The Zhitong Finance App learned that on May 27, Eisai/eSaly.us (Eisai/eSaly.us) and Biogen/Biib.us (Biogen/Biib.us) announced that Korea's Ministry of Food and Drug Safety (MFDS) has approved the launch of lecanemab (Chinese generic name: luncanemab) to treat early (mild) Alzheimer's disease or adult patients with mild cognitive impairment caused by Alzheimer's disease. According to Eisai's press release, this is the fourth time that lecanemab has been approved for listing in a country after the US, Japan, and China.

Alzheimer's disease (AD) is a progressive, irreversible neurodegenerative brain disease that causes intellectual disability, mental abnormalities, and loss of social and life functions, seriously affecting patients' cognitive ability and normal life. It is estimated that in 2021, there are about 900,000 people with dementia in South Korea. One-tenth of those over 65 have dementia, and one-fifth have mild cognitive impairment (MCI). Lecanemab can slow disease progression and slow cognitive and functional decline.

Furthermore, Eisai has recently submitted a BLA (biological product license application) for the subcutaneous injection of lecanemab-irmb for weekly maintenance administration to the US FDA. Previously, the drug was granted a rapid review channel by the FDA. If approved by the FDA, this subcutaneous injection can be given at home or in a healthcare facility, and the injection process takes less time than intravenous administration. In March of this year, Eisai also submitted a supplementary biologics license application (SBLA) for monthly intravenous (IV) maintenance doses of luncanemab to the FDA.