Biologics License Application for LEQEMBI® Accepted in China, Potentially Revolutionizing Alzheimer’s Treatment
On January 5, 2026, Eisai Co., Ltd. and Biogen Inc. (NASDAQ: BIIB) announced that the National Medical Products Administration (NMPA) in China has accepted their Biologics License Application (BLA) for the subcutaneous formulation of “LEQEMBI®” (generic name: lecanemab). If approved, this innovative treatment could be the first anti-amyloid therapy in China to allow for at-home injections, significantly improving the care options for patients with Alzheimer's disease (AD).
Details of the Subcutaneous Formulation
The subcutaneous autoinjector (SC-AI) of LEQEMBI delivers a dosage of 500 mg through two 250 mg injections, which can be administered once weekly at home. This offers a convenient alternative to the current intravenous (IV) administration that requires hospital visits. Each injection takes approximately 15 seconds and, if approved, could streamline the treatment process, saving valuable healthcare resources by reducing the need for healthcare professional monitoring during administration. Eisai estimates that there are over 17 million patients with mild cognitive impairment (MCI) or mild dementia due to AD in China, a number that is expected to grow significantly due to the aging population.
Addressing the Alzheimer’s Challenge
Protofibrils, the targeted form of amyloid beta (Aβ) by lecanemab, are believed to be critical in the progression of Alzheimer's disease. They not only contribute to the formation of damaging plaques in the brain but also cause injury to neurons, impacting cognitive function severely. Treatments aimed at reducing protofibrils can potentially halt cognitive decline associated with this debilitating condition.
The acceptance of the BLA is a significant milestone in providing new therapeutic options for Alzheimer's patients and demonstrates the ongoing collaboration between Eisai and Biogen. As part of the agreement, Eisai will lead the development and regulatory submissions primarily, while both companies will co-commercialize and promote LEQEMBI.
Leverage Developments in Alzheimer’s Treatment
LEQEMBI has already received approvals in 52 countries and is undergoing review in an additional eight. The treatment initially followed an intravenous protocol, switching to maintenance doses every four weeks, with current regulatory advancements aiming to ease the treatment process through subcutaneous delivery. This has the potential to shape how Alzheimer’s care is delivered, especially in home settings.
Background on Eisai and Biogen Collaborations
Eisai and Biogen have been partners in developing Alzheimer's treatments since 2014, with Eisai holding final authority on decision-making regarding LEQEMBI. Their joint efforts have included significant clinical studies aimed at understanding and managing Alzheimer's disease better. Additionally, Eisai has established a long-term collaboration with BioArctic, securing rights to study and market lecanemab globally, which emphasizes the combined efforts to tackle Alzheimer's through innovation.
Contact Information
For further inquiries or details on the acceptance of the BLA for lecanemab, the following media contacts can be reached:
- Eisai Co., Ltd. Public Relations Department: +81 (0)3-3817-5120
- Biogen Inc. (Public Affairs): Madeleine Shin, +1-781-464-3260, public.affairs@biogen.com
- Eisai Europe, Ltd. EMEA Communications: +44 (0) 797 487 9419, Emea-comms@eisai.net
- Eisai Inc. (U.S.): Libby Holman, +1-201-753-1945, Libby_Holman@Eisai.com
About LEQEMBI and Its Importance
LEQEMBI (lecanemab) is a monoclonal antibody aimed at treating Alzheimer’s disease by targeting amyloid beta protofibrils. Its recent developments, including the potential home administration method, signify favorable advancements in treating a condition that remains one of the most critical health challenges globally.