TOKYO and CAMBRIDGE, Mass., December 8, 2025 — Eisai Co., Ltd. and Biogen Inc. announced that LEQEMBI® (lecanemab), an anti-Aβ protofibril monoclonal antibody for the treatment of early Alzheimer’s disease (AD), has been included in China’s Commercial Insurance Innovative Drug List, a newly implemented mechanism designed to expand access to breakthrough medicines. This inclusion marks a critical milestone in improving affordability and accelerating national access to disease-modifying Alzheimer’s therapies in China.
Science Significance
LEQEMBI represents a significant advancement in Alzheimer’s disease neurobiology, targeting soluble and insoluble Aβ protofibrils, which are considered the most neurotoxic forms of amyloid-beta. Protofibrils are implicated in neuronal damage, synaptic dysfunction, and cognitive decline, and reducing them may slow Alzheimer’s progression. The monoclonal antibody’s design enables selective engagement with aggregated species that drive pathophysiological deterioration in early AD. Long-term clinical trials such as AHEAD 3-45 and Tau NexGen continue to validate LEQEMBI’s role as a backbone disease-modifying therapy, reinforcing its scientific impact on the evolving understanding of preclinical and early symptomatic Alzheimer’s.
Regulatory Significance
LEQEMBI has received regulatory approval in 51 countries, with additional submissions in progress. China’s decision to include LEQEMBI in its Commercial Insurance Innovative Drug List provides an early-access pathway independent of the National Reimbursement Drug List (NRDL), ensuring faster availability to patients while ongoing regulatory review and pricing decisions evolve. Recently, the U.S. FDA approved LEQEMBI’s subcutaneous maintenance dosing, and a Fast Track supplemental BLA for initiation treatment was completed in 2025, demonstrating global momentum behind efforts to broaden treatment modalities and improve convenience. China’s inclusion further strengthens LEQEMBI’s regulatory footprint across major markets.
Business Significance
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The listing is a major commercial milestone for Eisai and Biogen, significantly strengthening their positioning in one of the world’s largest Alzheimer’s disease populations. Eisai estimates 17 million Chinese patients with mild cognitive impairment or mild dementia due to AD in 2024—a number expected to rise sharply with demographic aging. LEQEMBI’s earlier launch in China’s private market in June 2024 established initial commercial availability, and the new insurance mechanism will dramatically accelerate uptake, reimbursement discussions, and long-term market penetration. Eisai leads global development and regulatory strategy, while both companies co-commercialize the product, enabling a broad business platform across markets.
Patients’ Significance
For patients and caregivers confronting Alzheimer’s disease, LEQEMBI’s insurance inclusion delivers meaningful improvements in access and affordability. As one of the few therapies that aims to modify the underlying disease process, rather than merely manage symptoms, LEQEMBI offers the potential to slow cognitive decline when administered early. The new insurance pathway enables commercial insurers to negotiate coverage terms and create specialized plans centered around innovative medicines, providing more equitable access for patients who previously faced high out-of-pocket costs. This development may help millions of individuals pursue treatment earlier, when interventions can be most effective.
Policy Significance
China’s Commercial Insurance Innovative Drug List is a notable policy innovation, reflecting government efforts to accelerate adoption of cutting-edge medical technologies. The mechanism closes the gap between the NRDL and emerging therapies, particularly for diseases with substantial unmet need such as Alzheimer’s. By encouraging insurers to develop targeted reimbursement products, the policy supports sustainable funding models while fostering national readiness for rapid therapeutic advancements. China’s decision positions the country at the forefront of innovative drug access policy, and may serve as a model for other health systems facing rising burdens of neurodegenerative disease.
The inclusion of LEQEMBI in China’s Commercial Insurance Innovative Drug List represents a decisive step in expanding access to disease-modifying Alzheimer’s treatment. With strong scientific validation, global regulatory momentum, and a rapidly aging population in need of effective interventions, this policy shift accelerates the availability of a therapy that may fundamentally alter the course of early Alzheimer’s disease. Eisai and Biogen’s continued collaboration ensures a robust strategy for ongoing development, global distribution, and patient-centered innovation as the Alzheimer’s treatment landscape undergoes rapid transformation.
Source: Biogen Inc. press release
