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Biogen Inc. Press Release: Biologics License Application for Subcutaneous Formulation of “LEQEMBI®” (lecanemab) for the Treatme
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# Biologics License Application for Subcutaneous Formulation of “LEQEMBI®” (lecanemab) for the Treatment of Early Alzheimer's Disease Accepted in China **Date:** 2026-01-05 20:00:00 **Company:** Biogen Inc. **Ticker:** BIIB **Source URL:** https://www.globenewswire.com/news-release/2026/01/06/3213279/0/en/Biologics-License-Application-for-Subcutaneous-Formulation-of-LEQEMBI-lecanemab-for-the-Treatment-of-Early-Alzheimer-s-Disease-Accepted-in-China.html --- [Accessibility: Skip TopNav](https://www.globenewswire.com/news-release/2026/01/06/3213279/0/en/Biologics-License-Application-for-Subcutaneous-Formulation-of-LEQEMBI-lecanemab-for-the-Treatment-of-Early-Alzheimer-s-Disease-Accepted-in-China.html#maincontainer) [](https://www.globenewswire.com/) - [Newsroom](https://www.globenewswire.com/newsroom) - [Services](https://www.globenewswire.com/services) - [Contact Us](https://insight.notified.com/...
# Biologics License Application for Subcutaneous Formulation of “LEQEMBI®” (lecanemab) for the Treatment of Early Alzheimer's Disease Accepted in China **Date:** 2026-01-05 20:00:00 **Company:** Biogen Inc. **Ticker:** BIIB **Source URL:** https://www.globenewswire.com/news-release/2026/01/06/3213279/0/en/Biologics-License-Application-for-Subcutaneous-Formulation-of-LEQEMBI-lecanemab-for-the-Treatment-of-Early-Alzheimer-s-Disease-Accepted-in-China.html --- [Accessibility: Skip TopNav](https://www.globenewswire.com/news-release/2026/01/06/3213279/0/en/Biologics-License-Application-for-Subcutaneous-Formulation-of-LEQEMBI-lecanemab-for-the-Treatment-of-Early-Alzheimer-s-Disease-Accepted-in-China.html#maincontainer) [](https://www.globenewswire.com/) - [Newsroom](https://www.globenewswire.com/newsroom) - [Services](https://www.globenewswire.com/services) - [Contact Us](https://insight.notified.com/globenewswire-contact-us?utm_medium=Website&utm_source=Contact%20Us&utm_campaign=Contact%20Us%20ENG) - English [Sign In](https://www.globenewswire.com/home/signin) [Register](https://portal.notified.com/en/registration) # [](https://www.biogen.com/) #  # Biologics License Application for Subcutaneous Formulation of “LEQEMBI®” (lecanemab) for the Treatment of Early Alzheimer’s Disease Accepted in China ## If approved, lecanemab may become the first and only anti-amyloid treatment in China to offer an at-home injection from the initiation of treatment for this progressive, relentless disease January 05, 2026 20:00 ET\| Source: [Biogen Inc.](https://www.globenewswire.com/en/search/organization/Biogen%2520Inc%C2%A7)FollowBiogen Inc. * * * Share - * * * TOKYO and CAMBRIDGE, Mass., Jan. 05, 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, has been accepted by the National Medical Products Administration (NMPA) in China. 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 in the 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. 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. Eisai will distribute the product in China and will conduct information provision activities through specialized Medical Representatives. \*Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of Aβ, having a primary role in the cognitive decline associated with this progressive, debilitating condition.1 Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.2 | | | | --- | --- | | **MEDIA CONTACTS** | | | **Eisai Co., Ltd.**<br>Public Relations Department<br>TEL: +81 (0)3-3817-5120 | **Biogen Inc.**<br>Madeleine Shin<br>+1-781-464-3260<br>[public.affairs@biogen.com](mailto:public.affairs@biogen.com "public.affairs@biogen.com") | | | | | **Eisai Europe, Ltd.** EMEA Communications Department<br>+44 (0) 797 487 9419<br>[Emea-comms@eisai.net](mailto:Emea-comms@eisai.net "Emea-comms@eisai.net") | | | | | | **Eisai Inc. (U.S.)**<br>Libby Holman<br>+1-201-753-1945<br>[Libby\_Holman@Eisai.com](mailto:Libby_Holman@Eisai.com "Libby_Holman@Eisai.com") | | | | | | **INVESTOR CONTACTS** | | | | | | **Eisai Co., Ltd.**<br>Investor Relations Department<br>TEL: +81 (0) 3-3817-5122 | **Biogen Inc.**<br>Tim Power<br>\+ 1-781-464-2442<br>[IR@biogen.com](mailto:IR@biogen.com "IR@biogen.com") | | | | **Notes to Editors** 1. **About LEQEMBI (generic name: lecanemab, Chinese brand name:** **乐意保** **)** Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). Lecanemab has been approved in 52 countries and is under regulatory review in 8 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in the U.S., China, the UK, and others, and applications have been filed in 4 countries and regions. The U.S. FDA approved Eisai’s Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. A rolling Supplemental Biologics License Application (sBLA) for initiation treatment was initiated under Fast Track status in September 2025, and completed in November 2025. In November 2025, an application for a subcutaneous injectable formulation in Japan was submitted. In December 2025, Lecanemab has been included in the “Commercial Insurance Innovative Drug List”, recently introduced by the National Healthcare Security Administration (NHSA) of China. Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy. 2. **About the Collaboration between Eisai and Biogen for AD** Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority. 3. **About the Collaboration between Eisai and BioArctic for AD** Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015. 4. **About Eisai Co., Ltd.** Eisai's Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as _human health care_ ( _hhc_) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. 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These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in our subsequent reports on Form 10-Q. 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Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors. **References** 1. Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. _Nat Commun_. 2021;12:3451. doi:10.1038/s41467-021-23507-z 2. Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer's Disease. _Int J Mol Sci._ 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706.  GlobeNewswire Company ProfileBiogen Inc.Industry: BiotechnologyWebsite: [https://www.biogen.com/](https://www.biogen.com/) Press Release Actions - [Print](https://www.globenewswire.com/news-release/2026/01/06/3213279/0/en/Biologics-License-Application-for-Subcutaneous-Formulation-of-LEQEMBI-lecanemab-for-the-Treatment-of-Early-Alzheimer-s-Disease-Accepted-in-China.html?print=1) - [Download PDF](https://www.globenewswire.com/news-release/2026/01/06/3213279/0/en/Biologics-License-Application-for-Subcutaneous-Formulation-of-LEQEMBI-lecanemab-for-the-Treatment-of-Early-Alzheimer-s-Disease-Accepted-in-China.html?pdf=1) - [Subscribe via RSS](https://www.globenewswire.com/rssfeed/organization/hNQxyS-FvexsgfoXWT62ZA==) - [Subscribe via ATOM](https://www.globenewswire.com/atomfeed/organization/hNQxyS-FvexsgfoXWT62ZA==) - [Javascript](https://www.globenewswire.com/JSWidget/organization/upt2Exqa8SOP4Cd_8ZhXJQ%3d%3d) ## Recommended Reading - February 11, 2026 17:00 ET\|Source: [Biogen Inc.](https://www.globenewswire.com/en/search/organization/Biogen%2520Inc%C2%A7) [Biogen Announces Board Chair Transition](https://www.globenewswire.com/news-release/2026/02/11/3236726/0/en/Biogen-Announces-Board-Chair-Transition.html) CAMBRIDGE, Mass., Feb. 11, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. 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