China’s National Medical Products Administration (NMPA) has granted approval for four-weekly intravenous (IV) maintenance dosing of Eisai and Biogen’s Leqembi (lecanemab) to treat early Alzheimer’s disease.
This follows the initial authorisation of the humanised anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody in January 2024 in the country for those with mild cognitive impairment or mild dementia, indicative of the early stages of Alzheimer’s.
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After undergoing an 18-month bi-weekly initiation phase with a 10 mg/kg dose, patients may now opt for a maintenance dose of the same amount administered once every four weeks or continue with the original regimen.
Eisai spearheads the global development and regulatory submissions for the antibody, in partnership with Biogen for joint commercialisation as well as promotion.
In China, Eisai manages the distribution and information provision activities through its medical representatives.
The development of Leqembi stems from a strategic partnership between Eisai and BioArctic, which has been in place since 2005.
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By GlobalDataEisai secured worldwide rights for its development and marketing for Alzheimer’s treatment in an agreement with BioArctic in December 2007.
A subsequent agreement was signed in May 2015 for the development and commercialisation of a backup antibody for lecanemab.
Lecanemab has secured approvals in 50 nations and is under review in 10 others.
The IV maintenance dosing schedule has been approved in countries including the US and China, with applications filed in five more regions.
The antibody’s approval in these jurisdictions is anchored in the Phase III data from Eisai’s Clarity Alzheimer’s study.
In August 2025, the US Food and Drug Administration (FDA) approved a biologics licence application (BLA) for subcutaneous maintenance dosing with Leqembi IQLIK.
A rolling supplemental BLA for subcutaneous initiation dosing was initiated in the same month.
In July 2025, Biogen announced plans to invest an additional $2bn in the Research Triangle Park in the US state of North Carolina.
