On January 9, the official website of the State Food and Drug Administration announced that the marketing application of Lecanemab Injection (Chinese trade name: Leyibao), a new class of Alzheimer's disease submitted by Eisai, was approved for mild cognitive impairment caused by Alzheimer's disease and mild dementia of Alzheimer's disease.
It is reported that lecanemab is the first fully approved new drug for Alzheimer's disease by the US FDA in the past 20 years, which was fully approved in the United States in July 2023 and in Japan in September 2023, and China is the third country to approve the drug for marketing.
Alzheimer's disease is a progressive and irreversible neurodegenerative brain disease, which can lead to intellectual disability, mental abnormalities, loss of social and life functions, and seriously affect patients' cognitive ability and normal life. It is estimated that by 2050, the number of Alzheimer's disease patients in China will increase to 40 million.
According to reports, the approval of lecanemab in China is based on a large-scale phase III study in the world, including China. In this study, lecanemab met the primary endpoint and all key secondary endpoints with statistically significant results. The results of the study were presented at the 2022 Alzheimer's Disease Clinical Trials (CTAD) Conference and published in the world-renowned medical journal New England Journal of Medicine.
How much does this new drug cost?The cost varies depending on the patient's weight. The reporter noted that the current domestic price of lecanemab has not been announced, but the sales data of Boao Lecheng can be used for public reference. In October 2023, lecanemab passed the review of the Hainan Provincial Drug Administration and landed in the Hainan Boao Lecheng International Medical Tourism Pilot Zone.
According to the data of the central pharmacy of Boao Lecheng Pilot Zone, the specification of lecanemab on the market in Lecheng, Hainan is 200 mg 2 ml, ** is 3328 yuan bottle, and in the instructions, the recommended dose of lecanemab is 10 mg kg, which is used once every two weeks. According to this calculation, a patient weighing 60 kg needs 600 mg of medicine, about 3 bottles of drugs, and the cost of a single use is about 9,984 yuan, the monthly cost is about 20,000 yuan, and the annual cost is about 240,000 yuan.
*: Beijing ** client Reporter: Yuan Lu.
Process edit: u060