Approval based on global Phase 3 program in children demonstrating Dupixent significantly reduced exacerbations (by 54% to 65%) and improved lung function (by 4.68% to 5.32%) compared to placebo

基于全球第三阶段儿童临床试验的批准，显示 Dupixent 显著减少了加重发作（减少 54% 至 65%）并改善了肺功能（改善 4.68% 至 5.32%），与安慰剂相比

Dupixent is the first and only biologic medicine to demonstrate improved lung function in this young patient group in a randomized Phase 3 trial, and inhibits IL-4 and IL-13, two key and central drivers of type 2 inflammation

Dupixent 是首个也是唯一一个在随机第三阶段试验中证明能改善这一年轻患者群体肺功能的生物制剂，且能够抑制 IL-4 和 IL-13，这两者是 2 型炎症的关键驱动因素

TARRYTOWN, N.Y. and PARIS, Dec. 23, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent® (dupilumab) for the treatment of bronchial asthma in children aged 6 to 11 years with severe or refractory disease whose symptoms are inadequately controlled with existing therapy. This expands the previous approval in Japan in this indication for patients aged 12 years and older.

纽约塔里敦和巴黎，2025年12月23日（全球新闻稿）——Regeneron 制药公司（NASDAQ: REGN）和赛诺菲今天宣布，日本厚生劳动省（MHLW）已批准 Dupixent®（dupilumab）用于治疗 6 至 11 岁患有严重或难治性支气管哮喘的儿童，这些患者的症状在现有治疗下控制不佳。这一批准扩展了之前在日本对 12 岁及以上患者的相应批准。

The approval in Japan is based on data from the overall population and those with a type 2 inflammation phenotype (defined by raised blood eosinophils and/or fractional exhaled nitric oxide) in VOYAGE, a global Phase 3 trial evaluating Dupixent in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. Additionally, data from EXCURSION, an open-label extension of VOYAGE that included a sub-study of exclusively Japanese pediatric patients supported the approval. In the VOYAGE trial, Dupixent added to standard-of-care asthma therapy significantly reduced severe exacerbations (by 54% to 65%, p<0.0001) and improved lung function (by 4.68% to 5.32%, p=0.0012, p=0.0009 and p=0.0036, respectively) in the overall population, those with type 2 inflammation, and those with raised blood eosinophils, compared to placebo. In the sub-study of Japanese pediatric patients, Dupixent improved lung function from baseline at 12 weeks and resulted in a low rate of severe asthma exacerbations over one year. The treatment-related adverse events most commonly reported with Dupixent were injection site reactions (erythema, edema and induration) in VOYAGE and fever, oral herpes, eosinophilia and injection site reactions (erythema and induration) in EXCURSION.

日本的批准基于 VOYAGE 这项全球第三阶段试验的数据，该试验评估了 Dupixent 在 6 至 11 岁患有未控制的中重度哮喘儿童中的效果，涵盖了整体人群及具有 2 型炎症表型（通过血液嗜酸细胞升高和/或呼气一氧化氮分数定义）。此外，EXCURSION 的开放标签扩展研究中包含了专门针对日本儿童患者的子研究，支持了这一批准。在 VOYAGE 试验中，Dupixent 与标准哮喘治疗联合使用显著减少了严重加重发作（减少 54% 至 65%，p<0.0001）并改善了肺功能（改善 4.68% 至 5.32%，p=0.0012，p=0.0009 和 p=0.0036），与安慰剂相比，适用于整体人群、2 型炎症患者和嗜酸细胞升高患者。在日本儿童患者的子研究中，Dupixent 在 12 周时改善了肺功能，并在一年内导致了低严重哮喘加重发作率。与 Dupixent 相关的最常见不良事件是在 VOYAGE 中报告的注射部位反应（红斑、水肿和硬结），以及在 EXCURSION 中报告的发热、口腔疱疹、嗜酸细胞增多和注射部位反应（红斑和硬结）。

Asthma is one of the most common chronic diseases in children. Despite treatment with current standard-of-care inhaled corticosteroids and bronchodilators, children may continue to experience serious symptoms, such as coughing, wheezing and difficulty breathing. Additionally, impaired lung function in young children can have potentially long-lasting impacts, such as reduced lung growth and persistent airway obstruction, if not addressed early. Patients also may require the use of multiple courses of systemic corticosteroids that carry significant risks. Uncontrolled asthma can interfere with day-to-day activities, like sleeping, attending school and playing sports.

哮喘是儿童中最常见的慢性疾病之一。尽管使用当前标准的吸入类固醇和支气管扩张剂进行治疗，儿童仍可能继续经历严重症状，如咳嗽、喘息和呼吸困难。此外，年轻儿童的肺功能受损如果不及早处理，可能会产生潜在的长期影响，如肺生长受限和持续的气道阻塞。患者还可能需要多次使用系统性类固醇，而这会带来显著风险。未控制的哮喘会干扰日常活动，如睡眠、上学和参加体育活动。

In addition to asthma, Dupixent is approved in Japan in certain patients with atopic dermatitis, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis, chronic spontaneous urticaria (CSU) and chronic obstructive pulmonary disease (COPD). Dupixent has been approved in 50 countries around the world for the treatment of asthma in children aged 6 to 11 years.

除了哮喘，Dupixent 在日本还获得了对某些特应性皮炎、慢性鼻窦炎伴鼻息肉（CRSwNP）、结节性瘙痒、慢性自发性荨麻疹（CSU）和慢性阻塞性肺病（COPD）患者的批准。Dupixent 已在全球 50 个国家获得批准，用于治疗 6 至 11 岁儿童的哮喘。

About Dupixent

关于 Dupixent

Dupixent is available in Japan as a 200 mg or 300 mg pre-filled syringe or pre-filled pen and is now available for children aged 6 to 11 years with asthma. Dupixent is intended for injection under the skin (subcutaneous injection) and is given every two or four weeks based on weight. It can be given in a clinic or at home by self-administration after training by a healthcare professional. In children younger than 12 years of age, Dupixent should be administered by a caregiver if given at home.

Dupixent 在日本以 200 毫克或 300 毫克的预填充注射器或预填充笔形式提供，现在可用于 6 至 11 岁患有哮喘的儿童。Dupixent 旨在皮下注射（皮下注射），根据体重每两周或四周给药。可以在诊所或在经过医疗专业人员培训后在家自我给药。对于 12 岁以下的儿童，如果在家给药，Dupixent 应由看护人进行管理。

Dupixent, which was invented using Regeneron’s proprietary VelocImmune ® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) 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 trials, establishing that IL-4 and IL-13 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 是使用 Regeneron 的专有_VelocImmune_®技术发明的，属于完全人源化单克隆抗体，能够抑制白细胞介素-4（IL-4）和白细胞介素-13（IL-13）信号通路，并非免疫抑制剂。Dupixent 开发项目在第三阶段试验中显示出显著的临床益处，并减少了 2 型炎症，确立了 IL-4 和 IL-13 是导致多种相关且常常合并疾病的 2 型炎症的两个关键驱动因素。

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 (EoE), prurigo nodularis, CSU, COPD and bullous pemphigoid (BP) in different age populations. More than 1,300,000 patients are being treated with Dupixent globally.1

Dupixent 在 60 多个国家获得了监管批准，适用于一种或多种适应症，包括某些特应性皮炎、哮喘、CRSwNP、嗜酸细胞食管炎（EoE）、结节性瘙痒、CSU、COPD 和水疱性类天疱疮（BP）等不同年龄段的患者。全球已有超过 130 万患者正在接受 Dupixent 治疗。1

About Regeneron’s VelocImmune Technology

关于 Regeneron 的 VelocImmune 技术

Regeneron's 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. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite ® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). In addition, REGEN-COV® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024.

Regeneron 的_VelocImmune_技术利用一种专有的基因工程小鼠平台，赋予其人源化的免疫系统，以生产优化的完全人源化抗体。当 Regeneron 的联合创始人、总裁兼首席科学官 George D. Yancopoulos 在 1985 年与他的导师 Frederick W. Alt 一起作为研究生时，他们首次设想制造这种人源化小鼠，Regeneron 花费了数十年时间发明和开发_VelocImmune_及相关的_VelociSuite_®技术。Yancopoulos 博士及其团队利用_VelocImmune_技术创造了大量所有原始的、FDA 批准的完全人源化单克隆抗体。这包括 Dupixent®（dupilumab）、Libtayo®（cemiplimab-rwlc）、Praluent®（alirocumab）、Kevzara®（sarilumab）、Evkeeza®（evinacumab-dgnb）、Inmazeb®（atoltivimab、maftivimab 和 odesivimab-ebgn）和 Veopoz®（pozelimab-bbfg）。此外，REGEN-COV®（casirivimab 和 imdevimab）在 COVID-19 大流行期间获得 FDA 授权，直至 2024 年。

Dupilumab Development Program

Dupilumab 开发项目

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

Dupilumab 由 Regeneron 和赛诺菲在全球合作协议下共同开发。迄今为止，dupilumab 已在超过 60 项临床试验中研究，涉及超过 10,000 名患有各种慢性疾病的患者，这些疾病部分是由 2 型炎症引起的。

In addition to the currently approved indications, Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including chronic pruritus of unknown origin, lichen simplex chronicus and allergic fungal rhinosinusitis. 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.

除了目前批准的适应症外，Regeneron 和赛诺菲还在第 3 期临床试验中研究 dupilumab 在由 2 型炎症或其他过敏过程引起的广泛疾病中的应用，包括原因不明的慢性瘙痒、单纯性苔藓和过敏性真菌性鼻窦炎。这些 dupilumab 的潜在用途目前正在临床研究中，尚未被任何监管机构全面评估其安全性和有效性。

U.S. INDICATIONS

美国适应症

DUPIXENT is a prescription medicine used:

DUPIXENT 是一种处方药，用于：

to treat adults and children 6 months of age and older with moderate-to-severe eczema (atopic dermatitis or AD) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with AD under 6 months of age.
with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in adults and children 6 years of age and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. It is not known if DUPIXENT is safe and effective in children with asthma under 6 years of age.
with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults and children 12 years of age and older whose disease is not controlled. It is not known if DUPIXENT is safe and effective in children with CRSwNP under 12 years of age.
to treat adults and children 1 year of age and older with eosinophilic esophagitis (EoE), who weigh at least 33 pounds (15 kg). It is not known if DUPIXENT is safe and effective in children with EoE under 1 year of age, or who weigh less than 33 pounds (15 kg).
to treat adults with prurigo nodularis (PN). It is not known if DUPIXENT is safe and effective in children with PN under 18 years of age.
with other medicines for the maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and a high number of blood eosinophils (a type of white blood cell that may contribute to your COPD). DUPIXENT is used to reduce the number of flare-ups (the worsening of your COPD symptoms for several days) and can improve your breathing. It is not known if DUPIXENT is safe and effective in children with COPD under 18 years of age.
to treat adults and children 12 years of age and older with chronic spontaneous urticaria (CSU) who continue to have hives that are not controlled with H1 antihistamine treatment. It is not known if DUPIXENT is safe and effective in children with CSU under 12 years of age, or who weigh less than 66 pounds (30 kg).
to treat adults with bullous pemphigoid (BP). It is not known if DUPIXENT is safe and effective in children with BP under 18 years of age.

治疗 6 个月及以上的成人和儿童中度至重度湿疹（特应性皮炎或 AD），该病症未能通过皮肤使用的处方疗法（外用）得到良好控制，或无法使用外用疗法。DUPIXENT 可以与或不与外用皮质类固醇一起使用。目前尚不清楚 DUPIXENT 在 6 个月以下的 AD 儿童中是否安全有效。
与其他哮喘药物联合用于 6 岁及以上成人和儿童中度至重度嗜酸性或依赖口服类固醇的哮喘的维持治疗，且其哮喘未能通过当前的哮喘药物得到控制。DUPIXENT 有助于预防严重的哮喘发作（加重），并可以改善呼吸。DUPIXENT 还可能有助于减少您在预防严重哮喘发作和改善呼吸时所需的口服皮质类固醇的用量。目前尚不清楚 DUPIXENT 在 6 岁以下的哮喘儿童中是否安全有效。
与其他药物联合用于 12 岁及以上成人和儿童中度至重度鼻息肉慢性鼻窦炎（CRSwNP）的维持治疗，且其疾病未能得到控制。目前尚不清楚 DUPIXENT 在 12 岁以下的 CRSwNP 儿童中是否安全有效。
治疗 1 岁及以上的成人和儿童嗜酸性食管炎（EoE），体重至少 33 磅（15 公斤）。目前尚不清楚 DUPIXENT 在 1 岁以下或体重低于 33 磅（15 公斤）的 EoE 儿童中是否安全有效。
治疗成人结节性瘙痒症（PN）。目前尚不清楚 DUPIXENT 在 18 岁以下的 PN 儿童中是否安全有效。
与其他药物联合用于维持治疗成人慢性阻塞性肺疾病（COPD）且血液嗜酸性粒细胞数量较高（可能导致 COPD 的白细胞类型）的患者。DUPIXENT 用于减少急性发作（COPD 症状加重数天）的次数，并可以改善呼吸。目前尚不清楚 DUPIXENT 在 18 岁以下的 COPD 儿童中是否安全有效。
治疗 12 岁及以上的成人和儿童慢性自发性荨麻疹（CSU），且在 H1 抗组胺治疗下仍持续出现荨麻疹。目前尚不清楚 DUPIXENT 在 12 岁以下或体重低于 66 磅（30 公斤）的 CSU 儿童中是否安全有效。
治疗成人大疱性类天疱疮（BP）。目前尚不清楚 DUPIXENT 在 18 岁以下的 BP 儿童中是否安全有效。

DUPIXENT is not used to relieve sudden breathing problems and will not replace an inhaled rescue medicine or to treat any other forms of hives (urticaria).

DUPIXENT 不用于 缓解突发的呼吸问题，且不会替代吸入式急救药物或用于治疗其他形式的荨麻疹（风疹）。

IMPORTANT SAFETY INFORMATION

重要安全信息

Do not use if you are allergic to dupilumab or to any of the ingredients in DUPIXENT®.

如果您对 dupilumab 或 DUPIXENT®中的任何成分过敏，请勿使用。

Before using DUPIXENT, tell your healthcare provider about all your medical conditions, including if you:

在使用 DUPIXENT 之前，请告知您的医疗提供者您的所有医疗状况，包括如果您：

have eye problems.
have a parasitic (helminth) infection.
are scheduled to receive any vaccinations. You should not receive a “live vaccine” right before and during treatment with DUPIXENT.
are pregnant or plan to become pregnant. It is not known whether DUPIXENT will harm your unborn baby.
- A pregnancy registry for women who take DUPIXENT during pregnancy collects information about the health of you and your baby. To enroll or get more information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/.
are breastfeeding or plan to breastfeed. It is not known whether DUPIXENT passes into your breast milk.

有眼部问题。
有寄生虫（蠕虫）感染。
计划接种任何疫苗。您在接受 DUPIXENT 治疗前和期间不应接种 “活疫苗”。
怀孕或计划怀孕。目前尚不清楚 DUPIXENT 是否会对未出生的婴儿造成伤害。
- 针对在怀孕期间使用 DUPIXENT 的女性的怀孕登记收集您和您婴儿的健康信息。要注册或获取更多信息，请拨打 1-877-311-8972 或访问 https://mothertobaby.org/ongoing-study/dupixent/。
正在哺乳或计划哺乳。目前尚不清楚 DUPIXENT 是否会进入您的母乳。

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

告知您的医疗提供者您所服用的所有药物，包括处方药和非处方药、维生素和草药补充剂。

Especially tell your healthcare provider if you are taking oral, topical, or inhaled corticosteroid medicines; have asthma and use an asthma medicine; or have AD, CRSwNP, EoE, PN, COPD, CSU, or BP and also have asthma. Do not change or stop your other medicines, including corticosteroid medicine or other asthma medicine, without talking to your healthcare provider. This may cause other symptoms that were controlled by those medicines to come back.

特别告知您的医疗提供者如果您 正在服用口服、外用或吸入的皮质类固醇药物；有哮喘并使用哮喘药物；或有 AD、CRSwNP、EoE、PN、COPD、CSU 或 BP 并且也有哮喘。请勿在未与您的医疗提供者讨论的情况下更改或停止其他药物，包括皮质类固醇药物或其他哮喘药物。这可能会导致那些药物控制的其他症状复发。

DUPIXENT can cause serious side effects, including:

DUPIXENT 可能会引起严重的副作用，包括：

Allergic reactions. DUPIXENT can cause allergic reactions, including skin reactions, that can sometimes be severe. Stop using DUPIXENT and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms: breathing problems or wheezing, swelling of the face, lips, mouth, tongue or throat, fainting, dizziness, feeling lightheaded, fast pulse, fever, hives, skin rash, including rash that looks like a bullseye, painful red or blue bumps under the skin, or red pus-filled spots on the skin, general ill feeling, itching, swollen lymph nodes, nausea or vomiting, joint pain, or cramps in your stomach area.
Eye pr ob l e m s. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision. Your healthcare provider may send you to an ophthalmologist for an exam if needed.
I n fl a mm a t i o n o f y ou r b l oo d v e ss e l s. Rarely, this can happen in people with asthma who receive DUPIXENT. This may happen in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. Tell your healthcare provider right away if you get: rash, chest pain, worsening shortness of breath, brown or dark colored urine, persistent fever, or a feeling of pins and needles or numbness of your arms or legs.
Psoriasis. This can happen in people with atopic dermatitis and asthma who receive DUPIXENT. Tell your healthcare provider about any new skin symptoms. Your healthcare provider may send you to a dermatologist for an examination if needed.
Joint aches and pain. Some people who use DUPIXENT have had trouble walking or moving due to their joint symptoms, and in some cases needed to be hospitalized. Tell your healthcare provider about any new or worsening joint symptoms. Your healthcare provider may stop DUPIXENT if you develop joint symptoms.

过敏反应。DUPIXENT 可能会引起过敏反应，包括皮肤反应，有时可能会很严重。 如果出现以下任何迹象或症状，请立即停止使用 DUPIXENT，并告知您的医疗提供者或寻求紧急帮助：呼吸困难或喘息，面部、嘴唇、口腔、舌头或喉咙肿胀，晕厥，头晕，感到头昏，心跳加快，发热，荨麻疹，皮疹，包括看起来像靶心的皮疹，皮肤下的红色或蓝色疼痛肿块，或皮肤上充满脓液的红点，整体不适，瘙痒，淋巴结肿大，恶心或呕吐，关节疼痛，或腹部痉挛。
眼部问题。 如果您有任何新的或加重的眼部问题，包括眼痛或视力变化（如视力模糊），请告知您的医疗提供者。如果需要，您的医疗提供者可能会将您转诊给眼科医生进行检查。
血管炎。 这种情况在接受 DUPIXENT 的哮喘患者中很少见。这可能发生在同时服用口服类固醇药物并正在停用或降低剂量的人身上。如果您出现以下症状，请立即告知您的医疗提供者：皮疹，胸痛，呼吸急促加重，尿液呈棕色或深色，持续发热，或手臂或腿部有针刺感或麻木感。
银屑病。 这种情况可能发生在接受 DUPIXENT 的特应性皮炎和哮喘患者中。请告知您的医疗提供者任何新的皮肤症状。如果需要，您的医疗提供者可能会将您转诊给皮肤科医生进行检查。
关节疼痛。 一些使用 DUPIXENT 的人因关节症状而在行走或移动时遇到困难，在某些情况下需要住院。请告知您的医疗提供者任何新的或加重的关节症状。如果您出现关节症状，您的医疗提供者可能会停止使用 DUPIXENT。

The most common side effects include:

最常见的副作用包括：

Eczema: injection site reactions, eye problems, including eye and eyelid inflammation, redness, swelling, itching, eye infection, dry eye, and blurred vision, cold sores in your mouth or on your lips, and high count of a certain white blood cell (eosinophilia).
A s t h ma: injection site reactions, high count of a certain white blood cell (eosinophilia), pain in the throat (oropharyngeal pain), and parasitic (helminth) infections.
Chronic Rhinosinusitis with Nasal Polyps: injection site reactions, eye problems, including eye and eyelid inflammation, redness, swelling, itching, eye infection, and blurred vision, high count of a certain white blood cell (eosinophilia), stomach problems (gastritis), joint pain (arthralgia), trouble sleeping (insomnia), and toothache.
Eosinophilic Esophagitis: injection site reactions, upper respiratory tract infections, cold sores in your mouth or on your lips, and joint pain (arthralgia).
Prurigo Nodularis: eye problems, including eye and eyelid inflammation, redness, swelling, itching, and blurred vision, herpes virus infections, common cold symptoms (nasopharyngitis), dizziness, muscle pain, and diarrhea.
Chronic Obstructive Pulmonary Disease: injection site reactions, common cold symptoms (nasopharyngitis), high count of a certain white blood cell (eosinophilia), viral infection, back pain, inflammation inside the nose (rhinitis), diarrhea, stomach problems (gastritis), joint pain (arthralgia), toothache, headache, and urinary tract infection.
Chronic Spontaneous Urticaria: injection site reactions.
Bullous Pemphigoid: joint pain (arthralgia), eye problems, including eye and eyelid inflammation, redness, swelling, itching, and blurred vision, and herpes virus infections.

湿疹： 注射部位反应，眼部问题，包括眼睛和眼睑炎症、红肿、瘙痒、眼部感染、干眼和视力模糊，嘴巴或嘴唇上的冷疮，以及某种白细胞（嗜酸性粒细胞增多症）计数增高。
哮喘： 注射部位反应，某种白细胞（嗜酸性粒细胞增多症）计数增高，喉咙痛（口咽痛），以及寄生虫（蠕虫）感染。
慢性鼻窦炎伴鼻息肉： 注射部位反应，眼部问题，包括眼睛和眼睑炎症、红肿、瘙痒、眼部感染和视力模糊，某种白细胞（嗜酸性粒细胞增多症）计数增高，胃部问题（胃炎），关节疼痛（关节痛），失眠，和牙痛。
嗜酸性食管炎： 注射部位反应，上呼吸道感染，嘴巴或嘴唇上的冷疮，以及关节疼痛（关节痛）。
结节性痒疹： 眼部问题，包括眼睛和眼睑炎症、红肿、瘙痒和视力模糊，单纯疱疹病毒感染，感冒症状（鼻咽炎），头晕，肌肉疼痛，和腹泻。
慢性阻塞性肺病： 注射部位反应，感冒症状（鼻咽炎），某种白细胞（嗜酸性粒细胞增多症）计数增高，病毒感染，背痛，鼻腔内炎症（鼻炎），腹泻，胃部问题（胃炎），关节疼痛（关节痛），牙痛，头痛，和尿路感染。
慢性自发性荨麻疹： 注射部位反应。
大疱性类天疱疮： 关节疼痛（关节痛），眼部问题，包括眼睛和眼睑炎症、红肿、瘙痒和视力模糊，以及单纯疱疹病毒感染。

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of DUPIXENT. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

如果您有任何让您困扰或不消失的副作用，请告知您的医疗提供者。这些并不是 DUPIXENT 所有可能的副作用。请致电您的医生以获取有关副作用的医疗建议。鼓励您向 FDA 报告处方药的负面副作用。访问 www.fda.gov/medwatch，或拨打 1-800-FDA-1088。

Use DUPIXENT exactly as prescribed by your healthcare provider. It’s an injection given under the skin (subcutaneous injection). Your healthcare provider will decide if you or your caregiver can inject DUPIXENT. Do not try to prepare and inject DUPIXENT until you or your caregiver have been trained by your healthcare provider. In children 12 years of age and older, it’s recommended DUPIXENT be administered by or under supervision of an adult. In children 6 months to less than 12 years of age, DUPIXENT should be given by a caregiver.

请按照医疗提供者的处方准确使用 DUPIXENT。这是一种皮下注射（皮下注射）。您的医疗提供者将决定您或您的看护者是否可以注射 DUPIXENT。请勿在您或您的看护者接受医疗提供者的培训之前尝试准备和注射 DUPIXENT。在 12 岁及以上的儿童中，建议由成年人或在成年人监督下给予 DUPIXENT。在 6 个月至 12 岁以下的儿童中，应由看护者给予 DUPIXENT。

P l ea se s e e a cc o mp any i n g f u l l P r e s cri b i n g I n f o r ma t i o n i nc l ud i n g P a t i en t I n f o r ma t i o n.

请参阅附带的完整处方信息，包括患者信息。

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. 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.

再生元（NASDAQ: REGN）是一家领先的生物技术公司，致力于为患有严重疾病的人们发明、开发和商业化改变生命的药物。公司由医师科学家创立并领导，我们独特的能力使我们能够反复且持续地将科学转化为医学，已导致多种获批治疗和正在开发的产品候选药物，其中大多数是在我们的实验室内自主研发的。我们的药物和研发管线旨在帮助患有眼病、过敏和炎症性疾病、癌症、心血管和代谢疾病、神经系统疾病、血液疾病、传染病和罕见疾病的患者。

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite, 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® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

再生元制药突破科学发现的界限，利用我们的专有技术加速药物开发，例如 VelociSuite，该技术能够生产优化的全人源抗体和新型双特异性抗体。我们通过再生元基因中心®的数据驱动洞察，塑造医学的下一个前沿，并开创基因医学平台，使我们能够识别创新的靶点和互补的方法，以潜在地治疗或治愈疾病。

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

欲了解更多信息，请访问 www.Regeneron.com 或在 LinkedIn、Instagram、Facebook 或 X 上关注再生元制药。

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、以人工智能为动力的生物制药公司，致力于改善人们的生活并实现可持续增长。我们运用对免疫系统的深刻理解，发明治疗和保护全球数百万人的药物和疫苗，拥有一个创新的产品管线，能够惠及更多人。我们的团队以一个目标为指导：追求科学的奇迹，以改善人们的生活；这激励我们推动进步，为我们的人和我们服务的社区带来积极影响，解决我们时代最紧迫的医疗、环境和社会挑战。

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

赛诺菲在 EURONEXT: SAN 和 NASDAQ: SNY 上上市。

Regeneron Forward-Looking Statements and Use of Digital Media

再生元前瞻性声明及数字媒体使用

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. 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 bronchial asthma in children aged 6 to 11 years pursuant to the approval by Japan’s Ministry of Health, Labour and Welfare (MHLW) discussed in this press release; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, including Dupixent for the treatment of chronic pruritus of unknown origin, lichen simplex chronicus, allergic fungal rhinosinusitis, and other potential indications; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products (such as Dupixent) 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 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 (such as Dupixent) and Regeneron’s Product Candidates 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 to drug pricing regulations and requirements and Regeneron’s pricing strategy; other 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 assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (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. 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 September 30, 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. 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.

本新闻稿包含前瞻性声明，这些声明涉及与 Regeneron Pharmaceuticals, Inc.（“Regeneron” 或 “公司”）未来事件和未来业绩相关的风险和不确定性，实际事件或结果可能与这些前瞻性声明存在重大差异。诸如 “预期”、“期望”、“打算”、“计划”、“相信”、“寻求”、“估计” 等词语及其变体，以及类似表达，旨在识别这些前瞻性声明，尽管并非所有前瞻性声明都包含这些识别词。这些声明涉及的风险和不确定性包括但不限于，Regeneron 及其合作伙伴或被许可方（统称 “Regeneron 的产品”）所销售或以其他方式商业化的产品的性质、时机、可能的成功和治疗应用，以及 Regeneron 及其合作伙伴或被许可方（统称 “Regeneron 的产品候选者”）正在开发的产品候选者，以及当前正在进行或计划中的研究和临床项目，包括但不限于 Dupixent®（dupilumab）用于治疗 6 至 11 岁儿童的支气管哮喘，依据日本厚生劳动省（MHLW）批准的内容；Regeneron 的产品候选者和 Regeneron 的产品的新适应症的可能监管批准和商业推出的可能性、时机和范围，包括用于治疗未知原因的慢性瘙痒、单纯性苔藓、过敏性真菌性鼻窦炎及其他潜在适应症的 Dupixent；Regeneron 的产品（如 Dupixent）和 Regeneron 的产品候选者的利用、市场接受度和商业成功的不确定性，以及研究（无论是由 Regeneron 还是其他方进行，无论是强制性还是自愿性）对上述任何事项的影响，包括本新闻稿中讨论或提及的研究；Regeneron 的合作伙伴、被许可方、供应商或其他第三方（如适用）在制造、灌装、完成、包装、标签、分销及与 Regeneron 的产品和 Regeneron 的产品候选者相关的其他步骤中的表现能力；Regeneron 管理多个产品和产品候选者的供应链的能力以及与关税和其他贸易限制相关的风险；因在患者中使用 Regeneron 的产品（如 Dupixent）和 Regeneron 的产品候选者而导致的安全问题，包括在临床试验中使用 Regeneron 的产品和 Regeneron 的产品候选者时出现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 Regeneron 继续开发或商业化 Regeneron 的产品和 Regeneron 的产品候选者的能力；影响 Regeneron 的产品、研究和临床项目及业务的持续监管义务和监督，包括与患者隐私相关的义务；第三方支付方和其他第三方（包括私人支付医疗和保险计划、健康维护组织、药房福利管理公司以及政府项目如医疗保险和医疗补助）对 Regeneron 的产品的报销或共付援助的可用性和范围；这些支付方和其他第三方的覆盖和报销决定以及这些支付方和其他第三方采用的新政策和程序；药品定价法规和要求的变化以及 Regeneron 的定价策略；影响医疗行业的其他法律、法规和政策的变化；可能优于或比 Regeneron 的产品和 Regeneron 的产品候选者更具成本效益的竞争药物和产品候选者（包括 Regeneron 产品的生物类似药）；Regeneron 及其合作伙伴或被许可方进行的研究和开发项目的结果在其他研究中可能被复制的程度，以及/或可能导致产品候选者进入临床试验、治疗应用或监管批准的程度；意外费用；开发、生产和销售产品的成本；Regeneron 满足其任何财务预测或指导的能力以及对这些预测或指导基础假设的变化；任何许可、合作或供应协议的潜在取消或终止，包括 Regeneron 与 Sanofi 和 Bayer（或其各自关联公司，如适用）之间的协议；公共卫生疫情、流行病或大流行对 Regeneron 业务的影响；以及与公司及其运营相关的诉讼和其他程序及政府调查的风险（包括美国司法部和马萨诸塞州地区检察官办公室发起或参与的待决民事诉讼），与其他方的知识产权相关的风险以及与之相关的待决或未来诉讼（包括但不限于与 EYLEA®（aflibercept）注射剂相关的专利诉讼和其他相关程序），任何此类程序和调查的最终结果，以及上述任何事项对 Regeneron 的业务、前景、运营结果和财务状况的影响。有关这些及其他重大风险的更完整描述可以在 Regeneron 向美国证券交易委员会提交的文件中找到，包括截至2024年12月31日的年度报告 Form 10-K 和截至2025年9月30日的季度报告 Form 10-Q。任何前瞻性声明均基于管理层当前的信念和判断，读者被提醒不要依赖 Regeneron 所作的任何前瞻性声明。Regeneron 不承担更新（公开或其他）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，无论是由于新信息、未来事件还是其他原因。

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 )

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要信息，包括可能被视为对投资者重要的信息。有关 Regeneron 的财务和其他信息会定期发布，并可在 Regeneron 的媒体和投资者关系网站（https://investor.regeneron.com）及其 LinkedIn 页面（https://www.linkedin.com/company/regeneron-pharmaceuticals）上获取。

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. 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. 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, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

本新闻稿包含根据 1995 年《私人证券诉讼改革法》及其修正案定义的前瞻性声明。前瞻性声明是指非历史事实的陈述。这些陈述包括关于产品的市场营销和其他潜力的预测和估计，或关于产品未来潜在收入的预测。前瞻性声明通常通过 “预计”、“预期”、“相信”、“打算”、“估计”、“计划” 等类似表达来识别。尽管赛诺菲管理层认为这些前瞻性声明中反映的预期是合理的，但投资者应注意，前瞻性信息和声明受到各种风险和不确定性的影响，其中许多是难以预测的，并且通常超出赛诺菲的控制，这可能导致实际结果和发展与前瞻性信息和声明中表达、暗示或预测的内容有实质性差异。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，或政府法规一般可能影响产品的可用性或商业潜力，产品可能未能实现商业成功，研发固有的不确定性，包括与产品相关的未来临床数据和现有临床数据的分析，包括上市后意外的安全性、质量或制造问题，竞争风险，知识产权相关的风险及任何相关未来诉讼及其最终结果，以及经济和市场条件的波动，以及全球危机可能对我们、我们的客户、供应商、供应商和其他商业伙伴的影响，以及他们的财务状况，以及对我们的员工和全球经济整体的影响。风险和不确定性还包括赛诺菲向 SEC 和 AMF 提交的公开文件中讨论或识别的不确定性，包括在赛诺菲截至2024年12月31日的年度报告的 “风险因素” 和 “关于前瞻性声明的警示性声明” 中列出的内容。除非适用法律要求，赛诺菲不承担更新或修订任何前瞻性信息或声明的义务。

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为赛诺菲集团的财产，除了 VelociSuite 和 Regeneron Genetics Center 。


Regeneron Contacts: Media Relations Sharon Chen Tel: +1 914-847-1546 Sharon.Chen@regeneron.com	Investor Relations Mark Hudson Tel: +1 914-847-3482 Mark.Hudson@regeneron.com

Sanofi Contacts: Media Relations Sandrine Guendoul Tel: +33 6 25 09 14 25 Sandrine.Guendoul@sanofi.com	Investor Relations Thomas Kudsk Larsen Tel: +44 7545 513 693 Thomas.Larsen@sanofi.com

Evan Berland Tel: +1 215-432-0234 Evan.Berland@sanofi.com L éo Le Bourhis Tel: + 33 6 75 06 43 81 leo.lebourhis@sanofi.com Victor Rouault Tel: +33 6 70 93 71 40 Victor.Rouault@sanofi.com Timothy Gilbert Tel: +1 516-521-2929 Timothy.Gilbert@sanofi.com L éa Ubaldi Tel: + 33 6 30 19 66 46 lea.ubaldi@sanofi.com	Alizé Kaisserian Tel: +33 6 47 04 12 11 Alize.Kaisserian@sanofi.com Keita Browne Tel: +1 781-249-1766 Keita.Browne@sanofi.com Nathalie Pham Tel: +33 7 85 93 30 17 Nathalie.Pham@sanofi.com Thibaud Châtelet Tel: +33 6 80 80 89 90 Thibaud.Chatelet@sanofi.com Yun Li Tel: +33 6 84 00 90 72 Yun.Li3@sanofi.com


Regeneron 联系人：媒体关系 Sharon Chen 电话：+1 914-847-1546 Sharon.Chen@regeneron.com	投资者关系 Mark Hudson 电话：+1 914-847-3482 Mark.Hudson@regeneron.com

赛诺菲联系人：媒体关系 Sandrine Guendoul 电话：+33 6 25 09 14 25 Sandrine.Guendoul@sanofi.com	投资者关系 Thomas Kudsk Larsen 电话：+44 7545 513 693 Thomas.Larsen@sanofi.com

Evan Berland 电话：+1 215-432-0234 Evan.Berland@sanofi.com L éo Le Bourhis 电话：+ 33 6 75 06 43 81 leo.lebourhis@sanofi.com Victor Rouault 电话：+33 6 70 93 71 40 Victor.Rouault@sanofi.com Timothy Gilbert 电话：+1 516-521-2929 Timothy.Gilbert@sanofi.com L éa Ubaldi 电话：+ 33 6 30 19 66 46 lea.ubaldi@sanofi.com	Alizé Kaisserian 电话：+33 6 47 04 12 11 Alize.Kaisserian@sanofi.com Keita Browne 电话：+1 781-249-1766 Keita.Browne@sanofi.com Nathalie Pham 电话：+33 7 85 93 30 17 Nathalie.Pham@sanofi.com Thibaud Châtelet 电话：+33 6 80 80 89 90 Thibaud.Chatelet@sanofi.com Yun Li 电话：+33 6 84 00 90 72 Yun.Li3@sanofi.com

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