中国新药杂志

mRNA药物的研发及挑战

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于玲莉 ¹ , 李香玉 ¹ , 陈桂良 ¹ , 何伍 ²

中国新药杂志 | 新药述评与论坛 2021,30(22): 2029-2033

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中国新药杂志 |新药述评与论坛 2021 , 30 (22) : 2029 -2033

mRNA药物的研发及挑战

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于玲莉¹, 李香玉¹, 陈桂良¹, 何伍²

作者信息

¹上海药品审评核查中心，上海　201203

²国家药品监督管理局药品审评中心，北京　100022

作者简介:

于玲莉，女，工程师，主要从事生物制品审评及检查工作。联系电话：(021)50121379，E-mail：yulingli@smda.sh.cn。

Development and challenges of mRNA-based therapeutics

Ling-li YU¹, Xiang-yu LI¹, Gui-liang CHEN¹, Wu HE²

Affiliations

¹Shanghai Center for Drug Evaluation and Inspection, Shanghai 201203, China

²Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China

出版时间: 2021-11-30

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摘要

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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。

关键词

mRNA药物 / 体外转录mRNA / mRNA药品生产

Abstract

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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.

Key words

mRNA therapeutics / IVT mRNA / mRNA manufacturing

引用本文

于玲莉, 李香玉, 陈桂良, 何伍. mRNA药物的研发及挑战. 中国新药杂志, 2021 , 30 (22) : 2029 -2033 .

Ling-li YU, Xiang-yu LI, Gui-liang CHEN, Wu HE. Development and challenges of mRNA-based therapeutics[J]. Chinese Journal of New Drugs, 2021 , 30 (22) : 2029 -2033 .

参考文献

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2021年第30卷第22期

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首发时间：2026-10-28
出版时间：2021-11-30

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录用日期：2021-06-24

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¹上海药品审评核查中心，上海　201203

²国家药品监督管理局药品审评中心，北京　100022

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2种不同金属材料的力学参数

科 Family	属数 Number of genus	种数 Number of species	占总种数比例 Percentage of total species (%)	属 Genus	种数 Number of species	占总种数比例 Percentage of total species (%)
鹅膏菌科Amanitaceae	2	11	5.26	鹅膏菌属 Amanita	10	4.78
小菇科 Mycenaceae	2	12	5.74	丝盖伞属 Inocybe	5	2.39
多孔菌科 Polyporaceae	8	14	6.70	蜡蘑属 Laccaria	5	2.39
红菇科 Russulaceae	3	23	11.00	小皮伞属 Marasmius	6	2.87
				小菇属 Mycena	11	5.26
				光柄菇属 Pluteus	5	2.39
				红菇属 Russula	17	8.13
				栓菌属 Trametes	5	2.39

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