Current status and prospects of immunogenicity evaluation of low molecular weight heparin in China and abroad

BAI Yu-bo; SHI De-ling; WANG Hao-ran; GENG Yu-xin; ZHANG Qun-ye; CHI Lian-li; SHI Feng

doi:10.20251/j.cnki.1003-3734.2025.11.011

Abstract：Low molecular weight heparin is a commonly applied anticoagulant drug in clinic,which is obtained through a variety of processes of depolymerization.After transformed into a lower molecular weight form,it has a favorable antithrombotic effect,a reduced incidence of adverse effects,and a lower risk of bleeding.However,low molecular weight heparins may also induce adverse reactions such as heparin-induced thrombocytopenia and thrombosis in clinical application.At present,low molecular weight heparin generic drugs are constantly emerging on the market.Due to the differences in raw materials,production environment,technology and other factors,the quality varies for different types and batches of low molecular weight heparin generic drugs.This inconsistency may give rise to disparities in the immunogenicity of the generic drugs in clinical practice,potentially engendering clinical safety concerns.It is particularly important to evaluate the immunogenicity of low molecular weight heparin generic drugs to ensure the clinical efficacy and safety.At the present stage,there are still deficiencies in the techniques and systems for evaluating the immunogenicity of low-molecular-weight heparins in China and abroad,which need to be improved.This article presents the guidance provided by the Food and Drug Administration,the European Medicines Agency and the Center for Drug Evaluation of National Medical Products Administration on the immunogenicity evaluation of low molecular weight heparins.It also introduces the existing research methods,the shortcomings of the existing evaluation system and the emerging evaluation technologies about the immunogenicity of low molecular weight heparins both domestically and internationally,with the aim of providing a reference for the establishment of a comprehensive evaluation system for the immunogenicity evaluation of low molecular weight heparins.