On January 5, 2026, Eisai Co., Ltd. and Biogen Inc. announced that China’s National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for the subcutaneous autoinjector (SC-AI) formulation of LEQEMBI® (lecanemab; brand name in China: “乐意保®”), a humanized IgG1 monoclonal antibody targeting soluble aggregated amyloid-beta protofibrils for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s and mild Alzheimer’s dementia).
This subcutaneous version, administered as a 500 mg weekly dose via two rapid 250 mg injections (each taking about 15 seconds), enables at-home self-administration from treatment initiation, contrasting with the existing intravenous (IV) formulation that requires biweekly clinic visits initially and hospital resources for infusion monitoring. If approved, it could become the first anti-amyloid therapy in China offering at-home injection from the start, streamlining care pathways, easing patient and caregiver burden, and optimizing healthcare utilization in a rapidly aging population.
Alzheimer’s disease poses a significant public health challenge in China, with Eisai estimating approximately 17 million individuals affected by mild cognitive impairment or mild dementia due to the condition in 2024—a figure projected to grow substantially. The IV formulation of lecanemab has already been approved and launched in China, with recent inclusion in the National Healthcare Security Administration’s Commercial Insurance Innovative Drug List enhancing accessibility.
Lecanemab, developed through a collaboration between Eisai and BioArctic, selectively binds toxic protofibrils believed to drive neurodegeneration even after plaque clearance. Global approvals span multiple countries, including the U.S., Japan, and others, with subcutaneous maintenance dosing approved in the U.S. in August 2025. Eisai leads global development, regulatory submissions, and commercialization in China, while partnering with Biogen for co-promotion elsewhere.
This BLA acceptance represents a key advancement toward more patient-centric Alzheimer’s therapies in the world’s most populous nation, potentially expanding treatment options amid rising prevalence and limited convenient alternatives.
