WESTON (dpa-AFX) - Drug makers Biogen Inc. (BIIB) and Japan's Eisai Co., Ltd. (ESALY.PK, 4523.T, EII.SG) announced Thursday that the National Medical Products Administration or NMPA of China has approved LEQEMBI (lecanemab) Subcutaneous Formulation as an initiation treatment for early alzheimer's disease.
As per the approval, treatment can be given for mild cognitive impairment or MCI due to Alzheimer's disease or mild AD dementia, collectively referred to as early AD.
The NMPA accepted the application in January 2026 and subsequently granted Priority Review designation. The companies plan to launch the drug during Eisai's fiscal 2026, ending March 31, 2027.
Eisai, a Japanese pharmaceutical company specializing in neurodegenerative and oncology treatments, serves as the lead developer of LEQEMBI with Biogen co-commercializing the product.
According to the companies, the drug is the first and only anti-amyloid therapy in China that enables at-home administration for alzheimer's disease, a progressive neurodegenerative disease.
LEQEMBI SC-AI is a self-administered autoinjector offering 500 milligrams administered once weekly as two consecutive 250 milligram injections. The subcutaneous option complements the existing intravenous administration every two weeks in a hospital setting. Patients may switch between subcutaneous and intravenous administration during treatment.
The subcutaneous formulation requires approximately 15 seconds per injection compared with intravenous infusions. At-home administration may reduce clinic visit burdens for patients and caregivers while enabling treatment flexibility.
The approval is based on integrated results from the 18-month core Phase 3 Clarity AD study and multiple subcutaneous administration sub-studies in the long-term extension, including a Chinese cohort. Once-weekly subcutaneous administration of 500 milligrams demonstrated exposure equivalent to intravenous administration every two weeks, with similar clinical and biomarker benefits.
The overall safety profile of subcutaneous administration was generally similar to intravenous administration. Injection-related reactions were observed with subcutaneous LEQEMBI, most of which were localized, while systemic reactions were less frequently observed.
Eisai estimates 17 million patients had mild cognitive impairment or mild dementia due to Alzheimer's disease in China in 2024, expected to increase as the population ages. LEQEMBI launched in China in June 2024 and is leading the establishment of anti-amyloid therapy in Alzheimer's disease management.
Eisai will distribute the product in China and conduct information provision activities through specialized medical representatives.
In Japan, Eisai shares were trading at 4,780.00 yen, up 1.01 percent.
On the Nasdaq, Biogen shares gained 0.60 percent in the after-hours trading, at $224.00, extending the 3.07 percent gain on Wednesday's regular trading close.
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