INCHEON, Korea, April 05, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced the initiation of Phase 3 clinical trial for SB27, the company's proposed biosimilar referencing Keytrudai (pembrolizumab). The Phase 3 clinical trial for SB27 is a randomized, double-blind, parallel group, multicenter studyii to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB27 and Keytruda in patients with metastatic non-squamous non-small cell lung cancer.

韩国仁川，2024年4月5日（环球通讯社）--三星生物制药有限公司今天宣布启动SB27的3期临床试验，该公司提议的生物仿制药参考Keytrudai（pembrolizumab）。SB27的3期临床试验是一项随机，双盲，平行组，多中心研究，旨在比较SB27和Keytruda在转移性非鳞状非小细胞肺癌患者中的疗效，安全性，药代动力学和免疫原性。

Patients will be randomized in a 1:1 ratio to receive either SB27 or Keytruda 200 mg intravenously every 3 weeks concurrently with chemotherapy (pemetrexed 500 mg/m2 with vitamin supplementation intravenous (IV) infusion over 10 minutes every 3 weeks and carboplatin area under the curve [AUC] 5 IV infusion over 15-60 minutes every 3 weeks for the first 4 cycles). More information on this study is available at clinicaltrials.gov (NCT06348199).

患者将以1:1的比例随机接受SB27或Keytruda 200 mg静脉注射，每3周同时接受化疗（培美曲塞500 mg/m2，每3周静脉补充维生素（IV）10分钟，卡铂面积曲线下[AUC]5静脉输注，前4个周期每3周15-60分钟）。有关这项研究的更多信息，请访问clinicaltrials.gov（NCT06348199）。

“We are thrilled to announce the initiation of Phase 3 clinical trial for SB27, after our successful Phase 1 clinical trial initiation in February 2024,” said Ilsun Hong, Vice President, Product Evaluation Team Leader of Samsung Bioepis. “Based on our extensive clinical trial experience accumulated over the years, we will work closely with study investigators to ensure successful completion of the clinical trials for SB27.” As of April 2024, Samsung Bioepis has eight biosimilars approved and seven available around the worldiii – SB4 (etanercept), SB2 (infliximab), SB5 (adalimumab), SB3 (trastuzumab), SB8 (bevacizumab), SB11 (ranibizumab), SB12 (eculizumab), and SB15 (aflibercept)iv – along with three biosimilar candidates in pipeline – SB16 (denosumab), SB17 (ustekinumab) and SB27 (pembrolizumab).v About Samsung Bioepis Co., Ltd.Established in 2012, Sams.

三星Bioepis副总裁、产品评估团队负责人Ilsun Hong表示：“在2024年2月成功启动第一阶段临床试验后，我们很高兴宣布SB27开始第三阶段临床试验。”。“根据我们多年来积累的广泛临床试验经验，我们将与研究人员密切合作，以确保成功完成SB27的临床试验。”截至2024年4月，三星生物仿制药已在全球批准了8种生物仿制药，其中7种可用于世界III–SB4（依那西普），SB2（英夫利昔单抗），SB5（阿达木单抗），SB3（曲妥珠单抗），SB8（贝伐单抗），SB11（雷尼珠单抗），SB12（依库利珠单抗）和SB15（阿柏西普）iv–以及三种生物仿制药候选药物–SB16（地诺单抗），SB17（ustekinumab）B）和SB27（pembrolizumab）.v关于2012年成立的三星生物科技有限公司，Sams。