摘要
新型冠状病毒的反复感染仍威胁着全球公众健康。研究人员依然致力于从疫苗、小分子抗病毒药物和中和抗体等多方面开展研究,为新型冠状病毒各类变异株的感染寻找更为有效的预防、治疗手段。其中,中和抗体具有作用机制明确、安全性高、便于大规模生产等优势,是极具潜力的新型冠状病毒肺炎(COVID-19)治疗药物之一,国内外针对新型冠状病毒中和抗体的研发项目发展迅速,本文简要介绍新型冠状病毒中和抗体研究现状,重点结合审评实践,提出对于此类品种药学评价的特殊考虑,以期促进国内同类产品尽快实现产业化。
Repeated SARS-CoV-2 infections still threaten public health around the world.Researchers are still committed to carrying out research on vaccines,small molecular antiviral drugs,and neutralizing antibodies to find more effective means of prevention and treatment for the infection of various mutants of novel coronavirus.Among them,neutralizing antibodies have the advantages of clear action mechanism,good safety,and convenience for large-scale production,so they are one of the therapeutic class of drugs with best potential to treat COVID-19.The research and development projects for SARS-CoV-2 neutralizing antibodies have been developing rapidly both at home and abroad.This paper briefly introduces the research status of SARS-CoV-2 neutralizing antibodies,focusing on providing special considerations for pharmaceutical evaluation of these class of drugs in combination with the practice of drug evaluation to promote the industrialization of the same class of domestic products as soon as possible.
作者
贾东晨
吴舟一
于鹏丽
JIA Dong-chen;WU Zhou-yi;YU Peng-i(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2023年第24期2495-2500,共6页
Chinese Journal of New Drugs
关键词
新型冠状病毒中和抗体
药学评价
特殊剂型
SARS-CoV-2 neutralizing antibodies
pharmaceutical assessment
special dosage form
