Eisai Co., Ltd. (EII.SG,ESALY.PK,4523.T) and Biogen Inc. (BIIB) announced that the National Medical Products Administration (NMPA) of China has granted priority review for the Biologics License Application (BLA) for the subcutaneous formulation of LEQEMBI for the Treatment of Early Alzheimer's Disease.
Eisai estimated that there were 17 million patients with mild cognitive impairment (MCI or mild dementia due to AD in China in 2024. This trend is anticipated to grow as the population ages.
If approved, the SC-AI of 500 mg (two 250 mg injections) 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 in a hospital setting, with an injection time of approximately 15 seconds.
Lecanemab is a humanised immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aß). It is a strategic alliance between Eisai and BioArctic.
Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007.
Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
Lecanemab has been approved in 53 countries and regions including Japan, the United States, China, Europe, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 6 countries.
The initial phase of treatment, every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in 7 countries, including the U.S., China, and the UK. And applications have been filed in 7 countries and regions.
Notably, the U.S. FDA had approved Eisai's Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025.
Following that, in January 2026, a Supplemental Biologics License Application (sBLA) for initiation of treatment was accepted, and a Prescription Drug User Fee Act (PDUFA) action date of May 24, 2026, was granted.
EII.SG closed Friday's trade at 23.91 Euros,1.73% down.
BIIB closed Friday's trade at$ 210.18, up 8.53%.In the overnight market, Biogen's shares are up 0.03% up at $201.24.
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