抗体融合蛋白已成为生物工程治疗药物中最成功的一员。其中的Fc融合蛋白，是一类通过基因工程平台技术将抗体的Fc部分与药物的活性成分融合表达而产生的蛋白。虽然构建Fc融合蛋白的初衷是为了延长其半衰期，但大量研究表明，Fc部分也参与免疫调节过程，引起一些免疫效应。随着生物治疗药物的飞速发展， Fc融合蛋白药物也取得了很大进展。此文从Fc融合蛋白的设计目的、设计原理、作用机理以及质量控制方面，对治疗性Fc融合蛋白药物的研究进展做一介绍。

 Antibody fusion protein has become one of the most successful drugs in bioengineering therapeutics，among which Fc fusion protein is a type of protein constructed by combining the Fc region of antibody with the active component of protein drug using genetic engineering platform technology. While Fc fusion protein was originally generated to extend its half-life, many researches have indicated that the Fc part also participates in immune regulations and results in immunological effect. Along with the rapid advance of biotherapeutic drugs, Fc fusion protein drugs also made great progress. This article briefly summarized the research progress of therapeutic Fc fusion protein drugs in aspects of design goal, design principle, mechanism, and quality control.