Biogen announced that the National Medical Products Administration accepted its Biologics License Application for the subcutaneous autoinjector version of LEQEMBI on January 5 2026, clearing the drug for a once‑weekly at‑home dosing option in China.
LEQEMBI had already been approved in China in January 2024 and launched in June 2024. In December 2025 the drug was added to China’s “Commercial Insurance Innovative Drug List,” a designation that takes effect on January 1 2026 and expands patient access through commercial insurance coverage.
The autoinjector delivers the antibody in a 15‑second injection, eliminating the need for weekly hospital visits required by the current intravenous infusion regimen. This convenience is expected to improve patient adherence and reduce the burden on healthcare facilities.
China’s Alzheimer’s market is projected to grow from a $1.24 billion valuation in 2022 to $2.64 billion by 2030, at a 9.42% compound annual growth rate. The country is home to an estimated 17 million people with mild cognitive impairment or mild dementia as of 2024, a number that is expected to rise as the population ages.
By adding a subcutaneous formulation, Biogen and its partner Eisai can broaden LEQEMBI’s reach in a key market, potentially increasing revenue streams and strengthening the company’s competitive position against other Alzheimer’s therapies that remain infusion‑based. The move also aligns with the partnership structure, where Eisai retains final decision‑making authority and will handle distribution in China.
The NMPA acceptance marks a significant regulatory milestone that positions Biogen to tap into China’s large Alzheimer’s patient population and accelerate market penetration for LEQEMBI in the region.
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