The Research Progress of mRNA Drugs

doi:10.19586/j.2095-2341.2025.0088

Current Biotechnology ›› 2025, Vol. 15 ›› Issue (6): 960-968.DOI: 10.19586/j.2095-2341.2025.0088

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The Research Progress of mRNA Drugs

Wen XUE(), Yifan JIANG, Yu JIA(), Liping YANG

NCPC New Drug Research and Development Co. ，Ltd. ，Shijiazhuang 052165，China

Received:2025-07-26 Accepted:2025-09-05 Online:2025-11-25 Published:2026-01-04
Contact: Yu JIA

Abstract

Abstract:

In recent years， mRNA drugs have accelerated their expansion into the pharmaceutical field as a disruptive biomedical technology. Owing to advantages such as short development cycles， rapid response capabilities， and significant therapeutic potential for previously “undruggable” targets， mRNA drugs offer new solutions to major medical challenges including viral epidemics， cancer， and rare diseases. With continuous technological advances， researchers have made breakthroughs in key areas such as molecular design and delivery systems. To date， more than 85 mRNA drug candidates have entered Phase Ⅱ/Ⅲ clinical trials globally， greatly boosting confidence in their therapeutic prospects. This article detailed structural modifications of in vitro transcribed mRNA， delivery systems for mRNA drugs， and their research progress and development trends across various disease areas， aiming to serve as a reference for research engaged in mRNA drug development.

Key words: mRNA drugs, delivery system, in vitro transcribed mRNA, structural modification

摘要：

近年来，mRNA药物作为一种颠覆性生物医药技术加速向医药领域深度拓展。其因研发周期短、响应速度快、针对“不可成药”靶点治疗潜力大等独特的技术优势，为病毒流行病、癌症、罕见病等重大医学挑战领域提供了全新的解决方案。随着技术的不断完善，研究者们已经在分子设计、递送系统等核心领域取得了突破性进展，目前全球已有超过85款mRNA药物进入临床Ⅱ/Ⅲ期阶段。详细介绍了体外转录mRNA的结构修饰、mRNA药物的递送系统及其在不同疾病领域的研究进程和研发展望，以期为mRNA药物研发相关研究提供参考。

关键词: mRNA药物, 递送系统, 体外转录mRNA, 结构修饰

CLC Number:

Q819

Wen XUE, Yifan JIANG, Yu JIA, Liping YANG. The Research Progress of mRNA Drugs[J]. Current Biotechnology, 2025, 15(6): 960-968.

薛雯, 江一帆, 贾宇, 杨丽萍. mRNA药物的研究进展[J]. 生物技术进展, 2025, 15(6): 960-968.

Figures/Tables 3

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适应症	名称	企业	进度
黑色素瘤、非小细胞肺癌	mRNA-4157	美国Moderna/美国默沙东	Ⅲ期临床
卵巢癌	WSK-IM02	中国威斯克	Ⅲ期临床
胰腺癌	BNT122 (autogene cevumeran)	德国BioNTech/瑞士罗氏	Ⅱ期临床
乳腺癌	AST-302	韩国ASton SCI	Ⅱ期临床
乳腺癌	AVX-901	美国AlphaVax Inc	Ⅱ期临床
肝癌	LK101	中国北京立康生命	Ⅰ/Ⅱ期临床
晚期实体瘤	EVM16	中国云顶新耀	Ⅰ期临床
人乳头瘤病毒	SYS6026	中国石药集团	Ⅰ期临床
多发性骨髓瘤、系统性红斑狼疮、重症肌无力	SYS6020	中国石药集团	Ⅰ期临床
淋巴瘤	WGc-043	中国威斯津生物	Ⅰ期临床
实体瘤	XH001	中国新合生物	Ⅰ期临床

适应症	名称	企业	进度
黑色素瘤、非小细胞肺癌	mRNA-4157	美国Moderna/美国默沙东	Ⅲ期临床
卵巢癌	WSK-IM02	中国威斯克	Ⅲ期临床
胰腺癌	BNT122 (autogene cevumeran)	德国BioNTech/瑞士罗氏	Ⅱ期临床
乳腺癌	AST-302	韩国ASton SCI	Ⅱ期临床
乳腺癌	AVX-901	美国AlphaVax Inc	Ⅱ期临床
肝癌	LK101	中国北京立康生命	Ⅰ/Ⅱ期临床
晚期实体瘤	EVM16	中国云顶新耀	Ⅰ期临床
人乳头瘤病毒	SYS6026	中国石药集团	Ⅰ期临床
多发性骨髓瘤、系统性红斑狼疮、重症肌无力	SYS6020	中国石药集团	Ⅰ期临床
淋巴瘤	WGc-043	中国威斯津生物	Ⅰ期临床
实体瘤	XH001	中国新合生物	Ⅰ期临床

适应症	名称	企业	进度
新型冠状病毒感染	Comirnaty	中国复星医药/德国BioNTech	2020年获批
新型冠状病毒感染	Spikevax	美国Moderna	2020年获批
新型冠状病毒感染	AWcorna	中国沃森生物/中国艾博生物	2022年获批
新型冠状病毒感染	斯维尔克	中国斯微生物	2022年获批
新型冠状病毒感染	RQ3033 疫苗	中国沃森生物/复旦大学/上海蓝鹊	2023年获批
新型冠状病毒感染	新冠病毒二价mRNA疫苗	中国石药集团	2023年获批
呼吸道合胞病毒	mRESVIA(mRNA-1345)	美国Moderna	2024年获批
流感病毒感染	mRNA-1010	美国Moderna	Ⅲ期临床
流感病毒感染	mRNA-1083	美国Moderna	Ⅲ期临床
新型冠状病毒感染、流感病毒感染	PF-07926307	美国Pfizer	Ⅲ期临床
流感病毒感染	BNT161	德国BioNTech/美国Pfizer	Ⅲ期临床
巨细胞病毒	mRNA-1647	美国Moderna	Ⅲ期临床
新型冠状病毒感染、流感病毒感染	mRNA-1073	美国Moderna	Ⅱ期临床
寨卡病毒感染	mRNA-1893	美国Moderna	Ⅱ期临床

适应症	名称	企业	进度
新型冠状病毒感染	Comirnaty	中国复星医药/德国BioNTech	2020年获批
新型冠状病毒感染	Spikevax	美国Moderna	2020年获批
新型冠状病毒感染	AWcorna	中国沃森生物/中国艾博生物	2022年获批
新型冠状病毒感染	斯维尔克	中国斯微生物	2022年获批
新型冠状病毒感染	RQ3033 疫苗	中国沃森生物/复旦大学/上海蓝鹊	2023年获批
新型冠状病毒感染	新冠病毒二价mRNA疫苗	中国石药集团	2023年获批
呼吸道合胞病毒	mRESVIA(mRNA-1345)	美国Moderna	2024年获批
流感病毒感染	mRNA-1010	美国Moderna	Ⅲ期临床
流感病毒感染	mRNA-1083	美国Moderna	Ⅲ期临床
新型冠状病毒感染、流感病毒感染	PF-07926307	美国Pfizer	Ⅲ期临床
流感病毒感染	BNT161	德国BioNTech/美国Pfizer	Ⅲ期临床
巨细胞病毒	mRNA-1647	美国Moderna	Ⅲ期临床
新型冠状病毒感染、流感病毒感染	mRNA-1073	美国Moderna	Ⅱ期临床
寨卡病毒感染	mRNA-1893	美国Moderna	Ⅱ期临床

适应症	名称	企业	进度
丙酸血症	mRNA-3927	美国Moderna	Ⅱ期临床
甲基丙二酸血症	mRNA-3705	美国Moderna	Ⅱ期临床
苯丙酮尿症	mRNA-3210	美国Moderna	Ⅱ期临床
OTC缺乏症	ARCT-810	美国Arcturus Therapeutics	Ⅱ期临床
囊性纤维化	MRT5005	美国Translate Bio	Ⅱ期临床
心肌缺血	AZD8601	美国Moderna/英国AZ	Ⅱ期临床
鸟氨酸氨基甲酰基转移酶缺乏症	MRT 5201	美国Translate Bio	Ⅰ/Ⅱ期临床
甲基丙二酸血症，甲基丙二酰辅酶a突变酶缺乏症	mRNA-3704	美国Moderna	Ⅰ/Ⅱ期临床

The Research Progress of mRNA Drugs

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[1]	Dongfeng CHANG, Zhaopeng SUN. Structure and Clinical Application of mRNA Drugs [J]. Current Biotechnology, 2024, 14(1): 1-16.
[2]	Dan YU, Yunlong MA, Fang WAN, Jianqiang WU. Advances on Research and Application of mRNA Vaccines [J]. Current Biotechnology, 2023, 13(4): 492-498.
[3]	YU Yi, WAN Chenlu, LIAO Yuxia, HE Zhendan, LI Ying. Application of Functionalized Mesoporous Silica Nanoparticles in the Diagnosis and Therapy of Malignant Tumors [J]. Curr. Biotech., 2018, 8(2): 118-123.