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“LEQEMBI®” (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease Approved in China
Globenewswire· 2025-09-28 23:30
Core Insights - Eisai Co., Ltd. and Biogen Inc. announced the approval of LEQEMBI (lecanemab) for intravenous maintenance dosing every four weeks in China, following its initial approval for treating early Alzheimer's disease in January 2024 [1][2] Group 1: Product Information - LEQEMBI is a humanized monoclonal antibody targeting both soluble and insoluble forms of amyloid-beta, addressing the neurodegenerative processes associated with Alzheimer's disease [3][7] - The drug has been approved in 50 countries and is under regulatory review in 10 additional countries, with a maintenance dosing regimen of 10 mg/kg every four weeks approved in China and the U.S. [7][8] - The primary endpoint for LEQEMBI's approval was the Clinical Dementia Rating Sum of Boxes (CDR-SB), with significant results from the global Clarity AD clinical trial [8] Group 2: Market Potential - As of 2024, there are an estimated 17 million patients in China with mild cognitive impairment or mild dementia due to Alzheimer's disease, a number expected to rise with the aging population [4] - The collaboration between Eisai and Biogen for the development and commercialization of Alzheimer's treatments has been ongoing since 2014, with Eisai leading regulatory submissions globally [10] Group 3: Research and Development - Ongoing clinical studies include the AHEAD 3-45 trial for individuals with preclinical Alzheimer's disease and the Tau NexGen study for Dominantly Inherited Alzheimer's Disease, both involving lecanemab [9]