"LEQEMBI®" (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease Approved in China

Group 1 - The AHEAD 3-45 Phase 3 clinical study for individuals with preclinical Alzheimer's disease (AD) has been ongoing since July 2020, focusing on those with elevated amyloid levels in their brains [1] - The Tau NexGen clinical study for Dominantly Inherited Alzheimer's Disease (DIAD) began in January 2022, utilizing lecanemab as the primary anti-amyloid therapy [1] - LEQEMBI received approvals in various countries based on Phase 3 data from the Clarity AD clinical trial, achieving its primary endpoint and all key secondary endpoints with statistically significant results [2] Group 2 - The U.S. FDA approved Eisai's Biologics License Application for subcutaneous maintenance dosing with LEQEMBI in August 2025, with a rolling sBLA application for subcutaneous initiation dosing initiated in September 2025 [2]