Zhu Zhenping, Yan Li
Kadmon Pharmaceuticals, New York, New York 10016, USA.
Chin J Cancer. 2011 May;30(5):293-302. doi: 10.5732/cjc.011.10123.
Monoclonal antibodies (mAbs) have become a major class of therapeutic agents providing effective alternatives to treating various human diseases. To date, 15 mAbs have been approved by regulatory agencies in the world for clinical use in oncology indications. The selectivity and specificity, the unique pharmacokinetics, and the ability to engage and activate the host immune system differentiate these biologics from traditional small molecule anticancer drugs. mAb-based regimens have brought clinical benefits, including improvements in overall survival, to patients with a variety of cancers. Many challenges still remain, however, to fully realize the potential of these new medicines. With our further understanding of cancer biology, mechanism of antibody action, and advancement of antibody engineering technologies, many novel antibody formats or antibody-derived molecules are emerging as promising new generation therapeutics. Carefully designed and engineered, they retain the advantage of specificity and selectivity of original antibodies, but in the meantime acquire additional special features such as improved pharmacokinetics, increased selectivity, and enhanced anticancer efficacy. Promising clinical results are being generated with these newly improved antibody-based therapeutics.
单克隆抗体（mAb）已成为一类主要的治疗药物，为治疗各种人类疾病提供了有效的替代方案。迄今为止，全球监管机构已批准15种单克隆抗体用于肿瘤适应症的临床治疗。这些生物制剂的选择性和特异性、独特的药代动力学以及与宿主免疫系统结合并激活的能力，使其有别于传统的小分子抗癌药物。基于单克隆抗体的治疗方案已给多种癌症患者带来了临床益处，包括总生存期的改善。然而，要充分发挥这些新药的潜力，仍存在许多挑战。随着我们对癌症生物学、抗体作用机制的进一步了解以及抗体工程技术的进步，许多新型抗体形式或抗体衍生分子正作为有前景的新一代治疗药物出现。经过精心设计和改造，它们保留了原始抗体特异性和选择性的优势，但同时还获得了其他特殊特性，如改善的药代动力学、更高的选择性和更强的抗癌疗效。这些新改进的基于抗体的治疗药物正在产生令人鼓舞的临床结果。
