LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fresenius, via its operating company Fresenius Kabi, announced today the immediate availability in the U.S. of its biosimilar Tyenne® (tocilizumab-aazg), in a subcutaneous formulation, which will increase access to affordable and cost-effective treatment options for use in the treatment of chronic autoimmune diseases..

伊利诺伊州苏黎世湖。--（商业新闻短讯）--费森尤斯通过其运营公司费森尤斯·卡比（Fresenius Kabi）今天宣布，其生物仿制药Tyenne®（tocilizumab aazg）在美国立即可用于皮下制剂，这将增加人们获得负担得起且具有成本效益的治疗选择，用于治疗慢性自身免疫性疾病。。

Tyenne is indicated for use in the treatment of chronic autoimmune diseases for certain indications of the reference product, Actemra® (tocilizumab). Fresenius Kabi previously launched Tyenne® in an intravenous (IV) formulation in April of this year.

Tyenne用于治疗慢性自身免疫性疾病，用于参考产品Actemra®（托珠单抗）的某些适应症。费森尤斯·卡比（Fresenius Kabi）曾于今年4月推出静脉注射（IV）配方的Tyenne®。

“After successfully launching Tyenne in more than 10 countries, we are on track to continue the momentum in the U.S with the launch of a second formulation,” said Sang-Jin Pak, M.D., President of Biopharma at Fresenius Kabi. “Introducing our subcutaneous formulation demonstrates our continued commitment to providing greater access to more patients living with autoimmune diseases.”.

Fresenius Kabi生物制药总裁Sang Jin Pak医学博士说：“在10多个国家成功推出Tyenne后，我们将继续在美国推出第二种配方，以保持这种势头。介绍我们的皮下配方表明，我们继续致力于为更多患有自身免疫性疾病的患者提供更多机会。”。

Trial data that compared Tyenne® to the reference product, Actemra® showed similar safety and tolerability.

将Tyenne®与参考产品Actemra®进行比较的试验数据显示出类似的安全性和耐受性。

Tyenne® is the first tocilizumab biosimilar with an intravenous and subcutaneous formulation approved by the FDA. Tyenne® received FDA approval on March 5, 2024, and an IV formulation was launched in April 2024 for use in the treatment of several inflammatory autoimmune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis..

Tyenne®是FDA批准的第一种具有静脉和皮下制剂的托珠单抗生物仿制药。Tyenne®于2024年3月5日获得FDA批准，并于2024年4月推出IV制剂，用于治疗几种炎症性自身免疫性疾病，包括类风湿性关节炎，巨细胞动脉炎，多关节幼年特发性关节炎和全身性幼年特发性关节炎。。

To learn more about how Fresenius Kabi provides comprehensive patient support for Tyenne® in the U.S. please click here.

要了解更多有关费森尤斯·卡比（Fresenius Kabi）如何在美国为Tyenne®提供全面的患者支持的信息，请单击此处。

About Tyenne®, a Tocilizumab Biosimilar

关于托珠单抗生物仿制药Tyenne®

Tyenne® (tocilizumab-aazg), a biosimilar to Actemra® (tocilizumab), is a prescription medicine called an Interleukin-6 (IL-6) receptor antagonist. It was developed by Fresenius Kabi using advanced analytical and manufacturing technologies for use in the treatment of several autoimmune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

Tyenne®（tocilizumab aazg）是Actemra®（tocilizumab）的生物仿制药，是一种称为白细胞介素-6（IL-6）受体拮抗剂的处方药。它是由费森尤斯·卡比（Fresenius Kabi）使用先进的分析和制造技术开发的，用于治疗几种自身免疫性疾病，包括类风湿性关节炎，巨细胞动脉炎，多关节幼年特发性关节炎和全身性幼年特发性关节炎。

Tyenne® includes a Boxed Warning for serious infections leading to hospitalization or death including tuberculosis (TB), bacterial, invasive fungal, viral, and other opportunistic infections that have occurred in patients receiving tocilizumab products. Tyenne® is contraindicated in patients with known hypersensitivity to tocilizumab products.

Tyenne®包括针对导致住院或死亡的严重感染的盒装警告，包括接受托珠单抗产品的患者发生的结核病（TB），细菌，侵袭性真菌，病毒和其他机会性感染。Tyenne®禁用于已知对托珠单抗产品过敏的患者。

For more information about Tyenne®, please see the important safety information and full prescribing information for the U.S..

有关Tyenne®的更多信息，请参阅美国的重要安全信息和完整处方信息。。

About Fresenius Kabi

关于费森尤斯·卡比

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients.

费森尤斯·卡比（Fresenius Kabi）是一家全球医疗保健公司，专门从事输液、输血和临床营养方面的救生药物和技术。该公司的产品和服务用于危重病和慢性病患者的治疗和护理。

Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products.

其产品组合包括一系列高度复杂的生物制药、临床营养、医疗技术和静脉注射仿制药。在生物制药领域，费森尤斯·卡比（Fresenius Kabi）除其他外，还提供专注于自身免疫性疾病和肿瘤学的生物仿制药。该公司的临床营养产品包括多种肠内和肠外营养产品。

In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face..

在医疗技术领域，其产品包括重要的一次性用品、输液泵、单采机、细胞治疗设备等。费森尤斯·卡比（Fresenius Kabi）将基本药物和技术交给了那些帮助患者并为他们面临的挑战找到最佳答案的人。。

Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leader globally in its product segments – all for the benefit of patients, its customers, and its stakeholders..

根据其“2026年愿景”战略（该战略是费森尤斯医疗保健集团（Fresenius healthcare group）未来费森尤斯（FutureFresenius）计划的关键部分），该公司还致力于提高患者治疗和护理的效率，并改善全球高质量医疗保健的获得。费森尤斯·卡比（Fresenius Kabi）渴望成为其产品领域的全球领导者，这一切都是为了患者、客户和利益相关者的利益。。

Fresenius SE & Co. KGaA (Frankfurt/Xetra: FRE) is a global healthcare company headquartered in Bad Homburg v. d. Höhe, Germany. In the 2023 fiscal year, Fresenius generated €22.3 billion in annual revenue with its more than 190,000 employees. Fresenius offers solutions to the social challenges posed by a growing and ageing population and the resulting need for affordable, high-quality healthcare.

Fresenius SE&Co.KGaA（法兰克福/塞特拉：法国）是一家全球医疗保健公司，总部位于德国巴德洪堡v.d.Höhe。在2023财政年度，费森尤斯拥有19万多名员工，年收入223亿欧元。费森尤斯为人口增长和老龄化带来的社会挑战以及由此产生的对负担得起的高质量医疗保健的需求提供了解决方案。

The Fresenius Group comprises the operating companies Fresenius Kabi and Fresenius Helios as well as the investment companies Fresenius Vamed and Fresenius Medical Care. With 140 hospitals and countless outpatient facilities, Fresenius Helios is the leading private hospital operator in Germany and Spain, treating around 26 million patients every year.

费森尤斯集团由经营公司费森尤斯·卡比和费森尤斯·赫利奥斯以及投资公司费森尤斯·瓦梅德和费森尤斯医疗保健公司组成。费森尤斯·赫利奥斯拥有140家医院和无数的门诊设施，是德国和西班牙领先的私立医院运营商，每年治疗约2600万患者。

Fresenius Kabi’s product portfolio.

费森尤斯·卡比的产品组合。

includes a range of highly complex biopharmaceuticals, clinical nutrition, medical technology, and generic intravenous drugs. Fresenius was established in 1912 by the Frankfurt pharmacist Dr. Eduard Fresenius. After his death, Else Kröner took over management of the company in 1952. She laid the foundations for a global enterprise that today pursues the goal of improving people’s health.

包括一系列高度复杂的生物制药，临床营养，医疗技术和仿制药。费森尤斯于1912年由法兰克福药剂师爱德华·费森尤斯博士创立。Else Kröner去世后，于1952年接管公司管理层。她为今天追求改善人民健康目标的全球企业奠定了基础。

The largest shareholder is the non-profit Else Kröner-Fresenius Foundation, which is dedicated to advancing medical research and supporting humanitarian projects..

最大股东是非营利性Else Kröner Fresenius基金会，该基金会致力于推进医学研究和支持人道主义项目。。