我国抗破伤风毒素单克隆抗体的临床开发和评价  

Clinical development and evaluation of anti-tetanus toxin monoclonal antibody in China

作　　者：任怡 赵建中 REN Yi;ZHAO Jian-zhong(Center for Drug Evaluation,National Medical Products Administration,Beijing 100061,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100061

出　　处：《中国临床药理学杂志》2022年第14期1701-1704,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：破伤风是一种极为严重的潜在致命性疾病,该病可用疫苗预防,在发达国家发病率较低,但在许多低收入国家和不发达地区仍普遍存在。我国已于2012年消除了新生儿破伤风,但非新生儿破伤风仍是一个严重的公共卫生问题。我国尚缺乏针对成人的主动免疫,被动免疫对免疫力低下或免疫状态不明患者中破伤风易感伤口具有预防性治疗意义。目前的被动免疫制剂仍存在诸多缺点,如:可能传播传染病、价格偏高、供应量有限等,抗破伤风毒素单克隆抗体具有批间差异小、安全性提高、可大量制备等优势,有替代现有抗破伤风被动免疫制剂的潜力,但其尚处于新药研发阶段。国内外尚无抗破伤风毒素单克隆抗体临床试验的指导原则,本文将讨论如何在我国进行抗破伤风毒素单克隆抗体新药的研发和评价,为各方提供参考。Tetanus was a serious and potentially fatal disease that was preventable by vaccines and had a low incidence in developed countries, but was prevalent in many low-income and underdeveloped regions. China had eliminated neonatal tetanus in 2012, but non-neonatal tetanus was still a serious public health problem. Active immunization for adults was lacking in China, passive immunization could prevent tetanus for tetanus-susceptible wounds in patients with low immunity or unknown immune status. The current passive immunization preparations had many shortcomings, such as the possibility of spreading infectious diseases, high prices, and limited supply. Anti-tetanus toxin monoclonal antibody had the advantages of small batch-to-batch variation, improved safety, and large-scale preparation and had the potential to replace the original anti-tetanus passive immunization preparations, but was in the stage of new drug development. There were no guidelines for clinical trials of anti-tetanus toxin monoclonal antibody in China and overseas. Here we would discuss how to develop and evaluate anti-tetanus toxin monoclonal antibody in China, and provide references for all parties.

关 键 词：破伤风 被动免疫 临床试验 抗破伤风毒素单克隆抗体 

分 类 号：R95[医药卫生—药学]