Nippon Shinyaku (4516) AdCom disclosed meeting materials for deramiocel, FDA’s rigorous stance confirmed

研报英文原文证据摘录

Nippon Shinyaku (4516) AdCom disclosed meeting materials for deramiocel, FDA’s rigorous stance confirmed

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

28 July 2026

Nippon Shinyaku (4516) Neutral

4516.T, 4516 JP

AdCom disclosed meeting materials for deramiocel, Price (27 Jul 26):¥4,079

FDA’s rigorous stance confirmed Price Target (Dec-26):¥4,000

On July 27, the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee Japan Equity Research

(AdCom) released materials for the deramiocel meeting, which is scheduled for

Biotechnology & Pharmaceuticals/

July 29 (09:30-16:50 local time, 22:30 July 29 to 05:50 July 30 Japan time). At the Medical Technologies & Services

AdCom meeting, two points will be discussed regarding the efficacy of AC Seiji Wakao, Ph.D.

Deramiocel: (1) whether the HOPE-3 trial’s left ventricular ejection fraction

(81-3) 6736-8612

(LVEF) results provide sufficient evidence of slowing Duchenne muscular seiji.wakao@jpmorgan.com

dystrophy (DMD) cardiomyopathy progression, and (2) whether the combined Yugo R. Kamimura, Ph.D.

skeletal muscle function (performance of the upper limb: PUL) and cardiac (81-3) 6736-8635

function data from HOPE-3 support deramiocel’s efficacy as a treatment for DMD yugo.kamimura@jpmorgan.com

cardiomyopathy. Based on these discussions, a final vote will be made on whether Naoko Saito

the HOPE-3 trial provided substantial evidence of deramiocel’s efficacy for DMD (81-3) 6736-8693

cardiomyopathy. The proposed indication and the final voting question for this naoko.saito@jpmorgan.com

application focus on DMD cardiomyopathy. While PUL is a primary endpoint, the JPMorgan Securities Japan Co., Ltd.

main criterion for approval is efficacy against cardiomyopathy.