INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Healthcare today presented Phase III data from the LIBERTY-CD and LIBERTY-UC clinical trials, for the investigational subcutaneous (SC) infliximab in inflammatory bowel disease (IBD) treatment at the United European Gastroenterology (UEG) Week 2023 in Copenhagen.1.

韩国仁川-（商业信息）-Celltrion Healthcare今天提供了LIBERTY-CD和LIBERTY-UC临床试验的III期数据，用于研究皮下（SC）英夫利昔单抗治疗炎症性肠病（IBD）在哥本哈根的欧洲胃肠病学（UEG）2023周。

Results from the LIBERTY studies, presented during a satellite symposium, evaluated the effectiveness of SC infliximab over placebo in patients with moderately to severely active Crohn's disease (CD) or ulcerative colitis (UC). SC infliximab had a similar safety profile to the placebo during the maintenance period.

在satellite研讨会期间提出的LIBERTY研究结果评估了SC英夫利昔单抗与安慰剂相比在中度至重度活动性克罗恩病（CD）或溃疡性结肠炎（UC）患者中的有效性。SC英夫利昔单抗在维持期间与安慰剂具有相似的安全性。

The proportion of patients who experienced adverse events (AEs), serious AEs, infection in the SC infliximab and placebo groups were generally comparable. No new safety concerns were identified.1.

SC英夫利昔单抗组和安慰剂组发生不良事件（AE），严重AE，感染的患者比例一般相当。没有发现新的安全问题。

LIBERTY-CD and LIBERTY-UC are registrational studies currently under review by the U.S. FDA as part of a Biologics License Application (BLA) submission. If approved by the FDA, CT-P13 SC would be the first subcutaneous formulation of infliximab.

LIBERTY-CD和LIBERTY-UC是美国FDA目前正在审查的注册研究，作为生物制剂许可申请（BLA）提交的一部分。如果FDA批准，CT-P13 SC将成为英夫利昔单抗的第一种皮下制剂。

Post-hoc analyses of the LIBERTY-CD and LIBERTY-UC studies were presented as posters at UEG Week 2023. The first post-hoc analysis examined the possible use of SC infliximab treatment without immunosuppressants and the second evaluated dose escalation in patients with loss of treatment response.

LIBERTY-CD和LIBERTY-UC研究的事后分析在UEG 2023周作为海报展示。第一次事后分析检查了不使用免疫抑制剂的SC英夫利昔单抗治疗的可能用途，第二次评估了治疗反应丧失患者的剂量递增。

The first post-hoc analysis supports the efficacy and safety of SC infliximab as a monotherapy without immunosuppressants for CD and UC patients. After 54 weeks, there were no statistical differences in efficacy outcomes between monotherapy and combination therapy with immunosuppressants. The overall safety profile during the maintenance period was also comparable between the two groups, suggesting limited benefit of combination therapy with immunosuppressants for IBD patients treated with SC infliximab.2.

第一次事后分析支持SC英夫利昔单抗作为单药治疗CD和UC患者无免疫抑制剂的有效性和安全性。54周后，单药治疗与免疫抑制剂联合治疗的疗效结果无统计学差异。维持期间的总体安全性在两组之间也是可比较的，这表明用SC英夫利昔单抗治疗的IBD患者与免疫抑制剂联合治疗的益处有限。

The second post-hoc analysis evaluated the impact of dose escalation of SC infliximab in managing the loss of response to treatment in IBD patients. The recommended dose for subcutaneous infliximab is 120 mg once every 2 weeks.3 Exploratory results suggest that dose escalation from 120mg to 240mg every two weeks may restore efficacy, while safety profiles, including immunogenicity and the incidence rate of adverse events, were shown to be comparable between patients with or without dose escalation.

第二项事后分析评估了SC英夫利昔单抗剂量递增对控制IBD患者治疗反应丧失的影响。皮下注射英夫利昔单抗的推荐剂量为每2周120 mg。探索性结果表明，每两周剂量从120mg增加到240mg可恢复疗效，而安全性概况，包括免疫原性和不良事件发生率，显示为在有或没有剂量递增的患者之间具有可比性。

In both UC and CD studies, patients showed improvement in terms of clinical remission [24.7% (20/81) in UC and 53.8% (21/39) in CD] or endoscopic response [28.2% (11/39) in CD] after dose escalation. Compared to the first dose escalation visits, patients on dose escalation had a statistically significant reduction in modified Mayo score (in UC) and CDAI score (in CD) at Week 54.4.

在UC和CD研究中，患者在临床缓解方面有所改善[UC为24.7%（20/81），CD为53.8%（21/39）]或内镜下反应[28.2%（11/39）]剂量递增后。与第一次剂量递增访视相比，剂量递增患者在第54.4周时改良Mayo评分（UC）和CDAI评分（CD）的统计学显着降低。

In a separate presentation at UEG Week 2023, real-world data on switching from intravenous (IV) to SC infliximab were evaluated. The findings may help support the practical application of this innovation.5

在UEG 2023周的另一个报告中，评估了从静脉注射（IV）切换到SC英夫利昔单抗的实际数据。这些发现可能有助于支持这项创新的实际应用

Stephen B. Hanauer, MD, medical director of the Digestive Health Center at Northwestern Medicine, and professor of medicine at the Feinberg School of Medicine said, “As a healthcare professional dedicated to improving the lives of IBD patients, I am excited to see further data that validate a subcutaneous treatment option allowing more patients in the U.S.

西北医学院消化健康中心医学主任，Feinberg医学院医学教授Stephen B.Hanauer博士说：“作为致力于改善IBD患者生活的医疗保健专业人员，我很高兴看到进一步的数据验证了皮下治疗方案，使美国有更多的患者。

to have greater control of their disease.”.

更好地控制他们的疾病。”。

Tom Nusbickel, Chief Commercial Officer at Celltrion USA said, “We have already seen the positive impact of subcutaneous infliximab on patients in Europe. We are committed to bringing SC infliximab to the U.S. to increase the therapeutic options for IBD once approved by the FDA which is to be marketed and sold by Celltrion USA.”.

美国Celltrion公司首席商业官Tom Nusbickel说：“我们已经看到皮下注射英夫利昔单抗对欧洲患者的积极影响，我们致力于将SC英夫利昔单抗带到美国，一旦获得FDA批准，将增加IBD的治疗选择由Celltrion USA销售和销售“。

The European Commission authorized CT-P13 SC in 2020 for multiple indications including CD and UC. FDA approval decision for CT-P13 SC is anticipated within the fourth quarter of 2023.

欧盟委员会于2020年授权CT-P13 SC用于多种适应症，包括CD和UC。FDA批准CT-P13 SC的决定预计在2023年第四季度内完成。

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About CT-P13 (biosimilar infliximab)

关于CT-P13（生物仿制药英夫利昔单抗）

CT-P13 is developed and manufactured by Celltrion and was the world's first monoclonal antibody biosimilar of reference infliximab. It is indicated for the treatment of eight autoimmune diseases including Crohn’s disease (CD) and ulcerative colitis (UC). It was approved by the European Commission under the trade name Remsima® in September 2013 and launched in major EU countries in early 2015.

CT-P13由Celltrion开发和制造，是世界上第一个参考英夫利昔单抗的单克隆抗体生物仿制药。它适用于治疗八种自身免疫性疾病，包括克罗恩病（CD）和溃疡性结肠炎（UC）。它于2013年9月获得欧盟委员会的批准，商品名为Remsima®，并于2015年初在欧盟主要国家推出。

The U.S. Food and Drug Administration approved CT-P13 in April 2016 under the trade name Inflectra®. Remsima® is authorized in over 100 countries worldwide as of January 2023, with a 55% market share in Europe in 2022.6.

美国食品和药物管理局于2016年4月以商品名Inflectra®批准CT-P13。截至2023年1月，Remsima®已在全球100多个国家获得授权，2022年在欧洲的市场份额为55%。

Subcutaneous infliximab (CT-P13 SC) has received EU marketing authorization for the treatment of patients with CD, UC, rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), and psoriasis in adult patients. In the United States, CT-P13 SC is being reviewed through the new drug pathway by the U.S.

皮下英夫利昔单抗（CT-P13 SC）已获得欧盟上市许可，用于治疗成人患者的CD，UC，类风湿性关节炎（RA），强直性脊柱炎（AS），银屑病关节炎（PsA）和牛皮癣患者。在美国，美国正在通过新药途径审查CT-P13 SC。

Food and Drug Administration (FDA) for the treatment of CD and UC..

美国食品和药物管理局（FDA）用于治疗CD和UC。。

About Celltrion Healthcare

关于Celltrion Healthcare

Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA Current Good Manufacturing Practice (cGMP) and the EU GMP guidelines.

Celltrion Healthcare致力于提供创新且价格合理的药物，以促进患者获得先进疗法。其产品在最先进的哺乳动物细胞培养设施中生产，其设计和制造符合美国FDA现行的良好生产规范（cGMP）和欧盟GMP指南。

Celltrion Healthcare endeavors to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 different countries..

Celltrion Healthcare致力于通过跨越110多个不同国家的广泛全球网络提供高质量，经济高效的解决方案。。

For more information, please visit: https://www.celltrionhealthcare.com

欲了解更多信息，请访问：https://www.celltrionhealthcare.com

About Celltrion USA

关于Celltrion USA

Celltrion USA is Celltrion Healthcare’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 currently has five biosimilars approved by the U.S. FDA: Inflectra® (infliximab-dyyb), Truxima® (rituximab-abbs), Herzuma® (trastuzumab-pkrb), Vegzelma® (bevacizumab-adcd), and Yuflyma®(adalimumab-aaty).

Celltrion USA是Celltrion Healthcare的美国子公司，成立于2018年。Celltrion USA总部设在新泽西州，致力于扩大创新生物制剂的使用范围，以改善对美国患者的护理。Celltrion目前有五种经美国FDA批准的生物仿制药：Inflectra®（英夫利昔单抗dyyb），Truxima®（利妥昔单抗abbs），Herzuma®（曲妥珠单抗pkrb），Vegzelma®（贝伐单抗adcd）和Yuflyma®（阿达木单抗aaty）。

Celltrion USA will continue to leverage Celltrion Healthcare’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..

Celltrion USA将继续利用Celltrion Healthcare在生物技术，供应链卓越和一流销售能力方面的独特遗产，改善美国患者获得高质量生物制药的机会。。

Important Safety Information

重要的安全信息

Please refer to the full Summary of Product Characteristics for full prescribing information for CT-P13 SC: https://www.ema.europa.eu/en/documents/product-information/remsima-epar-product-information_en.pdf

有关CT-P13 SC的完整处方信息，请参阅产品特性的完整摘要：https://www.ema.europa.eu/en/documents/product-information/remsima-epar-product-information_en.pdf

References

工具书类

1 S. Schreiber. (2023, October). Phase 3 Clinical Trials with Subcutaneous Infliximab in Patients with IBD (LIBERTY-CD & UC). In S. Schreiber (Chair), IS-10 Refining the Journey in the Treatment of IBD with Subcutaneous Infliximab [Symposium]. UEG Week 2023, Copenhagen, Denmark.

1 S.Schreiber。（2023年10月）。IBD患者皮下注射英夫利昔单抗的3期临床试验（LIBERTY-CD＆UC）。在S.Schreiber（主席）中，IS-10用皮下英夫利昔单抗治疗IBD的旅程[研讨会]。UEG 2023周，丹麦哥本哈根。

2 S. Schreiber et al., Efficacy, safety and immunogenicity of Subcutaneous Infliximab (CT-P13 SC) monotherapy versus combination therapy with Immunosuppressants – Post hoc analysis of LIBERTY-CD study and LIBERTY-UC study. Poster PP0757 Presented at UEGW 2023.

2 S.Schreiber等，皮下英夫利昔单抗（CT-P13 SC）单药治疗与免疫抑制剂联合治疗的疗效，安全性和免疫原性-LIBERTY-CD研究和LIBERTY-UC研究的事后分析。海报PP0757在UEGW 2023上发布。

3 European Medicines Agency. Subcutaneous Infliximab. Summary of product characteristics. 2023.

3欧洲药品管理局。皮下注射英夫利昔单抗。产品特性总结。2023.

https://www.ema.europa.eu/en/documents/product-information/remsima-epar-product-information_en.pdf, Accessed October 2023

https://www.ema.europa.eu/en/documents/product-information/remsima-epar-product-information_en.pdf，于2023年10月访问

4 S. Danese et al., Subcutaneous Infliximab (CT-P13 SC) dose escalation as an option for managing the loss of response in Inflammatory Bowel Disease: Post hoc analysis of LIBERTY-UC study and LIBERTY-CD study. Poster MP362 Presented at UEGW 2023.

4 S.Danese等人，皮下英夫利昔单抗（CT-P13 SC）剂量递增作为控制炎症性肠病反应丧失的一种选择：LIBERTY-UC研究和LIBERTY-CD研究的事后分析。海报MP362在UEGW 2023上发布。

5 N. Mathieu. (2023, October). Insights from Clinical Practice: Switching from Intravenous to Subcutaneous Infliximab in Patients with IBD. In S. Schreiber (Chair), IS-10 Refining the Journey in the Treatment of IBD with Subcutaneous Infliximab [Symposium]. UEG Week 2023, Copenhagen, Denmark.

5 N.Mathieu。（2023年10月）。临床实践的见解：IBD患者从静脉注射英夫利昔单抗转为皮下注射。在S.Schreiber（主席）中，IS-10用皮下英夫利昔单抗治疗IBD的旅程[研讨会]。UEG 2023周，丹麦哥本哈根。

6 Celltrion, Inc. Fourth-Quarter and Full Year 2022 Earnings Release. https://www.celltrion.com/en-us/irs/resultdata

6 Celltrion，Inc。第四季度和2022全年收益发布。https://www.celltrion.com/en-us/irs/resultdata