/PRNewswire/ -- Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication of the intravenous (IV) formulation of AVTOZMA

/PRNewswire/ -- Celltrion, Inc. 今天宣布，美国食品药品监督管理局 (FDA) 已批准 AVTOZMA 的静脉注射 (IV) 制剂的扩展适应症。

(tocilizumab-anoh) to include the treatment of cytokine release syndrome (CRS) in adults and pediatric patients aged 2 years and older. Following FDA approval of the additional indication for CRS, AVTOZMA IV now aligns with all indications approved for ACTEMRA

（托珠单抗-阿诺）包括用于治疗成人及2岁及以上儿童患者的细胞因子释放综合征（CRS）。在FDA批准了针对CRS的额外适应症后，AVTOZMA IV现在与ACTEMRA获批的所有适应症保持一致。

Earlier this year, the FDA approved AVTOZMA as a biosimilar to ACTEMRA in IV formulations for the treatment of multiple diseases including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and coronavirus disease (COVID-19)..

今年早些时候，FDA批准AVTOZMA作为ACTEMRA的生物类似药，用于静脉注射治疗多种疾病，包括类风湿性关节炎（RA）、巨细胞动脉炎（GCA）、多关节型幼年特发性关节炎（pJIA）、全身型幼年特发性关节炎（sJIA）以及冠状病毒病（COVID-19）。

CRS is a potentially life-threatening condition that occurs when the immune system is highly activated, leading to the rapid and excessive release of cytokines into the bloodstream. During a cytokine storm, the overactivated immune system can cause widespread inflammation and damage to healthy tissue and organs throughout the body with symptoms ranging from mild, flu-like symptoms to more severe complications such as low blood pressure, difficulty breathing, and multi-organ failure..

CRS是一种可能危及生命的状况，发生在免疫系统高度激活时，导致细胞因子迅速且过度地释放到血液中。在细胞因子风暴期间，过度激活的免疫系统可能引起全身广泛的炎症，并损害健康组织和器官，症状从轻微的类似流感的症状到更严重的并发症如低血压、呼吸困难和多器官衰竭不等。

'We are proud that AVTOZMA IV has now achieved full indication alignment with the reference ACTEMRA IV. This milestone marks an important step forward in our mission to deliver a safe and effective therapy for CRS,' said

“我们为AVTOZMA IV现已实现与参考药物ACTEMRA IV的完全适应症对齐感到自豪。这一里程碑标志着我们在为CRS提供安全有效治疗的使命中迈出了重要的一步，”

Thomas Nusbickel

托马斯·努斯比克尔

, Chief Commercial Officer at Celltrion

Celltrion首席商务官

USA

美国

. 'This FDA approval expands access to high-quality biologics and supports beneficial patient outcomes across multiple therapeutic areas.'

“FDA的这项批准扩大了获得高质量生物制剂的机会，并支持在多个治疗领域取得有益的患者结果。”

In accordance with the patent settlement agreement with Genentech, the IV formulation of AVTOZMA is expected to be available in the U.S. on

根据与基因泰克达成的专利和解协议，AVTOZMA的静脉注射制剂预计将在美国上市。

August 31, 2025

2025年8月31日

. Celltrion holds a license to market the subcutaneous formulation in the U.S. commencing on the licensed launch date, which remains confidential.

Celltrion持有在美国市场销售皮下注射制剂的许可，该许可自授权上市日期起生效，具体日期仍保密。

Notes to Editors:

编辑须知：

About AVTOZMA

关于AVTOZMA

(CT-P47, tocilizumab-anoh)

（CT-P47，托珠单抗-阿诺）

AVTOZMA

阿夫托兹马

(tocilizumab-anoh), containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. Based on data from the global Phase III clinical trial designed to evaluate the efficacy, pharmacokinetics (PK), safety, and immunogenicity of CT-P47 compared to reference tocilizumab.

（托珠单抗-anoh），含有活性成分托珠单抗，是一种重组人源化单克隆抗体，作为白细胞介素6（IL-6）受体拮抗剂。基于全球III期临床试验的数据，该试验旨在评估CT-P47与参照托珠单抗相比的疗效、药代动力学（PK）、安全性和免疫原性。

AVTOZMA received approval from the U.S. Food and Drug Administration (FDA) and European Commission (EC) in January and .

AVTOZMA于一月获得了美国食品和药物管理局（FDA）和欧洲委员会（EC）的批准。

February 2025

2025年2月

, respectively.

，分别。

INDICATION

适应症

AVTOZMA

阿夫托兹马

(tocilizumab-anoh) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of:

(tocilizumab-anoh) 是一种白细胞介素-6（IL-6）受体拮抗剂，适用于治疗：

Rheumatoid Arthritis

类风湿关节炎

Adult patients with moderately to severely active RA who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).

中度至重度活动性类风湿关节炎（RA）成年患者，对一种或多种疾病修饰抗风湿药物（DMARDs）反应不佳。

Giant Cell Arteritis (GCA):

巨细胞动脉炎 (GCA):

Adult patients with GCA.

患有GCA的成年患者。

Polyarticular Juvenile Idiopathic Arthritis

多关节幼年特发性关节炎

Patients 2+ years-old with active pJIA.

2岁及以上患有活动性pJIA的患者。

Systemic Juvenile Idiopathic Arthritis (sJIA):

全身型幼年特发性关节炎 (sJIA):

Patients 2+ years-old with active sJIA.

2岁及以上患有活动性全身型幼年特发性关节炎（sJIA）的患者。

Cytokine Release Syndrome (CRS)

细胞因子释放综合征 (CRS)

: Adults and pediatric patients 2+ years-old with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome.

：2岁及以上接受嵌合抗原受体（CAR）T细胞治疗后出现严重或危及生命的细胞因子释放综合征的成人和儿童患者。

COVID-19:

2019冠状病毒病：

Hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

住院的成年COVID-19患者，正在接受全身性皮质类固醇治疗，并需要补充氧气、非侵入性或侵入性机械通气或体外膜氧合（ECMO）。

About Celltrion

关于Celltrion

Celltrion is a leading biopharmaceutical company based in Incheon,

Celltrion是一家总部位于仁川的领先生物制药公司，

that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion endeavors to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 countries. Celltrion has seven biosimilars approved by the U.S.

专注于研究、开发、制造、营销和销售改善全球人民生活的创新疗法。Celltrion致力于通过覆盖110多个国家的广泛全球网络，提供高质量且经济实惠的解决方案。Celltrion已有七种生物类似药获得美国批准。