On Jan. 9, 2024, Biogen and Eisai announced that humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody ‘LEQEMBI’ (brand name in China, generic name: lecanemab-irmb) had been approved in China as a treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia.

LEQEMBI selectively binds to soluble Aβ aggregates (protofibrils), as well as insoluble Aβ aggregates (fibrils) which are a major component of Aβ plaques, thereby reducing both Aβ protofibrils and Aβ plaques in the brain. LEQEMBI is the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism. China is the third country to grant marketing approval, following the traditional approval in the U.S. in July 2023 and Japanese approval in September 2023.

LEQEMBI’s approval in China was based on the large global Phase III Clarity AD study. In the Clarity AD study, LEQEMBI met its primary endpoint and all key secondary endpoints with statistically significant results. Preparations for launch within the second quarter of Eisai’s FY 2024 (July 1 – September 30, 2024) were underway.