Trastuzumab-PKRB(Celltrion)

Findings from the post-hoc analysis of LIBERTY-CD study indicates efficacy of ZYMFENTRA® (subcutaneous infliximab) regardless of disease location, consistent across ileum-dominant and colon-dominant Crohn's disease (CD) Findings support the therapeutic potential of ZYMFENTRA in addressing persistent treatment gaps especially in ileum-dominant CD INCHEON, South Korea, Nov. 26, 2025 /PRNewswire/ -- Celltrion, Inc. today announced that a post-hoc analysis of the LIBERTY-CD study, which showed that the efficacy of ZYMFENTRA® (infliximab-dyyb) is consistent regardless of disease location, has been published in a peer reviewed journal, Clinical Gastroenterology and Hepatology.[1] "The consistency of treatment effect across disease locations is important, as ileal Crohn's disease (CD) is highly correlated with negative long-term outcomes and the fact that the terminal ileum being the most challenging segment to treat," said Prof. Jean-Frédéric Colombel, MD, Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai. "The consistent clinical and endoscopic outcomes observed with subcutaneous formulation of infliximab, regardless of disease location, suggest its potential as an effective therapy across different ileocolonic segments." The post hoc analysis utilized the endoscopic data from the phase 3 LIBERTY-CD trial of subcutaneous formulation of infliximab (infliximab SC), ZYMFENTRA, to investigate the clinical outcomes and related predictive factors by disease location in patients with moderately-to-severely active CD who received infliximab SC maintenance treatment. Among 329 patients, 52.6% had colon-dominant CD (n=173) and 47.4% had ileum-dominant CD (n=105). At Week 54, patients receiving infliximab SC achieved significantly greater efficacy outcomes across all endpoints compared with placebo, regardless of disease location. Rates of clinical remission were 60.95% in the ileum-dominant group and 66.95% in the colon-dominant group, versus 37.25% and 29.09%, respectively, in the placebo group. Clinical response and endoscopic response rates similarly favored infliximab SC over placebo in both location groups (clinical response: 62.86% vs 41.18% in ileum-dominant and 67.80% vs 38.18% in colon-dominant; endoscopic response: 53.33% vs 19.61% in ileum-dominant and 52.54% vs 18.18% in colon dominant). When assessed at the segment level, endoscopic responses at Week 54 were greater with infliximab SC versus placebo across all ileocolonic segments, including the terminal ileum, with consistent treatment effect sizes observed throughout each segment. "As 70-80% of patients with Crohn's disease have ileal involvement at diagnosis, effective treatment of the ileum has the potential to benefit a large proportion of patients with Crohn's disease," said Nam Lee, Vice President of Global Medical Affairs at Celltrion. "It is encouraging to have this additional analysis that supports consistent efficacy of subcutaneous infliximab regardless of different disease location and segments." The full manuscript "Endoscopic response to subcutaneous infliximab by disease location: A post hoc analysis of the LIBERTY-CD study" is available online at Clinical Gastroenterology and Hepatology today. Notes to Editors: About ZYMFENTRA® (infliximab-dyyb; subcutaneous infliximab) 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. Indication and Important Safety Information ZYMFENTRA® is a prescription medicine indicated in adults for maintenance treatment of: Moderately-to-severely active Crohn's disease following treatment with an infliximab product administered intravenously. Moderately-to-severely active ulcerative colitis following treatment with an infliximab product administered intravenously. It is not known if ZYMFENTRA is safe and effective in children under 18 years of age. What is the most important information I should know about ZYMFENTRA? SERIOUS INFECTIONS 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. Reported infections include: 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. 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. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. 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. 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. MALIGNANCIES Malignancies, some fatal, have been reported in children, adolescents, and young adults treated with TNF blockers, including infliximab products. 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. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants. 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. 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. 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. 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. CONTRAINDICATIONS 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). HEPATITIS B VIRUS REACTIVATION 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. 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. Exercise caution when considering resumption of ZYMFENTRA and monitor patients closely. HEPATOTOXICITY 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. 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. CONGESTIVE HEART FAILURE 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. ZYMFENTRA has not been studied in patients with a history of CHF and ZYMFENTRA should be used with caution in patients with CHF. HEMATOLOGIC REACTION 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. Consider discontinuation of ZYMFENTRA in patients who develop significant hematologic abnormalities. HYPERSENSITIVITY AND OTHER ADMINISTRATION REACTIONS 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. INJECTION SITE REACTIONS 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. NEUROLOGIC REACTIONS 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. Exercise caution when considering ZYMFENTRA in patients with these disorders and consider discontinuation if these disorders develop. RISK OF INFECTION WITH CONCURRENT ADMINISTRATION OF OTHER BIOLOGICS PRODUCTS 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. RISK OF ADDITIVE IMMUNOSUPPRESSIVE EFFECTS FROM PRIOR BIOLOGICAL PRODUCTS Consider the half-life and mode of action of prior biological products to avoid unintended additive immunosuppressive effects when initiating ZYMFENTRA. AUTOIMMUNITY 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. VACCINATIONS AND USE OF LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS 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 in utero to ZYMFENTRA. ADVERSE REACTIONS 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. Please click for Full U.S. Prescribing Information. Globally, prescribing information varies; refer to the individual country product label for complete information. About Celltrion , Inc. 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. For more information, please visit our website . and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook. About Celltrion USA 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. For more information, please visit and stay updated with our latest news and events on our social media: LinkedIn. FORWARD-LOOKING STATEMENT 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. 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. 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. 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. 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. 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. For further information please contact: Katie Gallagher [email protected] +1 617-657-1324 SOURCE Celltrion 21% more press release views with Request a Demo

一家从亚洲最大制药代工厂起步的企业，用20年时间完成了向全球生物制药巨头的华丽蜕变 2021年，韩国医药品出口额达到84.9亿美元，同比增长20.5%。在这一亮眼数据的背后，一家名为Celltrion的韩国药企正以惊人的速度崛起，成为全球生物制药领域不可忽视的力量。 从2002年成立时承接国际药企代工业务，到如今成为全球第二大单克隆抗体生产企业，Celltrion的发展轨迹堪称韩国制药业的缩影。这家总部位于仁川的企业，用20年时间走出了一条从“制造”到“智造”的升级之路。 1 8亿美元订单成就的转折点 2005年，成立仅3年的Celltrion迎来了关键转折点。百时美施贵宝将当时亚洲最大的生物制药订单授予了这家初创企业，合同价值高达8亿美元。这笔订单不仅为Celltrion提供了生存下去的资本，更让其获得了国际一流的生产标准和质量体系。 “2003年到2008年是Celltrion打下基业的阶段。”正如业内观察者所言，这次合作为Celltrion日后进军全球市场奠定了坚实基础。代工业务让Celltrion积累了宝贵的技术和经验，为后续的自主创新铺平了道路。 扫码加我 立即咨询 合作微信丨guoji799 联系电话丨13810954972 2 全球首个抗体生物类似药的诞生 2013年，Celltrion迎来了高光时刻。其开发的英夫利昔单抗类似物Remsima获得欧盟EMA批准，成为全球首个获批的抗体生物类似药。这一突破不仅让Celltrion一举成名，更为全球生物类似药市场打开了新局面。 Remsima的成功证明了Celltrion在生物药研发和生产方面的实力。更值得关注的是，2019年Celltrion进一步推出了Remsima SC皮下注射剂型，大大提升了患者用药的便利性。这种剂型创新被视为“颠覆市场格局的规则改变者”。 3 六大核心药物布局全球市场 经过多年发展，Celltrion已建立起丰富多元的产品管线。其核心生物类似药包括： 贝伐珠单抗（Vegzelma）：2022年9月获FDA批准，用于治疗六种癌症，包括转移性结直肠癌、非小细胞肺癌等。 阿达木单抗（Yuflyma）：2023年5月获FDA批准，是世界上首个高浓度、低体积和无柠檬酸盐的阿达木单抗生物类似药。 COVID-19治疗药物Regkirona：在疫情期间快速研发并获批，展示了Celltrion应对突发公共卫生事件的能力。 此外，利妥昔单抗（Truxima）和曲妥珠单抗（Herzuma）等产品也在各自治疗领域展现出强大的市场竞争力。这些产品均通过严谨的临床试验，证实与原研药具有高度相似的安全性和有效性。 扫码加我 立即咨询 合作微信丨guoji799 联系电话丨13810954972 4 生物药与化学药并重发展 Celltrion的成功不仅限于生物药。公司将业务分为化学事业本部和制药事业部，充分发挥各自领域的专业性。在化学药领域，Celltrion生产包括艾滋病治疗药物Temixys在内的多个重要产品。 尤其值得关注的是，Celltrion并没有满足于生物类似药的成功，而是积极向创新药研发迈进。公司在研管线包括针对哮喘和荨麻疹的CT-P39、骨质疏松症药物CT-P41、糖尿病黄斑水肿药物CT-P42等多个创新候选药物。 5 技术创新构筑护城河 Celltrion的持续创新能力源于其强大的研发投入。公司建立了涵盖生物制药学所有领域的研发中心，包括新药候选物质鉴定、干细胞开发、基因重组表达、规模化生产等完整产业链。 “Celltrion从一个制药行业相对欠发达的国家推出了世界上首个‘抗体生物类似药’，实现了人们认为不可能的事情。”这一成就背后，是公司对技术创新的执着追求。 在生物类似药领域取得成功后，Celltrion正将资源向创新药研发倾斜。这种“仿创结合”的策略，既保证了短期现金流，又为长期发展积蓄了力量。 6 对中国药企的启示 Celltrion的发展路径对中国药企具有重要借鉴意义： 其一，重视生产工艺和质量体系：Celltrion从代工起步的经历说明，过硬的生产质量是进军国际市场的基石。 其二，选择合适的创新路径：从生物类似药切入，再向创新药过渡，这种渐进式创新路径风险相对可控。 其三，坚持全球化视野：Celltrion从成立之初就瞄准全球市场，这种定位决定了其技术标准和发展策略。 其四，把握剂型创新机遇：如Remsima SC皮下注射剂型的开发，显示了剂型创新带来的市场机会。 随着全球生物药市场持续增长，生物类似药将迎来更大发展空间。据预测，到2025年全球生物类似药市场规模将超过千亿美元。Celltrion的成功经验表明，后发企业通过精准的战略定位和技术创新，完全可以在这一领域有所作为。 从代工厂到全球巨头，Celltrion只用了20年时间。这家韩国药企的故事告诉我们：在医药这个需要长期投入的行业，既要有仰望星空的远大目标，也要有脚踏实地的务实精神。随着全球医药市场格局变化，中国药企或可从Celltrion的发展历程中获得启示，找到属于自己的崛起之路。 扫码加我 立即咨询 合作微信丨guoji799 联系电话丨13810954972 END 使用说明： 本文部分内容与图片源于网络，仅用于学习交流，如有侵权，请联系删除  往期推荐  商业洞察 | “消费降级是骗局？年轻人宁愿多花30元配送费，却为9.9洗衣液纠结半天” 奥迪：揭秘“技术偏执”，5-7年磨一款车，年投5%营收搞研发，奥迪凭什么成豪华标杆？ 商汤科技：不止“港股AI第一股”：商汤科技如何让AI渗透千行百业？ 谷歌：AI领跑却遭股价暴击？谷歌云高增长背后，资本开支成“甜蜜的负担” 两个无印良品，傻傻分不清，同名不同源！中日无印良品24年互撕，你买对过吗？ 沙特吉达伊斯兰港：成本降30%+效率飙涨！吉达新航线让中国货横扫中东？ 韩国游戏考察：韩国游戏凭什么横扫全球？政策、技术、全球化，缺一个都成不了顶流 俄罗斯：从历史到现实，带你全方位读懂战斗民族俄罗斯 三菱电机：从百年品牌看技术实力，三菱电机凭什么称霸行业？ 新加坡樟宜机场：全球顶流！新加坡樟宜机场凭什么连续霸榜「世界最佳」空中花园？