#China #Beijing #Eisai #Leqembi #BioArctic

New Horizons in Alzheimer's Treatment: Leqembi® Undergoes Priority Review in China

In a significant advancement for Alzheimer's disease treatment, BioArctic AB's partner, Eisai, has announced that the Biologics License Application (BLA) for Leqembi® (lecanemab) has been granted Priority Review status by China's National Medical Products Administration (NMPA). This groundbreaking development relates to a new subcutaneous formulation of Leqembi, which utilizes an autoinjector (SC-AI) for patient-friendly self-administration.

The BLA, which focuses on administering Leqembi through subcutaneous means, was officially acknowledged for review by the NMPA in January 2026. The Priority Review procedure instituted by the NMPA seeks to expedite the process of evaluating medications that present significant clinical advantages. As a result, the timeframe for approval could be substantially shortened, allowing patients access to innovative treatments faster.

With the proposed subcutaneous formulation, patients will have the flexibility to self-administer Leqembi’s recommended dosage of 500 mg (administered via two 250 mg injections) once a week. This stands in stark contrast to the existing intravenous (IV) administration, which typically requires a hospital visit every two weeks. The convenience of at-home dosing not only enhances patient comfort but is expected to streamline the entire care pathway for those dealing with Alzheimer's disease.

Each injection using the autoinjector takes around 15 seconds, allowing for quick administration with minimal discomfort. This innovation also has the potential to alleviate pressures on healthcare resources, reducing the need for infusion preparation, nurse monitoring, and associated costs tied to hospital visits.

Alarming statistics indicate that as of 2024, around 17 million individuals in China suffered from Mild Cognitive Impairment (MCI) or early-stage dementia attributable to Alzheimer's disease. This figure is projected to rise as the nation's population continues to age, underscoring the urgent demand for effective treatments such as Leqembi.

Leqembi was launched in the Chinese market in June 2024 and is currently available in the private sector. Furthermore, it has been recently included in the newly introduced Commercial Insurance Innovative Drug List, effective from January 2026. This policy is part of the Chinese government’s initiative to encourage the access and development of innovative medications. Commercial insurance providers are expected to create coverage products for Leqembi, broadening its accessibility.

Leqembi's journey began through a robust collaboration between BioArctic and Eisai. The antibody was initially developed by BioArctic, inspired by Professor Lars Lannfelt's studies on the Arctic mutation related to Alzheimer's. Eisai oversees the clinical development and commercialization processes for Leqembi, while BioArctic retains rights for commercialization in the Nordic region – where both companies are preparing to launch together.

This press release serves as an important notice in compliance with the EU Market Abuse Regulation, reflecting BioArctic AB's commitment to providing timely updates to its stakeholders. Released for public knowledge on February 9, 2026, at 0645 CET, the announcement marks a pivotal moment in the pursuit of effective Alzheimer's treatments.

For further details or inquiries, interested parties can contact:

• - Oskar Bosson

VP Communications and Investor Relations
Email: [email protected]
Phone: +46 704 107 180

• - Jenny Ljunggren

External Communications and Investor Relations Manager
Email: [email protected]
Phone: +46 76 013 86 08

About Leqembi®

Leqembi is a humanized IgG1 monoclonal antibody targeting both aggregated and soluble forms of amyloid-beta (Aβ). Approved across 53 countries and undergoing regulatory review in 6 others, Leqembi represents a beacon of hope for Alzheimer's patients worldwide. The treatment protocol includes an initial IV administration transitioning to subcutaneous methods in some regions, greatly increasing patient autonomy and comfort.

With a vision to push the boundaries of neurodegenerative disease treatment, BioArctic is committed to furthering research on Alzheimer's and related disorders. The company continues to explore numerous avenues, including innovative drug delivery mechanisms like the BrainTransporter™ technology, aiming for enhanced efficacy of its existing and future treatments. BioArctic’s shares are publicly listed on the Nasdaq Stockholm Large Cap under the identifier BIOA B. For more insights, visit BioArctic’s website.