摘要
mRNA是一种极具潜力的新型治疗产品,随着技术的发展,mRNA已被越来越广泛应用于免疫学、肿瘤学、疫苗和先天性代谢疾病等领域的临床研究。近期,由于新型冠状病毒肺炎疫情暴发,mRNA疫苗的研发及上市化进程被大大提速,预示在不久的将来可能有更多的mRNA产品进入市场。为了适应mRNA药物产业未来发展的需求,本文对该种产品的特点及产业化现状进行了研究,对其生产的关注点进行了思考,期望能为在我国开展mRNA药物的开发提供一定参考。
mRNA-based drug has already become a focus as a potential new type of drug in recent years. With the rapidly evolving technologies, mRNA has been widely applied in various areas of clinical research, such as immune disease, oncological disease, infectious disease, and congenital metabolic disorder. Since the outbreak of COVID-19, there has been a great leap in mRNA vaccine development, forecasting that much more mRNA medicines will enter the market in the near future. In order to meet industrial requirements, this article provides an overview of the product profiles of mRNA-based drugs and their industrial landscape, and further discusses the key considerations in the manufacturing of such medicines.
作者
于玲莉
李香玉
陈桂良
何伍
YU Ling-li;LI Xiang-yu;CHEN Gui-liang;HE Wu(Shanghai Center for Drug Evaluation and Inspection,Shanghai 201203,China;Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2021年第22期2029-2033,共5页
Chinese Journal of New Drugs