The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Dupixent (dupilumab) in the EU for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents. This recommendation covers those aged 12 years and above with moderate to severe disease, with inadequate response to histamine-1 antihistamines (H1AH), and who are naive to anti-immunoglobulin E (IgE) therapy.

欧洲药品管理局人用药品委员会 (CHMP) 已采纳积极意见，推荐在欧盟批准 Dupixent（dupilumab）用于治疗成人和青少年的慢性自发性荨麻疹 (CSU)。该建议涵盖 12 岁及以上中至重度疾病患者，这些患者对组胺-1 抗组胺药 (H1AH) 反应不足，并且未曾接受过抗免疫球蛋白 E (IgE) 疗法。

A final decision is expected in the coming months..

预计将在未来几个月内做出最终决定。

The positive CHMP opinion is supported by data from two studies in the LIBERTY-CUPID phase 3 program (NCT04180488;

CHMP的积极意见得到了LIBERTY-CUPID 3期项目（NCT04180488）中的两项研究数据的支持；

Study A

研究 A

and

和

Study C

研究 C

), both of which demonstrated Dupixent significantly reduced itch and hives at 24 weeks compared to placebo. A third study from the LIBERTY-CUPID program,

），这两项研究均表明，与安慰剂相比，Dupixent 在 24 周内显著减少了瘙痒和荨麻疹。LIBERTY-CUPID 项目的第三项研究，

Study B

研究 B

, conducted in a different CSU patient population, provided additional safety data.

在不同的CSU患者群体中进行，提供了额外的安全数据。

The safety results of the studies were generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events more commonly observed with Dupixent (≥5%) than placebo in the studies of adults and adolescents with CSU were injection site reaction, COVID-19, hypertension, CSU, and accidental overdose..

研究的安全性结果通常与Dupixent在其已批准适应症中已知的安全性特征一致。在针对成人和青少年CSU患者的研究中，较安慰剂组更常观察到的Dupixent不良事件（≥5%）包括注射部位反应、COVID-19、高血压、CSU以及意外过量。

Dupixent is approved for CSU in certain adults and adolescents in several countries including Japan and the US. Outside of approved jurisdictions, the safety and efficacy of Dupixent for CSU has not been fully evaluated by any regulatory authority.

Dupixent 在包括日本和美国在内的几个国家已被批准用于某些成年人和青少年的慢性自发性荨麻疹（CSU）。在获批地区之外，任何监管机构均未完全评估 Dupixent 对于 CSU 的安全性和有效性。

About CSU

关于CSU

CSU is a chronic, inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and recurring itch. CSU is typically treated with H1AH, medicines that target H1 receptors on cells to control symptoms of itch and urticaria. However, the disease remains uncontrolled despite H1AH treatment in many patients, some of whom are left with limited alternative treatment options.

慢性自发性荨麻疹 (CSU) 是一种由 2 型炎症部分驱动的慢性炎症性皮肤病，会导致突发和虚弱性的荨麻疹以及反复发作的瘙痒。CSU 通常使用 H1抗组胺药 (H1AH) 进行治疗，这类药物通过作用于细胞上的 H1 受体来控制瘙痒和荨麻疹症状。然而，尽管许多患者接受了 H1AH 治疗，疾病仍然未能得到控制，其中一些患者的替代治疗选择有限。

These individuals continue to experience symptoms that can be debilitating and significantly impact their quality of life..

这些个体继续经历可能令人衰弱并显著影响其生活质量的症状。

About Dupixent

关于Dupixent

Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL4) and interleukin-13 (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（dupilumab）是一种全人源单克隆抗体，能够抑制白细胞介素-4（IL-4）和白细胞介素-13（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, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, CSU, chronic obstructive pulmonary disease, and bullous pemphigoid in different age populations.

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，包括某些特应性皮炎、哮喘、伴鼻息肉的慢性鼻窦炎、嗜酸性食管炎、结节性瘙痒症、慢性自发性荨麻疹（CSU）、慢性阻塞性肺病和大疱性类天疱疮患者，覆盖不同年龄段人群。

More than one million patients are being treated with Dupixent globally..

全球有一百多万患者正在接受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 studied 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正在由赛诺菲和再生元联合开发。迄今为止，Dupilumab已经在涉及超过10,000名部分由2型炎症引起的各种慢性疾病的患者中进行了60多项临床研究。

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 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..

除了目前已批准的适应症外，赛诺菲和再生元公司正在对度普利尤单抗进行广泛的3期研究，针对由2型炎症或其他过敏过程驱动的多种疾病，包括原因不明的慢性瘙痒和慢性单纯性苔藓。这些度普利尤单抗的潜在用途目前正在临床研究中，其在这些病症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的治疗方法，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

再生元利用我们的专有技术，推动科学发现的边界，加速药物开发，例如

VelociSuite

速度套件

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

这将产生优化的全人源抗体和新型双特异性抗体。我们正在通过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.

并且开创了基因医学平台，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

Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more.

赛诺菲是一家以研发为驱动、以人工智能为助力的生物制药公司，致力于改善人们的生活并实现令人瞩目的增长。我们凭借对免疫系统的深刻理解，开发药物和疫苗，为全球数百万人提供治疗和保护，同时拥有一条创新的研发管线，有望使数百万人进一步受益。

Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time..

我们的团队以一个目标为指导：我们追逐科学的奇迹以改善人们的生活；这激励我们推动进步，通过应对当今最紧迫的医疗、环境和社会挑战，为我们的员工和所服务的社区带来积极影响。

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.

赛诺菲在 EURONEXT（欧洲证券交易所）和 NASDAQ（纳斯达克）上市，股票代码分别为 SAN 和 SNY。