Biologics License Application for Subcutaneous Formulation of “LEQEMBI®” (lecanemab) for the Treatment of Early Alzheimer’s Disease Designated for Priority Review in China

TOKYO and CAMBRIDGE, Mass., Feb. 08, 2026 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the Biologics License Application (BLA) for the subcutaneous formulation (subcutaneous autoinjector: SC-AI) of “LEQEMBI ® ” (brand name in China: “乐意保 ® ”, generic name: lecanemab), an anti-amyloid beta (Aβ) protofibril antibody, which was accepted in January 2026, has been designated for Priority Review by the National Medical Products Administration (NMPA) of China. The Priority Review and Approval Procedure was implemented by the NMPA with the aim of accelerating research, development and launch of new medicines that have significant clinical value. Under this Procedure, the assessment period is expected to be shortened. If approved, the SC-AI of 500 mg (two 250 mg injections) could be used to administer a once-weekly dose at home from the initiation of treatment, as an alternative to the current IV administration every two weeks in a hospital setting. The potential approval of SC-AI would expand the option for patients and care partners to receive LEQEMBI treatment at home. The injection time for each autoinjector (250 mg injection) is approximately 15 seconds. The SC formulation also has the potential to reduce healthcare resources associated with IV dosing, such as preparation for infusion and nurse monitoring, while streamlining the overall AD treatment care pathway. Eisai estimates that there were 17 million patients with MCI or mild dementia due to AD in China in 2024, which is expected to increase with the aging of the population. LEQEMBI was launched in China in June 2024 and has been delivered in the private market. Furthermore, LEQEMBI has been included in the newly introduced “Commercial Insurance Innovative Drug List” (Chinese: 商业健康保险创新药品目录), which took effect in January 2026, under new Chinese government policies that support the development of and access to innovative medicines. Based on the Commercial Insurance Innovative Drug List, Commercial insurance companies will develop insurance products covering LEQEMBI. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. In China, Eisai will distribute the product and conduct information provision activities through specialized Medical Representatives. MEDIA CONTACTS Eisai Co., Ltd. Public Relations Department TEL: +81 (0)3-3817-5120

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