Eisai Co., Ltd. Secures Chinese Regulatory Acceptance for Subcutaneous Leqembi (Lecanemab)
Eisai Co., Ltd. (Tokyo Stock Exchange: ESALY) announced that the Biologics License Application (BLA) for the subcutaneous formulation of LEQEMBI® (lecanemab), an anti‑amyloid beta protofibril antibody, has been accepted by the National Medical Products Administration (NMPA) of China. The approval is a key regulatory milestone for the product, which is intended for the treatment of early‑stage Alzheimer’s disease.
Regulatory Context
- The BLA concerns the subcutaneous autoinjector (SC‑AI) formulation of lecanemab, allowing patients to self‑administer the drug at home from the beginning of therapy.
- Acceptance by the NMPA does not guarantee market approval; additional data, pricing, and post‑marketing commitments will be required.
- The approval follows similar regulatory milestones in other jurisdictions, including the U.S. Food and Drug Administration and the European Medicines Agency.
Strategic Significance for Eisai
- Expansion of Alzheimer’s Therapeutic Portfolio
- Leqembi is currently the only anti‑amyloid therapy approved in the United States for early Alzheimer’s disease.
- A home‑delivery SC formulation would broaden the drug’s appeal and ease of use, potentially increasing uptake in the Chinese market.
- Geographical Market Growth
- China represents a large and growing healthcare market with increasing demand for neurodegenerative disease treatments.
- Regulatory acceptance positions Eisai to pursue commercialization in the region, leveraging its existing distribution network and partnerships.
- Collaborative Development with Biogen
- Eisai has partnered with Biogen Inc. for the development and commercialization of lecanemab.
- The joint effort enhances the likelihood of successful market entry through shared expertise and resources.
Additional Developments
- On January 7, 2026, a subsidiary of Eisai, EA Pharma (through Newron Pharmaceuticals S.p.A.), announced the initiation of a Phase III clinical trial of Evenamide, a novel treatment for schizophrenia, in Japan.
- This trial underscores Eisai’s broader pipeline activities beyond Alzheimer’s disease, focusing on central nervous system disorders.
Financial Snapshot
| Item | Value |
|---|---|
| Market Capitalisation | ¥1,340,891,070,464 |
| Share Price (2026‑01‑05) | ¥4,761 |
| 52‑Week High (2025‑09‑08) | ¥5,349 |
| 52‑Week Low (2025‑07‑20) | ¥22.82 |
| P/E Ratio | 4,902.817 |
Eisai’s stock continues to trade within a narrow range around its 52‑week low, reflecting market volatility and the high expectations attached to its upcoming drug approvals.
Outlook
The NMPA acceptance is a positive signal for Eisai’s Alzheimer’s strategy and may catalyze further regulatory submissions in other markets. However, the company must navigate the competitive landscape, secure pricing agreements, and complete post‑marketing studies to achieve commercial success.
Source: www.finanznachrichten.de , www.markets.businessinsider.com , www.eqs-news.com , www.avanza.se , www.prnewswire.com
