OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) will present additional data from the Phase 2b trials (TAK-861-2001,TAK-861-2002) and long-term extension (LTE) study (TAK-861-2003) of TAK-861 in narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2) at Sleep Europe 2024, the 27th Congress of the European Sleep Research Society (ESRS), being held September 24-27, 2024 in Seville, Spain.

日本大阪和马萨诸塞州剑桥市。-（商业新闻短讯）--武田（东京证交所：4502/纽约证交所：TAK）将在2024年9月24日至27日在西班牙塞维利亚举行的欧洲睡眠研究学会（ESRS）第27届大会上，提供2b期试验（TAK-861-2001，TAK-861-2002）和TAK-861长期延伸（LTE）研究（TAK-861-2003）在发作性睡病1型（NT1）和发作性睡病2型（NT2）中的额外数据。

TAK-861 is an investigational oral orexin receptor 2 (OX2R) selective-agonist designed to address the orexin deficiency in NT1 by selectively stimulating the orexin receptor 2. TAK-861 has the potential to be the first treatment to address the underlying pathophysiology of NT1. Based on the positive Phase 2b trial results, Takeda has initiated the FirstLight Study, a global Phase 3 trial evaluating the efficacy and safety of TAK-861 in adults with NT1..

TAK-861是一种研究性口服食欲素受体2（OX2R）选择性激动剂，旨在通过选择性刺激食欲素受体2来解决NT1中的食欲素缺乏症。TAK-861有可能成为解决NT1潜在病理生理学的第一种治疗方法。基于2b期试验的阳性结果，武田启动了FirstLight研究，这是一项全球3期试验，评估TAK-861在NT1成人中的疗效和安全性。。

Takeda’s scientific presentations will include a podium presentation highlighting the effect of TAK-861 on cognitive impairment (Abstract No: 781) along with several poster presentations from additional exploratory endpoints including impacts on quality of nocturnal sleep and sustained attention. An interim analysis of safety and efficacy from the ongoing LTE study (Poster No: P1291) will also be presented..

武田的科学演讲将包括一个讲台演讲，强调TAK-861对认知障碍的影响（摘要编号：781），以及其他探索性终点的几张海报演讲，包括对夜间睡眠质量和持续注意力的影响。还将介绍正在进行的LTE研究（海报编号：P1291）的安全性和有效性中期分析。。

“People living with narcolepsy suffer from debilitating symptoms that significantly impact their daily life beyond excessive daytime sleepiness and cataplexy,” said Elena Koundourakis, head, orexin franchise development & neuroscience programs and portfolio strategy at Takeda. “As leaders in orexin science, we continue to develop one of the most extensive clinical datasets of orexin agonists, with some patients reaching one year of treatment within our clinical studies.

武田orexin特许经营发展与神经科学项目和投资组合策略负责人Elena Koundourakis说：“嗜睡症患者会出现虚弱的症状，这些症状会严重影响他们的日常生活，而不仅仅是白天过度嗜睡和瘫痪。”。“作为食欲素科学的领导者，我们继续开发食欲素激动剂最广泛的临床数据集之一，一些患者在我们的临床研究中达到了一年的治疗。

The data we are presenting at Sleep Europe add to the body of orexin agonist data we are building to improve our understanding of orexin biology and the potential of our investigative study drug TAK-861 towards establishing a new standard of care for the NT1 community.”.

我们在Sleep Europe上提供的数据增加了我们正在构建的食欲素激动剂数据的主体，以提高我们对食欲素生物学的理解，以及我们的研究性研究药物TAK-861在为NT1社区建立新的护理标准方面的潜力。”。

These data presentations add to the scientific community's growing understanding of the potential of OX2R agonists in redefining treatment outcomes for patients with NT1. Takeda is continuing the development of tailored assets to address the needs of people living with sleep-wake disorders including narcolepsy type 2 and idiopathic hypersomnia..

这些数据介绍增加了科学界对OX2R激动剂在重新定义NT1患者治疗结果方面的潜力的日益了解。武田正在继续开发量身定制的资产，以满足患有睡眠-觉醒障碍（包括2型嗜睡症和特发性嗜睡症）的人的需求。。

More information on the FirstLight Study, which is currently enrolling, can be found at www.clinicaltrials.gov (identifier: NCT06470828) and www.firstlightstudy.com (for U.S. Audiences only). Takeda does not have any approved therapies for narcolepsy.

有关目前正在注册的FirstLight研究的更多信息，请访问www.clinicaltrials.gov（标识符：NCT06470828）和www.firstlightstudy.com（仅限美国观众）。武田没有任何批准的嗜睡症治疗方法。

About Takeda’s Orexin Agonists for Sleep-Wake Disorders

关于武田的食欲素激动剂治疗睡眠-觉醒障碍

Takeda is advancing the field of orexin therapeutics with a multi-asset franchise offering tailored treatments to unlock the full potential of orexin science. Orexin is a key regulator of the sleep-wake cycle and is involved in other essential functions, including respiration and metabolism. TAK-861 is the leading program in this franchise and received Breakthrough Therapy designation for the treatment of excessive daytime sleepiness in narcolepsy type 1 from the U.S.

武田正在推进食欲素治疗领域，拥有多资产特许经营权，提供量身定制的治疗方法，以释放食欲素科学的全部潜力。食欲素是睡眠-觉醒周期的关键调节剂，并参与其他基本功能，包括呼吸和代谢。TAK-861是该系列中的领先项目，并从美国获得了突破性治疗指定，用于治疗1型嗜睡症的白天过度嗜睡。

Food and Drug Administration (FDA). The company is also progressing orexin agonists in patient populations with normal levels of orexin neuropeptides and other indications where orexin biology is implicated. This includes TAK-360, an oral OX2R agonist being investigated for narcolepsy type 2 and idiopathic hypersomnia, which recently initiated a Phase 1 trial and received Fast Track designation from the FDA..

美国食品和药物管理局（FDA）。该公司还在食欲素神经肽水平正常的患者人群和涉及食欲素生物学的其他适应症中开发食欲素激动剂。这包括TAK-360，一种正在研究2型发作性睡病和特发性嗜睡的口服OX2R激动剂，最近启动了一项1期试验，并获得了FDA的快速通道指定。。

About Takeda

关于武田

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines.

武田致力于为人们创造更好的健康，为世界创造更美好的未来。我们的目标是在我们的核心治疗和业务领域发现并提供改变生命的治疗方法，包括胃肠道和炎症、罕见疾病、血浆衍生疗法、肿瘤学、神经科学和疫苗。

Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet.

与我们的合作伙伴一起，我们的目标是通过我们动态多样的渠道改善患者体验，并推进治疗选择的新前沿。作为总部位于日本的领先的基于价值观、研发驱动的生物制药公司，我们以对患者、人民和地球的承诺为指导。

Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com..

我们在大约80个国家和地区的员工是由我们的目标驱动的，并以两个多世纪以来定义我们的价值观为基础。有关更多信息，请访问www.takeda.com。。

Important Notice

重要注意事项

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction.

就本通知而言，“新闻稿”是指武田制药有限公司（“武田”）就本新闻稿讨论或分发的本文件、任何口头陈述、任何问答环节以及任何书面或口头材料。本新闻稿（包括任何口头简报以及与之相关的任何问题和答案）不打算，也不构成、代表或构成在任何司法管辖区内购买、以其他方式获取、认购、交换、出售或以其他方式处置任何证券的任何要约、邀请或邀约的一部分，也不构成任何投票或批准的邀约、邀请或邀约的一部分。

No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction).

。除非根据经修订的《1933年美国证券法》进行登记或获得豁免，否则不得在美国发行证券。本新闻稿（连同可能向接收方提供的任何进一步信息）的发布条件是，该新闻稿仅供接收方用于信息目的（而非用于评估任何投资、收购、处置或任何其他交易）。

Any failure to comply with these restrictions may constitute a violation of applicable securities laws..

任何不遵守这些限制的行为都可能构成对适用证券法的违反。。

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them.

武田直接和间接拥有投资的公司是独立的实体。在本新闻稿中，通常提及武田及其子公司时，“武田”有时是为了方便起见。同样，“我们”、“我们”和“我们的”也用于指代一般的子公司或为其工作的人。

These expressions are also used where no useful purpose is served by identifying the particular company or companies..

如果识别特定公司没有任何有用的目的，也可以使用这些表达。。

Forward-Looking Statements

前瞻性声明

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof.

本新闻稿和与本新闻稿相关的任何材料可能包含有关武田未来业务、未来地位和经营成果的前瞻性声明、信念或意见，包括武田的估计、预测、目标和计划。不受限制，前瞻性陈述通常包括“目标”、“计划”、“相信”、“希望”、“继续”、“期望”、“目标”、“意图”、“确保”、“将”、“可能”、“应该”、“将”、“可能”、“预期”、“估计”、“项目”或类似表达或其负面含义。

These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to div.

这些前瞻性陈述基于对许多重要因素的假设，包括以下因素，这些因素可能导致实际结果与前瞻性陈述中明示或暗示的结果产生重大差异：围绕武田全球业务的经济情况，包括日本和美国的一般经济状况；竞争压力和发展；适用法律法规的变更，包括全球医疗保健改革；新产品开发固有的挑战，包括临床成功的不确定性以及监管机构的决策及其时间安排；新产品和现有产品商业成功的不确定性；制造困难或延误；利率和货币汇率波动；关于上市产品或候选产品的安全性或有效性的索赔或担忧；；与被收购公司进行并购后整合的时机和影响；潜水的能力。

Medical Information

医疗信息

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development..

本新闻稿包含的产品信息可能并非在所有国家都可用，也可能以不同商标、不同适应症、不同剂量或不同强度提供。此处所含内容不应视为任何处方药（包括正在开发的处方药）的招揽、促销或广告。。