Leqembi gains approval for Alzheimer’s treatment in Hong Kong

CHINA—Swedish research-based biopharma company BioArctic’s partner Eisai has received approval from Hong Kong’s Department of Health for Leqembi, a drug used to treat Alzheimer’s disease (AD).

 This approval marks Leqembi’s fifth, following those in the United States, China, Japan, and South Korea.

Leqembi, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody, was developed by BioArctic and Eisai as part of a strategic research alliance.

It is intended for patients with mild cognitive impairment or at the mild dementia stage of Alzheimer’s disease, which is the population targeted in clinical trials.

The approval is grounded in the Phase III Clarity AD study results, which demonstrated that the drug met its primary endpoint and all key secondary endpoints with statistically significant outcomes.

Leqembi reduces amyloid-beta aggregates in the brain by selectively binding to both soluble and insoluble amyloid-beta aggregates, which are believed to play a crucial role in the development of AD.

This mechanism is significant as it makes Leqembi the first treatment proven to slow the progression of the disease and the decline in cognitive and functional abilities.

Eisai will be responsible for the clinical development, market approval applications, and commercialization of Lecanemab for Alzheimer’s disease.

Eisai will be in charge of the global development and approval processes for lecanemab, and it will distribute Leqembi in Hong Kong to ensure that this innovative medication reaches needy individuals.

Both Eisai and BioArctic co-commercialize and co-promote the product, with Eisai holding the final decision-making authority.

As part of their agreement, BioArctic will receive payments linked to regulatory approvals and sales milestones and a 9% royalty on global sales.

Additionally, BioArctic retains the right to commercialize Leqembi in the Nordic region, subject to European approval. The company is currently preparing for joint commercialization with Eisai in this region.

The prevalence of Alzheimer’s disease in Hong Kong highlights the significance of this approval since 9.3% of persons aged 70 and older had dementia, with the prevalence increasing to 32% among those aged 85 and older.

Among people with dementia, 73.5% had Alzheimer’s disease, highlighting the region’s critical need for effective therapies such as Leqembi.

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