The Ministry of Health, Labour and Welfare in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled with existing therapy.

日本厚生劳动省已授予Dupixent（dupilumab）用于治疗现有疗法控制不佳的成人慢性阻塞性肺疾病（COPD）的上市和生产许可。

The approval in Japan was based on data from the landmark

在日本的批准是基于具有里程碑意义的数据

BOREAS

北风

phase 3 study. The study evaluated Dupixent added to background maximal standard-of-care inhaled therapy (with nearly all patients on triple therapy or double therapy if inhaled corticosteroids were contraindicated) in adults with uncontrolled COPD and elevated blood eosinophils. In the study, Dupixent significantly reduced exacerbations and improved lung function compared to placebo.

第三阶段研究。该研究评估了在背景最大标准护理吸入疗法（几乎所有患者都采用三联疗法，或者如果吸入性糖皮质激素禁忌，则采用双联疗法）基础上加用Dupixent的情况，研究对象为未控制的慢性阻塞性肺病（COPD）且血液嗜酸性粒细胞升高成年患者。在研究中，与安慰剂相比，Dupixent显著减少了急性加重并改善了肺功能。

Safety results in the study were generally consistent with the known safety profile of Dupixent in its approved indications. The most commonly reported adverse event with Dupixent was injection site reaction. Results from BOREAS and the replicate .

研究中的安全结果通常与Dupixent在其获批适应症中已知的安全性特征一致。Dupixent最常见的不良事件是注射部位反应。BOREAS研究及其重复研究的结果显示。

In addition to COPD, Dupixent is approved in Japan in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis, and chronic spontaneous urticaria (CSU). Dupixent for the treatment of COPD has been approved in more than 45 countries worldwide, including the 27 member countries of the EU..

除了慢性阻塞性肺病（COPD）外，Dupixent在日本还被批准用于某些特应性皮炎、哮喘、伴鼻息肉的慢性鼻窦炎（CRSwNP）、结节性瘙痒症和慢性自发性荨麻疹（CSU）患者。Dupixent用于治疗COPD已在包括欧盟27个成员国在内的全球45多个国家获得批准。

About COPD

关于慢性阻塞性肺病

COPD is a chronic respiratory disease that damages the lungs and causes progressive lung function decline and is the fourth leading cause of death worldwide. Symptoms include persistent cough, excessive mucus production, and shortness of breath that may impair the ability to perform routine daily activities, which may lead to sleep disturbances, anxiety, and depression.

慢性阻塞性肺疾病（COPD）是一种损害肺部并导致肺功能逐渐下降的慢性呼吸系统疾病，是全球第四大死亡原因。症状包括持续咳嗽、过多痰液分泌和呼吸急促，可能影响进行日常活动的能力，进而导致睡眠障碍、焦虑和抑郁。

COPD is also associated with a significant health and economic burden due to recurrent acute exacerbations that require systemic corticosteroid medicine and/or antibiotics. Smoking and exposure to noxious inhaled particles are key risk factors for COPD, and even individuals who stop smoking can still have progressive lung disease.

慢性阻塞性肺疾病还与反复急性加重相关的显著健康和经济负担有关，这些急性加重需要使用全身性皮质类固醇药物和/或抗生素。吸烟和接触有害吸入颗粒物是慢性阻塞性肺疾病的关键风险因素，即使戒烟者仍可能患有进行性肺病。

About half of COPD patients continue to experience exacerbations despite being on triple inhaled therapy. Patients with COPD and elevated eosinophils have an increased risk of exacerbations and COPD-related hospitalizations within a year..

约一半的慢阻肺患者尽管接受了三联吸入治疗，仍然会经历病情加重。慢阻肺患者如果嗜酸性粒细胞升高，在一年内病情加重和因慢阻肺相关住院的风险会增加。

About Sanofi and Regeneron’s COPD clinical research program

关于赛诺菲和再生元的COPD临床研究计划

Sanofi and Regeneron are motivated to transform the treatment paradigm of COPD by examining the role different types of inflammation play in the disease progression through the clinical assessment of two biologics, Dupixent and itepekimab.

赛诺菲和再生元公司致力于通过临床评估两种生物制剂（Dupixent和itepekimab），研究不同类型的炎症在疾病进展中的作用，从而改变COPD的治疗模式。

Dupixent is a first-in-class biologic that inhibits the signaling of the interleukin-4 (IL4) and interleukin-13 (IL13) pathways and the program focuses on a specific population of people with evidence of type-2 inflammation. Itepekimab is a fully human monoclonal antibody that binds to and inhibits interleukin-33 (IL33), an initiator and amplifier of broad inflammation in COPD..

Dupixent 是一种首创的生物制剂，能够抑制白细胞介素-4 (IL4) 和白细胞介素-13 (IL13) 信号通路，该计划专注于有2型炎症证据的特定人群。Itepekimab 是一种全人源单克隆抗体，可与白细胞介素-33 (IL33) 结合并抑制其作用，IL33 是慢性阻塞性肺疾病 (COPD) 中广泛炎症的启动因子和放大因子。

Itepekimab is currently under clinical investigation for COPD in two phase 3 studies and its safety and efficacy have not been evaluated by any regulatory authority.

Itepekimab目前正在进行两项针对COPD的三期临床研究，其安全性和有效性尚未得到任何监管机构的评估。

About Dupixent

关于Dupixent

Dupixent (dupilumab) is available in Japan in a 300 mg dose as a pre-filled syringe or pre-filled pen and is now available for COPD. Dupixent is intended for injection under the skin (subcutaneous injection) and is given every other week. It can be given in a clinic or at home by self-administration after training by a healthcare professional..

Dupixent（dupilumab）在日本有300毫克剂量的预充式注射器或预充式笔供应，现在也可用于慢性阻塞性肺病（COPD）。Dupixent 旨在通过皮下注射给药，每两周一次。经过医疗专业人员的培训后，可以在诊所或在家自行注射。

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the IL4 and IL13 pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type-2 inflammation in phase 3 studies, establishing that IL4 and IL13 are two of the key and central drivers of the type-2 inflammation that plays a major role in multiple related and often co-morbid diseases..

Dupixent是一种全人源单克隆抗体，可抑制IL-4和IL-13通路的信号传导，并非免疫抑制剂。Dupixent的开发项目在三期研究中显示出显著的临床益处并降低了2型炎症，证实了IL-4和IL-13是2型炎症的关键驱动因素，而这种炎症在多种相关且常为共病的疾病中起主要作用。

Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, CRSwNP, eosinophilic esophagitis, prurigo nodularis, CSU, and COPD in different age populations. More than one million patients are being treated with Dupixent globally..

Dupixent 已在 60 多个国家获得监管批准，适用于一个或多个适应症，包括特定的特应性皮炎、哮喘、伴鼻息肉的慢性鼻窦炎 (CRSwNP)、嗜酸性食管炎、结节性瘙痒症、慢性自发性荨麻疹 (CSU) 和慢性阻塞性肺病 (COPD) 的不同年龄人群。全球已有超过一百万名患者正在接受 Dupixent 的治疗。

Dupilumab development program

Dupilumab开发计划

Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been assessed across more than 60 clinical studies involving more than 10,000 patients with various chronic diseases driven in part by type-2 inflammation.

根据全球合作协议，Dupilumab正由赛诺菲和再生元联合开发。迄今为止，dupilumab已经在60多项临床研究中进行了评估，涉及10,000多名部分由2型炎症引发的各种慢性疾病患者。

In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type-2 inflammation or other allergic processes in phase 3 studies, including chronic pruritus of unknown origin, bullous pemphigoid, and lichen simplex chronicus. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority..

除了目前获批的适应症外，赛诺菲和再生元公司还在3期临床研究中评估度普利尤单抗对一系列由2型炎症或其他过敏过程驱动的疾病的效果，包括不明原因的慢性瘙痒、大疱性类天疱疮和慢性单纯性苔藓。这些度普利尤单抗的潜在用途目前正在临床研究中，其在这些疾病中的安全性和有效性尚未得到任何监管机构的全面评估。

About Regeneron

关于再生元

Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories.

再生元公司（纳斯达克代码：REGN）是一家领先的生物技术公司，致力于为患有严重疾病的患者发明、开发和商业化改变生命的药物。公司由医生科学家创立并领导，我们独特的能力在于能够反复且持续地将科学转化为医学成果，目前已推出众多获批疗法，并有多个在研产品候选药物，其中大多数是在我们实验室自主研发的。

Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases..

我们的药物和研发管线旨在帮助患有眼疾、过敏性和炎症性疾病、癌症、心血管和代谢疾病、神经疾病、血液病、传染病和罕见病的患者。

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as

Regeneron利用我们的专有技术，如[具体技术]，推动科学发现的边界，加速药物开发。

VelociSuite

极速套件

which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center

这使得我们能够生产优化的全人源抗体和新型双特异性抗体。我们正在利用再生元遗传学中心的数据驱动洞察力，塑造医学的下一个前沿。

and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

开创性的基因药物平台，使我们能够识别创新靶点和互补方法，有望治疗或治愈疾病。

About Sanofi

关于赛诺菲

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions..

我们是一家创新的全球医疗保健公司，由一个目标驱动：我们追逐科学的奇迹以改善人们的生活。我们的团队遍布全球，致力于通过努力将不可能变为可能来改变医学实践。我们为全球数百万人提供可能改变生命的治疗选择和拯救生命疫苗保护，同时将可持续发展和社会责任置于我们志向的核心。