Trastuzumab-PKRB(Celltrion)

- Celltrion confirms a KRW 294.9 billion supply agreement, which may expand to KRW 375.4 billion, subject to mutual agreement. - Consecutive CMO wins, including Eli Lilly, push cumulative order backlog beyond KRW 1 trillion, supporting future revenue growth. - Growing requests for CDMO partnerships and increasing production of Celltrion’s own products are driving the need for additional manufacturing capacity. INCHEON, South Korea – Celltrion announced today that it has signed a contract manufacturing (CMO) agreement with a global pharmaceutical company for the supply of drug substance. The counterparty remains undisclosed to ensure business confidentiality. Under the agreement, Celltrion will supply drug substance for three years from 2027 through 2029. The contract value is approximately KRW 294.9 billion and may expand to KRW 375.4 billion, subject to mutual agreement. Celltrion plans to complete production arrangements early to ensure stable delivery. Strong product quality leads to contracts and accelerates CDMO business growth Celltrion has consistently demonstrated high manufacturing quality, reliable supply capabilities, and efficient production operations in supplying biologics. The latest contract reflects strong recognition of Celltrion’s manufacturing quality and stable supply system that meets global standards. Celltrion’s global CMO business has been expanding rapidly since the company announced plans to strengthen the business last year. Earlier this year, Celltrion signed a KRW 678.7 billion[1] CMO contract with Eli Lilly, and with the addition of this agreement, the company’s cumulative CMO order backlog surpassed KRW 1 trillion within the first quarter of the year. These contracts with global pharmaceutical companies demonstrate growing recognition of Celltrion’s manufacturing technology and global supply capabilities in the market. Celltrion to review additional capacity expansion amid growing global CDMO demand As demand for CDMO partnerships from global pharmaceutical companies continues to grow, Celltrion is strengthening its global sales and project management capabilities through its subsidiary Celltrion BioSolutions to further streamline its CMO business operations. Celltrion differentiates its CMO business by offering technology-driven service models. One such service is its “formulation conversion CMO,” which provides partners with the company’s accumulated subcutaneous (SC) formulation technologies developed through products such as Remsima SC (marketed as Zymfentra in the United States) and Herzuma SC. Celltrion aims to move beyond traditional contract manufacturing to provide high-value CMO services that enhance partners’ product competitiveness, and will accelerate efforts to expand production capacity and infrastructure to support this strategy. In addition, as the global biopharmaceutical market continues to expand and pharmaceutical companies increasingly seek reliable manufacturing partners, interest in Celltrion’s manufacturing capabilities is also steadily growing. Celltrion currently has a total manufacturing capacity of 316,000 liters, including facilities in Songdo, Korea (Plants 1, 2 and 3 with a combined capacity of 250,000 liters) and its facility in Branchburg, New Jersey (66,000 liters). However, global sales of Celltrion’s own products, including Zymfentra, are expected to expand alongside the addition of new pipeline products. Consequently, a significant portion of existing production capacity is likely to be allocated to the manufacturing of Celltrion’s own products. At the same time, rapidly increasing CDMO demand from global pharmaceutical companies is further raising the need for additional manufacturing capacity in the mid to long term. Taking these factors into account, Celltrion is reviewing additional manufacturing facilities both domestically and overseas to ensure sufficient infrastructure and support growing global CDMO demand. “This large-scale CMO agreement once again shows that Celltrion’s manufacturing quality and supply capabilities are recognized in the global market,” a Celltrion official said. “Considering the need to expand manufacturing for our own products, along with the growth of the CDMO business and increasing global demand, we plan to actively pursue additional manufacturing capacity to support future growth.” [1] Initial base exchange rate (December 31, 2025): USD/KRW $1 = KRW 1,434.90.

AVTOZMA 阿夫托兹马® ®(tocilizumab-anoh) is among the first wave of tocilizumab biosimilars with both intravenous (IV) and subcutaneous (SC) formulations approved and commercially available in the United States （托珠单抗-anoh）是首批获得美国批准并上市销售的托珠单抗生物类似药之一，拥有静脉注射（IV）和皮下注射（SC）两种剂型。The launch of 发射 AVTOZMA SC AVTOZMA 科学中心further diversifies Celltrion's immunology portfolio beyond TNF-alpha and IL-12/23 inhibitors providing a broader range of treatment solutions for immune-mediated inflammatory diseases 进一步丰富了 Celltrion 在 TNF-α 和 IL-12/23 抑制剂之外的免疫学产品组合，为免疫介导的炎症性疾病提供了更广泛的治疗方案。INCHEON, South Korea 韩国仁川, ，March 16, 2026 2026年3月16日/PRNewswire/ -- Celltrion, Inc. today announced thatAVTOZMA /PRNewswire/ -- Celltrion, Inc. 今天宣布 AVTOZMA® ®(tocilizumab-anoh) subcutaneous (SC) formulation is now commercially available to patients in the United States. （托珠单抗-阿诺）皮下注射（SC）制剂现已在美国上市，供患者使用。With this launch, Celltrion's AVTOZMA becomes one of the first tocilizumab biosimilars to have both an intravenous (IV) and a SC formulation approved by the U.S. Food and Drug Administration (FDA) and available on the U.S. market. 通过此次上市，Celltrion的AVTOZMA成为美国食品药品监督管理局（FDA）批准并可在美上市的首批同时拥有静脉注射（IV）和皮下注射（SC）剂型的托珠单抗生物类似药之一。'The introduction of AVTOZMA SC is a pivotal moment for Celltrion, underscoring our dedication to delivering effective, accessible and user-friendly therapies for patients with chronic inflammatory diseases,' said Thomas Nusbickel, Chief Commercial Officer of Celltrion USA. 'By offering both IV and SC formulations, we aim to provide patients and healthcare professionals with greater flexibility in treatment decisions, while continuing to broaden our immunology portfolio with therapies that address diverse inflammatory pathways.'. “AVTOZMA SC的引入对Celltrion来说是一个关键时刻，彰显了我们致力于为慢性炎症疾病患者提供有效、可及且用户友好的治疗方案的承诺，”Celltrion美国首席商务官托马斯·努斯比克尔表示。“通过提供静脉注射（IV）和皮下注射（SC）两种剂型，我们旨在为患者和医疗专业人员在治疗决策上提供更大的灵活性，同时继续通过针对多样化炎症通路的疗法扩展我们的免疫学产品组合。”The SC formulation of AVTOZMA is indicated for the treatment of rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (PJIA) and systemic juvenile idiopathic arthritis (SJIA). AVTOZMA SC is available in a 162 mg/0.9 mL solution for injection in a single-dose prefilled syringe or a single-dose prefilled autoinjector, allowing patients the flexibility and convenience of administering their treatment at home. AVTOZMA的皮下注射制剂适用于治疗类风湿关节炎（RA）、巨细胞动脉炎（GCA）、多关节型幼年特发性关节炎（PJIA）和全身型幼年特发性关节炎（SJIA）。AVTOZMA皮下注射剂有162毫克/0.9毫升溶液，提供单剂量预填充注射器或单剂量预填充自动注射器，方便患者在家灵活便捷地进行治疗。. 。[1] [1]Celltrion provides support to U.S. patients prescribed AVTOZMA through its patient support program, Celltrion CONNECT™. Celltrion CONNECT™ offers tailored support to its patients and caregivers with a full range of services including injection training, reimbursement assistance and educational resources to patients and healthcare professionals.. Celltrion通过其患者支持计划Celltrion CONNECT™，为美国使用AVTOZMA的患者提供支持。Celltrion CONNECT™为患者和护理人员提供量身定制的支持，服务范围广泛，包括注射培训、报销协助以及为患者和医疗专业人员提供的教育资源。Notes to Editors: 编辑须知：About AVTOZMA 关于AVTOZMA® ®( (CT-P47, tocilizumab-anoh CT-P47，托珠单抗-anoh) )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, AVTOZMA received approval from the U.S. （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，可作为白细胞介素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获得了美国的批准。Food and Drug Administration (FDA) and European Commission (EC) in January and February 2025, respectively. In July 2025, the FDA approved an additional indication for the intravenous (IV) formulation of AVTOZMA for the treatment of cytokine release syndrome (CRS) in adult and pediatric patients aged two years and older.. 2025年1月和2月，美国食品药品监督管理局（FDA）和欧洲委员会（EC）分别批准。2025年7月，FDA批准了AVTOZMA的静脉注射（IV）制剂用于治疗两岁及以上成人和儿童患者的细胞因子释放综合征（CRS）的额外适应症。INDICATION 适应症AVTOZMA 汽车主题® ®(tocilizumab-anoh) IV is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: （托珠单抗-阿诺）静脉注射是一种白细胞介素-6（IL-6）受体拮抗剂，适用于治疗： Rheumatoid Arthritis 类风湿性关节炎(RA): （RA）：Adult patients with moderately to severely active RA who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). 对一种或多种疾病修饰抗风湿药物（DMARDs）反应不佳的中度至重度活动性类风湿关节炎（RA）成年患者。Giant Cell 巨细胞Arteritis (GCA): 动脉炎（GCA）：Adult patients with GCA. 成人GCA患者。Polyarticular Juvenile Idiopathic Arthritis 多关节幼年特发性关节炎(pJIA): (pJIA):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岁及以上活动性全身型幼年特发性关节炎（sJIA）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岁及以上患有嵌合抗原受体（CAR）T细胞诱导的严重或危及生命的细胞因子释放综合征的成人和儿科患者COVID-19: 新冠肺炎： 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）。AVTOZMA 汽车主题® ®(tocilizumab-anoh) SC is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: （托珠单抗-阿诺）皮下注射是一种白细胞介素-6（IL-6）受体拮抗剂，适用于治疗： Rheumatoid Arthritis 类风湿性关节炎(RA): （RA）：Adult patients with moderately to severely active RA who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). 对一种或多种疾病修饰抗风湿药物（DMARDs）反应不佳的中度至重度活动性类风湿关节炎（RA）成年患者。Giant Cell 巨细胞Arteritis (GCA): 动脉炎（GCA）：Adult patients with GCA. 成人GCA患者。Polyarticular Juvenile Idiopathic Arthritis 多关节幼年特发性关节炎(pJIA): (pJIA):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岁及以上活动性全身型幼年特发性关节炎（sJIA）患者。IMPORTANT SAFETY INFORMATION 重要安全信息 WARNING: RISK OF SERIOUS INFECTIONS 警告：严重感染风险AVTOZMA 阿夫托兹马® ®and other tocilizumab products may increase the risk of serious infections, potentially leading to hospitalization or death, especially in patients using concurrent immunosuppressants. 和其他托珠单抗产品可能会增加严重感染的风险，可能导致住院或死亡，特别是同时使用免疫抑制剂的患者。If a serious infection develops, interrupt AVTOZMA until the infection is controlled. Reported infections include: 如果出现严重感染，应中断使用AVTOZMA，直到感染得到控制。报告的感染包括：Active tuberculosis (TB) which may present with pulmonary or 活动性结核病 (TB)，可能表现为肺部或extrapulmonary disease. Test for latent TB before and during treatment (except in COVID-19 patients) and treat latent infections before starting AVTOZMA. 肺外疾病。在治疗前和治疗期间（COVID-19患者除外）检测潜伏性结核，并在开始使用AVTOZMA之前治疗潜伏感染。Invasive fungal infections: Such as 侵袭性真菌感染：例如candidiasis, aspergillosis, and pneumocystis, may present as disseminated rather than localized disease. 念珠菌病、曲霉菌病和肺孢子虫病可能表现为播散性疾病而非局部疾病。Opportunistic infections, including bacterial, viral and other opportunistic pathogens. 机会性感染，包括细菌、病毒和其他机会性病原体。Monitor patients for signs of infection, including TB, during and after AVTOZMA treatment. 在AVTOZMA治疗期间和之后，监测患者是否出现感染迹象，包括结核病（TB）。Contraindications: 禁忌症：Known hypersensitivity to tocilizumab products. 已知对托珠单抗产品过敏。Serious Infections. 严重感染。Serious and sometimes fatal infections have been reported with AVTOZMA. Do not use during active infections, including localized infections. Discontinue AVTOZMA if a serious infection occurs and resume only once controlled. 据报道，AVTOZMA可能引发严重甚至致命的感染。在活动性感染期间（包括局部感染）请勿使用。如果发生严重感染，应停止使用AVTOZMA，并仅在感染得到控制后方可恢复使用。Gastrointestinal (GI) Perforation 胃肠道（GI）穿孔. Gastrointestinal perforations, often linked to diverticulitis, have been reported with tocilizumab. Use AVTOZMA cautiously in high-risk patients and promptly evaluate new abdominal symptoms for early detection and management. 与憩室炎相关的胃肠道穿孔在使用托珠单抗时已有报道。在高危患者中应谨慎使用AVTOZMA，并及时评估新的腹部症状，以便早期发现和管理。Hepatoxicity 肝毒性.Monitor for hepatic injury signs. Avoid AVTOZMA if ALT/ AST >1.5x ULN (RA/GCA) or >10x ULN (COVID-19); discontinue if ALT/AST >5x ULN or symptoms of liver disease develop. 监测肝损伤迹象。如果ALT/AST >1.5倍正常上限（RA/GCA）或>10倍正常上限（COVID-19），避免使用AVTOZMA；如果ALT/AST >5倍正常上限或出现肝病症状，应停用。Changes in Laboratory Parameters 实验室参数的变化. Monitor neutrophils, platelets, liver enzymes, and lipids due to potential treatment-related changes; avoid initiating AVTOZMA in patients with critically low ANC or platelet counts. 由于可能的治疗相关变化，需监测中性粒细胞、血小板、肝酶和血脂；避免在ANC或血小板计数极低的患者中开始使用AVTOZMA。Immunosuppression. 免疫抑制。The impact of AVTOZMA on malignancy development is unknown, but it may increase risk as an immunosuppressant. AVTOZMA 对恶性肿瘤发展的影响尚不清楚，但作为一种免疫抑制剂，它可能会增加风险。Hypersensitivity Reactions 超敏反应, including anaphylaxis, and death, have occurred; administer IV infusions with anaphylaxis management support, discontinue permanently if reactions occur, and avoid use in patients with known hypersensitivity. ，包括过敏反应和死亡，已经发生；在有过敏反应管理支持的情况下进行静脉输液，如果出现反应则永久停用，并避免用于已知过敏的患者。Demyelinating Disorders. 脱髓鞘疾病。The impact of tocilizumab on demyelinating disorders is unknown, but rare cases were reported; monitor symptoms and use caution with preexisting or recent disorders. 托珠单抗对脱髓鞘疾病的影响尚不明确，但有罕见病例报告；应监测症状，并对既往或近期疾病谨慎使用。Active Hepatic Disease and Hepatic Impairment. 活动性肝病和肝功能损害。Treatment with AVTOZMA is not recommended. 不建议使用AVTOZMA进行治疗。Live Vaccines. 活疫苗。Avoid concurrent use with AVTOZMA. 避免与AVTOZMA同时使用。Adverse Reactions 不良反应(≥5%) include upper respiratory tract infections, nasopharyngitis, headache, hypertension, elevated ALT, and injection site reactions. （≥5%）包括上呼吸道感染、鼻咽炎、头痛、高血压、ALT升高和注射部位反应。For more information, see 有关更多信息，请参见Full 满的Prescribing Information 处方信息. 。About Celltrion 关于CelltrionCelltrion 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, 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. 我们的全球医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、眼科和内分泌学。除了生物仿制药产品外，我们还致力于通过创新药物推进研发管线，突破科学创新的界限，提供优质药物。For more information, please visit our website. 欲了解更多信息，请访问我们的网站。www.celltrion.com/en-us www.celltrion.com/zh-cnand stay updated with our latest news and events on our social media - 并通过我们的社交媒体了解我们的最新消息和活动 - LinkedIn 领英, ，Instagram Instagram, ，X X, and ，以及Facebook Facebook. 。About Celltrion USA 关于Celltrion美国分公司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, and endocrinology 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。Celltrion USA 致力于扩大创新生物制剂的获取渠道，以改善美国患者的护理。Celltrion 获得 FDA 批准的生物类似药产品涵盖免疫学、肿瘤学、血液学和内分泌学领域，其中包括：INFLECTRA。® ®(infliximab-dyyb), TRUXIMA 英夫利昔单抗-dyyb，TRUXIMA® ®(rituximab-abbs), HERZUMA （利妥昔单抗-abbs），赫尔祖玛® ®(trastuzumab-pkrb), VEGZELMA （曲妥珠单抗-pkrb），VEGZELMA® ®(bevacizumab-adcd),YUFLYMA 贝伐珠单抗-adcd，YUFLYMA® ®(adalimumab-aaty), AVTOZMA (阿达木单抗-aaty)，AVTOZMA® ®(tocilizumab-anho), STEQEYMA (托珠单抗-anho)，STEQEYMA® ®(Ustekinumab-stba) STOBOCLO 乌司奴单抗（Ustekinumab-stba）STOBOCLO® ®(denosumab-bmwo), OSENVELT (denosumab-bmwo)，OSENVELT® ®(denosumab-bmwo), and OMLYCLO (denosumab-bmwo)，以及OMLYCLO® ®(omalizumab-igec), as well as thenovel biologic 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. （奥马珠单抗-igec），以及新型生物制剂ZYMFENTRA®（英夫利昔单抗-dyyb）。Celltrion美国公司将继续利用Celltrion在生物技术领域的独特传承、卓越的供应链能力以及一流的销售能力，为美国患者提供更好的高质量生物制药产品。欲了解更多信息，请访问。www.celltrionusa.com www.celltrionusa.comand stay updated with our latest news and events on our social media - 并通过我们的社交媒体了解我们的最新消息和活动 - LinkedIn 领英. 。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. This press release contains forward looking statements. 本新闻稿中包含的某些信息涉及我们未来业务和财务表现以及与Celltrion Inc.及其子公司相关的未来事件或发展的陈述，这些陈述可能构成适用证券法下的前瞻性陈述。本新闻稿包含前瞻性陈述。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', 'anticipates', the negative of these words or such other variations thereon or comparable terminology.. 这些陈述也可能通过诸如“准备”、“希望”、“即将”、“计划”、“旨在”、“将推出”、“正在准备”、“一旦获得”、“可能”、“旨在”、“或许”、“一旦确定”、“将”、“朝着”、“预计”、“可用”、“有潜力”、“预期”、这些词的否定形式或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观点，以便他们可以将这些信念和观点作为评估投资的一个因素。这些声明并非未来业绩的保证，不应过度依赖它们。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的风险及不确定性，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任何前瞻性陈述中明示或暗示的未来业绩或结果存在重大差异。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. 如果情况或管理层的估计或意见发生变化，Celltrion Inc. 及其子公司没有义务更新前瞻性声明，除非适用的证券法要求。Trademarks 商标AVTOZMA 阿夫托兹马® ®is aregistered trademark of CelltrionInc. 是Celltrion公司的注册商标。ACTEMRA 托珠单抗® ®is aregistered trademark of Chugai Pharmaceutical Co., Ltd. 是中外制药株式会社的注册商标。References 参考文献[1] [1]AVTOZMA U.S. prescribing information (2025) AVTOZMA 美国处方信息（2025） For further information please contact: 如需更多信息，请联系：Brendi Bluitt 布伦迪·布鲁伊特[emailprotected] 电子邮件地址+1 202-545-7722 +1 202-545-7722SOURCE Celltrion 来源：Celltrion21 21% %more press release views with 更多新闻发布观点 Request a Demo 请求演示