由乙型肝炎病毒（HBV）感染导致的病毒性肝炎是世界范围内的一个重大公共卫生问题，抗HBV抗体药物乙型肝炎免疫球蛋白（HBIG）是阻断乙型肝炎母婴传播和移植性感染的主要用药。但HBIG本身存在一些问题，而重组抗HBV单克隆抗体能成为其有效替代物。在重组抗HBV抗体技术相对成熟的情况下，重组抗HBV单克隆抗体药物功能性评价体系的缺失成为阻碍抗HBV单克隆抗体药物研发的重要因素。本文就现有的抗HBV单克隆抗体药物的评价方法和体系进行综述。

Hepatitis B virus (HBV) infection is a global medical concern with huge social and economic impacts. In the current practice, hepatitis B immunoglobulin (HBIG) prepared from pooled serum of immunized donors is prescribed to prevent HBV transmissions, such as mother-to-child transmission, acute exposure, and donor-receptor infection for orthotopic liver transplant patients. As a plasma-derived product, the clinical application of HBIG is limited by serum supply, potential of unknown pathogens and other risk factors in the pooled blood, and up-limits of functional dose. Although recombinant anti-HBV monoclonal antibody is being sorted as a practical alternative for HBIG, its research and development is in a relatively slow pace comparing to the other products. One of the most critical speed-limiting steps is the lack of an established preclinical evaluating system for anti-HBV monoclonal antibodies. Current research progress on functional evaluation of anti-HBV antibodies are reviewed in this paper.