[Current situations and the future prospect of monoclonal antibody products].

Q4 Medicine Bulletin of National Institute of Health Sciences Pub Date : 2014-01-01
Teruhide Yamaguchi
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Abstract

Monoclonal antibody products and monoclonal antibody-based biopharmaceuticals have shown considerable effectiveness in the treatment for variety of diseases; cancer, auto-immune/auto-inflammation diseases and so on. Significant advance in monoclonal antibody products for cancer treatments was made with antibody-drug conjugates (ADC), and antibodies for blockade of immune checkpoints. Already 3 ADCs and 2 anti-immune-checkpoint antibodies products have been approved, and these monoclonal antibody-related product pipelines reach over 30. On the other hand, EU approved first monoclonal-antibody biosimilar, RemsimaTM (infliximab), suggesting that other monoclonal-antibody biosmilars will follow to the market. In this paper, several new issues about monoclonal antibody products will be discussed.

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【单克隆抗体产品的现状及未来展望】。
单克隆抗体产品和基于单克隆抗体的生物制药在治疗多种疾病方面显示出相当大的有效性;癌症、自身免疫/自身炎症疾病等。用于癌症治疗的单克隆抗体产品取得了重大进展,其中包括抗体-药物偶联物(ADC)和阻断免疫检查点的抗体。目前已有3个adc产品和2个抗免疫检查点抗体产品获批,这些单克隆抗体相关产品管线达到30多个。另一方面,欧盟批准了首个单克隆抗体生物仿制药RemsimaTM(英夫利昔单抗),这表明其他单克隆抗体生物仿制药将紧随其后进入市场。本文将讨论单克隆抗体产品的几个新问题。
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