Leqembi® approved for IV maintenance treatment in China
BioArctic AB (Nasdaq Stockholm: BIOA B) announced that its partner Eisai has received approval from China's NMPA for Leqembi's (lecanemab) IV maintenance treatment in early Alzheimer's disease. The new approval allows for a maintenance dosing regimen of 10 mg/kg once every four weeks after an 18-month initiation phase of bi-weekly dosing.
Leqembi, initially approved in China in January 2024, is notable as the only approved therapy targeting both amyloid plaque and protofibrils in Alzheimer's disease treatment. The drug was developed through a collaboration between BioArctic and Eisai, based on Professor Lars Lannfelt's research on the Arctic mutation in Alzheimer's disease.
BioArctic AB (Nasdaq Stockholm: BIOA B) ha annunciato che il suo partner Eisai ha ottenuto l'approvazione dall'NMPA cinese per il trattamento di mantenimento IV di Leqembi (lecanemab) nella fase iniziale di Alzheimer. La nuova approvazione prevede un regime di dosaggio di mantenimento di 10 mg/kg ogni quattro settimane dopo una fase di avvio di 18 mesi con dosi bisettimanali.
Leqembi, inizialmente approvato in Cina nel gennaio 2024, è noto come l'unica terapia approvata che prende di mira sia la placca amiloide che i protofibrilli nel trattamento della malattia di Alzheimer. Il farmaco è stato sviluppato attraverso una collaborazione tra BioArctic ed Eisai, sulla base della ricerca del professor Lars Lannfelt sulla mutazione Arctic nella malattia di Alzheimer.
BioArctic AB ( Nasdaq Stockholm: BIOA B ) anunció que su socio Eisai recibió la aprobación de la NMPA de China para el tratamiento de mantenimiento IV de Leqembi (lecanemab) en la enfermedad de Alzheimer en etapas tempranas. La nueva aprobación permite un esquema de dosificación de mantenimiento de 10 mg/kg cada cuatro semanas tras una fase de iniciación de 18 meses con dosificaciones quincenales.
Leqembi, aprobado inicialmente en China en enero de 2024, es notable por ser la única terapia aprobada que apunta tanto a la placa amiloide como a los protofibrilos en el tratamiento de la enfermedad de Alzheimer. El fármaco fue desarrollado mediante una colaboración entre BioArctic y Eisai, basada en la investigación del profesor Lars Lannfelt sobre la mutación Arctic en la enfermedad de Alzheimer.
BioArctic AB (Nasdaq Stockholm: BIOA B)는 파트너인 Eisai가 중국 NMPA로부터 초기 알츠하이머 병에서 Leqembi(레카네맙)의 IV 유지 치료에 대한 승인을 받았다고 발표했습니다. 새로운 승인은 18개월의 시작 기간 동안 주 2회 투여 후 4주마다 10 mg/kg의 유지 용량 요법을 허용합니다.
Leqembi는 2024년 1월 중국에서 처음 승인되었으며, 알츠하이머병 치료에서 아밀로이드 플라크와 프로토피브릴 모두를 표적으로 하는 유일한 승인 치료제로 주목됩니다. 이 약은 BioArctic과 Eisai의 협력을 통해 개발되었으며, 알츠하이머병의 Arctic 변이 연구에 기반한 Lars Lannfelt 교수의 연구에 기반합니다.
BioArctic AB (Nasdaq Stockholm: BIOA B) a annoncé que son partenaire Eisai a obtenu l'approbation de la NMPA chinoise pour le traitement d'entretien IV de Leqembi (lecanemab) dans la maladie d'Alzheimer à un stade précoce. La nouvelle approbation permet un régime de dosage d'entretien de 10 mg/kg toutes les quatre semaines après une phase d'initiation de 18 mois avec une administration bi-hebdomadaire.
Leqembi, initialement approuvé en Chine en janvier 2024, est notable en tant que unique thérapie approuvée ciblant à la fois les plaques amyloïdes et les protofibrilles dans le traitement de la maladie d'Alzheimer. Le médicament a été développé grâce à une collaboration entre BioArctic et Eisai, sur la base des recherches du professeur Lars Lannfelt sur la mutation Arctic dans la maladie d'Alzheimer.
BioArctic AB (Nasdaq Stockholm: BIOA B) gab bekannt, dass sein Partner Eisai von der chinesischen NMPA eine Zulassung für die IV-Erhaltungsbehandlung von Leqembi (Lecanemab) bei der frühen Alzheimer-Krankheit erhalten hat. Die neue Zulassung ermöglicht eine Erhaltungs-Dosierung von 10 mg/kg alle vier Wochen nach einer 18-monatigen Initiationsphase mit zweimal wöchentlicher Verabreichung.
Leqembi, das erstmals im Januar 2024 in China zugelassen wurde, ist bemerkenswert, weil es als einzige zugelassene Therapie sowohl auf Amyloid-Plaques als auch Protofibrillen abzielt in der Behandlung der Alzheimer-Krankheit. Das Medikament wurde durch eine Zusammenarbeit zwischen BioArctic und Eisai entwickelt, basierend auf Forschungen von Professor Lars Lannfelt zur Arctic-Mutation bei Alzheimer.
BioArctic AB (تداول في ناسدك ستوكهولم: BIOA B) أعلنت أن شريكها Eisai تلقّى موافقة من NMPA الصينية على علاج العناية المستمرة بالحقن الوريدي لـ Leqembi (lecanemab) في مرض الزهايمر في مراحله المبكرة. تسمح الموافقة الجديدة بنظام جرعات صيانة قدره 10 mg/kg كل أربعة أسابيع بعد مرحلة بدء تستمر 18 شهراً بجلسات جرعات كل أسبوعين.
Leqembi، الذي تمت الموافقة عليه في الصين مبدئياً في يناير 2024، يُعتبر العلاج الوحيد المعتمد الذي يهدف إلى كلاً من لويحات الأميلويد والبروتو-فبرلز في علاج مرض الزهايمر. تم تطوير الدواء من خلال تعاون بين BioArctic و Eisai، استناداً إلى بحث الأستاذ لارس لاننفلدت حول طفرة Arctic في مرض الزهايمر.
BioArctic AB（纳斯达克斯德哥尔摩：BIOA B）宣布其合作伙伴 Eisai 已获得中国药监局（NMPA）就早期阿尔茨海默病的 Leqembi（lecanemab）静脉维持治疗 的批准。新的批准允许在为期18个月的双周给药启动阶段后，实行 每四周一次、每次剂量10 mg/kg 的维持给药方案。
Leqembi 于2024年1月在中国首次获批，该药被认为是 唯一获批的既靶向淀粉样斑块又靶向前体纤维体的治疗药物，用于阿尔茨海默病治疗。该药物是 BioArctic 与 Eisai 通过合作开发，基于 Lannfelt 教授关于阿尔茨海默病 Arctic 突变的研究。
- Approval for maintenance dosing provides more flexible treatment options for patients
- Leqembi is uniquely positioned as the only therapy targeting both amyloid plaque and protofibrils
- Expanded market presence in China, a significant market for Alzheimer's treatment
- BioArctic maintains commercialization rights in Nordic region with Eisai
- Extended 18-month initiation phase required before maintenance dosing
- Treatment still requires regular hospital visits for IV administration
Insights
Leqembi's approval for maintenance dosing in China expands its market potential while offering Alzheimer's patients a less frequent treatment option.
The approval of Leqembi for a maintenance dosing regimen in China represents a significant advancement for BioArctic and Eisai's Alzheimer's treatment strategy. After the initial 18-month biweekly dosing phase, patients can now transition to a once-monthly maintenance regimen, potentially improving treatment adherence while maintaining efficacy.
This regulatory milestone builds upon Leqembi's initial January 2024 approval in China for early Alzheimer's disease patients. The less frequent dosing schedule addresses a critical challenge in chronic disease management - reducing treatment burden while maintaining therapeutic benefit.
What makes this particularly notable is Leqembi's dual-action mechanism targeting both amyloid plaque and protofibrils, which can affect tau downstream - a comprehensive approach to addressing Alzheimer's complex pathology. The maintenance dosing approval optimizes this therapeutic approach by balancing efficacy with patient convenience.
For BioArctic, this approval strengthens its collaborative relationship with Eisai while expanding Leqembi's commercial potential in the world's largest population. The Nordic commercialization rights further diversify BioArctic's revenue opportunities beyond royalties from their partnership with Eisai.
In January 2024, lecanemab 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
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.[i],[ii],[iii],[iv] The data show that Aβ protofibrils[1] and tau tangles play roles in the neurodegeneration process,i,ii and Leqembi is the only approved therapy that fights AD in two ways – targeting both amyloid plaque and protofibrils, which can impact tau downstream.
Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer's disease. Eisai is responsible for the clinical development, applications for market approval and commercialization of Leqembi for Alzheimer's disease. BioArctic has the right to commercialize Leqembi in the Nordic region together with Eisai and the two companies are preparing for a joint commercialization in the region.
This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact person below, on September 29, 2025, at 08:15 a.m. CET.
For further information, please contact:
Oskar Bosson, Vice President Communications and Investor Relations
E-mail: oskar.bosson@bioarctic.com
Telephone: +46 70 410 71 80
About lecanemab (Leqembi®)
Lecanemab is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).
Lecanemab is approved in 50 countries including the
Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical Alzheimer's disease, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between Eisai, Biogen and the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in Alzheimer's disease and related dementias in the
About the collaboration between BioArctic and Eisai
Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease. The most important agreements are the Development and Commercialization Agreement for the lecanemab antibody, which was signed 2007, and the Development and Commercialization agreement for the antibody Leqembi back-up for Alzheimer's disease, which was signed 2015. In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease. BioArctic has the right to commercialize lecanemab in the Nordic region and is currently preparing for commercialization in the Nordics together with Eisai. BioArctic has no development costs for lecanemab in Alzheimer's disease and is entitled to payments in connection with sales milestones as well as royalties on global sales.
About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with BioArctic's partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional projects against Alzheimer's disease. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, please visit www.bioarctic.com.
[1] 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. 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.
[i] 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
[ii] Hampel H, Hardy J, Blennow K, et al. The amyloid pathway in Alzheimer's disease. Mol Psychiatry. 2021;26(10):5481-5503.
[iii] 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
[iv] 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.
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