Swedish biopharma company BioArctic said its partner Eisai has filed a subcutaneous version of Leqembi in China. The application was accepted by China’s National Medical Products Administration.
BioArctic said the submission covers an autoinjector for lecanemab to treat early Alzheimer’s disease. If approved, it could allow once-weekly at-home injections from the start of treatment.
The company said the autoinjector dose is 500 mg weekly as an alternative to hospital IV dosing every two weeks. It said each 250 mg injection takes about 15 seconds.
Leqembi, also known as lecanemab, is a monoclonal antibody treatment designed to target amyloid-beta in the brain. BioArctic and Eisai said it is intended for people with early Alzheimer’s disease, including mild cognitive impairment or mild dementia due to Alzheimer’s.
BioArctic said similar submissions for subcutaneous initiation dosing were recently made in the United States and Japan. In the United States, Leqembi Iqlik is already approved for maintenance dosing by autoinjector.
Eisai estimates China had about 17 million people with mild cognitive impairment or mild dementia due to Alzheimer’s in 2024. BioArctic said it holds Nordic commercialisation rights and is preparing joint launch plans with Eisai.
