China’s National Medical Products Administration approved the subcutaneous autoinjector formulation of LEQEMBI (lecanemab) as an initiation treatment for mild cognitive impairment due to alzheimer’s disease and mild alzheimer’s disease dementia.
The approved regimen is 500 mg once weekly, administered as two consecutive 250 mg injections, and patients may switch between intravenous and subcutaneous administration during treatment.
The application was accepted in January 2026, granted Priority Review, and launch is planned during Eisai’s fiscal 2026 year ending 31 March 2027.
The approval was based on integrated data and modeling from the 18-month core Clarity AD study and subsequent subcutaneous administration sub-studies, including a Chinese cohort.
For ARIA monitoring, brain MRI is required before treatment initiation and at specified time points thereafter. The company claims subcutaneous self-administration can substantially reduce time compared with IV infusion, lower clinic visit burden for patients and care partners, and reduce certain healthcare resource needs associated with IV dosing.
Eisai serves as lead for global development, will distribute LEQEMBI in China and conduct information provision activities, and the company estimates there were 17 million people with MCI or mild dementia due to alzheimer’s disease in China in 2024.
