Biologics License Application for Subcutaneous Formulation of “LEQEMBI®” (lecanemab) for the Treatment of Early Alzheimer’s Disease Designated for Priority Review in China

Core Viewpoint - Eisai Co., Ltd. and Biogen Inc. announced that the Biologics License Application for the subcutaneous formulation of LEQEMBI has been designated for Priority Review by the National Medical Products Administration of China, which could significantly enhance patient access to treatment [1][2]. Group 1: Product Development and Approval - The subcutaneous formulation (SC-AI) of LEQEMBI allows for a once-weekly home administration, contrasting with the current intravenous method that requires hospital visits every two weeks [3]. - The injection time for each autoinjector is approximately 15 seconds, which could streamline the treatment process and reduce healthcare resource utilization [3]. - Eisai estimates that there were 17 million patients with mild cognitive impairment or mild dementia due to Alzheimer's disease in China in 2024, a number expected to rise with the aging population [4]. Group 2: Market Access and Insurance - LEQEMBI was launched in China in June 2024 and has been included in the "Commercial Insurance Innovative Drug List," effective January 2026, which supports access to innovative medicines [5]. - Commercial insurance companies are expected to develop insurance products covering LEQEMBI based on this new list [5]. Group 3: Collaboration and Regulatory Strategy - Eisai leads the global development and regulatory submissions for LEQEMBI, with both Eisai and Biogen co-commercializing and co-promoting the product [6][11]. - The U.S. FDA approved the Biologics License Application for subcutaneous maintenance dosing of LEQEMBI in August 2025, with a supplemental application for initiation treatment accepted in January 2026 [8]. Group 4: Scientific Background - Lecanemab is a humanized monoclonal antibody targeting aggregated forms of amyloid-beta, which is believed to play a significant role in cognitive decline associated with Alzheimer's disease [8][10]. - The reduction of protofibrils may prevent the progression of Alzheimer's disease by mitigating neuronal damage and cognitive dysfunction [10]. Group 5: Company Overview - Eisai's corporate concept focuses on patient-centric healthcare, aiming to address unmet medical needs, particularly in neurology and oncology [13]. - Biogen, founded in 1978, is a leading biotechnology company that emphasizes innovative science to transform patient lives and create shareholder value [16].