#China #N/A #Eisai #Leqembi #BioArctic

Eisai's Leqembi® Included in China's Commercial Insurance Innovative Drug List

In a significant development for Alzheimer's disease treatment in China, Eisai, a Japanese pharmaceutical company and a partner of BioArctic AB, recently announced the inclusion of Leqembi® (lecanemab) in the newly established "Commercial Insurance Innovative Drug List" by the National Healthcare Security Administration (NHSA) of China. This decision represents a pivotal step towards improving access to early treatment for patients suffering from Alzheimer's Disease (AD) in the region.

The new policy aims to promote innovative medications that can help bridge the existing coverage gaps between the National Reimbursement Drug List (NRDL) and cutting-edge treatments designed for serious health conditions. By adding Leqembi to this list, the Chinese government hopes to facilitate conversations between insurance companies and pharmaceutical firms about coverage details and to create tailored insurance products focused on listed innovative medicines. The policy is slated to take effect on January 1, 2026.

Eisai reports that as of 2024, there were approximately 17 million individuals in China living with mild cognitive impairment (MCI) or mild dementia related to Alzheimer's disease. This number is expected to rise significantly as the population ages, highlighting the urgency of this initiative.

Leqembi entered the Chinese market in June 2024 and has already been made available through private distribution channels. The drug was co-developed through a longstanding partnership between BioArctic and Eisai, drawing on the pioneering work of Professor Lars Lannfelt, who discovered the Arctic mutation in Alzheimer's disease. Eisai oversees the clinical development, market approval processes, and commercialization of Leqembi, while BioArctic retains rights for commercialization within the Nordics, with both companies progressing towards joint marketing initiatives in that region.

Leqembi®: The Insights

Leqembi is revolutionizing the landscape of Alzheimer's treatment. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody that targets aggregated forms of amyloid-beta (Aβ), aiming to mitigate the progression of Alzheimer's. The drug has already gained regulatory approval in over 51 countries and is undergoing review in nine others, underscoring its global significance.

In many countries, including the UK, China, and the US, Leqembi is administered via intravenous (IV) infusion every four weeks after an initial treatment phase of every two weeks for 18 months. Additionally, in the US market, the subcutaneous formulation—Leqembi Iqlik™—has been approved for maintenance treatment of early-stage Alzheimer's disease, offering another avenue for patient care.

Since 2020, Eisai has been conducting Phase 3 clinical trials with lecanemab, focusing on individuals with preclinical signs of Alzheimer’s. The AHEAD 3-45 study, which investigates the effects of the drug on participants exhibiting elevated levels of amyloid in their brains, aims to shed light on how early intervention might impact disease progression. This study became fully recruited by October 2024 and involves collaboration with the Alzheimer's Clinical Trial Consortium and Biogen.

The Collaboration That Made It Happen

The partnership between BioArctic and Eisai stems back to 2005, centered on developing and commercializing therapies for Alzheimer's disease. Key agreements included the Development and Commercialization agreement for the lecanemab antibody, signed in 2007, and subsequent agreements for additional Alzheimer's-related antibodies. Notably, in 2014, a joint development and commercialization agreement with Biogen was signed, laying the groundwork for Leqembi's advancements.

This collaboration has allowed BioArctic to share the commercial benefits without incurring development costs, as the company receives payments tied to sales milestones and royalties on global sales of lecanemab. BioArctic stands at the cutting edge of research, also developing antibody-based therapies for conditions like Parkinson's disease and ALS, utilizing their proprietary BrainTransporter™ technology for enhanced drug delivery across the blood-brain barrier.

Conclusion

With the inclusion of Leqembi in China’s Commercial Insurance Innovative Drug List, the landscape for Alzheimer's treatment is shifting toward a more accessible and innovative future. Patients and families affected by this progressive disease can remain hopeful about increased treatment options, and as the collaboration between BioArctic and Eisai continues to thrive, it may lead to more breakthroughs in neurodegenerative disease management.