“LEQEMBI®” (Lecanemab) for the Treatment of Alzheimer’s Disease Launched in China

China is the Third Country to Launch LEQEMBI Following the United States and Japan

TOKYO and CAMBRIDGE, Mass., June 27, 2024 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (brand name in China: “乐意保®”, generic name: lecanemab) has been launched in China. LEQEMBI received approval in January 2024 as a treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia. China is the third country to launch LEQEMBI following the United States and Japan.

LEQEMBI selectively binds to soluble Aβ aggregates (protofibrils*), as well as insoluble Aβ aggregates (fibrils) which are a major component of Aβ plaques in AD, thereby reducing both Aβ protofibrils and Aβ plaques in the brain. LEQEMBI is the world’s first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism.

Eisai estimates there will be 17 million patients with MCI or mild dementia due to AD (collectively referred to as early AD) in China in 2024, which is expected to increase as the population ages.  Eisai is distributing the product in China and conducting information provision activities through specialized Medical Representatives, while also working to build a unique early AD diagnosis and treatment pathway that combines online and offline services. In collaboration with commercial health insurance companies, private health checkups, and nursing homes, Eisai will widely provide disease awareness and pre-screening opportunities and encourage high-risk individuals to visit specialized hospitals early or refer them to "Yin Fa Tong,"** an online health platform for the elderly that is focused on dementia, developed in a joint venture with JD Health. “Yin Fa Tong” currently has approximately 300,000 registered users and 6,000 registered physicians, and introduces information on nearby hospitals and specialists, as well as online medical consultations, and follow-up after LEQEMBI treatment. Eisai is also working to build evidence for the implementation of definitive diagnosis of early AD using blood biomarkers.

In China, LEQEMBI will first be launched in the private market. In collaboration with Eisai, a major Chinese medical insurance company has developed and launched a healthcare insurance plan specifically for AD including partial coverage of the drug cost. Through these efforts, Eisai is committed to promoting the early detection, diagnosis, and treatment of AD in China, building the dementia ecosystem, and supporting people with early AD to “live their fullest lives”.

Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. 

* Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of Aβ, having a primary role in the cognitive decline associated with this progressive, debilitating condition.1 Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.2

 Notes to Editors 

1.    “乐意保®”(LEQEMBI®) Product Outline

Chinese Trade name: “乐意保” (LEQEMBI)Chinese generic name: 仑卡奈单抗注射液 (lecanemab injection)Indication for use: Treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementiaDosage and administration: The usual dose of lecanemab (recombinant) is 10mg/kg infused intravenously over approximately 1 hour, once every 2 weeks.Active ingredients and strength: 200mg (2mL)/1 vialDrug price: Lecanemab injection 200mg 2,508 CNY per vial

2.   About lecanemab (LEQEMBI®)

Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).3 Lecanemab is approved in the U.S.,4 Japan,5 China,6 and South Korea.7 In the U.S., Japan, China and South Korea, the indications are as follows:

LEQEMBI’s FDA approval was based on Phase 3 data from Eisai’s, global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results.8 The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB). In the Clarity AD clinical trial, treatment with lecanemab reduced clinical decline on CDR-SB by 27% at 18 months compared to placebo.8 The mean CDR-SB score at baseline was approximately 3.2 in both groups. The adjusted least-squares mean change from baseline at 18 months was 1.21 with lecanemab and 1.66 with placebo (difference, −0.45; 95% confidence interval [CI], −0.67 to −0.23; P