Celltrion today announced that the European Commission (EC) has granted marketing authorization for three products across two biosimilars: Eydenzelt® (CT-P42, aflibercept), a biosimilar to Eylea® to treat multiple retinal disorders, including neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO, branch RVO or central RVO), diabetic macular edema (DME) and myopic choroidal neovascularisation (myopic CNV); and Stoboclo® and Osenvelt® (CT-P41, denosumab), biosimilars referencing Prolia® and Xgeva® used for all indications of the reference products.

Celltrion今天宣布，欧盟委员会（EC）已授予两种生物类似药的三种产品的上市许可：Eydenzelt®（CT-P42，阿柏西普），这是Eylea®的生物类似药，用于治疗多种视网膜疾病，包括新生血管性（湿性）年龄相关性黄斑变性（AMD）、视网膜静脉阻塞（RVO，分支RVO或中央RVO）后的黄斑水肿、糖尿病性黄斑水肿（DME）和近视性脉络膜新生血管化（近视性CNV）；以及Stoboclo®和Osenvelt®（CT-P41，地诺单抗），这两种是参照Prolia®和Xgeva®的生物类似药，适用于参照产品的所有适应症。

The EC approval expands Celltrion’s diverse biosimilars portfolio across multiple therapeutic areas such as skeletal-related disorders and ophthalmology..

欧盟的批准扩大了Celltrion在多个治疗领域（如骨骼相关疾病和眼科）的多样化生物类似药组合。

“Celltrion is committed to expanding access to high-quality monoclonal antibody treatments for patients across Europe,” said Taehun Ha, Senior Vice President and Head of Europe at Celltrion. “Securing regulatory approval for three biosimilar products on the same day highlights our commitment to providing healthcare professionals with reliable, effective, and accessible treatment options for their patients.

“Celltrion致力于为全欧洲的患者扩大获得高质量单克隆抗体治疗的机会，”Celltrion高级副总裁兼欧洲区主管Taehun Ha表示。“同一天获得三种生物类似药的监管批准，凸显了我们为医疗专业人员提供可靠、有效且可及的治疗选择的承诺。”

With a portfolio of 11 biosimilar brands and a fully integrated approach—from research and development to manufacturing and direct supply—Celltrion is increasing treatment options, improving patient access to biologics, and strengthening its role as a trusted partner for healthcare professionals in Europe, all while supporting the sustainability of healthcare systems.”.

通过包含11种生物类似药品牌的产品组合，以及从研发到生产及直接供应的全方位整合方法，Celltrion正在增加治疗选择，改善患者获取生物制剂的机会，并强化其作为欧洲医疗专业人士信赖伙伴的角色，同时支持医疗系统的可持续性。"

Data showed that Eydenzelt® (40 mg/mL solution for injection in vial and pre-filled syringe), Stoboclo® (60 mg solution for injection in pre-filled syringe) and Osenvelt® (120 mg solution for injection in vial) have comparable quality, safety and efficacy when compared to their respective reference products, Eylea® (aflibercept) and Prolia® and Xgeva® (denosumab), respectively.

数据显示，Eydenzelt®（40 mg/mL 注射液，瓶装和预充式注射器）、Stoboclo®（60 mg 预充式注射器注射液）和 Osenvelt®（120 mg 注射液，瓶装）与其各自参照产品 Eylea®（阿柏西普）以及 Prolia® 和 Xgeva®（地诺单抗）在质量、安全性和有效性方面具有可比性。

1,2,3.

1,2,3。

“The European Commission approval of Eydenzelt®, Stoboclo® and Osenvelt® are a significant milestone and a welcome addition to our portfolio of medicines to address a significant unmet need in therapeutic areas including skeletal-related disorders and ophthalmology,” said Min Kyoung Jeon, Vice President and Head of Regulatory Affairs Division at Celltrion.

“欧盟委员会批准Eydenzelt®、Stoboclo®和Osenvelt®是我们产品组合中的重要里程碑，也是满足包括骨骼相关疾病和眼科等领域显著未满足需求的良药，”Celltrion副总裁兼监管事务部门负责人Min Kyoung Jeon表示。

“The approval highlights Celltrion’s continuous commitment to expanding the availability, access and uptake of these important treatment options to patients with unmet needs.”.

“此次批准突显了Celltrion持续致力于为有未满足需求的患者扩大这些重要治疗选择的可及性、获取性和使用率。”

The company’s therapeutics include a total of 11 biosimilar products: 4 immunology products, including Remsima®/Inflectra® (US), Remsima® SC, Yuflyma®, and SteQeyma®; 3 oncology products, including Truxima®, Herzuma®, and Vegzelma®; and other therapeutic areas, including Omlyclo®, Eydenzelt®, Stoboclo® and Osenvelt®..

该公司共有11种生物类似药产品：4种免疫学产品，包括Remsima®/Inflectra®（美国）、Remsima® SC、Yuflyma®和SteQeyma®；3种肿瘤学产品，包括Truxima®、Herzuma®和Vegzelma®；以及其他治疗领域的产品，包括Omlyclo®、Eydenzelt®、Stoboclo®和Osenvelt®。

About CT-P41 Phase III Clinical Trial

关于CT-P41的III期临床试验

The Phase III study randomised 479 patients to receive 60 mg of CT-P41 or reference product every six months (Weeks 0 and 26; treatment period [TP] I). Results of the study showed that CT-P41 had equivalent efficacy and pharmacodynamics to reference denosumab, with similar pharmacokinetic and comparable safety and immunogenicity profiles.3.

III 期研究随机分配了 479 名患者，每六个月（第 0 周和第 26 周；治疗期 [TP] I）接受 60 毫克的 CT-P41 或对照产品。研究结果显示，CT-P41 与对照地诺单抗具有相当的疗效和药效学特性，药代动力学相似，安全性和免疫原性也相当。

About CT-P42 Phase III Clinical Trial

关于CT-P42的III期临床试验

In a randomised, double-masked, parallel-group, multi-centre Phase III study of Eydenzelt® (CT-P42), the efficacy, safety, pharmacokinetics, usability and immunogenicity of Eydenzelt® was compared to Eylea® (aflibercept) in patients with diabetic macular edema (DME). Results of the study showed that Eydenzelt® met the predefined equivalence criteria, and secondary endpoints of efficacy, safety, and immunogenicity also showed trends similar to Eylea®.1,2.

在一项随机、双盲、平行组、多中心的三期临床研究中，对比了Eydenzelt®（CT-P42）与Eylea®（阿柏西普）在糖尿病性黄斑水肿（DME）患者中的疗效、安全性、药代动力学、可用性和免疫原性。研究表明，Eydenzelt®达到了预设的等效标准，且在疗效、安全性和免疫原性的次要终点上也显示出与Eylea®相似的趋势。1,2.

About Stoboclo® (CT-P41, biosimilar denosumab)

关于Stoboclo®（CT-P41，生物类似药地诺单抗）

Stoboclo® (denosumab), a receptor activator of NF-κb ligand (RANKL) inhibitor, is a treatment developed as a biosimilar to reference product Prolia® (denosumab). In Europe, Stoboclo® has been approved to treat osteoporosis in postmenopausal women and in men at increased risk of fractures, bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, and bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.4 Stoboclo® was also filed for regulatory approval with the U.S.

Stoboclo®（地诺单抗）是一种NF-κB配体受体激活剂（RANKL）抑制剂，作为与参考产品Prolia®（地诺单抗）相似的生物仿制药开发。在欧洲，Stoboclo®已被批准用于治疗绝经后女性和骨折风险增加的男性骨质疏松症、前列腺癌男性患者因激素去势导致的骨折风险增加相关的骨质流失，以及成人患者因长期系统性糖皮质激素治疗导致的骨折风险增加相关的骨质流失。Stoboclo®也已在美国提交监管审批。

Food and Drug Administration (FDA)..

食品和药物管理局 (FDA)。

About Osenvelt® (CT-P41, biosimilar denosumab)

关于Osenvelt®（CT-P41，生物类似药地诺单抗）

Osenvelt® (denosumab) is a receptor activator of NF-κb ligand (RANKL) inhibitor developed as a biosimilar referencing Xgeva® (denosumab). Osenvelt® has been approved in Europe to prevent skeletal-related events in adults with advanced malignancies involving bone, and to treat adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.5 Osenvelt® was also filed for regulatory approval with the U.S.

Osenvelt®（地诺单抗）是一种NF-κB配体受体激活剂（RANKL）抑制剂，作为参照Xgeva®（地诺单抗）开发的生物类似药。Osenvelt®已在欧洲获批用于预防患有晚期骨相关恶性肿瘤的成人发生骨骼相关事件，并用于治疗无法手术切除或手术切除可能导致严重病态的成人和骨骼成熟的青少年骨巨细胞瘤患者。Osenvelt®也已向美国提交了监管审批申请。

Food and Drug Administration (FDA)..

食品药品监督管理局 (FDA)。

About Eydenzelt® (CT-P42, biosimilar aflibercept)

关于Eydenzelt®（CT-P42，生物类似药阿柏西普）

Eydenzelt® (aflibercept) is a vascular endothelial growth factor (VEGF) inhibitor referencing Eylea®. Based on comprehensive data from a Phase III clinical trial confirming therapeutic equivalence to Eylea®3, Eydenzelt® is approved to treat neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO, branch RVO or central RVO), diabetic macular edema (DME) and myopic choroidal neovascularisation (myopic CNV).6 Eydenzelt® was also filed for regulatory approval with the U.S.

Eydenzelt®（阿柏西普）是一种参照Eylea®的血管内皮生长因子（VEGF）抑制剂。基于一项III期临床试验的全面数据，确认了Eydenzelt®与Eylea®的治疗等效性，Eydenzelt®被批准用于治疗新生血管性（湿性）年龄相关性黄斑变性（AMD）、视网膜静脉阻塞（RVO，包括分支RVO或中央RVO）后的黄斑水肿、糖尿病性黄斑水肿（DME）以及近视性脉络膜新生血管化（近视性CNV）。Eydenzelt®也已提交美国监管审批。

Food and Drug Administration (FDA)..

食品和药物管理局（FDA）。

About Celltrion

关于Celltrion

Celltrion is a leading biopharmaceutical company that specialises 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，专注于研究、开发、制造、营销和销售创新疗法，改善全球人民的生活。Celltrion是生物类似药领域的先驱，推出了全球首个单克隆抗体生物类似药。

Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, 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.

我们的全球制药产品组合涵盖了多个治疗领域，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，我们还致力于通过新型药物推进我们的研发管线，突破科学创新的界限，提供高质量的药物。

For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook..

如需更多信息，请访问我们的网站 www.celltrion.com/en-us，并通过我们的社交媒体（LinkedIn、Instagram、X 和 Facebook）关注我们最新的新闻和活动。

Forward-Looking-Statement

前瞻性声明

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.

本新闻稿中包含的某些信息涉及我们未来的业务、财务表现以及与Celltrion Inc.及其子公司相关的未来事件或发展，这些陈述可能构成相关证券法律下的前瞻性陈述。

These statements may be 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..

这些声明可能通过诸如“准备”，“希望”，“即将到来”，“计划”，“旨在”，“即将推出”，“正在准备”，“一旦获得”，“可以”，“旨在”，“可能”，“一旦确定”，“将”，“努力实现”，“到期”，“可用”，“有潜力”，这些词语的否定形式或其他类似变化或可比术语来识别。

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，我们的代表可能会做出口头的前瞻性陈述。这些陈述基于Celltrion Inc.及其子公司管理层的当前预期和某些假设，其中许多是超出其控制范围的。

Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of 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..

前瞻性声明旨在让潜在投资者有机会了解管理层对未来的信念和意见，以便他们可以将这些信念和意见作为评估投资的一个因素。这些声明并非未来表现的保证，不应过度依赖它们。

Such forward-looking statements necessarily involve known and unknown risks and uncertainties, 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 forward-looking statements..

此类前瞻性陈述必然涉及已知和未知的风险与不确定性，这些风险与不确定性可能导致未来期间的实际业绩和财务结果与该等前瞻性陈述明示或暗示的任何未来业绩或结果的预测存在重大差异。

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. 及其子公司在情况或管理层的估计或意见发生变化时，不承担更新前瞻性声明的义务，除非适用的证券法要求。

Trademarks

商标

Stoboclo® and Osenvelt® are registered trademarks of Celltrion Inc.

Stoboclo® 和 Osenvelt® 是 Celltrion Inc. 的注册商标。

Prolia® and Xgeva® are registered trademarks of Amgen Inc.

Prolia® 和 Xgeva® 是安进公司的注册商标。

Eydenzelt® is a registered trademark of Celltrion Inc.

Eydenzelt® 是 Celltrion Inc. 的注册商标。

Eylea® is a registered trademark of Bayer AG.

Eylea® 是拜耳股份公司的注册商标。

References

参考文献

Source: celltrion.com

来源：celltrion.com