Eisai and BioArctic Celebrate Leqembi® Approval for Alzheimer’s Treatment in China
On September 29, 2025, Eisai Co. Ltd., in a partnership with BioArctic AB, announced that lecanemab, marketed as Leqembi®, has been officially approved by China's National Medical Products Administration (NMPA). This approval allows for lecanemab to be administered intravenously for maintenance treatment every four weeks to patients diagnosed with early-stage Alzheimer's disease (AD). This breakthrough follows the drug's initial 2024 approval for treating Alzheimer’s Disease among individuals with mild cognitive impairment (MCI) or mild dementia.
The drug's approval is seen as a significant advancement in the global fight against AD, a debilitating and progressive neurodegenerative disease characterized by the build-up of protein plaques in the brain. These plaques, formed from amyloid-beta aggregates, lead to the neurodegeneration associated with AD. Leqembi is unique in its bi-modal approach to treating Alzheimer’s by targeting both amyloid plaques and the neurotoxic amyloid-beta protofibrils, which contribute to cognitive decline. This innovative treatment strategy not only aims at plaque removal but also addresses the underlying neuroinflammatory processes that lead to neurodegeneration.
To elaborate on the treatment regimen, patients will initially receive a dose of 10 mg/kg of lecanemab every two weeks for the first 18 months during the initiation phase. After this period, a shift to the maintenance phase with dosing every month is permissible, optimizing long-term patient care and aligning with clinical findings that support the drug's safety and efficacy.
Eisai's Chairman expressed pride in the collaborative efforts with BioArctic, emphasizing the years of research and development that led to this momentous occasion. "Our commitment to providing solutions for Alzheimer's patients is undeterred, and this approval signifies a new hope for those affected by this relentless illness," he stated.
This approval in China is especially crucial, as the country faces a growing elderly population with an increasing prevalence of Alzheimer's disease. The treatment landscape for AD has been rapidly evolving, and Leqembi stands out as one of the first therapies to show credible evidence of slowing disease progression in early stages.
BioArctic, a Swedish biopharma firm, has collaborated with Eisai since 2005 to develop innovative treatments for neurodegenerative diseases, making significant strides in Alzheimer’s research based on pioneering discoveries by Professor Lars Lannfelt. With Leqembi, medical professionals can expect not only to reduce cognitive impairment but potentially to change the course of this challenging disease.
Furthermore, Leqembi is already approved in numerous territories, including the United States and Japan, and is undergoing regulatory reviews in ten additional countries, highlighting its global impact potential.
As Eisai prepares for the commercial rollout of Leqembi in China alongside BioArctic, both companies express confidence in their joint capability to respond to a pressing medical need. This cooperation aims to ensure optimal accessibility for Alzheimer’s patients who will benefit from this innovative therapy nearing implementation.
In conclusion, the approval of lecanemab for intravenous maintenance therapy in China marks a pivotal development in the journey toward effective Alzheimer's disease management. It brings hope not only to patients but also to caregivers and families affected by this condition, paving the way for broader advancements in neurodegenerative disease treatment.
The drug's approval is seen as a significant advancement in the global fight against AD, a debilitating and progressive neurodegenerative disease characterized by the build-up of protein plaques in the brain. These plaques, formed from amyloid-beta aggregates, lead to the neurodegeneration associated with AD. Leqembi is unique in its bi-modal approach to treating Alzheimer’s by targeting both amyloid plaques and the neurotoxic amyloid-beta protofibrils, which contribute to cognitive decline. This innovative treatment strategy not only aims at plaque removal but also addresses the underlying neuroinflammatory processes that lead to neurodegeneration.
To elaborate on the treatment regimen, patients will initially receive a dose of 10 mg/kg of lecanemab every two weeks for the first 18 months during the initiation phase. After this period, a shift to the maintenance phase with dosing every month is permissible, optimizing long-term patient care and aligning with clinical findings that support the drug's safety and efficacy.
Eisai's Chairman expressed pride in the collaborative efforts with BioArctic, emphasizing the years of research and development that led to this momentous occasion. "Our commitment to providing solutions for Alzheimer's patients is undeterred, and this approval signifies a new hope for those affected by this relentless illness," he stated.
This approval in China is especially crucial, as the country faces a growing elderly population with an increasing prevalence of Alzheimer's disease. The treatment landscape for AD has been rapidly evolving, and Leqembi stands out as one of the first therapies to show credible evidence of slowing disease progression in early stages.
BioArctic, a Swedish biopharma firm, has collaborated with Eisai since 2005 to develop innovative treatments for neurodegenerative diseases, making significant strides in Alzheimer’s research based on pioneering discoveries by Professor Lars Lannfelt. With Leqembi, medical professionals can expect not only to reduce cognitive impairment but potentially to change the course of this challenging disease.
Furthermore, Leqembi is already approved in numerous territories, including the United States and Japan, and is undergoing regulatory reviews in ten additional countries, highlighting its global impact potential.
As Eisai prepares for the commercial rollout of Leqembi in China alongside BioArctic, both companies express confidence in their joint capability to respond to a pressing medical need. This cooperation aims to ensure optimal accessibility for Alzheimer’s patients who will benefit from this innovative therapy nearing implementation.
In conclusion, the approval of lecanemab for intravenous maintenance therapy in China marks a pivotal development in the journey toward effective Alzheimer's disease management. It brings hope not only to patients but also to caregivers and families affected by this condition, paving the way for broader advancements in neurodegenerative disease treatment.
Topics Health）
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