TARRYTOWN, N.Y. and PARIS, May 30, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that a Phase 3 trial, AERIFY-1, evaluating the investigational use of itepekimab in adults who were former smokers with inadequately controlled chronic obstructive pulmonary disease (COPD) met the primary endpoint of significantly reducing moderate or severe acute exacerbations by 27% compared to placebo at week 52, a clinically meaningful benefit.

纽约塔里敦和巴黎，2025年5月30日（环球新闻社）——再生元制药公司（纳斯达克代码：REGN）和赛诺菲今日宣布，一项名为AERIFY-1的III期试验评估了伊替匹单抗在曾为吸烟者且慢性阻塞性肺疾病（COPD）控制不佳的成人中的研究性用途，该试验达到了主要终点，与安慰剂相比，在第52周时中度或重度急性加重的发生率显著降低了27%，这一结果具有临床意义。

A second Phase 3 trial, AERIFY-2, did not meet the same primary endpoint, although a benefit was seen earlier in the trial..

第二项 III 期试验 AERIFY-2 未达到相同的首要终点，尽管在试验早期观察到了益处。

In the trials, patients were randomized to receive itepekimab every two weeks (AERIFY-1: n=375; AERIFY-2: n=326), every four weeks (AERIFY-1: n=377; AERIFY-2: n=303), or placebo (AERIFY-1: n=375; AERIFY-2: n=324), which was added to inhaled triple or double standard-of-care therapy. The primary endpoint for AERIFY-1 and AERIFY-2 was the reduction in the annualized rate of acute moderate or severe COPD exacerbations with itepekimab treatment..

在试验中，患者被随机分配每两周接受itepekimab（AERIFY-1：n=375；AERIFY-2：n=326）、每四周一次（AERIFY-1：n=377；AERIFY-2：n=303），或安慰剂（AERIFY-1：n=375；AERIFY-2：n=324），这些均添加到吸入性三联或双重标准治疗中。AERIFY-1和AERIFY-2的主要终点是使用itepekimab治疗后，中度或重度COPD急性加重的年化率降低情况。

The table below summarizes the reductions in moderate or severe exacerbations (itepekimab compared to placebo) through weeks 24 and 52:

下表总结了中度或重度恶化（伊替普单抗与安慰剂相比）在第24周和第52周的减少情况：

a

a

Formal significance testing was only performed at 52 weeks in the Phase 3 trials, with significance achieved for both the every-two-week arm and every-four-week arm in AERIFY-1.

在三期试验中，仅在 52 周时进行了正式的显著性检验，在 AERIFY-1 中，每两周一次组和每四周一次组均达到了显著性。

The total number of exacerbations was lower than prospectively anticipated, decreasing the power of both trials. Enrollment largely occurred during the time of the global COVID-19 pandemic, which could have contributed to the lower overall exacerbation rates.

急性加重的总次数低于预期，降低了两项试验的效力。入组主要发生在全球新冠疫情大流行期间，这可能导致了总体急性加重率较低。

The safety profile of itepekimab was consistent across dosing regimens, and adverse events (AEs) were generally comparable between treatment and placebo groups. In AERIFY-1, the overall rates of AEs were 67% and 68% for itepekimab every two weeks and every four weeks, respectively, compared to 68% for placebo.

Itepekimab 的安全性在不同剂量方案中表现一致，治疗组和安慰剂组的不良事件 (AEs) 总体相当。在 AERIFY-1 研究中，每两周一次和每四周一次 itepekimab 的总体不良事件发生率分别为 67% 和 68%，而安慰剂组为 68%。

In AERIFY-2, the overall rates of AEs were 64% and 71% for itepekimab every two weeks and every four weeks, respectively, compared to 64% for placebo. In AERIFY-1, the rate of serious infections was 7% for each itepekimab arm, compared to 10% for placebo. In AERIFY-2, the rate of serious infections was 10% and 7% for itepekimab every two weeks and every four weeks, respectively, compared to 7% for placebo.

在AERIFY-2中，每两周使用itepekimab和每四周使用itepekimab的总体不良事件（AE）发生率分别为64%和71%，而安慰剂组为64%。在AERIFY-1中，itepekimab各组严重感染的发生率为7%，而安慰剂组为10%。在AERIFY-2中，每两周使用itepekimab和每四周使用itepekimab的严重感染发生率分别为10%和7%，而安慰剂组为7%。

AEs leading to death were 1% for each itepekimab arm compared to 2% for placebo in AERIFY-1, and 3% for each itepekimab arm compared to 2% for placebo in AERIFY-2. The safety profile of itepekimab observed in the Phase 3 trials was consistent with prior clinical trials. Anti-drug antibodies were rare and had no apparent impact on itepekimab drug levels..

在AERIFY-1试验中，接受itepekimab的各组导致死亡的不良事件（AEs）发生率为1%，而安慰剂组为2%；在AERIFY-2试验中，接受itepekimab的各组发生率为3%，而安慰剂组为2%。在三期临床试验中观察到的itepekimab的安全性特征与之前的临床试验一致。抗药抗体很少见，且对itepekimab的药物水平没有明显影响。

“COPD is a particularly complex disease, and novel approaches are needed to address the multiple underlying biological disease drivers,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron. “We are proud of our work in this challenging treatment landscape, bringing Dupixent – the first-ever biologic medicine for COPD – to certain patients who previously had very limited options remaining.

“COPD 是一种特别复杂的疾病，需要新的方法来应对多种潜在的生物学疾病驱动因素，”再生元公司董事会联合主席、总裁兼首席科学官 George D. Yancopoulos 医学博士表示。“我们为在这一具有挑战性的治疗领域所做的工作感到自豪，为某些之前选择非常有限的患者带来了首款 COPD 生物药物 Dupixent。”

We are encouraged by the overall results from AERIFY-1 and the data through week 24 for AERIFY-2 and are reviewing the results from both itepekimab trials to inform next steps. We remain committed to our broader itepekimab development program and learnings from the AERIFY program will be invaluable as we continue to advance itepekimab in respiratory diseases with unmet need.”.

我们对AERIFY-1的总体结果以及AERIFY-2第24周的数据感到鼓舞，并正在审查这两项依特匹单抗试验的结果以确定下一步。我们仍然致力于更广泛的依特匹单抗开发计划，AERIFY计划的经验将在我们继续推进依特匹单抗用于存在未满足需求的呼吸系统疾病时发挥不可估量的价值。”

Regeneron and Sanofi are reviewing the data and will discuss with regulatory authorities to evaluate next steps.

再生元和赛诺菲正在审查数据，并将与监管机构讨论以评估接下来的步骤。

Detailed results from these trials will be presented at a future medical meeting. Itepekimab is currently being evaluated in other trials, including chronic rhinosinusitis without nasal polyps, chronic rhinosinusitis with nasal polyps and non-cystic fibrosis bronchiectasis.

这些试验的详细结果将在未来的医学会议上公布。Itepekimab目前正在其他试验中进行评估，包括无鼻息肉的慢性鼻窦炎、有鼻息肉的慢性鼻窦炎和非囊性纤维化支气管扩张症。

“While we are encouraged by the results of AERIFY-1, the results of both studies merit further exploration to have a full understanding of the data and the role that IL-33 plays in this complex disease,” said Houman Ashrafian, M.D., Ph.D., Executive Vice President, Head of Research and Development at Sanofi.

“虽然我们对AERIFY-1的结果感到鼓舞，但这两项研究的结果值得进一步探索，以全面理解数据以及IL-33在这种复杂疾病中的作用，”赛诺菲执行副总裁、研发主管侯曼·阿什拉菲安医学博士表示。

“Certain people with COPD are in desperate need of new treatment options, especially those who continue to experience exacerbations despite being on maximal therapy, and we remain committed to discussing these data with regulatory agencies to evaluate our path forward.”.

“某些慢性阻塞性肺病患者急需新的治疗选择，特别是那些即使在接受最大剂量治疗后仍然出现病情加重的患者，我们仍致力于与监管机构讨论这些数据，以评估我们未来的路径。”

The safety and efficacy of itepekimab are currently under clinical investigation and have not been fully evaluated by any regulatory authority.

伊替匹单抗的安全性和有效性目前正在临床研究中，尚未得到任何监管机构的全面评估。

About the Itepekimab COPD Trial Program

关于Itepekimab慢性阻塞性肺病试验计划

AERIFY-1 and AERIFY-2 are randomized, Phase 3, double-blind, placebo-controlled trials that evaluated the efficacy and safety of itepekimab in 1,127 (AERIFY-1) and 953 (AERIFY-2) adults aged 40-85 years who were former smokers with moderate-to-severe COPD. Former smokers were defined as those who have not smoked for at least six months..

AERIFY-1和AERIFY-2是随机、III期、双盲、安慰剂对照试验，评估了itepekimab在1,127名（AERIFY-1）和953名（AERIFY-2）年龄40-85岁的中重度慢性阻塞性肺病（COPD）且曾吸烟的成人中的疗效和安全性。曾吸烟者定义为至少六个月内未吸烟的人。

Treatments were administered subcutaneously and added to double therapy (inhaled corticosteroid [ICS] plus long-acting beta2-agonist [LABA] or long-acting muscarinic antagonist [LAMA] plus LABA) or a maximal standard-of-care inhaled triple therapy (ICS, LABA and LAMA).

治疗通过皮下注射进行，并添加到双重疗法（吸入性糖皮质激素 [ICS] 加上长效β2-激动剂 [LABA] 或长效毒蕈碱拮抗剂 [LAMA] 加上 LABA）或最大标准护理的三联吸入疗法（ICS、LABA 和 LAMA）。

The primary endpoint for AERIFY-1 and AERIFY-2 was the annualized rate of acute moderate or severe COPD exacerbations. Moderate exacerbations were defined as those requiring systemic steroids and/or antibiotics. Severe exacerbations were defined as those: requiring hospitalization; more than 24 hours of observation in an emergency department or urgent care facility; or resulting in death..

AERIFY-1 和 AERIFY-2 的主要终点是急性中度或重度 COPD 急性加重的年化率。中度加重定义为需要使用全身性类固醇和/或抗生素的加重。重度加重定义为以下情况：需要住院治疗；在急诊科或紧急护理机构观察超过 24 小时；或导致死亡。

The AERIFY program includes two additional ongoing trials: AERIFY-3, a Phase 2 mechanistic study assessing the impact of itepekimab on airway inflammation in patients with COPD, and AERIFY-4, a Phase 3 trial assessing the long-term safety of itepekimab in patients with COPD.

AERIFY项目还包括两项正在进行的试验：AERIFY-3，这是一项2期机制研究，评估Itepekimab对慢性阻塞性肺病（COPD）患者气道炎症的影响；以及AERIFY-4，这是一项3期试验，评估Itepekimab在慢性阻塞性肺病患者中的长期安全性。

About Itepekimab

关于Itepekimab

Itepekimab, which was invented using Regeneron’s proprietary

使用再生元公司专有的技术发明的Itepekimab，

VelocImmune

VelocImmune

®

®

technology, is a fully human monoclonal antibody that binds to and inhibits interleukin-33 (IL-33), an initiator and amplifier of broad inflammation in COPD. IL-33 is thought to be involved in different types of inflammation and is particularly elevated in the lungs of former smokers.

技术，是一种完全人源化的单克隆抗体，可与白细胞介素-33（IL-33）结合并抑制其作用，IL-33是慢性阻塞性肺疾病（COPD）中广泛炎症的引发剂和放大器。IL-33被认为参与了不同类型的炎症，尤其是在既往吸烟者的肺部中显著升高。

Itepekimab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement and is currently in clinical development programs for chronic rhinosinusitis with nasal polyps (Phase 3), non-cystic fibrosis bronchiectasis (Phase 2) and chronic rhinosinusitis without nasal polyps (Phase 2)..

依特匹单抗正在由再生元和赛诺菲根据全球合作协议共同开发，目前正在进行慢性鼻窦炎伴鼻息肉（第3期）、非囊性纤维化支气管扩张症（第2期）和慢性鼻窦炎不伴鼻息肉（第2期）的临床开发计划。

About Regeneron’s

关于再生元的

VelocImmune

VelocImmune

Technology

技术

Regeneron's

再生元的

VelocImmune

VelocImmune

technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W.

该技术利用了一个拥有基因人源化免疫系统的专利基因工程小鼠平台，以生成优化的全人源抗体。当Regeneron公司的联合创始人、总裁兼首席科学官乔治·D·扬科普洛斯还是他导师弗雷德里克·W.的研究生时。

Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing .

1985年，他们率先设想制造这种基因人性化的小鼠，而再生元公司花费了数十年的时间进行发明和开发。

VelocImmune

速度免疫

and related

和相关

VelociSuite

速件套件

®

®

technologies. Dr. Yancopoulos and his team have used

技术。Yancopoulos博士和他的团队已经使用了

VelocImmune

VelocImmune

technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent

技术创造了一大批所有原始的、FDA批准的全人单克隆抗体。这包括Dupixent。

®

®

(dupilumab), Libtayo

（dupilumab），Libtayo

®

®

(cemiplimab-rwlc), Praluent

（cemiplimab-rwlc），Praluent

®

®

(alirocumab), Kevzara

(阿利库单抗)，Kevzara

®

®

(sarilumab), Evkeeza

（萨利鲁单抗），Evkeeza

®

®

(evinacumab-dgnb), Inmazeb

(依维那单抗-dgnb)，Inmazeb

®

®

(atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz

（阿托利维单抗、马夫替维单抗和奥德西维单抗-ebgn）和维欧波兹

®

®

(pozelimab-bbfg). In addition, REGEN-COV

(pozelimab-bbfg)。此外，REGEN-COV

®

®

(casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024.

（casirivimab 和 imdevimab）在 COVID-19 大流行期间已获得 FDA 授权，直至 2024 年。

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（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，这已带来了众多获批的治疗方法以及正在开发的产品候选物，其中大多数都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，如某些特定技术，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.

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，以潜在治疗或治愈疾病。

For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.

有关更多信息，请访问 www.Regeneron.com 或在 LinkedIn、Instagram、Facebook 或 X 上关注 Regeneron。

About Sanofi

关于赛诺菲

Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating 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创造引人注目的增长。我们凭借对免疫系统的深刻理解，发明能够治疗和保护全球数百万人的药物和疫苗，并通过创新的研发管线使数百万人进一步受益。我们的团队秉持一个目标：追寻科学的奇迹以改善人们的生活；这激励我们推动进步，为员工及服务的社区带来积极影响，同时应对当今最紧迫的医疗、环境和社会挑战。

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。

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”）未来事件和未来业绩的前瞻性陈述，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 .

诸如“预期”、“预计”、“打算”、“计划”、“相信”、“寻求”、“估计”等词语及其变体和类似表述，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语。这些陈述涉及并包括以下风险和不确定性：由再生元及其合作者或被许可方（统称为“再生元产品”）营销或商业化的产品的性质、时间安排、可能的成功及治疗应用，以及由再生元及其合作者或被许可方开发的产品候选者（统称为“再生元产品候选者”）和正在进行或计划中的研究与临床项目，包括但不限于。

itepekimab in adults who were former smokers with inadequately controlled chronic obstructive pulmonary disease (“COPD”) and other potential indications

itepekimab用于曾经吸烟且慢性阻塞性肺疾病（“COPD”）控制不佳的成年人及其他潜在适应症

; 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

；再生元产品候选物及再生元产品新适应症可能获得的监管批准及其上市时机和范围，例如

itepekimab

伊替匹单抗

for the treatment of COPD as discussed in this press release as well as

用于治疗COPD，正如本新闻稿中所讨论的，以及

itepekimab

伊特匹单抗

for the treatment of chronic rhinosinusitis with nasal polyps, non-cystic fibrosis bronchiectasis, and chronic rhinosinusitis without nasal polyps; any feedback that may be provided by regulatory authorities on the results from the AERIFY-1 and AERIFY-2 trials discussed in this press release, including the impact of any such feedback on any potential regulatory approval of itepekimab; 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 or any potential regulatory approval of Regeneron’s Products and Regeneron’s Product Candidates (such as .

用于治疗伴有鼻息肉的慢性鼻窦炎、非囊性纤维化支气管扩张症以及不伴有鼻息肉的慢性鼻窦炎；监管机构可能就本新闻稿中讨论的AERIFY-1和AERIFY-2试验结果提供的任何反馈，包括此类反馈对itepekimab任何潜在监管批准的影响；再生元产品及其候选产品的使用、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）对上述任何方面或再生元产品及其候选产品任何潜在监管批准的影响，包括本新闻稿中讨论或引用的研究（例如）。

itepekimab

伊替匹单抗

); the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates (such as .

）；再生元的合作伙伴、被许可方、供应商或其他第三方（如适用）执行与再生元产品及候选产品相关的制造、填充、完成、包装、标签、分销及其他步骤的能力；再生元管理多种产品和候选产品供应链的能力，以及与关税和其他贸易限制相关的风险；因使用再生元产品及候选产品而引发的安全问题（例如 。

itepekimab

伊替匹单抗

) in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron’s Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes in laws, regulations, and policies affecting the healthcare industry; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates (including biosimilar versions of Regeneron’s Products); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assum.

）包括与在临床试验中使用再生元的产品及其候选产品相关的严重并发症或副作用；监管和行政政府机构的决定可能会延迟或限制再生元继续开发或商业化其产品及候选产品的能力；持续的监管义务和监督对再生元的产品、研究和临床项目以及业务的影响，包括与患者隐私相关的内容；第三方支付方及其他第三方对再生元产品的报销或共付援助的可用性及范围，包括私人支付方的医疗保健和保险计划、健康维护组织、药房福利管理公司以及如联邦医疗保险和医疗补助等政府计划；这些支付方及其他第三方的报销和覆盖决定以及他们采用的新政策和程序；影响医疗保健行业的法律法规和政策的变化；竞争药物和候选产品可能优于或比再生元的产品及其候选产品更具成本效益（包括再生元产品的生物类似药版本）；再生元及其合作者或许可方开展的研发项目的成果在其他研究中的可重复性，和/或将候选产品推进至临床试验、治疗应用或获得监管批准的程度；意外费用；开发、生产和销售产品的成本；再生元达成其任何财务预测或指导的能力以及假设条件的变化。

®

®

(aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S.

（阿柏西普）注射剂），任何此类诉讼和调查的最终结果，以及上述任何一项可能对再生元的业务、前景、经营结果和财务状况产生的影响。更完整的描述可以参见再生元向美国证券交易委员会提交的文件中的这些以及其他重大风险。

Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2024 and its Form 10-Q for the quarterly period ended March 31, 2025. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron.

美国证券交易委员会，包括其截至2024年12月31日的年度Form 10-K报告及其截至2025年3月31日的季度Form 10-Q报告。任何前瞻性声明均基于管理层当前的信念和判断，读者应注意不要依赖Regeneron所做的任何前瞻性声明。

Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise..

再生元不承担更新任何前瞻性声明的义务，包括但不限于任何财务预测或指导，无论是否由于新信息、未来事件或其他原因。

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 (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals)..

再生元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。有关再生元的财务及其他信息会定期发布，并可通过其媒体和投资者关系网站 (https://investor.regeneron.com) 及其领英页面 (https://www.linkedin.com/company/regeneron-pharmaceuticals) 获取。

Sanofi Disclaimers or Forward-Looking Statements

赛诺菲免责声明或前瞻性声明

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）所定义的前瞻性陈述。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预测和估计。

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.

前瞻性陈述通常可以通过“预期”、“预计”、“相信”、“打算”、“估计”、“计划”等词语以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因素的影响，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；普遍的竞争；与知识产权相关的风险及任何由此引发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、供应商等产生的影响。

All trademarks mentioned in this press release are the property of the Sanofi group except for

本新闻稿中提到的所有商标均为赛诺菲集团的财产，除非另有说明。

VelociSuite

速度套件

and

和

Regeneron Genetics Center

再生元遗传学中心

.

。

Source: Regeneron Pharmaceuticals, Inc.

来源：再生元制药公司

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