FDA approves Leqembi IQULIK for initiation dosing

研报英文原文证据摘录

FDA approves Leqembi IQULIK for initiation dosing

J P M O R G A N Asia Pacific Equity Research

14 July 2026

Eisai (4523) Neutral

4523.T, 4523 JP

FDA approves Leqembi IQLIK for initiation dosing Price (13 Jul 26):¥4,243

Price Target (Dec-27):¥4,800

Eisai and Biogen announced on July 14 that the FDA has approved Leqembi IQLIK Japan Equity Research

(lecanemab-irmb subcutaneous autoinjector) as an initiation dose for the treatment

Biotechnology & Pharmaceuticals/

of early Alzheimer’s disease. This subcutaneous (SC) administration option is an Medical Technologies & Services

alternative to intravenous (IV) administration, with two 250mg injections (500mg AC Seiji Wakao, Ph.D.

in total) administered once weekly approved as the initiation regimen. LEQEMBI

(81-3) 6736-8612

IQLIK may also be used for maintenance dosing at 360mg once weekly after 18 seiji.wakao@jpmorgan.com

months of the initiation regimen. LEQEMBI IQLIK is scheduled to be launched Yugo R. Kamimura, Ph.D.

in the US in late August 2026 and will be available through specialty pharmacies (81-3) 6736-8635

(pharmacies that handle specialty drugs). As the approval was expected, we view yugo.kamimura@jpmorgan.com

the implications for the share price as neutral. Naoko Saito

(81-3) 6736-8693

• Future focal points: FDA approval was received more than one month before naoko.saito@jpmorgan.com

the PDUFA date of August 24, but this was not surprising as Eisai had expected JPMorgan Securities Japan Co., Ltd.

to receive approval prior to the PDUFA date. The point to watch going forward

is whether the approval of Leqembi IQLIK as an initiation therapy will improve

the sales trend. Guidance for Leqembi sales in the US in FY2026 is $507

million (JPM estimate $496 million, Bloomberg consensus $492 million). As