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

基於全球第三階段兒童臨牀試驗的批准，顯示 Dupixent 顯著減少了加重發作（減少 54% 至 65%）並改善了肺功能（改善 4.68% 至 5.32%），與安慰劑相比

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 是首個也是唯一一個在隨機第三階段試驗中證明能改善這一年輕患者羣體肺功能的生物製劑，且能夠抑制 IL-4 和 IL-13，這兩者是 2 型炎症的關鍵驅動因素

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.

紐約塔裏敦和巴黎，2025年12月23日（全球新聞稿）——Regeneron 製藥公司（NASDAQ: REGN）和賽諾菲今天宣佈，日本厚生勞動省（MHLW）已批准 Dupixent®（dupilumab）用於治療 6 至 11 歲患有嚴重或難治性支氣管哮喘的兒童，這些患者的症狀在現有治療下控制不佳。這一批准擴展了之前在日本對 12 歲及以上患者的相應批准。

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.

日本的批准基於 VOYAGE 這項全球第三階段試驗的數據，該試驗評估了 Dupixent 在 6 至 11 歲患有未控制的中重度哮喘兒童中的效果，涵蓋了整體人羣及具有 2 型炎症表型（通過血液嗜酸細胞升高和/或呼氣一氧化氮分數定義）。此外，EXCURSION 的開放標籤擴展研究中包含了專門針對日本兒童患者的子研究，支持了這一批准。在 VOYAGE 試驗中，Dupixent 與標準哮喘治療聯合使用顯著減少了嚴重加重發作（減少 54% 至 65%，p<0.0001）並改善了肺功能（改善 4.68% 至 5.32%，p=0.0012，p=0.0009 和 p=0.0036），與安慰劑相比，適用於整體人羣、2 型炎症患者和嗜酸細胞升高患者。在日本兒童患者的子研究中，Dupixent 在 12 周時改善了肺功能，並在一年內導致了低嚴重哮喘加重發作率。與 Dupixent 相關的最常見不良事件是在 VOYAGE 中報告的注射部位反應（紅斑、水腫和硬結），以及在 EXCURSION 中報告的發熱、口腔皰疹、嗜酸細胞增多和注射部位反應（紅斑和硬結）。

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.

哮喘是兒童中最常見的慢性疾病之一。儘管使用當前標準的吸入類固醇和支氣管擴張劑進行治療，兒童仍可能繼續經歷嚴重症狀，如咳嗽、喘息和呼吸困難。此外，年輕兒童的肺功能受損如果不及早處理，可能會產生潛在的長期影響，如肺生長受限和持續的氣道阻塞。患者還可能需要多次使用系統性類固醇，而這會帶來顯著風險。未控制的哮喘會干擾日常活動，如睡眠、上學和參加體育活動。

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 在日本還獲得了對某些特應性皮炎、慢性鼻竇炎伴鼻息肉（CRSwNP）、結節性瘙癢、慢性自發性蕁麻疹（CSU）和慢性阻塞性肺病（COPD）患者的批准。Dupixent 已在全球 50 個國家獲得批准，用於治療 6 至 11 歲兒童的哮喘。

About Dupixent

關於 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 毫克的預填充注射器或預填充筆形式提供，現在可用於 6 至 11 歲患有哮喘的兒童。Dupixent 旨在皮下注射（皮下注射），根據體重每兩週或四周給藥。可以在診所或在經過醫療專業人員培訓後在家自我給藥。對於 12 歲以下的兒童，如果在家給藥，Dupixent 應由看護人進行管理。

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 的專有_VelocImmune_®技術發明的，屬於完全人源化單克隆抗體，能夠抑制白細胞介素-4（IL-4）和白細胞介素-13（IL-13）信號通路，並非免疫抑制劑。Dupixent 開發項目在第三階段試驗中顯示出顯著的臨牀益處，並減少了 2 型炎症，確立了 IL-4 和 IL-13 是導致多種相關且常常合併疾病的 2 型炎症的兩個關鍵驅動因素。

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 多個國家獲得了監管批准，適用於一種或多種適應症，包括某些特應性皮炎、哮喘、CRSwNP、嗜酸細胞食管炎（EoE）、結節性瘙癢、CSU、COPD 和水皰性類天皰瘡（BP）等不同年齡段的患者。全球已有超過 130 萬患者正在接受 Dupixent 治療。1

About Regeneron’s VelocImmune Technology

關於 Regeneron 的 VelocImmune 技術

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_技術利用一種專有的基因工程小鼠平台，賦予其人源化的免疫系統，以生產優化的完全人源化抗體。當 Regeneron 的聯合創始人、總裁兼首席科學官 George D. Yancopoulos 在 1985 年與他的導師 Frederick W. Alt 一起作為研究生時，他們首次設想製造這種人源化小鼠，Regeneron 花費了數十年時間發明和開發_VelocImmune_及相關的_VelociSuite_®技術。Yancopoulos 博士及其團隊利用_VelocImmune_技術創造了大量所有原始的、FDA 批准的完全人源化單克隆抗體。這包括 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 大流行期間獲得 FDA 授權，直至 2024 年。

Dupilumab Development Program

Dupilumab 開發項目

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 和賽諾菲在全球合作協議下共同開發。迄今為止，dupilumab 已在超過 60 項臨牀試驗中研究，涉及超過 10,000 名患有各種慢性疾病的患者，這些疾病部分是由 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.

除了目前批准的適應症外，Regeneron 和賽諾菲還在第 3 期臨牀試驗中研究 dupilumab 在由 2 型炎症或其他過敏過程引起的廣泛疾病中的應用，包括原因不明的慢性瘙癢、單純性苔蘚和過敏性真菌性鼻竇炎。這些 dupilumab 的潛在用途目前正在臨牀研究中，尚未被任何監管機構全面評估其安全性和有效性。

U.S. INDICATIONS

美國適應症

DUPIXENT is a prescription medicine used:

DUPIXENT 是一種處方藥，用於：

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.

治療 6 個月及以上的成人和兒童中度至重度濕疹（特應性皮炎或 AD），該病症未能通過皮膚使用的處方療法（外用）得到良好控制，或無法使用外用療法。DUPIXENT 可以與或不與外用皮質類固醇一起使用。目前尚不清楚 DUPIXENT 在 6 個月以下的 AD 兒童中是否安全有效。
與其他哮喘藥物聯合用於 6 歲及以上成人和兒童中度至重度嗜酸性或依賴口服類固醇的哮喘的維持治療，且其哮喘未能通過當前的哮喘藥物得到控制。DUPIXENT 有助於預防嚴重的哮喘發作（加重），並可以改善呼吸。DUPIXENT 還可能有助於減少您在預防嚴重哮喘發作和改善呼吸時所需的口服皮質類固醇的用量。目前尚不清楚 DUPIXENT 在 6 歲以下的哮喘兒童中是否安全有效。
與其他藥物聯合用於 12 歲及以上成人和兒童中度至重度鼻息肉慢性鼻竇炎（CRSwNP）的維持治療，且其疾病未能得到控制。目前尚不清楚 DUPIXENT 在 12 歲以下的 CRSwNP 兒童中是否安全有效。
治療 1 歲及以上的成人和兒童嗜酸性食管炎（EoE），體重至少 33 磅（15 公斤）。目前尚不清楚 DUPIXENT 在 1 歲以下或體重低於 33 磅（15 公斤）的 EoE 兒童中是否安全有效。
治療成人結節性瘙癢症（PN）。目前尚不清楚 DUPIXENT 在 18 歲以下的 PN 兒童中是否安全有效。
與其他藥物聯合用於維持治療成人慢性阻塞性肺疾病（COPD）且血液嗜酸性粒細胞數量較高（可能導致 COPD 的白細胞類型）的患者。DUPIXENT 用於減少急性發作（COPD 症狀加重數天）的次數，並可以改善呼吸。目前尚不清楚 DUPIXENT 在 18 歲以下的 COPD 兒童中是否安全有效。
治療 12 歲及以上的成人和兒童慢性自發性蕁麻疹（CSU），且在 H1 抗組胺治療下仍持續出現蕁麻疹。目前尚不清楚 DUPIXENT 在 12 歲以下或體重低於 66 磅（30 公斤）的 CSU 兒童中是否安全有效。
治療成人大皰性類天皰瘡（BP）。目前尚不清楚 DUPIXENT 在 18 歲以下的 BP 兒童中是否安全有效。

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 不用於 緩解突發的呼吸問題，且不會替代吸入式急救藥物或用於治療其他形式的蕁麻疹（風疹）。

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®.

如果您對 dupilumab 或 DUPIXENT®中的任何成分過敏，請勿使用。

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

在使用 DUPIXENT 之前，請告知您的醫療提供者您的所有醫療狀況，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.

有眼部問題。
有寄生蟲（蠕蟲）感染。
計劃接種任何疫苗。您在接受 DUPIXENT 治療前和期間不應接種 “活疫苗”。
懷孕或計劃懷孕。目前尚不清楚 DUPIXENT 是否會對未出生的嬰兒造成傷害。
- 針對在懷孕期間使用 DUPIXENT 的女性的懷孕登記收集您和您嬰兒的健康信息。要註冊或獲取更多信息，請撥打 1-877-311-8972 或訪問 https://mothertobaby.org/ongoing-study/dupixent/。
正在哺乳或計劃哺乳。目前尚不清楚 DUPIXENT 是否會進入您的母乳。

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

告知您的醫療提供者您所服用的所有藥物，包括處方藥和非處方藥、維生素和草藥補充劑。

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.

特別告知您的醫療提供者如果您 正在服用口服、外用或吸入的皮質類固醇藥物；有哮喘並使用哮喘藥物；或有 AD、CRSwNP、EoE、PN、COPD、CSU 或 BP 並且也有哮喘。請勿在未與您的醫療提供者討論的情況下更改或停止其他藥物，包括皮質類固醇藥物或其他哮喘藥物。這可能會導致那些藥物控制的其他症狀復發。

DUPIXENT can cause serious side effects, including:

DUPIXENT 可能會引起嚴重的副作用，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.

過敏反應。DUPIXENT 可能會引起過敏反應，包括皮膚反應，有時可能會很嚴重。 如果出現以下任何跡象或症狀，請立即停止使用 DUPIXENT，並告知您的醫療提供者或尋求緊急幫助：呼吸困難或喘息，面部、嘴唇、口腔、舌頭或喉嚨腫脹，暈厥，頭暈，感到頭昏，心跳加快，發熱，蕁麻疹，皮疹，包括看起來像靶心的皮疹，皮膚下的紅色或藍色疼痛腫塊，或皮膚上充滿膿液的紅點，整體不適，瘙癢，淋巴結腫大，噁心或嘔吐，關節疼痛，或腹部痙攣。
眼部問題。 如果您有任何新的或加重的眼部問題，包括眼痛或視力變化（如視力模糊），請告知您的醫療提供者。如果需要，您的醫療提供者可能會將您轉診給眼科醫生進行檢查。
血管炎。 這種情況在接受 DUPIXENT 的哮喘患者中很少見。這可能發生在同時服用口服類固醇藥物並正在停用或降低劑量的人身上。如果您出現以下症狀，請立即告知您的醫療提供者：皮疹，胸痛，呼吸急促加重，尿液呈棕色或深色，持續發熱，或手臂或腿部有針刺感或麻木感。
銀屑病。 這種情況可能發生在接受 DUPIXENT 的特應性皮炎和哮喘患者中。請告知您的醫療提供者任何新的皮膚症狀。如果需要，您的醫療提供者可能會將您轉診給皮膚科醫生進行檢查。
關節疼痛。 一些使用 DUPIXENT 的人因關節症狀而在行走或移動時遇到困難，在某些情況下需要住院。請告知您的醫療提供者任何新的或加重的關節症狀。如果您出現關節症狀，您的醫療提供者可能會停止使用 DUPIXENT。

The most common side effects include:

最常見的副作用包括：

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.

濕疹： 注射部位反應，眼部問題，包括眼睛和眼瞼炎症、紅腫、瘙癢、眼部感染、乾眼和視力模糊，嘴巴或嘴唇上的冷瘡，以及某種白細胞（嗜酸性粒細胞增多症）計數增高。
哮喘： 注射部位反應，某種白細胞（嗜酸性粒細胞增多症）計數增高，喉嚨痛（口咽痛），以及寄生蟲（蠕蟲）感染。
慢性鼻竇炎伴鼻息肉： 注射部位反應，眼部問題，包括眼睛和眼瞼炎症、紅腫、瘙癢、眼部感染和視力模糊，某種白細胞（嗜酸性粒細胞增多症）計數增高，胃部問題（胃炎），關節疼痛（關節痛），失眠，和牙痛。
嗜酸性食管炎： 注射部位反應，上呼吸道感染，嘴巴或嘴唇上的冷瘡，以及關節疼痛（關節痛）。
結節性癢疹： 眼部問題，包括眼睛和眼瞼炎症、紅腫、瘙癢和視力模糊，單純皰疹病毒感染，感冒症狀（鼻咽炎），頭暈，肌肉疼痛，和腹瀉。
慢性阻塞性肺病： 注射部位反應，感冒症狀（鼻咽炎），某種白細胞（嗜酸性粒細胞增多症）計數增高，病毒感染，背痛，鼻腔內炎症（鼻炎），腹瀉，胃部問題（胃炎），關節疼痛（關節痛），牙痛，頭痛，和尿路感染。
慢性自發性蕁麻疹： 注射部位反應。
大皰性類天皰瘡： 關節疼痛（關節痛），眼部問題，包括眼睛和眼瞼炎症、紅腫、瘙癢和視力模糊，以及單純皰疹病毒感染。

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.

如果您有任何讓您困擾或不消失的副作用，請告知您的醫療提供者。這些並不是 DUPIXENT 所有可能的副作用。請致電您的醫生以獲取有關副作用的醫療建議。鼓勵您向 FDA 報告處方藥的負面副作用。訪問 www.fda.gov/medwatch，或撥打 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.

請按照醫療提供者的處方準確使用 DUPIXENT。這是一種皮下注射（皮下注射）。您的醫療提供者將決定您或您的看護者是否可以注射 DUPIXENT。請勿在您或您的看護者接受醫療提供者的培訓之前嘗試準備和注射 DUPIXENT。在 12 歲及以上的兒童中，建議由成年人或在成年人監督下給予 DUPIXENT。在 6 個月至 12 歲以下的兒童中，應由看護者給予 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.

請參閲附帶的完整處方信息，包括患者信息。

About Regeneron

關於再生元

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）是一家領先的生物技術公司，致力於為患有嚴重疾病的人們發明、開發和商業化改變生命的藥物。公司由醫師科學家創立並領導，我們獨特的能力使我們能夠反覆且持續地將科學轉化為醫學，已導致多種獲批治療和正在開發的產品候選藥物，其中大多數是在我們的實驗室內自主研發的。我們的藥物和研發管線旨在幫助患有眼病、過敏和炎症性疾病、癌症、心血管和代謝疾病、神經系統疾病、血液疾病、傳染病和罕見疾病的患者。

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.

再生元製藥突破科學發現的界限，利用我們的專有技術加速藥物開發，例如 VelociSuite，該技術能夠生產優化的全人源抗體和新型雙特異性抗體。我們通過再生元基因中心®的數據驅動洞察，塑造醫學的下一個前沿，並開創基因醫學平台，使我們能夠識別創新的靶點和互補的方法，以潛在地治療或治癒疾病。

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

欲瞭解更多信息，請訪問 www.Regeneron.com 或在 LinkedIn、Instagram、Facebook 或 X 上關注再生元製藥。

About Sanofi

關於賽諾菲

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.

賽諾菲是一家以研發為驅動、以人工智能為動力的生物製藥公司，致力於改善人們的生活並實現可持續增長。我們運用對免疫系統的深刻理解，發明治療和保護全球數百萬人的藥物和疫苗，擁有一個創新的產品管線，能夠惠及更多人。我們的團隊以一個目標為指導：追求科學的奇蹟，以改善人們的生活；這激勵我們推動進步，為我們的人和我們服務的社區帶來積極影響，解決我們時代最緊迫的醫療、環境和社會挑戰。

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

賽諾菲在 EURONEXT: SAN 和 NASDAQ: SNY 上上市。

Regeneron Forward-Looking Statements and Use of Digital Media

再生元前瞻性聲明及數字媒體使用

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.

本新聞稿包含前瞻性聲明，這些聲明涉及與 Regeneron Pharmaceuticals, Inc.（“Regeneron” 或 “公司”）未來事件和未來業績相關的風險和不確定性，實際事件或結果可能與這些前瞻性聲明存在重大差異。諸如 “預期”、“期望”、“打算”、“計劃”、“相信”、“尋求”、“估計” 等詞語及其變體，以及類似表達，旨在識別這些前瞻性聲明，儘管並非所有前瞻性聲明都包含這些識別詞。這些聲明涉及的風險和不確定性包括但不限於，Regeneron 及其合作伙伴或被許可方（統稱 “Regeneron 的產品”）所銷售或以其他方式商業化的產品的性質、時機、可能的成功和治療應用，以及 Regeneron 及其合作伙伴或被許可方（統稱 “Regeneron 的產品候選者”）正在開發的產品候選者，以及當前正在進行或計劃中的研究和臨牀項目，包括但不限於 Dupixent®（dupilumab）用於治療 6 至 11 歲兒童的支氣管哮喘，依據日本厚生勞動省（MHLW）批准的內容；Regeneron 的產品候選者和 Regeneron 的產品的新適應症的可能監管批准和商業推出的可能性、時機和範圍，包括用於治療未知原因的慢性瘙癢、單純性苔蘚、過敏性真菌性鼻竇炎及其他潛在適應症的 Dupixent；Regeneron 的產品（如 Dupixent）和 Regeneron 的產品候選者的利用、市場接受度和商業成功的不確定性，以及研究（無論是由 Regeneron 還是其他方進行，無論是強制性還是自願性）對上述任何事項的影響，包括本新聞稿中討論或提及的研究；Regeneron 的合作伙伴、被許可方、供應商或其他第三方（如適用）在製造、灌裝、完成、包裝、標籤、分銷及與 Regeneron 的產品和 Regeneron 的產品候選者相關的其他步驟中的表現能力；Regeneron 管理多個產品和產品候選者的供應鏈的能力以及與關税和其他貿易限制相關的風險；因在患者中使用 Regeneron 的產品（如 Dupixent）和 Regeneron 的產品候選者而導致的安全問題，包括在臨牀試驗中使用 Regeneron 的產品和 Regeneron 的產品候選者時出現的嚴重併發症或副作用；監管和行政政府機構的決定可能會延遲或限制 Regeneron 繼續開發或商業化 Regeneron 的產品和 Regeneron 的產品候選者的能力；影響 Regeneron 的產品、研究和臨牀項目及業務的持續監管義務和監督，包括與患者隱私相關的義務；第三方支付方和其他第三方（包括私人支付醫療和保險計劃、健康維護組織、藥房福利管理公司以及政府項目如醫療保險和醫療補助）對 Regeneron 的產品的報銷或共付援助的可用性和範圍；這些支付方和其他第三方的覆蓋和報銷決定以及這些支付方和其他第三方採用的新政策和程序；藥品定價法規和要求的變化以及 Regeneron 的定價策略；影響醫療行業的其他法律、法規和政策的變化；可能優於或比 Regeneron 的產品和 Regeneron 的產品候選者更具成本效益的競爭藥物和產品候選者（包括 Regeneron 產品的生物類似藥）；Regeneron 及其合作伙伴或被許可方進行的研究和開發項目的結果在其他研究中可能被複制的程度，以及/或可能導致產品候選者進入臨牀試驗、治療應用或監管批准的程度；意外費用；開發、生產和銷售產品的成本；Regeneron 滿足其任何財務預測或指導的能力以及對這些預測或指導基礎假設的變化；任何許可、合作或供應協議的潛在取消或終止，包括 Regeneron 與 Sanofi 和 Bayer（或其各自關聯公司，如適用）之間的協議；公共衞生疫情、流行病或大流行對 Regeneron 業務的影響；以及與公司及其運營相關的訴訟和其他程序及政府調查的風險（包括美國司法部和馬薩諸塞州地區檢察官辦公室發起或參與的待決民事訴訟），與其他方的知識產權相關的風險以及與之相關的待決或未來訴訟（包括但不限於與 EYLEA®（aflibercept）注射劑相關的專利訴訟和其他相關程序），任何此類程序和調查的最終結果，以及上述任何事項對 Regeneron 的業務、前景、運營結果和財務狀況的影響。有關這些及其他重大風險的更完整描述可以在 Regeneron 向美國證券交易委員會提交的文件中找到，包括截至2024年12月31日的年度報告 Form 10-K 和截至2025年9月30日的季度報告 Form 10-Q。任何前瞻性聲明均基於管理層當前的信念和判斷，讀者被提醒不要依賴 Regeneron 所作的任何前瞻性聲明。Regeneron 不承擔更新（公開或其他）任何前瞻性聲明的義務，包括但不限於任何財務預測或指導，無論是由於新信息、未來事件還是其他原因。

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 利用其媒體和投資者關係網站以及社交媒體渠道發佈有關公司的重要信息，包括可能被視為對投資者重要的信息。有關 Regeneron 的財務和其他信息會定期發佈，並可在 Regeneron 的媒體和投資者關係網站（https://investor.regeneron.com）及其 LinkedIn 頁面（https://www.linkedin.com/company/regeneron-pharmaceuticals）上獲取。

Sanofi Disclaimers or Forward-Looking Statements

賽諾菲免責聲明或前瞻性聲明

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.

本新聞稿包含根據 1995 年《私人證券訴訟改革法》及其修正案定義的前瞻性聲明。前瞻性聲明是指非歷史事實的陳述。這些陳述包括關於產品的市場營銷和其他潛力的預測和估計，或關於產品未來潛在收入的預測。前瞻性聲明通常通過 “預計”、“預期”、“相信”、“打算”、“估計”、“計劃” 等類似表達來識別。儘管賽諾菲管理層認為這些前瞻性聲明中反映的預期是合理的，但投資者應注意，前瞻性信息和聲明受到各種風險和不確定性的影響，其中許多是難以預測的，並且通常超出賽諾菲的控制，這可能導致實際結果和發展與前瞻性信息和聲明中表達、暗示或預測的內容有實質性差異。這些風險和不確定性包括但不限於，意外的監管行動或延遲，或政府法規一般可能影響產品的可用性或商業潛力，產品可能未能實現商業成功，研發固有的不確定性，包括與產品相關的未來臨牀數據和現有臨牀數據的分析，包括上市後意外的安全性、質量或製造問題，競爭風險，知識產權相關的風險及任何相關未來訴訟及其最終結果，以及經濟和市場條件的波動，以及全球危機可能對我們、我們的客户、供應商、供應商和其他商業夥伴的影響，以及他們的財務狀況，以及對我們的員工和全球經濟整體的影響。風險和不確定性還包括賽諾菲向 SEC 和 AMF 提交的公開文件中討論或識別的不確定性，包括在賽諾菲截至2024年12月31日的年度報告的 “風險因素” 和 “關於前瞻性聲明的警示性聲明” 中列出的內容。除非適用法律要求，賽諾菲不承擔更新或修訂任何前瞻性信息或聲明的義務。

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

本新聞稿中提到的所有商標均為賽諾菲集團的財產，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 聯繫人：媒體關係 Sharon Chen 電話：+1 914-847-1546 Sharon.Chen@regeneron.com	投資者關係 Mark Hudson 電話：+1 914-847-3482 Mark.Hudson@regeneron.com

賽諾菲聯繫人：媒體關係 Sandrine Guendoul 電話：+33 6 25 09 14 25 Sandrine.Guendoul@sanofi.com	投資者關係 Thomas Kudsk Larsen 電話：+44 7545 513 693 Thomas.Larsen@sanofi.com

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

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