Lecanemab (Leqembi®) Approved in China for Early Alzheimer's Disease Treatment

LEQEMBI® (Lecanemab, Chinese trade name: Lèyìbǎo®), a humanized anti-soluble β-amyloid (Aβ) monoclonal antibody, has been approved in China for the treatment of mild cognitive impairment and mild dementia caused by Alzheimer's disease.

Lecanemab can selectively bind to soluble Aβ polymers (protofibrils) as well as insoluble Aβ polymers (fibrils), the main component of Aβ plaques, thereby clearing Aβ protofibrils and Aβ plaques from the brain. This product is the first and currently the only fully approved therapy that can delay disease progression and reduce the rate of cognitive and functional decline through this mechanism of action. Following full approval in the United States in July 2023 and in Japan in September, China is the third country to approve the marketing of lecanemab.

Lecanemab has been approved in China based on the global large-scale Phase III study ClarityAD, which included China. In the ClarityAD study, lecanemab met the primary endpoint and all key secondary endpoints, with results that were statistically significant. The results of the ClarityAD study were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference and simultaneously published in the world-renowned peer-reviewed medical journal, The New England Journal of Medicine.

It was reported that, as of 2018, among the population aged 60 and above in China, there were 9.83 million patients with Alzheimer's disease and 38.77 million patients with mild cognitive impairment. It is estimated that by 2050, the number of Alzheimer's disease patients will increase to 40 million2,3,4.

Eisai Leads Global Development and Regulatory Submissions for Lecanemab, while the Product is Commercialized and Promoted Jointly by Eisai and Biogen, with Eisai Having Final Decision-Making Authority. Eisai will Market the Product in China and Conduct Information-Providing Activities through Specialized Medical Representatives (MR). In Preparation for the Launch of Lecanemab in the First Half of Fiscal Year 2024, Eisai will not only Raise Awareness about Early Alzheimer’s Disease but also Utilize the Online Health Platform "Silver Hair Connect" to Facilitate Collaboration with Experts, Providing Patients with Comprehensive Disease Management Services Including Early Screening, Online Consultations, Follow-Up Services, Cognitive Training, and More. This Effort Aims to Complete the Alzheimer’s Disease Diagnosis and Treatment Loop, Creating a Convenient Patient Journey in China.

References:
1.van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in Early Alzheimer's Disease. N Engl J Med. 2023;388(1):9-21. doi:10.1056/NEJMoa2212948
2.  Jia L, Du Y, Chu L, et al. Prevalence, risk factors, and management of dementia and mild cognitive impairment in adults aged 60 years or older in China: a cross-sectional study. Lancet Public Health. 2020;5(12):e661-e671.
3. Wang YQ, Jia RX, Liang JH, et al. Dementia in China (2015-2050) estimated using      the 1% population sampling survey in 2015. Geriatr Gerontol Int.      2019;19(11):1096-1100.
4. Chinese  Geriatrics Society [Internet]. Beijing: The Society; 2015-2023 [updated 21      Sep 2020; cited 11 Sep 2023]. CGS office. Available from: https://www.zglnyxxh.com/en/details/635209498205622272

Editor: Penicillin

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