OMLYCLO®（omalizumab-igec）是首款且唯一获美国食品药品监督管理局（FDA）批准的可互换XOLAIR®生物类似药，现已在美国上市销售-动脉网

OMLYCLO® (omalizumab-igec), the first and only FDA-approved interchangeable biosimilar to XOLAIR®, now commercially available in the U.S.

CISION 等信源发布 2026-10-05 20:45

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OMLYCLO

奥姆利克洛

(omalizumab-igec) is the first and only

（omalizumab-igec）是首个且唯一的

FDA-approved omalizumab biosimilar approved for all four indications of XOLAIR

FDA批准的奥马珠单抗生物类似药获批用于XOLAIR的全部四项适应症

(omalizumab) and designated as interchangeable with XOLAIR; OMLYCLO

（奥马珠单抗）并被指定为与XOLAIR可互换；OMLYCLO

will be available in 75 mg/0.5 mL, 150 mg/mL and 300mg/2mL in a single-dose prefilled syringe for subcutaneous injection in the U.S.

在美国，该药品将以75 mg/0.5 mL、150 mg/mL和300 mg/2 mL的规格提供，采用单剂量预充式注射器，用于皮下注射。

The availability of the first omalizumab biosimilar introduces an additional treatment option for eligible patients with allergic and inflammatory conditions

首款奥马珠单抗生物类似药的上市，为符合条件的过敏性及炎症性疾病患者提供了额外的治疗选择。

JERSEY CITY, N.J.

新泽西州泽西市

，

Oct. 5, 2026

2026年10月5日

/PRNewswire/ -- Celltrion USA, Inc. today announced the availability of OMLYCLO

/美通社/ -- Celltrion USA, Inc. 今日宣布OMLYCLO现已上市

(omalizumab-igec), the first and only U.S. Food and Drug Administration (FDA) approved interchangeable biosimilar to XOLAIR

（omalizumab-igec），美国食品药品监督管理局（FDA）批准的首个且唯一可与XOLAIR互换的生物类似药

(omalizumab). OMLYCLO

（奥马珠单抗）。OMLYCLO

is now available in 75 mg/0.5 mL, 150 mg/mL and 300mg/2mL in a single-dose prefilled syringe for subcutaneous injection.

现已提供75 mg/0.5 mL、150 mg/mL和300 mg/2 mL三种规格，采用单剂量预充式注射器，用于皮下注射。

OMLYCLO

is approved for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous urticaria (CSU).

已获批用于治疗中重度持续性哮喘、伴鼻息肉的慢性鼻窦炎（CRSwNP）、免疫球蛋白E（IgE）介导的食物过敏以及慢性自发性荨麻疹（CSU）。

As the first interchangeable biosimilar to omalizumab approved for all four indications of XOLAIR, OMLYCLO

作为首个获批用于XOLAIR全部四项适应症的奥马珠单抗可互换生物类似药，OMLYCLO

expands treatment options for eligible patients and healthcare providers while reinforcing Celltrion's commitment to increasing access to high-quality biologic medicines.

为符合条件的患者和医疗保健提供者拓展了治疗选择，同时强化了Celltrion致力于提高高质量生物制剂可及性的承诺。

Omalizumab has historically played an important role in the treatment of chronic allergic and inflammatory diseases, helping patients whose conditions may not be adequately controlled with standard therapies. The commercial availability of OMLYCLO

奥马珠单抗历来在慢性过敏性和炎症性疾病的治疗中发挥着重要作用，帮助那些病情无法通过标准疗法得到充分控制的患者。OMLYCLO 的商业化供应

marks an important milestone for the allergy and immunology community by introducing the first interchangeable biosimilar in this class and expanding access to an established biologic treatment option.

通过推出该类别中首个可互换生物类似药，并扩大已确立的生物制剂治疗选择的可及性，为过敏与免疫学界标志着一个重要的里程碑。

'Omalizumab has helped transform the treatment landscape for many patients living with allergic and inflammatory conditions,' said Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA. 'Yet the high cost of biologic therapies has limited access for many patients, creating challenges for both individuals and the healthcare system.

“奥马珠单抗已帮助改变了许多患有过敏性和炎症性疾病患者的治疗格局，”Celltrion USA 高级副总裁兼首席医疗官 Juby Jacob-Nara 博士表示。“然而，生物制剂疗法的高昂费用限制了许多患者的可及性，给个人和医疗保健系统都带来了挑战。”

The introduction of the first interchangeable omalizumab biosimilar provides a new opportunity to improve affordability and expand access, enabling health plans to offer more patients a proven treatment option. At Celltrion, we are committed to developing high-quality biosimilars that increase treatment choice while helping reduce barriers to care.'.

首款可互换的奥马珠单抗生物类似药的推出，为提高可负担性和扩大可及性提供了新机遇，使健康保险计划能够为更多患者提供经过验证的治疗选择。Celltrion致力于开发高质量的生物类似药，在增加治疗选择的同时，帮助降低就医障碍。

'In allergy practice, omalizumab is used across conditions that can look very different from one patient to the next, from uncontrolled allergic asthma and nasal polyps to food allergy and chronic hives,' said Michael S. Blaiss, MD, Clinical Professor of Pediatrics, Division of Allergy, Immunology, and Pediatric Rheumatology, Medical College of Georgia at Augusta University, Augusta, Georgia.

“在过敏症临床实践中，奥马珠单抗适用于多种病症，这些病症在不同患者身上的表现可能截然不同，包括未控制的过敏性哮喘、鼻息肉、食物过敏以及慢性荨麻疹。”佐治亚州奥古斯塔市奥古斯塔大学佐治亚医学院儿科过敏、免疫学和儿科风湿病学分部临床教授迈克尔·S·布莱斯医学博士表示。

'The availability of OMLYCLO.

OMLYCLO 的可用性。

gives clinicians the first interchangeable omalizumab biosimilar option, now with a 300 mg prefilled syringe alongside the 75 mg and 150 mg presentations.'

为临床医生提供了首个可互换的奥马珠单抗生物类似药选择，现已在75毫克和150毫克规格的基础上，增加300毫克预充式注射器规格。

'Biosimilars have become an established part of care across therapeutic areas including oncology, rheumatology, and gastroenterology,' said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. 'Now, we have the opportunity to bring that same experience and benefits to allergy and immunology.

“生物类似药已成为包括肿瘤学、风湿病学和胃肠病学在内的多个治疗领域护理体系中不可或缺的一部分，”Celltrion USA首席商务官Thomas Nusbickel表示。“现在，我们有机会将同样的经验和益处带到过敏与免疫学领域。”

For Celltrion, this is more than entering a new category – it is about applying the manufacturing discipline, quality focus and commercial infrastructure we have built over more than two decades to make an additional omalizumab option available to U.S. patients and their care teams.'.

对Celltrion而言，这不仅仅是进入一个新领域——而是将我们二十多年来建立的制造规范、质量专注和商业基础设施应用于为美国患者及其护理团队提供额外的奥马珠单抗选择。

This launch builds on Celltrion's ongoing commitment to expanding its biosimilars portfolio into new therapeutic areas and underscores the company's strategy of bringing high-quality biologic medicines to patients. Backed by more than two decades of experience developing and manufacturing biosimilars, Celltrion USA will continue to work with healthcare stakeholders to support the reliable adoption of high-quality biosimilars across the U.S.

此次发布延续了Celltrion不断将其生物类似药产品组合拓展至新治疗领域的承诺，并凸显了该公司为患者提供高质量生物制剂的战略。凭借在生物类似药研发和生产方面超过二十年的经验，Celltrion USA将继续与医疗利益相关方合作，支持高质量生物类似药在美国的可靠应用。

healthcare system..

医疗保健系统

About OMLYCLO

关于 OMLYCLO

(omalizumab-igec)

（奥马珠单抗-igec）

OMLYCLO

奥姆利克洛

注册商标

(omalizumab-igec) is the first U.S. Food and Drug Administration (FDA)-approved anti-IgE antibody biosimilar referencing XOLAIR

(omalizumab-igec) 是美国食品药品监督管理局（FDA）批准的首个参照 XOLAIR 的抗 IgE 抗体生物类似药

(omalizumab). OMLYCLO 75 mg/0.5 mL, 150 mg/mL and 300 mg/2mL solutions in a single-dose prefilled syringe is approved as interchangeable with the reference product for all indications based on comprehensive data and clinical evidence confirming the therapeutic equivalence to XOLAIR.

（奥马珠单抗）。OMLYCLO 75 mg/0.5 mL、150 mg/mL 和 300 mg/2 mL 单剂量预充式注射液，基于全面的数据和临床证据证实其与参照药品 XOLAIR 具有治疗等效性，因此被批准在所有适应症中与参照药品可互换使用。

OMLYCLO was approved by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) in March 2025 and May 2024, respectively.

OMLYCLO 分别于 2025 年 3 月和 2024 年 5 月获得美国食品药品监督管理局（FDA）和欧盟委员会（EC）的批准。

INDICATION

适应症

OMLYCLO

(omalizumab-igec) injection, is an anti-IgE antibody indicated for:

奥马珠单抗-igec 注射液是一种抗 IgE 抗体，适用于：

Moderate to severe persistent asthma

中度至重度持续性哮喘

in adults and pediatric patients ≥6 years of age with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids

适用于皮肤试验阳性或体外对常年性气传过敏原有反应，且症状经吸入性糖皮质激素控制不佳的成人及6岁及以上儿科患者

Chronic rhinosinusitis with nasal polyps (CRSwNP)

伴鼻息肉的慢性鼻窦炎（CRSwNP）

in adult patients ≥18 years of age with inadequate response to nasal corticosteroids, as add-on maintenance treatment

作为附加维持治疗，用于对鼻用皮质类固醇反应不足的≥18岁成年患者

IgE-mediated food allergy

IgE介导的食物过敏

in adult and pediatric patients aged ≥1 year age for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance

适用于1岁及以上的成人和儿科患者，用于减少因意外接触一种或多种食物而可能发生的过敏反应（I型），包括过敏性休克。应与避免食用食物过敏原联合使用

Chronic spontaneous urticaria (CSU)

慢性自发性荨麻疹（CSU）

in adults and adolescents ≥12 years of age who remain symptomatic despite H1 antihistamine treatment

适用于尽管接受H1抗组胺药治疗但仍存在症状的成人及12岁及以上青少年

Limitations of Use

使用限制

: Not indicated for: acute bronchospasm or status asthmaticus; emergency treatment of allergic reactions, including anaphylaxis; other forms of urticaria.

不适用于：急性支气管痉挛或哮喘持续状态；过敏反应（包括过敏性休克）的紧急治疗；其他形式的荨麻疹。

IMPORTANT SAFETY INFORMATION

重要安全信息

WARNING: ANAPHYLAXIS

警告：过敏性休克

Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of omalizumab products. Anaphylaxis has occurred as early as after the first dose of omalizumab products, but also has occurred beyond 1 year after beginning regularly administered treatment.

已有报告指出，在使用奥马珠单抗产品后，可能出现以支气管痉挛、低血压、晕厥、荨麻疹和/或咽喉或舌头血管性水肿为表现的过敏性休克。过敏性休克可能在首次使用奥马珠单抗产品后即发生，也可能在开始规律治疗1年后发生。

Because of the risk of anaphylaxis, initiate OMLYCLO therapy in a healthcare setting and closely observe patients for an appropriate period of time after OMLYCLO administration. .

由于存在过敏性休克的风险，应在医疗机构中开始OMLYCLO治疗，并在给药后对患者进行适当时间的密切观察。

Health care providers administering OMLYCLO should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of OMLYCLO should be based on criteria to mitigate risk from anaphylaxis..

给予 OMLYCLO 的医疗保健提供者应准备好处理可能危及生命的过敏反应。告知患者过敏反应的体征和症状，并指导他们在出现症状时立即寻求医疗护理。选择自行给药 OMLYCLO 的患者应基于减轻过敏反应风险的标准。

Contraindications:

禁忌症：

Severe hypersensitivity reaction to omalizumab products or any ingredient of OMLYCLO.

对奥马珠单抗制剂或OMLYCLO的任何成分发生严重超敏反应。

Anaphylaxis.

过敏性休克。

Omalizumab products, including OMLYCLO, have been associated with anaphylaxis, reported in both clinical trials and postmarketing data. Patients with a history of anaphylaxis to foods, medications, or other causes face an increased risk. Initiate OMLYCLO only in a healthcare setting with anaphylaxis management capabilities.

包括OMLYCLO在内的奥马珠单抗产品已与过敏反应相关，这在临床试验和上市后数据中均有报告。有食物、药物或其他原因导致的过敏反应史的患者面临更高的风险。仅在具备过敏反应管理能力的医疗环境中开始使用OMLYCLO。

Patients should be monitored for an appropriate period post-administration, informed of signs and symptoms of anaphylaxis, and instructed to seek immediate medical care if they occur..

患者应在给药后接受适当时期的监测，被告知过敏反应的体征和症状，并 instructed 在出现这些症状时立即寻求医疗护理。

Malignancy.

恶性肿瘤。

Malignancies have been observed in clinical studies, with various cancer types reported. The long-term risk, especially in high-risk groups, is unknown.

在临床研究中已观察到恶性肿瘤，并报告了多种癌症类型。长期风险，尤其是在高危人群中的风险，尚不明确。

Acute Asthma Symptoms and Deteriorating Disease.

急性哮喘症状与病情恶化

Omalizumab products have not been shown to alleviate asthma exacerbations acutely. Do not use OMLYCLO to treat acute bronchospasm or status asthmaticus.

奥马珠单抗制剂尚未被证实能急性缓解哮喘加重。请勿使用OMLYCLO治疗急性支气管痉挛或哮喘持续状态。

Corticosteroid Reduction.

皮质类固醇减量。

Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of OMLYCLO therapy for asthma or CRSwNP.

在开始使用 OMLYCLO 治疗哮喘或慢性鼻窦炎伴鼻息肉（CRSwNP）时，不得突然停用全身性或吸入性皮质类固醇。

Eosinophilic Conditions.

嗜酸性粒细胞相关疾病

Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy, especially upon reduction of oral corticosteroids.

警惕嗜酸性粒细胞增多、血管炎性皮疹、肺部症状加重、心脏并发症和/或神经病变，尤其是在减少口服皮质类固醇时。

Fever, Arthralgia, and Rash.

发热、关节痛和皮疹。

Stop OMLYCLO if a patient develops a constellation of signs and symptoms, including arthritis/arthralgia, rash, fever, and lymphadenopathy.

如果患者出现包括关节炎/关节痛、皮疹、发热和淋巴结病在内的一系列体征和症状，应停用OMLYCLO。

Parasitic (Helminth) Infection.

寄生虫（蠕虫）感染。

Monitor patients at high risk of geohelminth infection while on OMLYCLO therapy.

对接受 OMLYCLO 治疗且有地理性蠕虫感染高风险的患者进行监测。

Laboratory Tests.

实验室检查。

Administration of omalizumab products increases serum total IgE due to drug:IgE complexes. Do not use serum total IgE levels within one year of discontinuation of omalizumab products to reassess dosing regimen, as they may not reflect steady-state free IgE.

使用奥马珠单抗产品会因形成药物-IgE复合物而导致血清总IgE水平升高。在停用奥马珠单抗产品后的一年内，不要利用血清总IgE水平重新评估给药方案，因为这些水平可能无法反映稳态下的游离IgE水平。

Potential Medication Error Related to Emergency Treatment of Anaphylaxis.

与过敏性休克紧急治疗相关的潜在用药错误。

OMLYCLO should not be used for the emergency treatment of allergic reactions, including anaphylaxis. Instruct patients that OMLYCLO is for maintenance use to reduce allergic reactions, including anaphylaxis, while avoiding food allergens.

OMLYCLO 不应用于过敏反应（包括过敏性休克）的紧急治疗。应指导患者，OMLYCLO 用于维持治疗，以减少在避免食物过敏原的同时发生的过敏反应（包括过敏性休克）。

Most Common Adverse Reactions

最常见不良反应

Asthma

哮喘

: In patients ≥12 years, reported in ≥1%: arthralgia, general pain, leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, and earache. In pediatric patients (6 to <12 years), reported in ≥3%: nasopharyngitis, headache, pyrexia, upper abdominal pain, streptococcal pharyngitis, otitis media, viral gastroenteritis, arthropod bites, and epistaxis..

在≥12岁的患者中，发生率≥1%的不良反应包括：关节痛、全身疼痛、腿痛、疲劳、头晕、骨折、手臂疼痛、瘙痒、皮炎和耳痛。在儿科患者（6至<12岁）中，发生率≥3%的不良反应包括：鼻咽炎、头痛、发热、上腹痛、链球菌性咽炎、中耳炎、病毒性胃肠炎、节肢动物叮咬和鼻出血。

CRSwNP

慢性鼻窦炎伴鼻息肉

: In patients ≥3% of adults: headache, injection site reactions, arthralgia, upper abdominal pain, and dizziness.

：在≥3%的成年患者中：头痛、注射部位反应、关节痛、上腹痛和头晕。

IgE-Mediated Food Allergy

IgE介导的食物过敏

: In ≥3% of patients: injection site reactions and pyrexia.

：在≥3%的患者中：注射部位反应和发热。

CSU

科罗拉多州立大学

: In ≥2% of patients: nausea, nasopharyngitis, sinusitis, upper respiratory tract infections (viral and non-viral), arthralgia, headache, and cough.

：在≥2%的患者中：恶心、鼻咽炎、鼻窦炎、上呼吸道感染（病毒性和非病毒性）、关节痛、头痛和咳嗽。

For more information, see

更多信息，请参阅

Full Prescribing Information

完整处方信息

。

About Celltrion

关于赛尔群

Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar.

Celltrion 是一家领先的生物制药公司，专注于研发、生产、营销和销售改善全球人民生活的创新疗法。作为生物类似药领域的先驱，Celltrion 推出了全球首款单克隆抗体生物类似药。

Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines.

我们的全球药品组合涵盖多个治疗领域，包括免疫学、肿瘤学、血液学、眼科学和内分泌学。除了生物类似药产品外，我们致力于通过创新药物推进研发管线，突破科学创新的边界，提供高质量的药品。

For more information, please visit our website .

更多信息，请访问我们的网站。

www.celltrion.com/en-us

www.celltrion.com/zh-cn

and stay updated with our latest news and events on our social media:

并关注我们的社交媒体，获取最新的新闻和活动信息：

领英

，

Instagram

，

, and

，和

Facebook

脸书

。

About Celltrion USA

关于Celltrion美国公司

Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion's FDA-approved biosimilar products in immunology, oncology, hematology, endocrinology and ophthalmology include: INFLECTRA.

Celltrion USA 是 Celltrion 于 2018 年成立的美国子公司。总部位于新泽西州的 Celltrion USA 致力于扩大创新生物制剂的可及性，以改善美国患者的医疗护理。Celltrion 获得美国食品药品监督管理局（FDA）批准的生物类似药产品涵盖免疫学、肿瘤学、血液学、内分泌学和眼科学等领域，其中包括 INFLECTRA。

(infliximab-dyyb), TRUXIMA

（英夫利昔单抗-dyyb），TRUXIMA

注册商标符号

(rituximab-abbs), HERZUMA

（利妥昔单抗-abbs），HERZUMA

(trastuzumab-pkrb), VEGZELMA

（曲妥珠单抗-pkrb），VEGZELMA

(bevacizumab-adcd), YUFLYMA

（贝伐珠单抗-adcd），YUFLYMA

注册商标符号

(adalimumab-aaty), AVTOZMA

（阿达木单抗-aaty），AVTOZMA

(tocilizumab-anho), STEQEYMA

（托珠单抗-anho），STEYEYMA

(ustekinumab-stba), STOBOCLO

（乌司奴单抗-stba），STOBOCLO

(denosumab-bmwo), OSENVELT

（地舒单抗-bmwo），OSENVELT

(denosumab-bmwo), OMLYCLO

（地舒单抗-bmwo），OMLYCLO

(omalizumab-igec), and EYDENZELT

（奥马珠单抗-igec）和 EYDENZELT

(aflibercept-boav), as well as the novel biologic ZYMFENTRA

（阿柏西普-boav）以及新型生物制剂 ZYMFENTRA

(infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit

（英夫利昔单抗-dyyb）。Celltrion USA 将继续依托 Celltrion 在生物技术领域的独特积淀、卓越的供应链能力以及行业领先的销售实力，提升美国患者对高品质生物制药的可及性。欲了解更多信息，请访问

www.celltrionusa.com

and stay updated with our latest news and events on our social media -

并在我们的社交媒体上随时了解我们的最新新闻和活动 -

领英

。

FORWARD-LOOKING STATEMENT

前瞻性陈述

Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws.

本新闻稿中载有的某些信息包含与我们的未来业务和财务表现以及涉及Celltrion Inc.及其子公司的未来事件或发展相关的陈述，根据相关证券法律，这些陈述可能构成前瞻性陈述。

These statements may be also identified by words such as 'prepares', 'hopes to', 'upcoming', 'plans to', 'aims to', 'to be launched', 'is preparing', 'once gained', 'could', 'with the aim of', 'may', 'once identified', 'will', 'working towards', 'is due', 'become available', 'has potential to', the negative of these words or such other variations thereon or comparable terminology..

这些陈述也可以通过诸如“准备”、“希望”、“即将”、“计划”、“旨在”、“将推出”、“正在准备”、“一旦获得”、“可能”、“以……为目标”、“也许”、“一旦确定”、“将会”、“致力于”、“预计”、“可用”、“有潜力”等词语，或这些词语的否定形式、其他变体或类似术语来识别。

In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control.

此外，我们的代表可能会作出口头前瞻性陈述。此类陈述基于Celltrion Inc.及其子公司管理层当前的预期和某些假设，其中许多因素超出其控制范围。

Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect to the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them..

提供前瞻性陈述旨在让潜在投资者有机会了解管理层对未来的信念和观点，以便其在评估投资时将这些信念和观点作为考量因素之一。这些陈述并非对未来表现的保证，不应对其产生过度依赖。

Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements..

此类前瞻性陈述必然涉及与公司业务相关的已知和未知风险及不确定性，包括其年度报告和/或季度报告中披露的风险因素，这些因素可能导致未来期间的实际业绩和财务结果与此类陈述所明示或暗示的任何未来业绩或结果预测存在重大差异。

Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws.

Celltrion Inc. 及其子公司不承担在情况或管理层的估计或意见发生变化时更新前瞻性陈述的义务，除非适用的证券法律另有要求。

Trademarks

商标

OMLYCLO

奥姆利克洛

is a registered trademark of CELLTRION, Inc.

是CELLTRION公司的注册商标。

XOLAIR

奥马珠单抗

is a registered trademark of Novartis AG.

是诺华股份有限公司的注册商标。

References

参考文献

OMLYCLO U.S. prescribing information (2026)

OMLYCLO 美国处方信息（2026年）

Sarbjit Singh Saini et al., CT-P39 Compared With Reference Omalizumab in Chronic Spontaneous Urticaria: Results From a Double-Blind, Randomized, Active-Controlled, Phase 3 Study. Available at:

Sarbjit Singh Saini 等，CT-P39 与参照药奥马珠单抗在慢性自发性荨麻疹中的比较：一项双盲、随机、活性对照的 III 期研究结果。获取地址：

https://onlinelibrary.wiley.com/doi/pdf/10.1111/all.16446?msockid=30d535870b30638b14c920090a18627c

[Last accessed

[最后访问

October 2026

2026年10月

]

For further information please contact:

如需更多信息，请联系：

Carly Scaduto,

卡莉·斯卡杜托，

[email protected]