INCHEON, South Korea--(BUSINESS WIRE)--Celltrion today announced two-year results of subcutaneous infliximab (CT-P13 SC) dose escalation therapy at United European Gastroenterology (UEG) Week 2024 in Vienna. The post-hoc analysis from the LIBERTY-CD (Crohn’s disease) and LIBERTY-UC (ulcerative colitis) studies suggest that dose escalation of CT-P13 SC following intravenous (IV) induction in patients who initially respond but subsequently lose response, showed clinical efficacy over an extended period of 102 weeks..

。LIBERTY-CD（克罗恩病）和LIBERTY-UC（溃疡性结肠炎）研究的事后分析表明，在最初有反应但随后失去反应的患者中，静脉注射（IV）诱导后CT-P13 SC的剂量增加，在102周的延长期内显示出临床疗效。。

In the study, patients showed improvement in clinical remission at Week 102 [70.3% (26/37) in CD and 35.2% (25/71) in UC] or endoscopic response [40.5% (15/37) in CD] after dose escalation. Compared to the first dose escalation visit, patients who escalated the dose had a statistically significant reduction in mean modified Mayo score in UC (5.9 vs 2.1, P<0.0001) and mean CDAI score in CD (270.58 vs 76.31, P<0.0001) at Week 102..

在该研究中，患者在剂量递增后的第102周[CD为70.3%（26/37），UC为35.2%（25/71）]或内镜反应[CD为40.5%（15/37）]的临床缓解有所改善。。。

The 2-year data from the LIBERTY studies (LIBERTY-CD and LIBERTY-UC) suggest that dose escalation of subcutaneous infliximab is effective for patients who experience a loss of response after induction therapy, with comparable safety profiles. No new safety concerns were found after dose escalation in long term treatment.

LIBERTY研究（LIBERTY-CD和LIBERTY-UC）的2年数据表明，皮下英夫利昔单抗的剂量递增对于诱导治疗后反应丧失的患者是有效的，具有可比的安全性。长期治疗剂量增加后，未发现新的安全问题。

These findings indicate that dose escalation could be considered a potential option for managing loss of response in IBD.1,2.

这些发现表明，剂量递增可以被认为是管理IBD反应丧失的潜在选择[1,2]。

“Dose escalation has long been an option for individual optimisation of IBD patients, particularly in those who lose response after induction therapy with IV infliximab,” said Professor Stefan Schreiber, University Hospital Schleswig-Holstein, Department of Internal Medicine I, Kiel, Germany. “The post-hoc analysis indicates that dose escalation of CT-P13 SC is a possibility to restore efficacy and optimize outcome in those who initially responded to induction.

“剂量递增长期以来一直是IBD患者个体优化的一种选择，特别是那些在静脉注射英夫利昔单抗诱导治疗后失去反应的患者，”德国基尔石勒苏益格-荷尔斯泰因大学医院Stefan Schreiber教授说。“事后分析表明，CT-P13 SC的剂量递增有可能恢复最初对诱导有反应的患者的疗效并优化结果。

Dose escalation in SC infliximab has a comparable safety profile and makes a valuable contribution to long-term management strategies for patients with moderately to severely active IBD.”.

SC英夫利昔单抗的剂量递增具有可比的安全性，并为中度至重度活动性IBD患者的长期管理策略做出了有价值的贡献。”。

“We are proud to share these important findings at UEGW, as they reinforce our commitment to advancing treatment options for patients with IBD,” said Mr. Kevin Byoung Seo Choi, Executive VP and head of the marketing division at Celltrion. “The updated SmPC in Crohn’s disease which notes that patients who initially responded to 5mg/kg but who lost response may regain response with dose escalation, along with the latest data, provide healthcare professionals with a personalised approach to IBD care, by addressing the complexities of managing this challenging condition.”3.

Celltrion执行副总裁兼营销部负责人凯文·拜翁·赛奥·蔡先生说：“我们很荣幸能在UEGW上分享这些重要发现，因为它们加强了我们对推进IBD患者治疗选择的承诺。”。“克罗恩病最新SmPC指出，最初对5mg/kg有反应但失去反应的患者可能会随着剂量增加而恢复反应，以及最新数据，通过解决管理这种具有挑战性的疾病的复杂性，为医疗保健专业人员提供了一种个性化的IBD护理方法。”3。

About the subcutaneous (SC) formulation of CT-P13

关于CT-P13的皮下（SC）制剂

CT-P13 SC is the world’s first subcutaneous formulation of infliximab. A 120mg fixed dose of CT-P13 SC has been approved for use in 60 countries including the US, UK, EU, Canada, Brazil, Australia and Taiwan, in adults regardless of body weight. The SC formulation of infliximab has the potential to enhance treatment options by providing high consistency in drug exposure and a convenient method of administration.4,5.

CT-P13 SC是世界上第一种英夫利昔单抗皮下制剂。120mg固定剂量的CT-P13 SC已被批准在60个国家使用，包括美国，英国，欧盟，加拿大，巴西，澳大利亚和台湾，无论体重如何。英夫利昔单抗的SC制剂有可能通过提供高度一致的药物暴露和方便的给药方法来增强治疗选择[4,5]。

About Celltrion

关于Celltrion

Celltrion is a leading biopharmaceutical company based in Incheon, South Korea that specialises in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. The company’s solutions include world-class monoclonal antibody biosimilars such as Remsima®, Truxima® and Herzuma®, providing broader patient access globally.

Celltrion是一家位于韩国仁川的领先生物制药公司，专门从事创新疗法的研究、开发、制造、营销和销售，以改善全球人民的生活。该公司的解决方案包括世界一流的单克隆抗体生物仿制药，如Remsima®、Truxima®和Herzuma®，为全球患者提供更广泛的服务。

Celltrion has also received U.S. FDA and EC approval for Vegzelma® and Yuflyma®, FDA approval for Zymfentra®, and EC approval for Remsima® SC, Omlyclo®, SteQeyma®. To learn more, please visit www.celltrion.com/en-us..

。欲了解更多信息，请访问www.celltrion.com/en-us。。

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.

本新闻稿中的某些信息包含与我们未来的业务和财务业绩以及涉及Celltrion Inc.及其子公司的未来事件或发展相关的报表，这些报表可能构成相关证券法下的前瞻性报表。

These statements may be 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”, the negative of these words or such other variations thereon or comparable terminology..

这些声明可以用“准备”，“希望”，“即将到来”，“计划”，“目标”，“即将推出”，“正在准备”，“一旦获得”，“可能”，“目的”，“可能”，“一旦确定”，“将”，“致力于”，“是到期”，“变得可用”，“有潜力”，这些单词的负面或其他类似变体或类似术语。。

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，我们的代表可能会发表口头前瞻性声明。此类声明基于Celltrion Inc.及其子公司管理层的当前预期和某些假设，其中许多超出其控制范围。

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..

提供前瞻性陈述是为了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。这些声明并不能保证未来的业绩，不应过分依赖这些声明。。

Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements..

此类前瞻性报表必然涉及已知和未知的风险和不确定性，这可能导致未来期间的实际业绩和财务业绩与此类前瞻性报表明示或暗示的未来业绩或结果的任何预测存在重大差异。。

Although forward-looking statements contained in this presentation are based upon what management of Celltrion Inc. and its subsidiaries believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.

尽管本演示文稿中包含的前瞻性陈述是基于Celltrion Inc.及其子公司的管理层认为合理的假设，但不能保证前瞻性陈述会被证明是准确的，因为实际结果和未来事件可能与此类陈述中的预期大不相同。

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. The reader is cautioned not to place undue reliance on forward-looking statements..

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报表，除非适用的证券法另有要求。提醒读者不要过度依赖前瞻性陈述。。

References

参考文献

1 S. Schreiber et al., Two-year results of subcutaneous infliximab (CT-P13 SC) dose escalation therapy as an option for managing loss of response in inflammatory bowel disease – from LIBERTY-UC and LIBERTY-CD study. Oral presentation. Presented at UEGW 2024.

1 S.Schreiber等人，LIBERTY-UC和LIBERTY-CD研究中皮下英夫利昔单抗（CT-P13 SC）剂量递增疗法作为治疗炎症性肠病反应丧失的一种选择的两年结果。口头陈述。于2024年UEGW上发布。

2 Hanauer SB et al., Subcutaneous Infliximab (CT-P13) as Maintenance Therapy for Inflammatory Bowel Disease: Two Randomized Phase 3 Trials (LIBERTY) Gastroenterology. 2024. https://www.gastrojournal.org/article/S0016-5085(24)04918-7/fulltext#%20. [Last accessed October 2024]

2 Hanauer SB等人，皮下英夫利昔单抗（CT-P13）作为炎症性肠病的维持治疗：两项随机3期试验（LIBERTY）胃肠病学。2024https://www.gastrojournal.org/article/S0016-5085（24）04918-7/全文#%20。[上次访问时间为2024年10月]

3 European Medicines Agency. Subcutaneous and Intravenous Infliximab. Summary of product characteristics. 2024. https://www.ema.europa.eu/en/documents/product-information/remsima-epar-product-information_en.pdf. [Last accessed October 2024]

3欧洲药品管理局。皮下和静脉注射英夫利昔单抗。产品特性总结。2024https://www.ema.europa.eu/en/documents/product-information/remsima-epar-product-information_en.pdf.[上次访问时间为2024年10月]

4 Schreiber S et al., Gastroenterology. 2021;160(7):2340-2353.

4 Schreiber S等人，胃肠病学。2021年；160（7）：2340-2353。

5 Westhovens R et al., Rheumatology. 2021;60(5):2277-2287.

5 Westhovens R等人，风湿病。2021年；60（5）：2277-2287。