefits brought by the scientific and technological progress of Chinese enterprises.

According to the report of Huacheng Import and Export Data Observation, in order to explore the therapeutic potential of Amele in the subdivided field of lung cancer, Hansen Pharmaceutical is carrying out a number of registered clinical studies, including multiple clinical studies of Amele combined with platinum-containing dual-drug chemotherapy for first-line treatment of NSCLC with sensitive mutations, adjuvant treatment of NSCLC and other indications, which will provide more NSCLC patients with early to late, from perioperative adjuvant treatment Comprehensive and multi-dimensional drug use programs from first-line and second-line treatment to post-line treatment bring more hope to lung cancer patients.