Eisai Co., Ltd. announced that Eisai has initiated submission of data for Biologics License Application (BLA) to the National Medical Products Administration (NMPA) of China for lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Aß) protofibril antibody. The registration category of lecanemab was designated as a Category 1 drug (innovative biologics not approved in China or any other countries). The data submitted in this package includes data from the Phase II clinical trial (Study 201) in mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed Aß accumulation in the brain and the top-line data of the large global Phase III Clarity AD study.

Eisai will submit additional data including full data of the Clarity AD study, as directed by the NMPA. In the U.S., lecanemab was granted Breakthrough Therapy and Fast Track designations by the U.S. Food and Drug Administration (FDA) in June and December 2021, respectively. In July 2022, the FDA accepted Eisai's BLA for lecanemab under the accelerated approval pathway and granted it Priority Review.

The Prescription Drug User Fee Act (PDUFA) action date is January 6, 2023. Eisai aims to file for traditional approval in the U.S. and for marketing authorization applications in Japan and the Europe by the end of Eisai's FY2022, which ends March 31, 2023.