Dupixent approved in the US as the only targeted medicine to treat patients with bullous pemphigoid

Dupixent在美国获批，成为唯一一种用于治疗大疱性类天疱疮患者的靶向药物。

Approval based on pivotal results showing improvements in sustained disease remission and reductions in itch and oral corticosteroid use compared to placebo in adults with BP

基于关键结果的批准显示，与安慰剂相比，BP成年患者的持续疾病缓解有所改善，瘙痒和口服皮质类固醇的使用减少。

BP is a chronic, debilitating, and relapsing rare skin disease affecting approximately 27,000 adults in the US whose disease is uncontrolled by systemic corticosteroids

BP是一种慢性、致残、反复发作的罕见皮肤病，影响美国约27,000名成人，这些患者的疾病无法通过系统性皮质类固醇得到控制。

Dupixent is now approved in the US to treat eight distinct diseases with underlying type 2 inflammation, including diseases of the skin, gut, and respiratory system that affect a broad range of patients, from infants to elderly people

Dupixent目前已在美国获批用于治疗八种不同的由2型炎症引起的疾病，包括影响皮肤、肠道和呼吸系统的疾病，患者范围广泛，从婴儿到老年人不等。

Paris and Tarrytown, NY, June 20, 2025.

巴黎和纽约塔里敦，2025年6月20日。

The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adult patients with bullous pemphigoid (BP).

美国食品和药物管理局（FDA）已批准 Dupixent（dupilumab）用于治疗患有大疱性类天疱疮（BP）的成年患者。

BP primarily affects elderly patients, and is characterized by intense itch, painful blisters, and lesions, as well as reddening of the skin. It can be chronic and relapsing with underlying type 2 inflammation. The blisters and rash can form over much of the body and cause the skin to bleed and break down, resulting in patients being more prone to infection and affecting their daily functioning.

BP主要影响老年患者，其特征是剧烈瘙痒、疼痛性水疱和病变，以及皮肤发红。它可能呈慢性复发性，并伴有潜在的2型炎症。水疱和皮疹可能遍布全身，导致皮肤出血和破损，使患者更容易感染并影响其日常功能。

Available treatment options are limited and can add to overall disease burden by suppressing a patient’s immune system..

可用的治疗方案有限，且会通过抑制患者的免疫系统增加整体疾病负担。

Patrick Dunn

帕特里克·邓恩

Executive Director, International Pemphigus and Pemphigoid Foundation

国际天疱疮和类天疱疮基金会执行董事

“People affected by bullous pemphigoid endure unrelenting itch and painful blisters that can damage the skin. Until now, these primarily elderly patients have had limited therapeutic options available, with potential side effects that have often added to their burden. The approval of Dupixent for bullous pemphigoid brings a novel treatment approach to patients and their caregivers, and we are grateful for the tireless efforts of the scientific community who helped us reach this critical milestone.”.

“受大疱性类天疱疮影响的人群常常要忍受持续的瘙痒和痛苦的水疱，这些水疱可能会损害皮肤。到目前为止，这些以老年人为主的患者可选择的治疗方法有限，并且潜在的副作用往往加重了他们的负担。Dupixent获批用于治疗大疱性类天疱疮为患者及其护理人员带来了全新的治疗方案，我们对科学界帮助我们实现这一关键里程碑的不懈努力深表感谢。”

Alyssa Johnsen, MD, PhD

艾莉莎·约翰森，医学博士，哲学博士

Global Therapeutic Area Head, Immunology and Oncology Development, Sanofi

全球治疗领域负责人，免疫学与肿瘤学开发，赛诺菲

“Until now, treating bullous pemphigoid was very challenging for elderly patients struggling with the debilitating impact of blisters and lesions, and potentially co-morbid conditions. By addressing two central drivers of the underlying type 2 inflammation that contributes to bullous pemphigoid, Dupixent is the first targeted medicine to allow patients the potential to achieve sustained remission and reduce itch.

“迄今为止，对于遭受水疱和皮损带来的衰弱影响、并可能伴有其他合并症的老年患者来说，治疗大疱性类天疱疮一直非常具有挑战性。通过针对导致大疱性类天疱疮的两种关键2型炎症驱动因素，Dupixent成为首个能让患者实现持续缓解并减轻瘙痒的靶向药物。”

This approval in the US is important for the thousands of patients living with bullous pemphigoid, and we look forward to working with regulators around the world to bring this innovative medicine to more patients in need.” .

“美国的这项批准对数千名患有大疱性类天疱疮的患者而言至关重要，我们期待与全球监管机构合作，将这种创新药物带给更多有需要的患者。”

The FDA approval is based on data from the pivotal ADEPT phase 2/3 study that evaluated the efficacy and safety of Dupixent compared to placebo in adults with moderate-to-severe BP. Patients were randomized to receive Dupixent 300 mg (n=53) or placebo (n=53) added to standard-of-care oral corticosteroids (OCS).

FDA 的批准基于关键的 ADEPT 2/3 期研究数据，该研究评估了 Dupixent 与安慰剂在中度至重度 BP 成人患者中的有效性和安全性。患者被随机分配接受 Dupixent 300 毫克（n=53）或安慰剂（n=53），同时联合标准治疗口服糖皮质激素 (OCS)。

During treatment, all patients underwent a protocol-defined OCS tapering regimen if control of disease activity was maintained. During the FDA review, the analyses were updated; the FDA-approved results at 36 weeks in the label for Dupixent compared to placebo are:.

在治疗期间，如果疾病活动得到控制，所有患者均按照方案规定的逐步减少口服糖皮质激素（OCS）的方案进行。在FDA审查期间，分析得到了更新；Dupixent在标签中36周时与安慰剂相比、经FDA批准的结果为：

18.3% of patients experienced sustained disease remission compared to 6.1% (12.2% difference; 95% confidence interval: -0.8% to 26.1%), the primary endpoint

18.3%的患者经历了持续的疾病缓解，相比之下6.1%（相差12.2%；95%置信区间：-0.8%至26.1%），这是主要终点。

38.3% of patients achieved clinically meaningful itch reduction compared to 10.5%

38.3%的患者实现了有临床意义的瘙痒减轻，而相比之下，另一组为10.5%。

Median cumulative OCS dose was 2.8 grams compared to 4.1 grams

中位累积OCS剂量为2.8克，而另一组为4.1克。

In this elderly population, the most common adverse events (≥2%) more frequently observed in patients on Dupixent compared to placebo were arthralgia, conjunctivitis, blurred vision, herpes viral infections, and keratitis. Additionally, one case of acute generalized exanthematous pustulosis was reported in one patient treated with Dupixent and zero patients treated with placebo..

在这一老年人群中，与安慰剂相比，接受Dupixent治疗的患者中最常见（≥2%）的不良事件包括关节痛、结膜炎、视力模糊、疱疹病毒感染和角膜炎。此外，在接受Dupixent治疗的患者中有1例报告了急性泛发性脓疱病，而接受安慰剂治疗的患者中则没有发生此类病例。

George D. Yancopoulos, MD, PhD

乔治·D·扬科普洛斯，医学博士，哲学博士

Board co-Chair, President, and Chief Scientific Officer at Regeneron

再生元公司的董事会联合主席、总裁兼首席科学官

“This approval extends the remarkable ability of Dupixent to transform treatment paradigms for people living with a variety of diseases with underlying type 2 inflammation, from common conditions like asthma and atopic dermatitis, to rarer ones such as eosinophilic esophagitis and prurigo nodularis, and now including bullous pemphigoid.

“此次批准进一步扩展了Dupixent对患有各种基础2型炎症疾病的患者治疗模式的显著改变能力，从哮喘和特应性皮炎等常见疾病，到嗜酸性食管炎和结节性痒疹等较罕见疾病，现在还包括大疱性类天疱疮。”

Dupixent has shown the potential to improve the most challenging effects of bullous pemphigoid, while helping some patients achieve sustained disease remission and decreased oral corticosteroid use. Additionally, this approval further reinforces the demonstrated safety profile of Dupixent in a broad age range of patients, from infants to elderly people, and across dermatological, respiratory, and gastrointestinal diseases.” .

Dupixent 已显示出改善大疱性类天疱疮最具挑战性症状的潜力，同时帮助一些患者实现持续疾病缓解并减少口服皮质类固醇的使用。此外，这一批准进一步强化了 Dupixent 在从婴儿到老年人的广泛年龄范围患者中，以及在皮肤病、呼吸系统疾病和胃肠道疾病方面已证明的安全性。

The FDA evaluated Dupixent under priority review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions. Dupixent was previously granted orphan drug designation by the FDA for BP, which applies to investigational medicines intended for the treatment of rare diseases that affect fewer than 200,000 people in the US.

美国食品药品监督管理局（FDA）对Dupixent进行了优先审查，这种审查是为那些在治疗严重疾病方面可能显著提高疗效或安全性的药物保留的。Dupixent之前还获得了FDA针对BP（大疱性类天疱疮）的孤儿药资格认定，该资格适用于在美国影响不到20万人的罕见病治疗研究药物。

Additional regulatory applications are also under review around the world, including in the EU, Japan, and China..

世界各地也在审查其他监管申请，包括欧盟、日本和中国。

About the Dupixent BP pivotal study

关于Dupixent BP关键研究

ADEPT was a randomized, phase 2/3, double-blind, placebo-controlled study evaluating the efficacy and safety of Dupixent in 106 adults with moderate-to-severe BP for a 52-week treatment period. After randomization, patients received Dupixent or placebo every two weeks after an initial loading dose, along with OCS treatment.

ADEPT 是一项随机、二期/三期、双盲、安慰剂对照研究，评估了 Dupixent 在 106 名中度至重度 BP 成人患者中的疗效和安全性，治疗周期为 52 周。随机分组后，患者在初始负荷剂量后每两周接受 Dupixent 或安慰剂治疗，同时接受 OCS 治疗。

During treatment, OCS taper was initiated after patients experienced two weeks of sustained control of disease activity. OCS tapering could start between four to six weeks after randomization and was continued if disease control was maintained, with the intent of completion by 16 weeks. After OCS tapering, patients were only treated with Dupixent or placebo for at least 20 weeks (rescue treatment could be used if required)..

在治疗期间，患者在经历两周持续疾病活动控制后开始逐渐减少OCS用量。OCS减量可以在随机分组后的四到六周之间开始，如果疾病控制得以维持，则继续减量，并计划在16周内完成。在OCS减量后，患者仅接受Dupixent或安慰剂治疗至少20周（如有需要可以使用补救治疗）。

The primary endpoint evaluated the proportion of patients achieving sustained disease remission at 36 weeks. Sustained disease remission was defined as complete clinical remission with completion of OCS taper by 16 weeks without relapse after completion of the OCS taper and no rescue therapy use during the 36-week treatment period.

主要终点评估了在36周时达到持续疾病缓解的患者比例。持续疾病缓解定义为在16周内完成OCS减量并达到完全临床缓解，且在完成OCS减量后无复发，并在36周治疗期间未使用挽救治疗。

Relapse was defined as appearance of ≥3 new lesions a month or ≥1 large lesion or urticarial plaque (>10 cm in diameter) that did not heal within a week. Rescue therapy could include treatment with high-potency topical corticosteroids, OCS (including increase of OCS dose during the taper or re-initiation of OCS after completion of the OCS taper), or systemic non-steroidal immunosuppressive medications, or immunomodulating biologics..

复发定义为每月出现≥3个新病灶，或≥1个大病灶或荨麻疹斑块（直径>10厘米），且在一周内未愈合。挽救治疗可包括使用高效外用皮质类固醇、口服皮质类固醇（OCS）（包括在减量期间增加OCS剂量或在完成OCS减量后重新开始OCS），或系统性非甾体免疫抑制药物，或免疫调节生物制剂。

Select secondary endpoints evaluated at 36 weeks included:

选择在36周评估的次要终点包括：

Proportion of patients with ≥4-point reduction in Peak Pruritus Numerical Rating Scale (scale 0-10)

在峰值瘙痒数值评分量表（0-10分）中，减少≥4分的患者比例

Total cumulative OCS dose

总累积OCS剂量

About Dupixent

关于Dupixent

Dupixent (dupilumab) is an injection administered under the skin (subcutaneous injection) at different injection sites. In adults with BP, Dupixent 300 mg is administered every other week after an initial loading dose, and in combination with a tapering course of oral corticosteroids. Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home after training by a healthcare professional..

Dupixent（dupilumab）是一种在不同注射部位进行皮下注射的药物。对于患有BP的成人，Dupixent 300 mg在初始负荷剂量后每两周给药一次，并与逐渐减量的口服皮质类固醇联合使用。Dupixent 需要在医疗专业人员的指导下使用，可以在诊所或在家由医疗专业人员培训后进行注射。

Dupixent 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 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，并且不是免疫抑制剂。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，证明了 IL-4 和 IL-13 是 2 型炎症的关键驱动因素，这种炎症在多种相关且常为共病的疾病中起主要作用。

Sanofi and Regeneron are committed to helping patients in the US who are prescribed Dupixent gain access to the medicine and receive the support they may need with the DUPIXENT

赛诺菲和再生元致力于帮助美国被处方 Dupixent 的患者获得该药物，并通过 DUPIXENT 获取他们可能需要的支持。

MyWay

我的方式

®

®

program. For more information, please call 1-844-DUPIXENT (1-844-387-4936) or visit

项目。欲了解更多信息，请拨打1-844-DUPIXENT（1-844-387-4936）或访问

www.DUPIXENT.com

www.DUPIXENT.com

.

。

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, chronic spontaneous urticaria, chronic obstructive pulmonary disease, and BP 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、结节性痒疹、慢性自发性荨麻疹、慢性阻塞性肺疾病和不同年龄人群的 BP。

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.

Dupilumab由赛诺菲和再生元根据全球合作协议共同开发。迄今为止，Dupilumab已经在涉及超过10,000名患有各种慢性疾病（部分由2型炎症驱动）患者的60多项临床研究中进行了研究。

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还在3期临床试验中研究度普利尤单抗针对多种由2型炎症或其他过敏过程驱动的疾病，包括不明原因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仍在临床研究中，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药物，目前已推出众多获批疗法及在研产品候选物，其中大部分都是在我们自己的实验室中自主研发的。

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并加速药物开发。

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

这使得我们能够生产优化的全人源抗体和新种类的双特异性抗体。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.

以及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。

For more information, please visit

更多信息，请访问

www.Regeneron.com

www.Regeneron.com

or follow Regeneron on

或关注再生元公司

LinkedIn

领英

,

，

Instagram

Instagram

,

，

Facebook

Facebook

or

或

X

X

.

。

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. 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.

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引人注目的增长。我们凭借对免疫系统的深刻理解，研发药物和疫苗，为全球数百万人提供治疗与保护，同时我们的创新研发管线有望惠及更多人群。我们的团队秉持一个使命：追寻科学的奇迹以改善人们的生活；这激励我们通过应对当今最紧迫的医疗、环境和社会挑战，推动进步并为我们服务的人群和社区带来积极影响。

.

。

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

赛诺菲在欧洲证券交易所上市，代码为SAN，在纳斯达克上市，代码为SNY。

Sanofi Media Relations

赛诺菲媒体关系

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| +1 781 249 1766 |

keita.browne@sanofi.com

keita.browne@sanofi.com

Nathalie Pham

娜塔莉·范

| +33 7 85 93 30 17 |

| +33 7 85 93 30 17 |

nathalie.pham@sanofi.com

纳塔莉·法姆@赛诺菲.com

Tarik Elgoutni

塔里克·埃尔戈特尼

| +1 617 710 3587 |

| +1 617 710 3587 |

tarik.elgoutni@sanofi.com

塔里克·埃尔古蒂尼@赛诺菲.com

Thibaud Châtelet

蒂博·沙特莱

| +33 6 80 80 89 90 |

| +33 6 80 80 89 90 |

thibaud.chatelet@sanofi.com

thibaud.chatelet@sanofi.com

Yun Li

李云

| +33 6 84 00 90 72 |

| +33 6 84 00 90 72 |

yun.li3@sanofi.com

yun.li3@sanofi.com

Regeneron Media Relations

再生元媒体关系

Anna Hodge

安娜·霍奇

| +1 914-255-6475|

| +1 914-255-6475 |

anna.hodge@regeneron.com

安娜·霍奇@再生元.com

Regeneron Investor Relations

再生元投资者关系

Mark Hudson

马克·哈德森

| +1 914-847-3482 |

| +1 914-847-3482 |

mark.hudson@regeneron.com

mark.hudson@regeneron.com

Sanofi forward-looking statements

赛诺菲前瞻性声明

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product.

本新闻稿包含1995年《私人证券诉讼改革法案》（经修订）定义的前瞻性陈述。前瞻性陈述并非历史事实。这些陈述包括关于产品市场及其他潜力的预测和估计，或关于产品未来潜在收入的陈述。

Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”, and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.

前瞻性陈述通常通过“预期”、“预计”、“相信”、“打算”、“估计”、“计划”等词语及类似表述加以识别。尽管赛诺菲的管理层认为这些前瞻性陈述中反映的预期是合理的，但投资者应注意，前瞻性信息和陈述受到各种风险和不确定性的约束，其中许多难以预测且通常超出赛诺菲的控制范围，可能导致实际结果和发展与这些前瞻性信息和陈述中表达或暗示或预测的内容存在重大差异。

These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, ven.

这些风险和不确定性包括但不限于：意外的监管行动或延迟，或一般性的政府监管，可能影响产品的可用性或商业潜力；产品可能无法取得商业成功；研发过程中固有的不确定性，包括未来临床数据及与产品相关的现有临床数据（包括上市后）的分析；意外的安全性、质量或生产问题；普遍存在的竞争；与知识产权相关的风险及任何相关的未来诉讼及其最终结果；不稳定的经济和市场状况；以及全球危机可能对我们、我们的客户、供应商产生的影响。

All trademarks mentioned in this press release are the property of the Sanofi group except for VelociSuite and Regeneron Genetics Center.

本新闻稿中提到的所有商标均属于赛诺菲集团，VelociSuite和Regeneron Genetics Center除外。

Regeneron Forward-Looking Statements and Use of Digital Media

再生元前瞻性声明与数字媒体的使用

This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements.

本新闻稿包含关于再生元制药公司（“再生元”或“公司”）未来事件及未来表现的前瞻性陈述，这些陈述涉及风险和不确定性，实际事件或结果可能与这些前瞻性陈述存在重大差异。

Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation Dupixent® (dupilumab) for the treatment of bullous pemphigoid as discussed in this press release; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, such as Dupixent for the treatment of chronic pruritus of unknown origin, lichen simplex chronicus, and other.

诸如“预期”、“预计”、“打算”、“计划”、“相信”、“寻求”、“估计”之类的词语及其变体和类似的表达旨在识别这些前瞻性陈述，尽管并非所有前瞻性陈述都包含这些识别词。这些陈述涉及的问题，以及这些风险和不确定性包括但不限于：再生元及其合作者或许可方（统称为“再生元的产品”）已上市或商业化的产品的性质、时间安排、可能的成功及治疗应用；再生元及其合作者或许可方正在开发的产品候选者（统称为“再生元的产品候选者”）；现在正在进行或计划中的研究和临床项目，包括不限于本新闻稿中讨论的用于治疗大疱性类天疱疮的Dupixent®（度普利尤单抗）；再生元产品及其产品候选者的使用、市场接受度和商业成功的不确定性，以及研究（无论是由再生元还是其他机构进行，无论是强制性的还是自愿的）对前述内容的影响，包括本新闻稿中讨论或提及的研究；再生元产品候选者和新产品适应症（例如，用于治疗未知原因的慢性瘙痒、慢性单纯性苔藓等的Dupixent）可能获得监管批准并进行商业发布的可能性、时间和范围。

Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (.

Regeneron利用其媒体和投资者关系网站以及社交媒体渠道发布有关公司的重大信息，其中可能包含对投资者而言重要的信息。Regeneron的财务及其他信息会定期发布，并可通过Regeneron的媒体和投资者关系网站获取。

https://investor.regeneron.com

https://investor.regeneron.com

) and its LinkedIn page (

）及其领英页面（

https://www.linkedin.com/company/regeneron-pharmaceuticals

https://www.linkedin.com/company/regeneron-pharmaceuticals

).

).

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