Eisai's Lecanemab SC Formulation Approved for Early Alzheimer's in China
News provided byEisai Co., Ltd · 2 min read
TOKYO and CAMBRIDGE, Mass., Sept. 3, 2026, Eisai Co., Ltd. and Biogen Inc. announced today that the National Medical Products Administration (NMPA) of China has approved the subcutaneous (SC) formulation of LEQEMBI® (generic name: lecanemab) as an initiation treatment for early Alzheimer's disease (AD). This approval follows an application accepted by the NMPA in January 2026 and a subsequent Priority Review designation. LEQEMBI SC-AI, a self-administered autoinjector, is set to launch during Eisai’s fiscal year 2026, ending March 31, 2027.
LEQEMBI SC-AI is designed for once-weekly administration, with each dose consisting of two consecutive 250 mg injections. This new formulation offers patients a home-based treatment option, in addition to the intravenous (IV) administration already available in hospital settings. The subcutaneous administration can also be switched to IV or vice versa during treatment, providing greater flexibility for patients.
The SC formulation significantly reduces the time required compared to IV infusions, with an approximate injection time of 15 seconds per injection. Home administration not only decreases the frequency of clinic visits but also enables treatment that better suits patients' lifestyles. This increased convenience is expected to facilitate the initiation and continuation of treatment, while also potentially reducing healthcare resource demands associated with IV dosing, such as nurse monitoring.
In terms of safety, the overall profile of LEQEMBI SC-AI administration was generally similar to that of IV administration. Injection-related reactions were localized, while systemic reactions were less frequently observed. For amyloid-related imaging abnormalities (ARIA), monitoring will follow the same protocols as with IV administration, including brain magnetic resonance imaging (MRI) before treatment initiation and at specific time points after treatment.
AD is characterized by continuous neurotoxic processes driven by amyloid-beta (Aβ) protofibrils and tau proteins. LEQEMBI is the only therapy that targets both protofibrils and amyloid plaques, making it a unique treatment for AD. The approval of LEQEMBI SC-AI in China marks the second global country to approve this formulation, following similar approvals in other regions.
Eisai estimates that there were approximately 17 million patients with mild cognitive impairment (MCI) or mild AD dementia in China in 2024. The launch of LEQEMBI in China in June 2024 has been pivotal in establishing anti-amyloid therapy in AD management, with a focus on early AD patients.
Eisai, as the global lead for LEQEMBI development and regulatory submissions, will distribute the product in China and conduct information provision activities through specialized medical representatives. Eisai and Biogen will co-commercialize and co-promote the product, with Eisai holding the final decision-making authority.
This approval is expected to streamline the AD treatment pathway, offering a more flexible and convenient treatment option for patients, and potentially lowering barriers to initiating and continuing therapy.