OSAKA, Japan, December 19, 2024 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter 'Shionogi') and Nxera Pharma Co., Ltd.（Head office: Tokyo, Chief Executive Officer: Christopher Cargill, hereafter ”Nxera Pharma”) announced that QUVIVIQ™ (daridorexant) 25 and 50 mg has been launched and is now available in Japan as a new treatment for adults with insomnia..

2024年12月19日，日本大阪-Shionogi＆Co.，Ltd.（总部：日本大阪；首席执行官：Isao Teshirogi博士；以下简称“Shionogi”）和Nxera Pharma Co.，Ltd.（总部：东京，首席执行官：Christopher Cargill，以下简称“Nxera Pharma”）宣布，QuviviIQ™（daridorexant）25和50 mg已在日本上市，目前可作为成人失眠的新疗法。。

QUVIVIQ™ is an oral Dual Orexin Receptor Antagonist for the treatment of insomnia that selectively binds to receptors of the wake-promoting neuropeptide orexin (OX1R and OX2R), inhibiting excessive wakefulness and facilitating the transition to sleep.

QUVIVIQ™是一种用于治疗失眠的口服双食欲素受体拮抗剂，可选择性结合促醒神经肽食欲素（OX1R和OX2R）的受体，抑制过度觉醒并促进睡眠过渡。

Shionogi will be solely responsible for distribution and sales activities for QUVIVIQ™ in Japan under the commercial partnership agreement with Nxera Pharma announced on 1 October 2024. Nxera Pharma Japan Co., Ltd. (a wholly owned subsidiary of Nxera Pharma) is the approval holder and will be responsible in part for provision of drug product1,2..

Shionogi将根据2024年10月1日宣布的与Nxera Pharma的商业合作协议，全权负责QUVIVIQ™在日本的分销和销售活动。Nxera Pharma Japan Co.，Ltd.（Nxera Pharma的全资子公司）是批准持有人，将部分负责提供药品1,2。。

For Nxera, reaching this important milestone highlights its ability to develop novel therapeutics for patients in Japan and reinforces its ambition to be a partner of choice for companies looking to develop and commercialize new therapeutics for the Japanese market.

对于 Nxera 而言，达到这一重要里程碑彰显了其为日本患者开发新型疗法的能力，并坚定了其成为那些希望为日本市场开发和商业化新疗法的公司首选合作伙伴的雄心壮志。

As a new pillar, Shionogi is focusing on the 'QOL disease area,' which is less affected by trends. Starting with the launch of QUVIVIQTM, we are working to strengthen the 'QOL disease area' as a solid pillar

作为一个新的支柱，Shionogi专注于“QOL疾病领域”，该领域受趋势影响较小。从推出QUVIVIQTM开始，我们正在努力加强“生活质量疾病领域”作为一个坚实的支柱

Together, Nxera and Shionogi are committed to deliver QUVIVIQ™ as quickly as possible as a product that has the potential to meet the needs of insomnia patients for a long time to come.

Nxera和Shionogi共同致力于尽快提供QUVIVIQ™产品，该产品有可能在未来很长一段时间内满足失眠患者的需求。

QUVIVIQ™ (daridorexant) is a dual orexin receptor antagonist, discovered by Idorsia Pharmaceuticals Ltd, that blocks the binding and activity of the wake-promoting neuropeptides known as orexins. In October 2022, daridorexant achieved positive Phase 3 top-line results in Japanese patients with insomnia and Nxera Pharma Japan has obtained the manufacturing and marketing approval in Japan for QUVIVIQTM as a treatment for adult patients with insomnia, as of September 24, 2024*.

QUVIVIQ™（daridorexant）是一种双重食欲素受体拮抗剂，由Idorsia Pharmaceuticals Ltd发现，可阻断称为食欲素的促醒神经肽的结合和活性。2022年10月，daridorexant在日本失眠症患者中取得了积极的3期顶线结果，截至2024年9月24日，Nxera Pharma Japan已获得日本制造和销售QUVIVIQTM的批准，用于治疗成年失眠症患者*。

Daridorexant is approved in the US, Europe and Canada, and marketed in these territories under the brand name QUVIVIQ™ by Idorsia Pharmaceuticals Ltd..

Daridorexant在美国、欧洲和加拿大获得批准，并由Idorsia Pharmaceuticals Ltd以QUVIVIQ™品牌在这些地区销售。

About Insomnia Disorder

关于失眠障碍

Insomnia disorder is defined as difficulty initiating or maintaining sleep, causing clinically significant distress or impairment in important areas of daytime functioning. As defined this impact on sleep quantity or quality should be present for at least three nights per week, lasts for at least three months, and occurs despite an adequate opportunity to sleep..

失眠障碍被定义为难以启动或维持睡眠，在白天功能的重要区域引起临床上显着的痛苦或损害。根据定义，这种对睡眠数量或质量的影响应该每周至少出现三个晚上，持续至少三个月，并且在有足够的睡眠机会的情况下发生。。

Insomnia is a condition of overactive wake signaling and studies have shown that areas of the brain associated with wakefulness remain more active during sleep in patients with insomnia. According to a survey by Japan’s Ministry of Health, Labour and Welfare in 2018, about 20% of Japanese adults struggle to get enough rest from sleep..

失眠是一种过度活跃的唤醒信号，研究表明，失眠患者在睡眠期间，与清醒相关的大脑区域保持更活跃。根据日本厚生劳动省2018年的一项调查，约20%的日本成年人难以从睡眠中获得足够的休息。。

Insomnia as a disorder is quite different from a brief period of poor sleep, and it can take its toll on both physical and mental health. It is a persistent condition with a negative impact on daytime functioning. Research has shown that poor quality sleep can affect many aspects of daily life, including the ability to concentrate, mood, and energy levels..

失眠作为一种疾病，与短暂的睡眠不足完全不同，它可能会损害身心健康。这是一种持续性疾病，对白天的功能产生负面影响。研究表明，睡眠质量差会影响日常生活的许多方面，包括注意力、情绪和能量水平。。

The goal of treatments for insomnia is to improve sleep quality and quantity, as well as daytime functioning, while avoiding adverse events and next-morning residual effects. Current recommended treatment of insomnia includes sleep hygiene therapy, cognitive behavioral therapy, and pharmacotherapy.

失眠治疗的目标是改善睡眠质量和数量，以及白天的功能，同时避免不良事件和第二天早上的残留影响。目前推荐的失眠治疗方法包括睡眠卫生疗法、认知行为疗法和药物疗法。

About Shionogi

关于Shionogi

Shionogi strives constantly to supply the best possible medicine (healthcare solutions) to protect the health and wellbeing of the patients we serve, and as a united group. We have identified Contributing to a Healthy and Prosperous Life as a material focus. We are committed to creating a society where everyone can lead a longer, more vibrant life, realizing their goals..

Shionogi作为一个团结的团队，不断努力提供尽可能最好的药物（医疗保健解决方案），以保护我们服务的患者的健康和福祉。我们已将促进健康和繁荣的生活确定为物质重点。我们致力于创建一个每个人都可以过上更长、更有活力的生活，实现自己目标的社会。。

For more information, please visit https://www.shionogi.com/global/en/

有关更多信息，请访问https://www.shionogi.com/global/en/

About Nxera Pharma

关于Nxera Pharma

Nxera Pharma (formerly Sosei Heptares) is a technology powered biopharma company, in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally. For more information, please visit www.nxera.life

Nxera Pharma（前身为Sosei Heptares）是一家以技术为动力的生物制药公司，致力于开发新的专业药物，以改善日本和全球需求未得到满足的患者的生活。有关更多信息，请访问www.nxera.life