EN
登录

盐野义制药获得国内生产和销售批准,用于治疗小儿注意力缺陷/多动障碍(ADHD)的数字治疗应用程序“ENDEAVORRIDE®”

Shionogi Obtains Domestic Manufacturing and Marketing Approval for the Digital Therapeutic App "ENDEAVORRIDE®" for Pediatric Attention-Deficit/Hyperactivity Disorder (ADHD)

盐野义 等信源发布 2025-02-18 14:34

可切换为仅中文


OSAKA, Japan, February 18, 2025

日本大阪,2025年2月18日

- Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter 'Shionogi') is pleased to announce that it has obtained manufacturing and marketing approval in Japan for the digital therapeutic app 'ENDEAVORRIDE

日本盐野义制药株式会社(总部:日本大阪;首席执行官:手代木功博士;以下简称“盐野义”)欣然宣布,其数字治疗应用“ENDEAVORRIDE”已获得日本的生产和销售许可。

®

®

' (Development Code: SDT-001; hereinafter 'ENDEAVORRIDE') as of [February 13, 2025]. This app was developed by Akili, Inc. (Headquarters: Washington, USA; CEO: Dan Elenbaas; hereinafter 'Akili'), from which Shionogi has acquired exclusive development and commercialization rights for Japan and Taiwan.

(开发代码:SDT-001;以下简称“ENDEAVORRIDE”)截至[2025年2月13日]。该应用程序由Akili, Inc.(总部:美国华盛顿;首席执行官:Dan Elenbaas;以下简称“Akili”)开发,盐野义制药已获得其在日本和台湾的独家开发和商业化权利。

1

1

.

ENDEAVORRIDE is a digital therapeutic app designed for pediatric patients with attention-deficit/hyperactivity disorder (ADHD). Based on the favorable results of a Phase 3 clinical trial conducted in Japan

ENDEAVORRIDE 是一款专为注意力缺陷/多动障碍(ADHD)儿童患者设计的数字治疗应用程序。基于在日本进行的第三阶段临床试验的良好结果。

2

2

, the app has been approved as an adjunctive therapy for pediatric ADHD. In Japan, therapeutic apps designed to promote behavioral changes have been available for patients with nicotine dependence and hypertension. However, ENDEAVORRIDE is the first therapeutic app in the country specifically developed for pediatric patients with ADHD.

,该应用程序已被批准作为儿科ADHD的辅助治疗。在日本,旨在促进行为改变的治疗应用程序已经可供尼古丁依赖和高血压患者使用。然而,ENDEAVORRIDE是该国首个专门为患有多动症的儿童患者开发的治疗应用程序。

Moving forward, the availability of digital therapeutics, alongside psychosocial interventions such as counseling and pharmacological treatments, is expected to provide a new treatment option, contributing to symptom improvement and enhanced treatment satisfaction for pediatric ADHD patients..

预计随着数字疗法的出现,以及心理社会干预(如咨询)和药物治疗,将为儿科ADHD患者提供一种新的治疗选择,有助于症状改善和提高治疗满意度。

Shionogi is committed to realizing the SHIONOGI Group Vision of 'Building Innovation Platforms to Shape the Future of Healthcare' by transforming into a 'Healthcare as a Service (HaaS)' company. While enhancing our strengths as a research-based pharmaceutical company, we aim to provide diverse treatment options beyond medicinal products, including collaborations with external partners, to contribute to improving the quality of life for patients and their families..

盐野义制药致力于通过转型为“健康服务(HaaS)”公司,实现SHIONOGI集团的愿景——“构建创新平台,塑造医疗保健的未来”。在强化我们作为一家研发型制药公司的优势的同时,我们旨在提供包括与外部合作伙伴协作在内的多样化治疗选择,超越药物产品,为改善患者及其家人的生活质量做出贡献。

【About ENDEAVORRIDE】

【关于ENDEAVORRIDE】

ENDEAVORRIDE is a digital therapeutic app targeting pediatric ADHD that is expected to improve symptoms of ADHD by engaging through smartphones and tablets. Based on the Akili Selective Stimulus Management Engine (SSME

ENDEAVORRIDE 是一款针对儿童 ADHD 的数字治疗应用程序,通过智能手机和平板电脑的互动,有望改善 ADHD 症状。该应用基于 Akili 选择性刺激管理引擎 (SSME)。

TM

商标

) core technology, ENDEAVORRIDE is designed to activate the brain's prefrontal cortex, which plays a crucial role in cognitive function. SSME

)核心技术,ENDEAVORRIDE旨在激活大脑的前额叶皮层,这对认知功能起着至关重要的作用。SSME

TM

商标

stimulates the cerebral cortex by performing optimized dual tasks for each patient, aiming to improve inattention, hyperactivity, and impulsivity in patients.

通过为每位患者执行优化的双重任务来刺激大脑皮层,旨在改善患者的注意力不集中、多动和冲动。

【About Akili】

【关于Akili】

Akili is a company dedicated to developing digital therapeutic apps and advancing their application to medical innovation through innovative technology. Utilizing technology that directly targets the brain, Akili continues to approach new medicine validated through clinical trials, such as high-quality digital therapeutic apps and medical devices.

Akili是一家致力于开发数字治疗应用程序,并通过创新技术推动其在医疗创新中的应用的公司。利用直接针对大脑的技术,Akili不断通过临床试验验证的新医学方法,例如高质量的数字治疗应用程序和医疗器械。

Akili has obtained authorization from the U.S. Food and Drug Administration (FDA) for the world's first digital therapeutic app for improving inattention symptoms in pediatric ADHD patients aged 8-17, sold in the U.S. under the product name EndeavorRx.

Akili已经获得了美国食品和药物管理局(FDA)的授权,推出了全球首款用于改善8-17岁儿科ADHD患者注意力不集中症状的数字治疗应用程序,并在美国以产品名称EndeavorRx销售。