Eisai Co., Ltd, a Japanese pharmaceutical company, along with its co-development partner Biogen Inc. (NASDAQ: BIIB), has announced that they have received marketing approval in Hong Kong for their Alzheimer’s disease (AD) therapy Leqembi (lecanemab). Known as 乐意保 in Chinese, the drug is administered intravenously every two weeks and is indicated for the treatment of patients with mild cognitive impairment (MCI) due to AD and/or mild AD dementia.
Leqembi is a humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody that binds to soluble Aβ and insoluble Aβ aggregates, which are a major component of Aβ plaques associated with AD. The drug’s mechanism of action is designed to reduce both Aβ protofibrils and Aβ plaques in the brain. The Phase III Clarity AD study demonstrated that Leqembi treatment resulted in a statistically significant reduction in the decline of measures related to cognition and function compared to placebo at 18 months (27% slowing over 18 months). Prior to this, the drug was approved in the United States in January 2023, followed by full approval in June 2023, in Japan in September 2023, and in mainland China in July 2024.
Eisai takes the lead on global development and regulatory filing for Leqembi, with commercialization and promotion shared between Eisai and Biogen, with Eisai holding final decision-making rights. In Hong Kong, Eisai is responsible for the commercial promotion of the drug.- Flcube.com
