BioArctic AB's (publ) partner Eisai announced 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. 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. 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'sPharmaceuticals and Medical Devices Agency (PMDA).
Leqemab 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(TM). 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. 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 Lann felt 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. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) andinsoluble forms of amyloid-beta (Ab). Leqemab is approved in 52 countries and is under regulatory review in 8 countries.
Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks is approved in the United Kingdom, China, the U.S. and other countries, and applications have been filed in 4 countries and regions. In the U.S., Leqembi IqlIK(TM) is approved for subcutaneous dosing with an autoinjector for maintenance treatment of early Alzheimer's disease (AD). In November 2025, a rolling sBLA application to the U.S. FDA for the subcutaneous initiation dosing with Leqembi was also completed and a new drug application for subcutaneous formulation of Leqembi was submitted in Japan.
In December 2025, lecanemab has been included in the "Commercial Insurance Innovative Drug List", recently introduced by the National Healthcare Security Administration (NHSA) of China. Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical Alzheimer's disease meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024.
AHEAD 3-45 is a four-year study conducted as a public-private partnership between Eisai, Biogen and the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S., funded by the National Institute on Aging, part of the National Institutes of Health. Since January 2022, the National Institutes of Health.
