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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, whi
About this update from Eisai Co., Ltd.
[{"type":"image","alt":"Biogen Inc.","displaySize":"","headline":null,"caption":"Biogen Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":101,"url":"https://media.zenfs.com/en/globenewswire.com/d780d0e9a7ba00777730acf271f9e937"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/wH5zYbm3mC0cXQRHhCXgVw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE0MTtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/d780d0e9a7ba00777730acf271f9e937","width":300,"height":101}},"lazy":false},{"type":"text","content":"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.","length":637,"tagName":"p"},{"type":"text","content":"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.","length":260,"tagName":"p"},{"type":"text","content":"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.","length":662,"tagName":"p"},{"type":"text","content":"Eisai estimates that there were 17 million patients with MCI or mild dementia due to AD in China in 2024, which is expected to in...