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01 Oct 2025
Admin
News Article

BioArctic and Eisai: China Approves Monthly Maintenance Dosing of Leqembi for Early Alzheimer’s Disease

BioArctic AB’s partner Eisai announced that China’s National Medical Products Administration (NMPA) has approved lecanemab (Leqembi) for once-every-four-weeks intravenous (IV) maintenance dosing in patients with early Alzheimer’s disease (AD).

Background on Approval

January 2024: Lecanemab received approval in China for patients with mild cognitive impairment (MCI) or mild dementia (collectively early AD).
Treatment path: Following an initial 18 months of 10 mg/kg IV every two weeks, patients may transition to 10 mg/kg IV every four weeks, or continue biweekly dosing.

Why It Matters

AD is a progressive neurodegenerative condition marked by amyloid-beta plaques and tau tangles. Lecanemab is unique because it targets both amyloid plaque and protofibrils, which can influence tau downstream—making it the only approved therapy with this dual mechanism.

Development History

Origins: Based on discoveries by Professor Lars Lannfelt, including the Arctic mutation in AD.
Collaboration: BioArctic developed the antibody; Eisai is responsible for clinical development, regulatory filings, and commercialization.
Commercial rights: BioArctic will co-commercialize in the Nordic region with Eisai.

Clinical & Regulatory Status

Approved in 50 countries (US, Japan, China, EU among them).
Leqembi Iqlik (subcutaneous version): Approved in the US for maintenance dosing.
Maintenance dosing (IV every 4 weeks): Approved in China, US, and others. Applications filed in 5 additional countries/regions.
Ongoing studies:
- AHEAD 3-45 trial: Phase 3, started July 2020, in preclinical AD patients (clinically normal but amyloid-positive). Fully recruited in October 2024.
- Tau NexGen trial: Since January 2022, evaluating lecanemab in Dominantly Inherited AD (DIAD), conducted by DIAN-TU and led by Washington University School of Medicine, St. Louis.

Strategic Partnerships

2005–present: Long-term BioArctic–Eisai collaboration on AD therapies.
2007 agreement: Development and commercialization of lecanemab.
2014 agreement: Eisai and Biogen entered joint development/commercialization for lecanemab.
2015 agreement: Development of Leqembi back-up antibody.
BioArctic’s role: No development costs; entitled to milestone payments and royalties on global sales.

About Leqembi (lecanemab)

A humanized IgG1 monoclonal antibody targeting both soluble protofibrils and insoluble amyloid-beta aggregates.
Proven to slow disease progression and reduce cognitive decline in early AD—the first drug worldwide with this demonstrated effect.

About BioArctic

BioArctic AB (publ) is a Swedish research-based biopharma company dedicated to treatments for neurodegenerative diseases. Its discovery and invention of Leqembi has established it as a pioneer in Alzheimer’s drug development.

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