By Fineline Cube 
Japanese drugmaker Eisai Co., Ltd. (TYO: 4523) and U.S. biopharma Biogen Inc. (NASDAQ: BIIB) announced that the National Medical Products Administration (NMPA) has cleared the once‑every‑four‑weeks Leqembi (lecanemab) IV maintenance regimen for patients with mild cognitive impairment (MCI) and mild Alzheimer’s disease (AD) in China.
What the Approval Means
- Maintenance Dosing Flexibility – After the 18‑month, every‑two‑weeks induction phase, patients may switch to a 10 mg/kg every‑four‑weeks maintenance schedule, or continue the bi‑weekly dose.
- Targeted Mechanism – Leqembi binds soluble and insoluble amyloid‑β (Aβ) aggregates, reducing both proto‑fibrils and plaques that drive cognitive decline.
- Regulatory Milestone – The NMPA decision follows Leqembi’s 2024 approval for MCI and mild AD, marking the first Chinese authorization of an anti‑Aβ therapy with a simplified maintenance schedule.
Strategic Impact
- For Manufacturers – The simplified dosing is expected to lower logistics costs, improve patient adherence, and expand the market for Eisai and Biogen in China’s growing neurodegenerative‑disease sector.
- For Patients – Fewer clinic visits may translate to a better quality of life and reduced treatment burden for thousands of patients with early‑stage Alzheimer’s.
- For the Market – The approval positions Leqembi as a leading therapeutic option in China, potentially reshaping the competitive landscape dominated by symptomatic treatments.
Investor Takeaway
- Revenue Upside – Easier maintenance dosing could accelerate uptake, boosting sales for both partners in a market projected to reach USD 3 billion by 2030.
- Strategic Partnerships – The collaboration underscores a trend toward joint development and licensing deals to navigate China’s stringent regulatory environment.-Fineline Info & Tech