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Drug Design, Development and Therapy Volume 13, 2019 - Issue
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Clinical Trial Report

Physicochemical characterization and phase I study of CMAB008, an infliximab biosimilar produced by a different expression system

Qing An1 Nanjing Medical University Affiliated Cancer Hospital, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, Jiangsu, China
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Yingxin Zheng2 State Key Laboratory of Antibody Medicine and Targeted Therapy; Shanghai, China, [email protected]; [email protected];3 Obstetrics and Gynecology Hospital of Fudan University; Shanghai, China
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Yirong Zhao2 State Key Laboratory of Antibody Medicine and Targeted Therapy; Shanghai, China, [email protected]; [email protected]
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Tao Liu2 State Key Laboratory of Antibody Medicine and Targeted Therapy; Shanghai, China, [email protected]; [email protected]
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Huaizu Guo2 State Key Laboratory of Antibody Medicine and Targeted Therapy; Shanghai, China, [email protected]; [email protected]
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Dapeng Zhang2 State Key Laboratory of Antibody Medicine and Targeted Therapy; Shanghai, China, [email protected]; [email protected];3 Obstetrics and Gynecology Hospital of Fudan University; Shanghai, China;4 School of Pharmacy, Liaocheng University, Liaocheng, China, [email protected]
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Weizhu Qian5 Shanghai Key Laboratory of Cell Engineering, Shanghai, China
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Hao Wang5 Shanghai Key Laboratory of Cell Engineering, Shanghai, China
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Yajun Guo2 State Key Laboratory of Antibody Medicine and Targeted Therapy; Shanghai, China, [email protected]; [email protected];4 School of Pharmacy, Liaocheng University, Liaocheng, China, [email protected];6 School of Bioscience and Bioengineering, South China University of Technology, Guangzhou, China;7 Institute of Molecular and Cell Biology, Proteos, Singapore
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Sheng Hou2 State Key Laboratory of Antibody Medicine and Targeted Therapy; Shanghai, China, [email protected]; [email protected];4 School of Pharmacy, Liaocheng University, Liaocheng, China, [email protected]Correspondence[email protected] [email protected]
&
Jing Li2 State Key Laboratory of Antibody Medicine and Targeted Therapy; Shanghai, China, [email protected]; [email protected];8 Shanghai Zhangjiang Biotechnology Co., Ltd; Shanghai, China, [email protected]Correspondence[email protected] [email protected]
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Pages 791-805 | Published online: 12 Mar 2019

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Tommaso Lorenzo Parigi, Ferdinando D’Amico, Laurent Peyrin-Biroulet & Silvio Danese. (2021) Evolution of infliximab biosimilar in inflammatory bowel disease: from intravenous to subcutaneous CT-P13. Expert Opinion on Biological Therapy 21:1, pages 37-46.
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Articles from other publishers (7)

Iván Lamela-Gómez, Lídia M. Gonçalves, António J. Almeida & Asteria Luzardo-Álvarez. (2023) Infliximab microencapsulation: an innovative approach for intra-articular administration of biologics in the management of rheumatoid arthritis—in vitro evaluation. Drug Delivery and Translational Research.
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Hua Ye, Shengyun Liu, Jian Xu, Kexia Chai, Dongyi He, Yongfei Fang, Qibing Xie, Huaxiang Liu, Ying Liu, Bingzhu Hua, Jiankang Hu, Zhiyi Zhang, Mingxuan Zhou, Dongbao Zhao, Yan Li, Zhenyu Jiang, Meimei Wang, Jingyang Li, Zhuoli Zhang, Xiaomei Li, Yang Li, Erwei Sun, Liqi Bi, Wei Wei, Ning Tie, Lan He, Xiangyang Huang, Yan Zhang, Qingchun Huang, Xiaofei Wang, Xiangyuan Liu, Jing Li & Yin Su. (2023) Efficacy and Safety of CMAB008 Compared with Innovator Infliximab in Patients with Moderate-to-Severe Rheumatoid Arthritis Receiving Concomitant Methotrexate: A Randomized, Double-blind, Multi-center, Phase III Non-inferiority Study. Rheumatology and Therapy 10:3, pages 757-773.
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Elliot Offman, Noopur Singh, Mark W. Julian, Landon W. Locke, Sabahattin Bicer, Jonah Mitchell, Thomas Matthews, Kirsten Anderson & Elliott D. Crouser. (2023) Leveraging in vitro and pharmacokinetic models to support bench to bedside investigation of XTMAB-16 as a novel pulmonary sarcoidosis treatment. Frontiers in Pharmacology 14.
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Ruirui Zhou, Qian Chen, Sheng Hou, Huaizu Guo, Jing Li, Weizhu Qian, Hao Wang, Lun Ou, XiaoFei Chen, Fan Jiang & Jingying Jia. (2022) A Randomized, Double‐Blind, Parallel Controlled, Single‐Dose Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of the Infliximab Biosimilar CMAB008 and the Reference Product in Healthy Chinese Male Subjects. Clinical Pharmacology in Drug Development 11:9, pages 1028-1035.
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Seyedeh Zohreh Mirjalili, Reyhaneh Sabourian, Mona Sadeghalvad & Nima Rezaei. (2021) Therapeutic applications of biosimilar monoclonal antibodies: Systematic review of the efficacy, safety, and immunogenicity in autoimmune disorders. International Immunopharmacology 101, pages 108305.
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Ferdinando D'Amico, Virginia Solitano, Daniel Aletaha, Ailsa Hart, Fernando Magro, Carlo Selmi, Siew C. Ng, Sameer Al Awadhi, Ernest Choy, Hendrik Schulze-Koops, Peter Bossuyt, Pablo A. Olivera, Paulo Gustavo Kotze, Subrata Ghosh, Laurent Peyrin-Biroulet & Silvio Danese. (2021) Biobetters in patients with immune-mediated inflammatory disorders: An international Delphi consensus. Autoimmunity Reviews 20:7, pages 102849.
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Ali M. Alsamil, Thijs J. Giezen, Toine C. Egberts, Hubert G. Leufkens, Arnold G. Vulto, Martijn R. van der Plas & Helga Gardarsdottir. (2020) Reporting of quality attributes in scientific publications presenting biosimilarity assessments of (intended) biosimilars: a systematic literature review. European Journal of Pharmaceutical Sciences 154, pages 105501.
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