Health
BLA for subcutaneous formulation of Leqembi® accepted in China
BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the Biologics License Application (BLA) for the subcutaneous formulation (subcutaneous autoinjector: SC-AI) of Leqembi (lecanemab) for treatment of early Alzheimer's disease has been accepted by the National Medical Products Administration (NMPA) in China. If approved, lecanemab may become the first and only anti-amyloid treatment in China to offer an at-home injection from the initiation of treatment for this pr
About this update from Bioarctic Ab Class B
[{"type":"text","content":"STOCKHOLM, Jan. 6, 2026 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the Biologics License Application (BLA) for the subcutaneous formulation (subcutaneous autoinjector: SC-AI) of Leqembi (lecanemab) for treatment of early Alzheimer's disease has been accepted by the National Medical Products Administration (NMPA) in China. If approved, lecanemab may become the first and only anti-amyloid treatment in China to offer an at-home injection from the initiation of treatment for this progressive, relentless disease.","length":578,"tagName":"p"},{"type":"text","content":"If approved, the SC-AI of 500 mg could be used to administer a once-weekly dose at home from the initiation of treatment, as an alternative to the current IV administration every two weeks dose in the hospital setting. The injection time for each autoinjector (250mg injection) is approximately 15 seconds. The SC formulation also has the potential to reduce healthcare resources associated with IV dosing, such as preparation for infusion and nurse monitoring, while streamlining the overall AD treatment care pathway.","length":519,"tagName":"p"},{"type":"text","content":"Similar applications for initiation dosing with subcutaneous injection of lecanemab was recently submitted to the U.S. Food and Drug Administration (FDA) and to Japan's Pharmaceuticals and Medical Devices Agency (PMDA). Lecanemab has previously been approved for subcutaneous injection for maintenance dosing for the treatment of early Alzheimer's disease in the United States under the brand name Leqembi Iqlik™.","length":421,"tagName":"p"},{"type":"text","content":"Eisai estimates that there were 17 million patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease in China in 2024, which is expected to increase with the aging of the population.","length":218,"tagName":"p"},{"type":"text","content":"Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer's disease. Eisai is responsible for the clinical development, applications for market approval and commercialization of Leqembi for Alzheimer's disease. BioArctic h...