Can a New Antibody Therapy Slow Down Alzheimer's Disease Progression in China?

LEQEMBI®, a humanized monoclonal antibody called lenkanizumab, has received approval in China for the treatment of mild cognitive impairment (MCI) and mild dementia caused by Alzheimer's disease (AD). This groundbreaking therapy selectively binds to both soluble and insoluble forms of beta-amyloid (Aβ) polymers, effectively removing Aβ fibrils and plaques from the brain. It is the first approved treatment that can slow disease progression and reduce cognitive and functional decline in this manner. China is now the third country, following the United States and Japan, to approve lenkanizumab for Alzheimer's disease.

The approval in China was based on the results of the ClarityAD1 study, a large global phase III trial that included participants from China. The study demonstrated significant positive outcomes for lenkanizumab, meeting its primary and key secondary endpoints. The results were presented at the 2022 Clinical Trials in Alzheimer's Disease (CTAD) meeting and published in the prestigious New England Journal of Medicine.

According to reports, China has a significant population of individuals affected by Alzheimer's disease and mild cognitive impairment. In 2018, there were approximately 9.83 million people with Alzheimer's disease and 38.77 million with mild cognitive impairment among individuals aged 60 and above. It is projected that the number of people with Alzheimer's disease will reach 40 million by 2050.

The global development and regulatory submission of lenkanizumab were led by Eisai, in collaboration with Biogen for commercialization and marketing. Eisai will be responsible for selling the product in China and conducting information provision activities through healthcare professionals. In preparation for the product launch in the first half of fiscal year 2024, Eisai aims to raise awareness of early Alzheimer's disease and provide comprehensive disease management services through the online health platform "Yinfat Tong." These services will include early screening, online consultations, follow-up care, cognitive training, and more, aiming to improve the diagnosis and treatment process for Alzheimer's disease patients in China and create a more convenient patient journey.

In conclusion, the approval of lenkanizumab in China marks a significant advancement in the treatment of Alzheimer's disease. This antibody therapy offers the potential to slow down disease progression and reduce cognitive decline in individuals with mild cognitive impairment and mild dementia caused by Alzheimer's. With the anticipated increase in the number of affected individuals in China, lenkanizumab provides hope for improved management and care for Alzheimer's patients in the country.