LEQEMBI® (Lecanemab) for Alzheimer's Disease Launched in China

Eisai Co., Ltd. and Biogen Inc. have announced the launch of LEQEMBI®, an anti-amyloid-beta monoclonal antibody, in China. This drug, known locally as “乐意保®” (lecanemab), received approval in January 2024 for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and early-stage AD dementia. Following the United States and Japan, China becomes the third country to introduce LEQEMBI.

LEQEMBI targets both soluble amyloid-beta protofibrils and insoluble fibrils, major components of amyloid plaques in the brain, thereby reducing these aggregates. It is the first and only treatment approved to slow the progression of the disease and cognitive decline through this mechanism. According to Eisai, China's aging population could result in 17 million people with MCI or early AD by the end of 2024.

Eisai will distribute LEQEMBI in China and provide information through specialized medical representatives. The company is also working on developing a pathway for early AD diagnosis and treatment that combines online and offline services. Collaborating with commercial health insurers, private health checkups, and nursing homes, Eisai aims to raise disease awareness and provide pre-screening opportunities. High-risk individuals will be encouraged to visit specialized hospitals or use "Yin Fa Tong," an online health platform for the elderly, developed jointly with JD Health. "Yin Fa Tong" currently hosts 300,000 registered users and 6,000 physicians, offering information on nearby hospitals, specialists, and online medical consultations.

To support the implementation of early AD diagnosis, Eisai is building evidence for definitive diagnostic methods using blood biomarkers. Initially, LEQEMBI will be available in China’s private market. In collaboration with a major Chinese medical insurance company, Eisai has developed a healthcare insurance plan that includes partial drug coverage for AD patients. These efforts are part of Eisai's commitment to promoting early detection, diagnosis, and treatment of AD in China, ultimately aiming to support individuals with early AD in living fulfilling lives.

Eisai leads LEQEMBI's development and regulatory submissions globally. Both Eisai and Biogen co-commercialize and co-promote the product, with Eisai retaining final decision-making authority. LEQEMBI represents a significant advancement in AD treatment, targeting protofibrils believed to cause brain injury and cognitive decline in AD patients. Reducing protofibrils may prevent further neuronal damage and cognitive dysfunction.

In China, LEQEMBI has been launched with a dosage of 10mg/kg infused intravenously over an hour, every two weeks. Lecanemab’s development stems from a partnership between Eisai and BioArctic. Approved in the U.S., Japan, China, and South Korea, LEQEMBI demonstrated efficacy in the Phase 3 Clarity AD clinical trial. The trial showed a 27% reduction in clinical decline on the Clinical Dementia Rating Sum of Boxes (CDR-SB) scale at 18 months compared to a placebo. Additionally, the drug showed a significant benefit in daily living activities, as measured by the AD Cooperative Study-Activities of Daily Living Scale for MCI.

Adverse events reported in the clinical trials included infusion reactions, cerebral microhemorrhages, edema, headaches, and falls. Eisai has also submitted applications for LEQEMBI approval in 14 other countries and regions, including the European Union. A supplemental Biologics License Application for an intravenous maintenance dose was accepted by the U.S. FDA in June 2024. 

Eisai and Biogen have been collaborating on AD treatments since 2014, with Eisai taking the lead on global development and regulatory activities. The collaboration aims to address high unmet medical needs, particularly in neurology and oncology, through innovative product development.

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