BioArctic's Alzheimer's Drug Leqembi Approved in Subcutaneous Form in China

BioArctic AB (publ) announced on September 3, 2026, that its partner Eisai has received approval from China's National Medical Products Administration (NMPA) for the subcutaneous autoinjector formulation of Leqembi (Leqembi SC-AI). The approval is for initiation treatment in patients with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD dementia, collectively referred to as early AD.

The application was accepted by the NMPA in January 2026 and subsequently granted Priority Review designation. This designation aims to expedite the availability of the treatment in the Chinese market.

Leqembi (lekanemabi) is an antibody designed to remove amyloid beta plaques in the brain, which are associated with the progression of Alzheimer's disease. The subcutaneous formulation offers a more convenient and less invasive administration route for patients compared to the intravenous formulation.

Eisai plans to launch the drug in China during its fiscal year 2026. BioArctic AB is a Swedish biopharmaceutical company focused on treatments for central nervous system disorders, with Leqembi developed in partnership with Eisai.