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抗体药物是发展最快的生物药物之一,为创新药物市场带来了巨大的利益,其中抗肿瘤抗体药物占主导地位[1]。自1979年第一个治疗癌症的抗体药物利妥昔单抗被美国FDA批准上市以来,已有17个抗体药物被批准用于癌症治疗,但是其中的吉妥单抗撤出了市场[2-3]。2013年的统计显示,目前处于临床研究的抗体药物大约有350个,其中大部分都处在早期评估阶段[4]。处在III期临床研究的治疗性抗体包括28个单抗药物和1个单抗混合物,主要用于癌症、炎症或免疫疾病、高胆固醇、骨质疏松症、阿尔茨海
Antibody drugs, one of the fastest growing biopharmaceuticals, have brought tremendous benefits to the innovative drug market, with anti-tumor antibody drugs dominating [1]. Seventeen antibody drugs have been approved for cancer treatment since the first cancer-treating antibody, rituximab, was approved by the FDA in 1979. However, gemtuzumab was withdrawn from the market [2- 3]. According to the statistics of 2013, there are about 350 antibody drugs currently in clinical research, most of which are in the early assessment phase [4]. Therapeutic antibodies in phase III clinical studies included 28 monoclonal antibody drugs and 1 monoclonal antibody mixture and are mainly used in cancer, inflammatory or immune diseases, hypercholesterolemia, osteoporosis, Alzheimer’s disease