Biogen's LEQEMBI Gains Approval in China for Early Alzheimer's
The approval opens a significant new market for the breakthrough Alzheimer's drug, targeting an estimated 17 million eligible patients.
Biogen and its partner Eisai have secured a critical victory in the global fight against Alzheimer's disease, announcing that their treatment LEQEMBI (lecanemab) has been approved in China. The decision by Chinese regulators allows for the use of the drug to treat mild cognitive impairment and mild dementia stages of the disease, unlocking a vast and previously untapped market.
The approval is a significant milestone for Biogen, positioning LEQEMBI as a key long-term growth driver for the company. , following clearances in the United States and Japan. The potential patient population in China is substantial, with Eisai estimating that approximately 17 million people could be eligible for treatment in 2024, a figure expected to grow alongside the country's aging demographic.
LEQEMBI is the first and only approved treatment in China that directly targets and removes amyloid-beta (Aβ) plaques, a hallmark pathology of Alzheimer's, thereby slowing the progression of the disease. This gives the therapy a crucial first-mover advantage in the disease-modifying treatment landscape. Analysts have described the launch as a , addressing a significant unmet medical need.
"The approval of LEQEMBI in China is a significant step forward for the Alzheimer's community globally," a company spokesperson noted in a . The launch also includes a newly approved monthly intravenous (IV) maintenance dosing regimen, which allows patients who have completed the initial bi-weekly IV treatment phase to transition to a more convenient schedule.
To facilitate patient access, Eisai has partnered with JD Health to create an online platform to support individuals from diagnosis through treatment. While the drug will initially be available on the private market, its pricing is notably lower than in the U.S. and Japan, and a major Chinese insurer has already developed a plan to help cover the cost for patients. Wall Street sees the successful rollout in this new market as a , with sales in China projected to approach $400 million by 2030.