China’s National Medical Products Administration (NMPA) Grants Priority Review To Eisai And Biogen’s Subcutaneous LEQEMBI For Alzheimer’s Disease

Eisai and Biogen announced that China’s National Medical Products Administration (NMPA) has granted Priority Review to the Biologics License Application for the subcutaneous autoinjector (SC-AI) version of LEQEMBI®, following acceptance of the filing in January 2026. The Priority Review pathway is intended to speed the assessment of medicines with meaningful clinical value, potentially shortening regulatory timelines in the country.

If approved, the 500 mg weekly subcutaneous dose, delivered as two quick 250 mg injections, could be administered at home from the start of therapy, replacing the current biweekly intravenous infusions given in hospital settings. Each injection takes about 15 seconds, and the at-home option could reduce the need for infusion preparation, nursing supervision and other healthcare resources, helping simplify Alzheimer’s disease care for patients and caregivers.

Eisai estimates that around 17 million people in China were living with mild cognitive impairment or mild dementia due to Alzheimer’s disease in 2024, a figure expected to rise as the population ages. LEQEMBI has been available in China’s private market since mid-2024 and was recently added to the new Commercial Insurance Innovative Drug List, which took effect in January 2026 and encourages insurers to develop coverage for novel therapies.

Eisai leads global development and regulatory submissions for LEQEMBI, while Eisai and Biogen jointly commercialise and promote the medicine. In China, Eisai will handle distribution and medical information activities through specialised representatives, reflecting the company’s coordinated approach to expanding access to the treatment.