Adalimumab biosimilar(Celltrion)

Seven abstracts accepted for presentation include data from long-term follow-up studies and a post-hoc analysis of the pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC) of ZYMFENTRA® (infliximab-dyyb) Findings emphasize clinical decision-making in long-term management of inflammatory bowel disease (IBD), reinforcing Celltrion's commitment to elevating the standard of care and addressing unmet medical need in gastroenterology April 21, 2026 -- Celltrion, Inc. today announced that seven abstracts will be presented at the 2026 Digestive Disease Week® (DDW) Annual Meeting, taking place May 2-5 in Chicago, Illinois. The oral and poster presentations will feature data including post-hoc analysis of its pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC) of ZYMFENTRA®, the first and only FDA-approved subcutaneous infliximab. "The findings provide additional evidence that disease control can be effectively recaptured with a convenient subcutaneous option, with the potential to advance the treatment paradigm for people living with Crohn's disease and ulcerative colitis," said Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA. "The research Celltrion is presenting at DDW reflects our ongoing commitment to transforming IBD care through innovative therapies that improve patient outcomes." Celltrion is driving scientific discovery and expanding access to comprehensive clinical and real-world evidence to support informed treatment decisions in an increasingly complex and evolving IBD landscape. ZYMFENTRA® (infliximab-dyyb) is a prescription medicine used as an injection under the skin (subcutaneous injection) by adults for the maintenance treatment of moderately-to-severely active ulcerative colitis following treatment with an infliximab product given by intravenous infusion (IV), Moderately-to-severely active Crohn's disease following treatment with an infliximab product given by intravenous infusion (IV). ZYMFENTRA blocks the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and cause the immune system to attack normal, healthy parts of the body. ZYMFENTRA was approved by the FDA through the Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act (a "stand-alone" BLA). ZYMFENTRA is considered a new biologic with a first-approved subcutaneous administration form and thus will be under patent protection for its dosage form by 2037 and for its route of administration by 2040. Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 2-5, 2026. 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. 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. 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® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (ustekinumab-stba), STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo), OMLYCLO® (omalizumab-igec), and EYDENZELT® (aflibercept-boav) as well as the novel 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. The content above comes from the network. if any infringement, please contact us to modify.

Seven abstracts accepted for presentation include data from long-term follow-up studies and a post-hoc analysis of the pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC) of ZYMFENTRA 七年摘要被接受用于展示，其中包括长期随访研究的数据以及对 ZYMFENTRA 的关键 LIBERTY 研究（LIBERTY-CD 和 LIBERTY-UC）的事后分析。® ®(infliximab-dyyb) 英夫利昔单抗-dyybFindings emphasize clinical decision-making in long-term management of inflammatory bowel disease (IBD), reinforcing Celltrion's commitment to elevating the standard of care and addressing unmet medical need in gastroenterology 研究结果强调了在炎症性肠病（IBD）的长期管理中临床决策的重要性，进一步巩固了Celltrion致力于提升护理标准和满足胃肠病学领域未被满足的医疗需求的承诺。INCHEON, South Korea 韩国仁川, ，April 21, 2026 2026年4月21日/PRNewswire/ -- Celltrion, Inc. today announced that seven abstracts will be presented at the 2026 Digestive Disease Week /PRNewswire/ -- Celltrion公司今天宣布，将在2026年消化疾病周上展示七篇摘要。® ®(DDW) Annual Meeting, taking place May 2-5 in Chicago, Illinois. The oral and poster presentations will feature data including post-hoc analysis of its pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC) of ZYMFENTRA （DDW）年会，将于5月2日至5日在伊利诺伊州芝加哥举行。口头和海报展示将包括其关键LIBERTY研究（LIBERTY-CD和LIBERTY-UC）的ZYMVENTRA事后分析数据。® ®, the first and only FDA-approved subcutaneous infliximab. ，首个也是唯一一个获得FDA批准的皮下注射英夫利昔单抗。'The findings provide additional evidence that disease control can be effectively recaptured with a convenient subcutaneous option, with the potential to advance the treatment paradigm for people living with Crohn's disease and ulcerative colitis,' said Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA. Juby Jacob-Nara，Celltrion美国公司的高级副总裁兼首席医疗官表示：“这些研究结果提供了更多的证据，表明通过一种便捷的皮下注射选项可以有效重新控制疾病，这有可能推动克罗恩病和溃疡性结肠炎患者的治疗模式。”'The research Celltrion is presenting at DDW reflects our ongoing commitment to transforming IBD care through innovative therapies that improve patient outcomes.'. “Celltrion在DDW上展示的研究反映了我们通过创新疗法改善患者预后，持续致力于变革IBD治疗的承诺。”Celltrion is driving scientific discovery and expanding access to comprehensive clinical and real-world evidence to support informed treatment decisions in an increasingly complex and evolving IBD landscape. Celltrion正在推动科学发现，并扩大对综合临床和真实世界证据的获取，以支持在日益复杂和不断变化的IBD领域中做出明智的治疗决策。The details of Celltrion's abstracts are as follows Celltrion的摘要详情如下 : ：Abstract Title 摘要标题Presentation Details 演示详情All times CT 所有时间均为中部时间PROFILE 4-year follow-up shows that early 4年随访的个人资料显示早期effective 'top-down' therapy is associated with 有效的“自上而下”疗法与reduced long-term Crohn's disease complications 减少克罗恩病的长期并发症Oral Presentation 口头报告Late Breakers in IBD IBD领域的最新突破Tuesday, May 5, 2026/ 10:00 AM – 2026年5月5日，星期二/上午10:00 –10:15 AM 上午10点15分 Randomised controlled trial of withdrawal of 随机对照试验退出thiopurines in patients with IBD switching from 从使用硫嘌呤类药物转换的IBD患者 intravenous to subcutaneous infliximab: Results 静脉注射到皮下注射英夫利昔单抗：结果of the MINIMISE study MINIMISE 研究的Oral Presentation 口头报告 IBD: Controlled Clinical Trials 2 IBD：对照临床试验 2Tuesday, May 5, 2026/ 8:30 AM – 2026年5月5日，星期二 / 上午8:30 –8:45 AM 早上8点45分Randomised controlled trial of continued 随机对照试验继续进行intravenous versus switching to subcutaneous 静脉注射与转为皮下注射infliximab in inflammatory bowel disease: the 英夫利昔单抗在炎症性肠病中的应用：Subcutaneous Infliximab Switch Study (SISS) 皮下注射英夫利昔单抗转换研究 (SISS)Oral Presentation 口头报告IBD: Controlled Clinical Trials 2 IBD：对照临床试验 2Tuesday, May 5, 2026/ 8:00 AM– 2026年5月5日，星期二 / 上午8:00–8:15 AM 早上8点15分Comparison of effectiveness between 比较有效性之间subcutaneous infliximab as monotherapy or 皮下注射英夫利昔单抗作为单一疗法或combined with an immunosuppressant in patients 结合免疫抑制剂用于患者with Crohn's disease: interim results from the 克罗恩病：中期结果来自 REMONO-CD study REMONO-CD 研究Oral Presentation #537 口头报告 #537Comparative Effectiveness in IBD 比较有效性在IBD中Sunday May 3, 2026 / 4:30PM – 2026年5月3日，星期日 / 下午4:30 –4:45PM 下午4点45分Long-term effectiveness, safety, acceptability, and 长期有效性、安全性、可接受性、和progression of bowel damage of switching from 转换过程中的肠道损伤进展intravenous to subcutaneous infliximab in 静脉注射转为皮下注射英夫利昔单抗patients with inflammatory bowel diseases 炎症性肠病患者treated with intensified doses: The REMSWITCH- 使用强化剂量治疗：REMSWITCH-VLT study VLT研究Oral Presentation 口头报告 Advances in Medical Therapy of IBD 炎症性肠病医学治疗的进展Tuesday, May 5, 2026/ 4:45 PM – 2026年5月5日，星期二，下午4点45分 –5:00 PM 下午5:00 Recapturing disease control with subcutaneous 通过皮下注射重新控制疾病infliximab after a drug holiday following 在药物假期后使用英夫利昔单抗intravenous infliximab induction: A post hoc 静脉注射英夫利昔单抗诱导：事后分析analysis of LIBERTY-CD and -UC studies LIBERTY-CD 和 -UC 研究的分析 Poster Presentation 海报展示 Inflammatory Bowel Disease ePoster Showcase 炎症性肠病电子海报展示Sunday, May 3, 2026/11:57 AM – 2026年5月3日，星期日/上午11点57分 –12:03 PM 下午12:03 Subcutaneous infliximab (CT-P13 SC) as 皮下注射英夫利昔单抗（CT-P13 SC）作为maintenance therapy for Crohn's disease in Japan: 日本克罗恩病的维持治疗：Safety and efficacy over 44 weeks 44周内的安全性和有效性ePoster (online only) 电子海报（仅在线）Notes to Editors: 编辑须知：About ZYMFENTRA 关于ZYMFENTRA® ®(infliximab-dyyb) 英夫利昔单抗-dyybZYMFENTRA ZYMFENTRA® ®(infliximab-dyyb) is a prescription medicine used as an injection under the skin (subcutaneous injection) by adults for the maintenance treatment of moderately-to-severely active ulcerative colitis following treatment with an infliximab product given by intravenous infusion (IV), Moderately-to-severely active Crohn's disease following treatment with an infliximab product given by intravenous infusion (IV). (infliximab-dyyb) 是一种处方药，用于成人通过皮下注射（皮下注射）维持治疗中度至重度活动性溃疡性结肠炎，该治疗是在接受静脉输注（IV）的英夫利昔单抗产品治疗后进行的；以及在静脉输注（IV）的英夫利昔单抗产品治疗后，用于中度至重度活动性克罗恩病的治疗。ZYMFENTRA blocks the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and cause the immune system to attack normal, healthy parts of the body.. ZYMFENTRA 阻断肿瘤坏死因子-α（TNF-α）的作用，这种蛋白质在某些疾病中可能会过度产生，导致免疫系统攻击身体正常、健康的部分。ZYMFENTRA was approved by the FDA through the Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act (a 'stand-alone' BLA). ZYMFENTRA is considered a new biologic with a first-approved subcutaneous administration form and thus will be under patent protection for its dosage form by 2037 and for its route of administration by 2040.. ZYMFENTRA通过《公共卫生服务法》351(a)途径的生物制品许可申请（BLA）获得了FDA的批准（属于“独立”BLA）。ZYMFENTRA被认为是一种新型生物制品，其首次获批的皮下注射剂型将受到专利保护，剂型专利保护至2037年，给药途径专利保护至2040年。Indication and Important Safety Information 适应症和重要的安全信息ZYMFENTRA ZYMFENTRA® ®is a prescription medicine indicated in adults for maintenance treatment of: 是一种处方药，适用于成人以下方面的维持治疗：Moderately-to-severely active Crohn's disease 中度至重度活动性克罗恩病following treatment with an infliximab product administered intravenously. 静脉注射英夫利昔单抗产品治疗后。Moderately-to-severely active ulcerative colitis 中度至重度活动性溃疡性结肠炎following treatment with an infliximab product administered intravenously. 静脉注射英夫利昔单抗产品治疗后。It is not known if ZYMFENTRA is safe and effective in children under 18 years of age. 不知道ZYMFENTRA在18岁以下儿童中是否安全有效。What is the most important information I should know about ZYMFENTRA? 我应该了解的关于ZYMFENTRA的最重要的信息是什么？SERIOUS INFECTIONS 严重感染Patients treated with ZYMFENTRA are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis. 使用ZYMFENTRA治疗的患者面临更高的风险，可能会发生涉及多个器官系统和部位的严重感染，这些感染可能导致住院或死亡。如果患者出现严重感染或败血症，应停止使用ZYMFENTRA。Reported infections include: 报告的感染包括：Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before and during treatment with ZYMFENTRA. Treatment for latent infection should be initiated prior to treatment with ZYMFENTRA.. 活动性结核病（TB），包括潜伏性结核的再激活。患者常表现为播散性或肺外疾病。在使用ZYMFENTRA治疗之前和期间，应检测患者是否存在潜伏性结核。潜伏性感染的治疗应在ZYMFENTRA治疗之前开始。Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.. 侵袭性真菌感染，包括组织胞浆菌病、球孢子菌病、念珠菌病、曲霉菌病、芽生菌病和肺孢子虫病。患者可能表现为播散性而非局部性疾病。对于有侵袭性真菌感染风险且出现严重全身性疾病的患者，应考虑经验性抗真菌治疗。Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. 由包括军团菌和李斯特菌在内的机会性病原体引起的细菌、病毒和其他感染。The risks and benefits of treatment with ZYMFENTRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with ZYMFENTRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.. 在慢性或反复感染患者开始使用ZYMFENTRA治疗之前，应仔细权衡治疗的风险和益处。在ZYMFENTRA治疗期间及之后，密切监测患者是否出现感染的体征和症状，包括在治疗前潜伏性结核病检测呈阴性的患者中可能发生结核病的情况。Risk of infection may be higher in patients greater than 65 years of age, patients with comorbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with infliximab included arthritis bacterial, pneumonia, and urinary tract infection.. 年龄大于65岁的患者、有合并症的患者和/或接受伴随免疫抑制治疗的患者感染风险可能更高。在临床试验中，接受英夫利昔单抗治疗的患者中观察到的其他严重感染包括细菌性关节炎、肺炎和尿路感染。MALIGNANCIES 恶性肿瘤Malignancies, some fatal, have been reported in children, adolescents, and young adults treated with TNF blockers, including infliximab products. 据报道，使用包括英夫利昔单抗产品在内的TNF抑制剂治疗的儿童、青少年和年轻成人中出现了恶性肿瘤，其中一些是致命的。Approximately half of these cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. 大约一半的病例是淋巴瘤，包括霍奇金和非霍奇金淋巴瘤。其他病例则代表了各种各样的恶性肿瘤，包括通常与免疫抑制相关的罕见恶性肿瘤以及通常不会在儿童和青少年中观察到的恶性肿瘤。The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.. 恶性肿瘤发生在首次治疗剂量后的中位30个月后。大多数患者同时接受免疫抑制剂治疗。Post-marketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported cases have occurred in patients with Crohn's disease or ulcerative colitis, and most were in adolescent and young adult males. 在使用包括英夫利昔单抗产品在内的TNF抑制剂治疗的患者中，已有报告发生肝脾T细胞淋巴瘤（一种罕见的T细胞淋巴瘤）的上市后病例。这些病例的病程极为侵袭性，并导致死亡。大多数报告的病例发生在克罗恩病或溃疡性结肠炎患者中，且多数为青少年和年轻成年男性。Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treatment with ZYMFENTRA, especially in these patient types.. 几乎所有这些患者在诊断时或之前都曾同时接受过硫唑嘌呤或6-巯基嘌呤与TNF阻滞剂的治疗。仔细评估使用ZYMFENTRA治疗的风险和益处，尤其是在这些患者类型中。In clinical trials of all TNF blockers, more cases of malignancies were observed compared with controls and the expected rate in the general population. In clinical trials of some TNF blockers, including infliximab products, more cases of other malignancies were observed compared with controls. As the potential role of TNF blocker therapy in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy.. 在所有TNF阻滞剂的临床试验中，与对照组及普通人群的预期比率相比，观察到更多的恶性肿瘤病例。在包括英夫利昔单抗产品在内的某些TNF阻滞剂的临床试验中，与其他对照组相比，观察到更多其他类型的恶性肿瘤病例。由于TNF阻滞剂治疗在恶性肿瘤发展中的潜在作用尚不清楚，在考虑对当前或过去有恶性肿瘤病史的患者进行治疗时，应谨慎行事。Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including infliximab products. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. 据报道，接受包括英夫利昔单抗产品在内的TNF阻滞剂治疗的患者中出现了黑色素瘤和默克尔细胞癌。建议所有患者，特别是具有皮肤癌风险因素的患者，定期进行皮肤检查。CONTRAINDICATIONS 禁忌症ZYMFENTRA is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab-dyyb, other infliximab products, any of the inactive ingredients of ZYMFENTRA or any murine proteins (severe hypersensitivity reactions have included anaphylaxis, hypotension and serum sickness). ZYMFENTRA 禁用于既往对英夫利昔单抗-dyyb、其他英夫利昔单抗产品、ZYMFENTRA 的任何非活性成分或任何鼠源蛋白有严重超敏反应的患者（严重超敏反应包括过敏性休克、低血压和血清病）。HEPATITIS B VIRUS REACTIVATION 乙型肝炎病毒再激活 TNF blockers, including infliximab products, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating ZYMFENTRA. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. 包括英夫利昔单抗产品在内的TNF抑制剂，与慢性携带乙型肝炎病毒（HBV）患者的病毒再激活有关。一些病例是致命的。在开始使用ZYMFENTRA之前，应对患者进行HBV感染检测。对于检测呈阳性的患者，请咨询具有乙型肝炎治疗经验的医生。 Exercise caution when prescribing ZYMFENTRA for patients identified as carriers of HBV and monitor closely for active HBV infection during and following termination of therapy with ZYMFENTRA. Discontinue ZYMFENTRA in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. 对确定为乙肝病毒携带者的患者开ZYMFENTRA时应谨慎，并在ZYMFENTRA治疗期间及治疗结束后密切监测活动性乙肝病毒感染情况。对于出现乙肝病毒再激活的患者，应停用ZYMFENTRA，并开始适当的抗病毒治疗和支持治疗。Exercise caution when considering resumption of ZYMFENTRA and monitor patients closely.. 在考虑恢复使用ZYMFENTRA时要谨慎，并密切监测患者。HEPATOTOXICITY 肝毒性Hepatobiliary disorders, including acute liver failure, jaundice abnormal hepatic function, hepatic steatosis, hepatitis, hepatotoxicity, hyperbilirubinemia and non-alcoholic fatty liver, have been reported in patients receiving infliximab products post-marketing. Some cases were fatal or required liver transplant. 已有报告指出，接受英夫利昔单抗产品治疗的患者在上市后出现了肝胆疾病，包括急性肝衰竭、黄疸、肝功能异常、脂肪肝、肝炎、肝毒性、高胆红素血症和非酒精性脂肪肝。某些病例导致死亡或需要进行肝脏移植。Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, ZYMFENTRA should be discontinued and a thorough investigation of the abnormality should be undertaken.. 在许多情况下，在发现肝损伤之前并未注意到转氨酶升高。出现肝功能障碍症状或体征的患者应评估是否存在肝损伤的证据。如果出现黄疸和/或显著的肝酶升高（例如，≥正常上限的5倍），应停用ZYMFENTRA，并对异常情况进行彻底调查。CONGESTIVE HEART FAILURE 充血性心力衰竭Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. Some cases had a fatal outcome. In several exploratory trials of other TNF blockers in the treatment of CHF, there were greater proportions of TNF-blocker-treated patients who had CHF exacerbations requiring hospitalization or increased mortality. 已有报告显示，使用肿瘤坏死因子（TNF）抑制剂会导致充血性心力衰竭（CHF）恶化和新发CHF的病例，其中一些病例为致命结局。在其他几种关于TNF抑制剂治疗CHF的探索性试验中，接受TNF抑制剂治疗的患者中有更高比例出现需要住院治疗的CHF加重或死亡率增加的情况。ZYMFENTRA has not been studied in patients with a history of CHF and ZYMFENTRA should be used with caution in patients with CHF.. ZYMFENTRA 尚未在有充血性心力衰竭（CHF）病史的患者中进行研究，因此 ZYMFENTRA 在充血性心力衰竭（CHF）患者中应谨慎使用。HEMATOLOGIC REACTION 血液反应Cases of leukopenia, neutropenia, thrombocytopenia and pancytopenia (some fatal) have been reported. The causal relationship to infliximab-product therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. 已有报告白细胞减少、中性粒细胞减少、血小板减少和全血细胞减少（部分致命）的病例。其与英夫利昔单抗治疗的因果关系尚不明确。对于持续存在或既往有显著血液学异常的患者，应谨慎使用。若患者出现血液系统疾病或感染的症状和体征，应建议其立即寻求医疗帮助。Consider discontinuation of ZYMFENTRA in patients who develop significant hematologic abnormalities.. 考虑在出现显著血液学异常的患者中停用ZYMFENTRA。HYPERSENSITIVITY AND OTHER ADMINISTRATION REACTIONS 超敏反应及其他管理反应 In post-marketing experience, serious systemic hypersensitivity reactions (including anaphylaxis, hypotension and serum sickness) have been reported following administration of infliximab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue ZYMFENTRA.. 在上市后经验中，已有报告指出在使用英夫利昔单抗产品后出现严重的全身性过敏反应（包括过敏性休克、低血压和血清病）。如果发生过敏性反应或其他临床上显著的过敏反应，应采取适当的治疗并停止使用ZYMFENTRA。INJECTION SITE REACTIONS 注射部位反应In clinical studies, localized injection-site reactions were reported following administration of ZYMFENTRA. If a clinically significant injection-site reaction occurs, institute appropriate therapy and discontinue ZYMFENTRA. 在临床研究中，注射ZYMFENTRA后报告了局部注射部位反应。如果出现有临床意义的注射部位反应，应采取适当的治疗并停止使用ZYMFENTRA。NEUROLOGIC REACTIONS 神经系统反应Agents that inhibit TNF have been associated with central nervous system (CNS) manifestation of systemic vasculitis, seizure and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis and peripheral demyelinating disorders, including Guillain-Barré syndrome. 抑制TNF的药物与系统性血管炎、癫痫发作以及中枢神经系统脱髓鞘疾病（包括多发性硬化和视神经炎）的新发或恶化有关，也与周围神经系统脱髓鞘疾病（包括吉兰-巴雷综合征）有关。Exercise caution when considering ZYMFENTRA in patients with these disorders and consider discontinuation if these disorders develop.. 在考虑对这些疾病患者使用ZYMFENTRA时要谨慎，如果这些疾病发作，请考虑停药。RISK OF INFECTION WITH CONCURRENT ADMINISTRATION OF OTHER BIOLOGICS PRODUCTS 与其他生物制品同时使用时的感染风险Serious infections and neutropenia have been reported with concurrent use of ZYMFENTRA with other immunosuppressive biological products. The concurrent use of ZYMFENTRA with other immunosuppressive biological products used to treat UC and CD may increase the risk of infection and is not recommended.. 同时使用 ZYMFENTRA 和其他免疫抑制生物制品已报告出现严重感染和中性粒细胞减少。同时使用 ZYMFENTRA 和其他用于治疗 UC 和 CD 的免疫抑制生物制品可能会增加感染风险，因此不建议这样做。RISK OF ADDITIVE IMMUNOSUPPRESSIVE EFFECTS FROM PRIOR BIOLOGICAL PRODUCTS 既往生物制品的免疫抑制叠加效应风险Consider the half-life and mode of action of prior biological products to avoid unintended additive immunosuppressive effects when initiating ZYMFENTRA. 在开始使用ZYMFENTRA时，应考虑先前生物制品的半衰期和作用方式，以避免意外的叠加免疫抑制效应。AUTOIMMUNITY 自身免疫性疾病Treatment with TNF blockers may result in the formation of autoantibodies and in the development of a lupus-like syndrome. Discontinue ZYMFENTRA treatment if symptoms of a lupus-like syndrome develop. 使用肿瘤坏死因子（TNF）阻滞剂治疗可能导致自身抗体的形成，并引发类似狼疮综合征的症状。如果出现类似狼疮综合征的症状，请停止使用ZYMFENTRA治疗。VACCINATIONS AND USE OF LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS 疫苗接种和使用活疫苗/治疗性感染因子Prior to initiating ZYMFENTRA, update vaccinations in accordance with current vaccination guidelines. Live vaccines or therapeutic infectious agents should not be given with ZYMFENTRA due to the possibility of clinical infections, including disseminated infections. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed . 在开始使用ZYMFENTRA之前，应根据当前的疫苗接种指南更新疫苗接种。由于可能存在临床感染，包括播散性感染，因此不应与ZYMFENTRA同时接种活疫苗或使用治疗性感染剂。对于接触过的婴儿，建议在出生后至少等待6个月再接种任何活疫苗。in utero 子宫内to ZYMFENTRA. 给ZYMFENTRA。ADVERSE REACTIONS 不良反应In clinical trials with ZYMFENTRA, the most common adverse reactions occurring in ≥3% of ZYMFENTRA-treated patients included site reactions, COVID-19, anemia, arthralgia, infection site reaction, increased alanine aminotransferase and abdominal pain for UC, and COVID-19, headache, upper respiratory tract infection, injection site reaction, diarrhea, increased blood creatine phosphokinase, arthralgia, increased alanine aminotransferase, hypertension, urinary tract infection, neutropenia, dizziness and leukopenia for CD.. 在使用ZYMFENTRA的临床试验中，最常见的不良反应（发生在≥3%的ZYMFENTRA治疗患者中）包括：UC患者的注射部位反应、COVID-19、贫血、关节痛、感染部位反应、丙氨酸氨基转移酶升高和腹痛；CD患者的COVID-19、头痛、上呼吸道感染、注射部位反应、腹泻、血肌酸磷酸激酶升高、关节痛、丙氨酸氨基转移酶升高、高血压、尿路感染、中性粒细胞减少、头晕和白细胞减少。Please click for Full U.S. Prescribing Information. 请点击查看完整的美国处方信息。Globally, prescribing information varies; refer to the individual country product label for complete information. 全球范围内，处方信息各不相同；如需完整信息，请参阅各个国家的产品标签。About Digestive Disease Week 关于消化疾病周® ®Digestive Disease Week 消化疾病周® ®(DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 2-5, 2026. （DDW）是胃肠病学、肝病学、内窥镜检查和胃肠道外科领域中规模最大的国际性医生、研究人员和学者聚会。该会议由美国肝病研究协会（AASLD）、美国胃肠病学协会（AGA）、美国胃肠内窥镜学会（ASGE）以及消化道外科学会（SSAT）联合主办，将于2026年5月2日至5日以线下和线上形式举行。More information can be found at . 更多信息可在此处找到：。www.ddw.org www.ddw.orgAbout Celltrion, Inc. 关于Celltrion公司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. 我们的全球制药产品组合涵盖多个治疗领域，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 . 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，包括：INFLECTRA。® ®(infliximab-dyyb), TRUXIMA (infliximab-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-stba)，STOBOCLO® ®(denosumab-bmwo), OSENVELT (denosumab-bmwo)，OSENVELT® ®(denosumab-bmwo), OMLYCLO (denosumab-bmwo)，OMLYCLO® ®(omalizumab-igec), and EYDENZELT (奥马珠单抗-igec)，以及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). （英夫利昔单抗-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 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，这些陈述可能构成相关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', 'anticipate' 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”、“努力实现”、“预计”、“可供使用”、“有潜力”、“预期”这些词语的否定形式或其他类似变化或相等术语来识别。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 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该等陈述所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. 细胞生物技术公司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声明的义务，除非适用的证券法要求。For further information please contact: 如需更多信息，请联系：Brendi Bluitt 布伦迪·布鲁伊特[email protected] 电子邮件地址+1 202-545-7722 +1 202-545-7722SOURCE Celltrion 来源：Celltrion21 21% %more press release views with 更多新闻稿浏览量与 Request a Demo 请求演示