Japan – “LEQEMBI(R)” (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease Approved in China

“LEQEMBI(R)” (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease Approved in China

TOKYO and CAMBRIDGE, Mass., Sept. 29, 2025 – (JCN Newswire) – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate head office: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) revealed today that humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI ®” (generic name: lecanemab) has actually been authorized for when every 4 weeks intravenous (IV) upkeep dosing by the National Medical Products Administration (NMPA) in China.

In January 2024, LEQEMBI was authorized for the treatment of Alzheimer’s illness (ADVERTISEMENT) in clients with moderate cognitive problems (MCI) or moderate dementia phase of illness (jointly described as early advertisement) in China. After 18 months of a dosing program of 10 mg/kg when every 2 weeks throughout initiation stage, a shift to the upkeep dosing program of 10 mg/kg when every 4 weeks might be thought about or the program of 10 mg/kg when every 2 weeks might be continued.

Advertisement is a progressive, ruthless illness defined by development of protein deposits referred to as plaques made from amyloid-beta aggregates and neurofibrillary tangles made from tau protein in the brains of individuals dealing with advertisement. It is triggered by a constant underlying neurotoxic procedure that starts before amyloid plaque build-up and continues after plaque elimination.1,2,3,4 The information reveal that Aβ protofibrils * and tau tangles play functions in the neurodegeneration procedure,2,3 and LEQEMBI is the only accepted treatment that combats advertisement in 2 methods– targeting both amyloid plaque and protofibrils, which can affect tau downstream.

Eisai approximates that, since 2024, there were 17 million clients with MCI or moderate dementia due to advertisement in China in 2024, which is anticipated to increase with the aging of the population.

Eisai works as the lead for lecanemab’s advancement and regulative submissions worldwide with Eisai and Biogen co-commercializing and co-promoting the item and Eisai having last decision-making authority. In China, Eisai disperses the item and performs info arrangement activities through specialized Medical Representatives.

* Protofibrils are thought to add to the brain injury that accompanies advertisement and are thought about to be the most poisonous type of Aβ, having a main function in the cognitive decrease related to this progressive, incapacitating condition.1 Protofibrils trigger injury to nerve cells in the brain, which in turn, can adversely affect cognitive function by means of numerous systems, not just increasing the advancement of insoluble Aβ plaques however likewise increasing direct damage to brain cell membranes and the connections that send signals in between afferent neuron or afferent neuron and other cells. It is thought the decrease of protofibrils might avoid the development of advertisement by minimizing damage to nerve cells in the brain and cognitive dysfunction.4

MEDIA CONTACTS

About LEQEMBI (generic name: lecanemab)

Lecanemab is the outcome of a tactical research study alliance in between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed versus aggregated soluble (protofibril) and insoluble kinds of amyloid-beta (Aβ). Protofibrils are thought to add to the brain injury that accompanies advertisement and are thought about to be the most hazardous type of Aβ, having aprimary function in the cognitive decrease connected with this progressive, devastating condition.

Lecanemab has actually been authorized in 50 nations and is under regulative evaluation in 10 nations. Following the preliminary stage with treatment every 2 weeks for 18 months, intravenous (IV) upkeep dosing with treatment every 4 weeks was authorized in China, the U.S. and others, and applications have actually been submitted in 5 nations and areas.

LEQEMBI’s approvals in these nations were based upon Phase 3 information from Eisai’s, international Clarity advertisement medical trial, in which it satisfied its main endpoint and all crucial secondary endpoints with statistically substantial outcomes. The main endpoint was the worldwide cognitive and practical scale, Clinical Dementia Rating Sum of Boxes (CDR-SB).1,5 The U.S. FDA authorized Eisai’s Biologics License Application (BLA) for subcutaneous upkeep dosing with LEQEMBI IQLIK in August 2025. In September 2025, the rolling sBLA application to the U.S. FDA for the subcutaneous initiation dosing with LEQEMBI IQLIK was likewise started.

Given that July 2020 the Phase 3 medical research study (AHEAD 3-45) for people with preclinical advertisement, indicating they are scientifically regular and have intermediate or raised levels of amyloid in their brains, is continuous. AHEAD 3-45 is performed as a public-private collaboration in between the Alzheimer’s Clinical Trial Consortium that supplies the facilities for scholastic scientific trials in advertisement and associated dementias in the U.S, moneyed by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Considering that January 2022, the Tau NexGen scientific research study for Dominantly Inherited Advertisement (DIAD), that is carried out by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is continuous and consists of lecanemab as the foundation anti-amyloid treatment.

About the Collaboration in between Eisai and Biogen for advertisement

Eisai and Biogen have actually been working together on the joint advancement and commercialization of advertisement treatments because 2014. Eisai functions as the lead of lecanemab advancement and regulative submissions worldwide with Eisai and Biogen co-commercializing and co-promoting the item and Eisai having last decision-making authority.

About the Collaboration in between Eisai and BioArctic for advertisement

Because 2005, Eisai and BioArctic have actually had a long-lasting cooperation relating to the advancement and commercialization of advertisement treatments. Eisai got the international rights to study, establish, make and market lecanemab for the treatment of advertisement pursuant to a contract with BioArctic in December 2007. The advancement and commercialization arrangement on the antibody lecanemab back-up was checked in May 2015.

About Eisai Co., Ltd.

Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept (likewise called human healthcare (hhc) Concept), we intend to efficiently accomplish social excellent in the type of easing stress and anxiety over health and minimizing health variations. With a worldwide network of R&D centers, making websites and marketing subsidiaries, we make every effort to produce and provide ingenious items to target illness with high unmet medical requirements, with a specific focus in our tactical locations of Neurology and Oncology.

In addition, we show our dedication to the removal of overlooked tropical illness(NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by dealing with different activities together with worldwide partners.

To find out more about Eisai, please go to www.eisai.com (for international head office: Eisai. Co., Ltd.), us.eisai.com (for U.S. head office: Eisai, Inc.) or www.eisai.eu (for Europe, Middle East, Africa, Russia, Australia and New Zealand head office: Eisai Europe Ltd.), and get in touch with us on X (worldwide and U.S), LinkedIn (for international, U.S. and EMEA) and Facebook (international).

About Biogen

Established in 1978, Biogen is a leading biotechnology business that leaders ingenious science to provide brand-new medications to change clients’ lives and to produce worth for investors and our neighborhoods. We use deep understanding of human biology and utilize various techniques to advance first-in-class treatments or treatments that provide exceptional results. Our method is to take vibrant dangers, stabilized with roi to provide long-lasting development.

To learn more, go to: https://www.eisai.com/news/2025/pdf/enews202567pdf.pdf