“LEQEMBI®” (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease Approved in China
Biogen (NASDAQ:BIIB) and Eisai announced that their Alzheimer's treatment LEQEMBI® (lecanemab) has received approval in China for once-every-four-weeks intravenous maintenance dosing. This approval follows the initial January 2024 authorization for treating early Alzheimer's disease patients with mild cognitive impairment or mild dementia.
The maintenance dosing allows patients to transition from the initial bi-weekly 10 mg/kg dosing to a more convenient monthly schedule after 18 months of treatment. LEQEMBI is notable as the only approved therapy targeting both amyloid plaque and protofibrils, which can impact tau downstream. The market potential is significant, with an estimated 17 million patients with early-stage Alzheimer's in China as of 2024.
Biogen (NASDAQ:BIIB) ed Eisai hanno annunciato che il loro trattamento per l'Alzheimer LEQEMBI (lecanemab) ha ottenuto l'autorizzazione in Cina per la somministrazione di mantenimento endovenosa ogni quattro settimane. L'approvazione segue l'autorizzazione iniziale di gennaio 2024 per trattare pazienti con Alzheimer in fase iniziale con compromissione cognitiva lieve o demenza lieve. La dose di mantenimento consente ai pazienti di passare dalla dose iniziale ogni due settimane di 10 mg/kg a un regime mensile più comodo dopo 18 mesi di trattamento. LEQEMBI è notevole in quanto l'unico trattamento approvato che mira sia alle placche amiloidi sia ai protofibrilli, che possono influire sul tau a valle. Il potenziale di mercato è significativo, con un numero stimato di 17 milioni di pazienti con Alzheimer nelle fasi iniziali in Cina nel 2024.
Biogen (NASDAQ:BIIB) y Eisai anunciaron que su tratamiento para el Alzheimer LEQEMBI (lecanemab) ha recibido aprobación en China para la dosificación de mantenimiento intravenosa cada cuatro semanas. Esta aprobación sigue a la autorización inicial de enero de 2024 para tratar a pacientes con Alzheimer en etapas tempranas con deterioro cognitivo leve o demencia leve. La dosificación de mantenimiento permite a los pacientes pasar de la dosis quincenal inicial de 10 mg/kg a un calendario mensual más cómodo después de 18 meses de tratamiento. LEQEMBI destaca como la única terapia aprobada que apunta tanto a la placa amiloidea como a los protofibrilos, lo cual puede afectar al tau downstream. El potencial de mercado es significativo, con un estimado de 17 millones de pacientes con Alzheimer en etapas tempranas en China en 2024.
Biogen (NASDAQ:BIIB) 및 에이자는 알츠하이머 치료제 LEQEMBI(레카넴암)가 중국에서 4주마다 정맥 유지 투여로 승인되었다고 발표했습니다. 이 승인은 2024년 1월 초기에 경도인지장애 또는 경도치매를 동반한 초기에 알츠하이머 질환 환자 치료를 위한 초기 허가에 이어 나온 것입니다. 유지 요법은 18개월 치료 후 초기 2주마다 10 mg/kg 용량에서 더 편리한 월간 일정으로 전환할 수 있게 합니다. LEQEMBI는 아밀로이드 플라그와 프로토피브릴을 모두 표적으로 하는 유일한 승인을 받은 치료제로 주목되며, 아래에 tau에 영향을 미칠 수 있습니다. 중국의 2024년 기준 초기 단계 알츠하이머 환자 수는 약 1700만 명으로 시장 잠재력이 큽니다.
Biogen (NASDAQ:BIIB) et Eisai ont annoncé que leur traitement de l'Alzheimer LEQEMBI® (lecanemab) a obtenu l'approbation en Chine pour une posologie d'entretien administrée par voie intraveineuse tous les quatre semaines. Cette approbation fait suite à l'autorisation initiale de janvier 2024 pour traiter des patients atteints d'un Alzheimer à un stade précoce avec une démence légère ou un déclin cognitif léger. La posologie d'entretien permet aux patients de passer de la dose initiale toutes les deux semaines de 10 mg/kg à un calendrier mensuel plus pratique après 18 mois de traitement. LEQEMBI se distingue comme la seule thérapie approuvée ciblant à la fois les plaques amyloïdes et les protofibrilles, ce qui peut influencer Tau en aval. Le potentiel de marché est significatif, avec environ 17 millions de patients atteints d'Alzheimer à un stade précoce en Chine en 2024.
Biogen (NASDAQ:BIIB) und Eisai gaben bekannt, dass ihr Alzheimer-Behandlung LEQEMBI® (Lecanemab) in China eine Zulassung für eine vierteljährliche intravenöse Erhaltungstherapie erhalten hat. Diese Zulassung folgt der ersten Genehmigung im Januar 2024 zur Behandlung von Patienten mit frühzeitigem Alzheimer-Symptomen und leichter kognitiver Beeinträchtigung oder leichter Demenz. Die Erhaltungstherapie ermöglicht es Patienten, nach 18 Monaten Behandlung von der anfänglichen zweiwöchentlichen Dosis von 10 mg/kg zu einem bequemeren monatlichen Zeitplan zu wechseln. LEQEMBI ist bemerkenswert als die einzige zugelassene Therapie, die sowohl auf Amyloid-Plaques als auch auf Protofibrillen abzielt, was sich auf Tau downstream auswirken kann. Das Marktpotenzial ist beträchtlich, mit geschätzten 17 Millionen Patienten mit Alzheimer in der Frühphase in China im Jahr 2024.
أعلنت Biogen (ناسداك: BIIB) وإيساي أن علاجهما لمرض الزهايمر LEQEMBI® (lecanemab) قد حصل على موافقة في الصين لاستخدام صيانة وريدي كل أربعة أسابيع. تأتي هذه الموافقة تلبيةً للترخيص الأول في يناير 2024 لعلاج المرضى في مرحلة مبكرة من الزهايمر مع تدهور معرفي خفيف أو خرف خفيف. تسمح جرعة الصيانة للمرضى بالانتقال من الجرعة الأولية كل أسبوعين بواقع 10 ملغ/كغ إلى جدول شهري أكثر ملاءمة بعد 18 شهراً من العلاج. LEQEMBI هو العلاج الوحيد المعتمد الذي يستهدف كل من اللُدْم الأميلويدي والبروتو فبريل، وهو ما قد يؤثر على Tau لاحقاً. الإمكانات السوقية كبيرة، مع تقدير وجود 17 مليون مريض بمرض الزهايمر في مراحله المبكرة في الصين حتى عام 2024.
Biogen（纳斯达克股票代码：BIIB）与 Eisai 宣布，他们的阿尔茨海默病治疗药物 LEQEMBI®（lecanemab）已获中国批准进行每四周一次的静脉维持用药。这一批准是在2024年1月初步授权用于治疗早期阿尔茨海默病、伴轻度认知障碍或轻度痴呆的患者之后。维持用药使患者在18个月治疗后可从初始的两周一次、每次10 mg/kg的剂量，转为更方便的月度方案。LEQEMBI 之所以引人注目，是因为它是< b>唯一获批的同时靶向淀粉样斑块和原纤维体的治疗药物，这可能对下游 Tau 产生影响。市场潜力巨大，2024年中国早期阿尔茨海默病患者约为< b>1700万人。
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Insights
LEQEMBI's approved maintenance dosing in China enhances Biogen's commercial prospects in a massive 17M patient market with improved administration convenience.
The approval of LEQEMBI's less frequent maintenance dosing regimen in China represents a meaningful commercial advancement for Biogen and Eisai. After initially receiving approval in January 2024 for early Alzheimer's disease treatment in China, patients can now transition to once-monthly dosing after 18 months of biweekly treatment, significantly improving the administration burden while maintaining therapeutic effect.
This dosing flexibility addresses a critical adherence challenge for chronic neurological treatments, particularly important in Alzheimer's where consistent therapy is essential for efficacy. The once-every-four-weeks maintenance option should improve the real-world utility of LEQEMBI, potentially expanding its adoption in clinical practice.
China represents an enormous market opportunity with an estimated 17 million patients with early Alzheimer's disease. The aging demographics in China suggest this patient population will continue growing substantially. LEQEMBI's dual mechanism targeting both amyloid plaques and protofibrils - which Eisai identifies as particularly toxic contributors to neurodegeneration - differentiates it from other treatments.
The partnership structure between Eisai and Biogen appears well-defined, with Eisai leading development and maintaining final decision authority while both companies share commercialization responsibilities. In China specifically, Eisai handles distribution and educational outreach through specialized representatives, leveraging their expertise while Biogen benefits from the commercial arrangement.
TOKYO and CAMBRIDGE, Mass., Sept. 28, 2025 (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 humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (brand name in China: “乐意保®”, generic name: lecanemab) has been approved for once every four weeks intravenous (IV) maintenance dosing by the National Medical Products Administration (NMPA) in China.
In January 2024, LEQEMBI was approved for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD) in China. After 18 months of a dosing regimen of 10 mg/kg once every two weeks during initiation phase, a transition to the maintenance dosing regimen of 10 mg/kg once every four weeks may be considered or the regimen of 10 mg/kg once every two weeks may be continued.
AD is a progressive, relentless disease characterized by formation of protein deposits known as plaques made of amyloid-beta aggregates and neurofibrillary tangles made of tau protein in the brains of people living with AD. It is caused by a continuous underlying neurotoxic process that begins before amyloid plaque accumulation and continues after plaque removal.1,2,3,4 The data show that Aβ protofibrils* and tau tangles play roles in the neurodegeneration process,2,3 and LEQEMBI is the only approved therapy that fights AD in two ways — targeting both amyloid plaque and protofibrils, which can impact tau downstream.
Eisai estimates that, as of 2024, there were 17 million patients with MCI or mild dementia due to AD in China in 2024, which is expected to increase with the aging of the population.
Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. In China, Eisai distributes the product and conducts information provision activities through specialized Medical Representatives.
| * | 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.4 |
| MEDIA CONTACTS | |
| Eisai Co., Ltd. Public Relations Department +81 (0)3-3817-5120 Eisai Europe, Ltd. (UK, Europe, Australia, New Zealand and Russia) EMEA Communications Department +44 (0) 7739 600678 EMEA-comms@eisai.net Eisai Inc. (U.S.) Libby Holman + 1-201-753-1945 Libby_Holman@eisai.com | Biogen Inc. Madeleine Shin + 1-781-464-3260 public.affairs@biogen.com |
| INVESTOR CONTACTS | |
| Eisai Co., Ltd. Investor Relations Department +81 (0) 3-3817-5122 | Biogen Inc. Tim Power + 1-781-464-2442 IR@biogen.com |
| Notes to Editors | |
| 1. | About LEQEMBI (generic name: lecanemab, Chinese brand name: 乐意保) Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). 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.Lecanemab has been approved in 50 countries and is under regulatory review in 10 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in China, the U.S. and others, and applications have been filed in 5 countries and regions. LEQEMBI's approvals in these countries were 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. The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB).1,5 The U.S. FDA approved Eisai’s Biologics License Application (BLA) for subcutaneous maintenance 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 also initiated. Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy. |
| 2. | About the Collaboration between Eisai and Biogen for AD Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. |
| 3. | About the Collaboration between Eisai and BioArctic for AD Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015. |
| 4. | 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 (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners. For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai. Co., Ltd.), us.eisai.com (for U.S. headquarters: Eisai, Inc.) or www.eisai.eu (for Europe, Middle East, Africa, Russia, Australia and New Zealand headquarters: Eisai Europe Ltd.), and connect with us on X (global and U.S), LinkedIn (for global, U.S. and EMEA) and Facebook (global). |
| 5. | About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube. |
| Biogen Safe Harbor This news release contains forward-looking statements, including about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab (marketed as 乐意保 in China); potential regulatory discussions, submissions and approvals and the timing thereof; the causes and treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "possible," "potential," "will," "would" and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.These forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to differ materially from those stated or implied in this document, including, among others, uncertainty of our long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans, prospects and timing of actions relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other markets in which we compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; our ability to effectively implement our corporate strategy; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; the drivers for growing our business, including our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks related to commercialization of biosimilars, which is subject to such risks related to our reliance on third-parties, intellectual property, competitive and market challenges and regulatory compliance; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; and the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC’s website at www.sec.gov. These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise. | |
References
- Eisai presents full results of lecanemab Phase 3 confirmatory Clarity AD study for early Alzheimer's disease at Clinical Trials on Alzheimer's Disease (CTAD) conference. Available at: https://www.eisai.co.jp/news/2022/news202285.html
- Hampel H, Hardy J, Blennow K, et al. The amyloid pathway in Alzheimer's disease. Mol Psychiatry. 2021;26(10):5481-5503.
- 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
- 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.
- van Dyck. C, et al. Lecanemab in Early Alzheimer’s Disease. The New England Journal of Medicine. DOI: 10.1056/NEJMoa2212948. https://www.nejm.org/doi/full/10.1056/NEJMoa2212948
FAQ
What is the new LEQEMBI dosing schedule approved in China for Alzheimer's treatment?
How many potential early-stage Alzheimer's patients could benefit from LEQEMBI in China?
What makes LEQEMBI unique in treating Alzheimer's disease?
Who handles LEQEMBI's distribution and marketing in China?
When was LEQEMBI first approved in China for early Alzheimer's treatment?
