Eisai and Biogen received a priority review award from China’s National Medical Products Administration (NMPA) for the subcutaneous formulation of Leqembi (lecanemab). This application, accepted in January 2026, seeks approval for a weekly at-home autoinjector for patients with early Alzheimer’s disease. If authorized, the formulation would provide an alternative to the bi-weekly intravenous infusions currently administered in hospital settings. The subcutaneous dose consists of 500 mg delivered via two 15-second injections.
In China, the intravenous version of Leqembi was first approved in January 2024 and launched in the private market in June 2024. In September 2025, the NMPA approved a maintenance dosing schedule allowing for intravenous infusions every four weeks after an initial treatment phase. As of January 2026, Leqembi is included in China’s Commercial Insurance Innovative Drug List to facilitate patient access.
Outside of China, the subcutaneous autoinjector has reached different regulatory stages. The U.S. FDA approved the formulation for maintenance dosing in August 2025. In January 2026, the FDA granted priority review for its use as a starting dose, with a decision deadline set for May 24, 2026. In Japan, an application for the subcutaneous formulation was submitted in November 2025 and is currently under review.