Eisai Co., Ltd.
Astellas and Biogen Announce China Approval of Leqembi (lecanemab)
Lequembi® (lecanemab) subcutaneous injectable SC-AI is approved in China as an early therapy for mild Alzheimer's disease. With a once-weekly 500 mg dose, home administration becomes possible, with a planned switch from IV administration. Launch is scheduled for fiscal year 2026. Minor impact expected on the earnings forecast for the fiscal year ending March 2027.
Key Figures
- Approval: Leqembi SC-AI subcutaneous 500 mg weekly (IV exposure equivalent)
- Planned launch: Fiscal year 2026
- Impact: Minor; no change to 2027 fiscal year earnings guidance
AI要約
Section heading
This release announces the approval of the subcutaneous injectable SC-AI of lecanemab in China under the joint development and commercialization framework of Astellas and Biogen. SC-AI enables home administration with a weekly 500 mg dose, with the possibility of switching from IV administration. The approval is based on data from the Clarity AD trial and the long-term extension study LTE. Safety is generally comparable to IV administration, with local reactions but low frequency of systemic events.
Section 2 heading
In the Chinese market, the already launched Leqembi in June 2024 gains an additional at-home administration option through this approval, potentially improving treatment pathways and patient quality of life. Astellas leads global development and regulatory submissions, with co-promotion with Biogen. In China, Astellas handles sales and medical information through specialist MRs.
Astellas Pharma Inc.
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