Leqembi® approved for the treatment of Alzheimer disease in China

BioArctic AB's, partner Eisai announced today that Leqembi® (brand name in China: Willing to protect, generic name: lecanemab-irmb) has been approved in China as a treatment for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia. China is the third country to grant marketing approval, following the traditional approval in the United States in July 2023 and Japanese approval in September 2023. Eisai's preparations for the Chinese launch in the of the third quarter 2024 are underway.

Amyloid-beta (Aβ) is a protein that forms and breaks down naturally in the brain. In Alzheimer's disease, there is an imbalance between the production and elimination of Aβ, which then causes the protein to aggregate, first in smaller, soluble forms, oligomers and protofibrils, and eventually insoluble fibrils and plaques. These aggregates interfere with normal brain functions and cause gradual loss of nerve cells and memory. Leqembi selectively binds to soluble (protofibrils), as well as insoluble Aβ aggregates (fibrils), thereby reducing both Aβ protofibrils and Aβ plaques in the brain. Leqembi is the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism.

Leqembi's approval in China is based on the large global Phase 3 Clarity AD study. In the Clarity AD study, Leqembi met its primary endpoint and all key secondary endpoints with statistically significant results. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine, a peer-reviewed medical journal.

Eisai estimates that there are 17 million patients with MCI or mild dementia due to AD in China today, which is expected to increase with the aging of the population. Eisai will distribute the product in China and will conduct information provision activities through specialized Medical Representatives. Moving forward, Eisai will focus on AD awareness via omnichannel systems and collaborate with specialists to improve the diagnostic environment, including blood-based biomarkers. In addition, by utilizing online health platform for the elderly "Yin Fa Tong"[1], which is already being accessed by a certain number of users and helping provide treatments, Eisai is providing a one-stop service that promotes early consultation by referring patients to medical specialists and follow-up after treatment. Eisai will work to improve access environments including the development of insurance programs for AD in collaboration with insurance companies. Through these efforts, Eisai will accelerate the construction of a simple patient journey in China.

BioArctic has a long-term collaboration with Eisai regarding the development and commercialization for Leqembi. Eisai is responsible for the clinical development, applications for market approval and commercialization of the drug. BioArctic has no development costs for Leqembi in Alzheimer's disease and is entitled to payments in connection with certain regulatory approvals, and sales milestones as well as royalties on global sales. In addition, BioArctic has the right to commercialize lecanemab in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region.

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