{"id":78766,"date":"2026-09-04T16:11:23","date_gmt":"2026-09-04T08:11:23","guid":{"rendered":"https:\/\/flcube.com\/?p=78766"},"modified":"2026-09-04T16:11:24","modified_gmt":"2026-09-04T08:11:24","slug":"nmpa-approves-eisais-lecanemab-subcutaneous-autoinjector-for-early-alzheimers-disease-in-china","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=78766","title":{"rendered":"NMPA Approves Eisai\u2019s Lecanemab Subcutaneous Autoinjector for Early Alzheimer\u2019s Disease in China"},"content":{"rendered":"\n

Eisai Co., Ltd. (TYO: 4523<\/a>)<\/strong> and Biogen Inc. (NASDAQ: BIIB<\/a>)<\/strong> announced that China\u2019s National Medical Products Administration (NMPA)<\/strong> has approved the subcutaneous formulation (SC-AI autoinjector)<\/strong> of the anti-amyloid-beta (A\u03b2) protofibril antibody LEQEMBI (lecanemab)<\/strong> as an initial treatment for early Alzheimer\u2019s disease (AD)<\/strong>, including patients with mild cognitive impairment (MCI)<\/strong> or mild Alzheimer\u2019s disease dementia<\/strong>. The approval introduces a weekly, home-based injection option alongside the established biweekly intravenous (IV) infusion regimen in hospital settings.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Agency<\/td>National Medical Products Administration (NMPA)<\/strong>, China<\/td><\/tr>
Approval Type<\/td>New formulation approval<\/td><\/tr>
Product<\/td>LEQEMBI (lecanemab)<\/strong> subcutaneous autoinjector (SC-AI)<\/td><\/tr>
Indication<\/td>Initial treatment of early Alzheimer\u2019s disease<\/strong> (MCI or mild AD dementia)<\/td><\/tr>
Dosing Regimen<\/td>500 mg per week<\/strong>, administered as two consecutive injections of 250 mg each<\/td><\/tr>
Date<\/td>03 Sept 2026<\/td><\/tr>
Next Steps<\/td>Launch and commercialization of the SC formulation in China<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Drug Profile & Formulation Overview<\/h2>\n\n\n\n