Biologics License Application for Subcutaneous LEQEMBI® (lecanemab) for Early Alzheimer’s Disease Accepted in China

Eisai Co., Ltd. and Biogen Inc. announced that the National Medical Products Administration (NMPA) in China has accepted the Biologics License Application (BLA) for a subcutaneous formulation of LEQEMBI® (generic name: lecanemab), an anti‑amyloid beta protofibril antibody for treating early Alzheimer’s disease. If approved, this new subcutaneous autoinjector (SC‑AI) — containing a 500 mg dose delivered as two 250 mg injections — could allow patients to receive once‑weekly at‑home injections starting from the initiation of treatment, offering a more convenient alternative to the current intravenous (IV) hospital‑based infusions. Each injection takes approximately 15 seconds, and the formulation could reduce healthcare resource use related to infusion preparation and monitoring, while simplifying the Alzheimer’s disease care pathway. Eisai estimates that about 17 million people in China were living with mild cognitive impairment or mild dementia due to Alzheimer’s in 2024, a number likely to grow with population aging. The SC formulation would expand treatment options for patients and care partners, potentially improving accessibility and convenience if regulatory approval is granted. #LEQEMBI #AlzheimersTreatment #Biogen #Eisai #SlimScan #GrowthStocks #CANSLIM