Leqembi® (lecanemab) debuts in China

BioArctic AB's partner Eisai has announced the launch of Leqembi® (lecanemab) in China. Approved in January 2024, Leqembi is designed to treat mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia. With China being the third country to introduce this treatment, after the United States and Japan, it marks a significant milestone in the fight against Alzheimer's.

Eisai's estimates indicate that in 2024, approximately 17 million individuals in China are suffering from early AD, either in the form of MCI or mild dementia. This number is expected to rise as the demographic ages. Eisai plans to support Leqembi's rollout by disseminating information through specialized Medical Representatives and establishing a novel diagnosis and treatment pathway for early AD that integrates online and offline services. Eisai is also focusing on collecting evidence to support the definitive diagnosis of early AD using blood biomarkers.

Initially, Leqembi will be available in China's private market at a price of CNY 2,508 for a 200 mg vial. Additionally, Eisai has collaborated with a major Chinese medical insurance company to develop and introduce a healthcare insurance plan specifically tailored for AD, which includes partial coverage for Leqembi. These initiatives are part of Eisai's commitment to advancing the early detection, diagnosis, and treatment of AD in China.

Leqembi operates by selectively binding to soluble amyloid-beta (Aβ) aggregates (protofibrils) and insoluble Aβ aggregates (fibrils), which are principal components of Aβ plaques in AD. This binding helps to reduce both Aβ protofibrils and Aβ plaques in the brain, mitigating the disease's progression and slowing cognitive and functional decline. Leqembi is the first and only approved treatment that demonstrates this ability.

The development of Leqembi stems from the collaboration between BioArctic and Eisai, based on Professor Lars Lannfelt's discovery of the Arctic mutation in Alzheimer's disease. While BioArctic initially developed the antibody, Eisai has taken responsibility for its clinical development, market approval applications, and commercialization. BioArctic bears no development costs for Leqembi in Alzheimer's disease, but it is entitled to payments linked to regulatory approvals, sales milestones, and a 9 percent royalty on global sales. BioArctic also has the commercialization rights for Leqembi in the Nordic region, pending European approval, and preparations for joint commercialization with Eisai are underway in that region.

Lecanemab, branded as Leqembi®, is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody targeting both soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). Approved in the U.S., Japan, China, and South Korea, it is prescribed for the treatment of MCI due to AD and mild AD dementia. The approval of lecanemab in these regions is based on the successful results from the global Phase 3 Clarity AD study, which met its primary and key secondary endpoints with statistically significant results.

Ongoing studies, such as Eisai's Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD and the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), continue to explore the potential of lecanemab. These studies are collaborative efforts involving multiple institutions and aim to further understand and combat Alzheimer's disease.

Since 2005, BioArctic and Eisai have collaborated on developing and commercializing treatments for Alzheimer's disease. Their partnership has resulted in significant advancements, with Eisai handling clinical development and market approval while BioArctic retains some regional commercialization rights.

BioArctic AB, a Swedish biopharma company, focuses on developing innovative treatments for neurodegenerative diseases. In addition to Leqembi, the company has a broad research portfolio that includes treatments for Parkinson's disease and ALS, utilizing its proprietary BrainTransporter™ technology to enhance treatment efficacy by improving antibody delivery across the blood-brain barrier. BioArctic's B share is listed on Nasdaq Stockholm Large Cap.