Home Leqembi® (Lecanemab) Approved in China as the Third Global Market Following the U.S. and Japan for Early Alzheimer’s Disease Treatment

Leqembi® (Lecanemab) Approved in China as the Third Global Market Following the U.S. and Japan for Early Alzheimer’s Disease Treatment

Jun 28, 2024 12:01 CST Updated 12:01
Eisai

Pharmaceutical Product R&D and Manufacturer

Biogen

New Drug Developer

China follows the United States and Japan to become the third "willing to protect®"Listed Country

Eisai and Biogen Announce Humanized Anti-Soluble Aggregating Amyloid-β (Aβ) Monoclonal Antibody Leqembi®(Leqembi) Launched in China. The drug was approved by the China National Medical Products Administration in January 2024 for the treatment of mild cognitive impairment and mild dementia caused by Alzheimer's disease. China is the third country, following the United States and Japan, to launch Leqembi.

 

Lecanemab selectively binds to soluble Aβ aggregates (protofibrils*) and insoluble Aβ aggregates (fibrils), the main component of Aβ plaques in AD, thereby reducing Aβ protofibrils and Aβ plaques in the brain. Lecanemab is the first and only fully approved treatment that slows disease progression and reduces cognitive and brain function decline through this mechanism.

 

Eisai estimates that by 2024, there will be approximately 17 million patients in China with mild cognitive impairment and mild dementia caused by Alzheimer's disease, a figure expected to rise continuously with the aging population. Eisai will market the product in China and provide information services through professional medical representatives. Additionally, the company will focus on creating a unique, integrated online and offline pathway for the early diagnosis and treatment of Alzheimer’s disease. Collaborations will be established with commercial insurance companies, health examination centers, and elderly care institutions to widely promote disease awareness and pre-screening opportunities, encouraging high-risk groups to seek early consultation at specialized hospitals or be referred to "Silver Hair Connect," an online health platform co-developed with JD Health. The "Silver Hair Connect" platform offers a range of convenient services, including information on nearby hospitals and specialists, online medical consultations, and post-treatment follow-up services. Currently, "Silver Hair Connect" has about 300,000 registered users and 6,000 registered doctors, providing details on nearby hospitals and specialists, as well as online medical consultations and follow-up services after LEQEMBI treatment. Eisai is also committed to using blood biomarkers to provide scientific evidence for the definitive diagnosis of early-stage Alzheimer’s disease.

 

In China, lecanemab will first be sold in the self-pay market. Eisai will partner with a major health insurance company to develop and launch a specialized medical insurance plan for Alzheimer's disease, covering part of the medical expenses.

 

Through the above measures, Eisai is committed to promoting the early detection, early diagnosis, and early treatment of Alzheimer's disease in China, building an elderly dementia ecosystem, and supporting patients with early Alzheimer's disease to "enjoy the most fulfilling life."

 

Eisai Co., Ltd. leads the global development and registration application of lecanemab, while the product is co-commercialized and promoted by Eisai Co., Ltd. and Biogen Inc. Among them, Eisai Co., Ltd. has the final decision-making authority.

 

*Fibrils are considered the culprit behind brain damage in AD patients, containing the highest toxicity among Aβ, and playing a major role in the cognitive decline associated with this progressively debilitating disease.1。Fibrils cause damage to brain neurons, and then negatively affect cognitive function through various mechanisms. They not only increase the formation of insoluble β plaques but also enhance direct injury to connections that transmit signals between brain cell membranes and neurons or between neurons and other cells. Reducing fibrils can decrease damage to brain neurons and cognitive dysfunction, thereby halting the progression of Alzheimer's disease.2

 

**Silver Hair Pass is the online business of Enjoy Life Health Industry Development (Shanghai) Co., Ltd., a joint venture between Eisai China and JD Health.

 

Media Contact:

Public Relations Department of Eisai (China) Investment Co., Ltd.
TEL: +86 (0)21-24192888
PR@eisai.com.cn

 

 

References:

  1. Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi:10.1038/s41467-021-23507-z
  2. Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer’s Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706.