创新链/学科链/研发链/产业链

新药研发前沿动态 / 医药领域趋势进展

重组人凝血因子Ⅷ药物的结构改造及其类似物开发的研究进展

Research Progress on Structural Modification of Recombinant Factor VIII and Its Antibody Mimetics

  • 摘要: 目前,凝血因子Ⅷ(FⅧ)替代疗法是临床治疗血友病A的主要手段,但传统血浆来源的FⅧ存在着病毒污染、成本高等问题,且FⅧ替代疗法本身存在的蛋白稳定性差、半衰期短和易产生抑制物等问题仍未得到解决。近年来,随着蛋白质工程技术和抗体技术的飞速发展,多种基于提高蛋白稳定性、延长半衰期和减少抑制物产生的重组FⅧ改构药物和FⅧ抗体模拟类似物已经获批上市或处于临床研究阶段。就近年来已上市或正在研究中的重组FⅧ改构药物及类似物进行综述,以期为后续的新药开发提供参考。

     

    Abstract: Coagulation factorⅧ (FⅧ) replacement therapy is currently the main method for the clinical treatment of hemophilia A. Since traditional FⅧ is derived from human plasma, it has such problems as potential virus contamination and high cost. Moreover, problems caused by FⅧreplacement therapy such as poor protein stability, short half-life and inhibitor production still remain unsolved. In recent years, a variety of recombinant FⅧ-modified drugs and FⅧ antibody mimetics based on the rapid development of protein engineering technology and antibody technology have been approved for marketing or for clinical trials, which aims at improving protein stability, prolonging half-life and reducing inhibitor production. This article reviews the recombinant FⅧ-modified drugs and mimetics on the market or under investigation in recent years, which provides reference for further development of new drugs.

     

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