Frontiers of Data and Computing ›› 2023, Vol. 5 ›› Issue (4): 57-76.
CSTR: 32002.14.jfdc.CN10-1649/TP.2023.04.006
doi: 10.11871/jfdc.issn.2096-742X.2023.04.006
• Special Issue: Basic Research • Previous Articles Next Articles
LI Dongqiao1,*(
),WANG Xi1,2
Received:2023-06-30
Online:2023-08-20
Published:2023-08-23
LI Dongqiao, WANG Xi. Study on the R&D Pipeline Analysis of mRNA Technology Based on Cortellis Database[J]. Frontiers of Data and Computing, 2023, 5(4): 57-76, https://cstr.cn/32002.14.jfdc.CN10-1649/TP.2023.04.006.
Fig.1
Annual trend analysis of mRNA products in each clinical research stage"
Fig.2
Mainly R&D countries/regions of mRNA products"
Table 1
Mainly distribution and R&D status of mRNA products"
| 机构名称 | 机构所属国家 | 临床前 阶段 | 初步发现 阶段 | 临床 Ⅰ期 | 临床 Ⅱ期 | 临床 Ⅲ期 | 预注册 | 注册 | 上市 | 产品 总数 |
|---|---|---|---|---|---|---|---|---|---|---|
| Moderna | 美国 | 22 | 3 | 13 | 16 | 7 | — | — | 3 | 64 |
| BioNTech | 德国 | 10 | — | 4 | 6 | 1 | 1 | 1 | 2 | 25 |
| CureVac | 德国 | 6 | 3 | 4 | — | — | — | — | — | 13 |
| 斯微（上海）生物科技有限公司 | 中国 | 8 | 3 | — | — | 1 | — | — | — | 12 |
| Pfizer | 美国 | 3 | — | 1 | 2 | 1 | 1 | 1 | 2 | 11 |
| Arcturus Therapeutics | 加拿大 | 4 | — | — | 3 | — | 1 | — | — | 8 |
| Sanofi | 法国 | 4 | 1 | 3 | — | — | — | — | — | 8 |
| Translate Bio | 美国 | 5 | — | 1 | 1 | — | — | — | — | 7 |
| Glaxo Smith Kline | 英国 | 1 | — | 5 | — | — | — | — | — | 6 |
| Acuitas Therapeutics | 加拿大 | 5 | — | — | — | — | — | — | — | 5 |
| Eyam Vaccines and Immunotherapeutics | 加拿大 | 5 | — | — | — | — | — | — | — | 5 |
| Providence Therapeutics Holdings | 加拿大 | 3 | — | — | 1 | — | — | — | — | 4 |
| Ziphius vaccines | 比利时 | 4 | — | — | — | — | — | — | — | 4 |
Table 2
Mainly target distribution and development stage of mRNA products"
| 靶点 | 报道不活跃的产品 | 临床前阶段 | 初步发现阶段 | 临床Ⅰ期 | 临床Ⅱ期 | 临床Ⅲ期 | 预注册 | 注册 | 上市 | 产品 总数 |
|---|---|---|---|---|---|---|---|---|---|---|
| COVID19尖峰糖蛋白 | — | 20 | 1 | 7 | 9 | 7 | 1 | 1 | 5 | 51 |
| CD40配体/基因 | 1 | 3 | — | — | 1 | — | — | — | — | 5 |
| CFTR基因 | 1 | 3 | — | — | 1 | — | — | — | — | 5 |
| 血凝素 | — | 1 | 1 | 1 | 1 | — | — | — | — | 4 |
| CD70基因 | — | 2 | — | — | 1 | — | — | — | — | 3 |
| OX-40受体 | — | 1 | — | 1 | 1 | — | — | — | — | 3 |
| TLR4基因 | — | 2 | — | — | 1 | — | — | — | — | 3 |
| 基底蛋白 | — | 1 | — | 1 | — | — | — | — | — | 2 |
| Claudin 18 | — | — | — | — | 2 | — | — | — | — | 2 |
| DMPK基因 | 1 | 1 | — | — | — | — | — | — | — | 2 |
| DNAI1基因 | — | 2 | — | — | — | — | — | — | — | 2 |
| 人巨细胞病毒糖蛋白B | — | — | — | 1 | — | 1 | — | — | — | 2 |
| 人巨细胞病毒糖蛋白H | — | — | — | 1 | — | 1 | — | — | — | 2 |
| 白细胞介素-12基因 | — | 1 | — | 1 | — | — | — | — | — | 2 |
| 白细胞介素-2基因 | 1 | — | — | 1 | — | — | — | — | — | 2 |
| 白细胞介素-7基因 | — | 1 | — | 1 | — | — | — | — | — | 2 |
| mRNA帽鸟嘌呤N7甲基转移酶 | — | 2 | — | — | — | — | — | — | — | 2 |
| OTC基因 | — | 1 | — | — | 1 | — | — | — | — | 2 |
| 程序性细胞死亡配体1 | — | 1 | — | — | 1 | — | — | — | — | 2 |
| Ras GTPase | 1 | — | 1 | — | — | — | — | — | — | 2 |
| 呼吸道合胞病毒蛋白F | — | 1 | — | — | — | 1 | — | — | — | 2 |
| SIRT3基因 | — | 2 | — | — | — | — | — | — | — | 2 |
| 剪接因子 | — | 1 | — | — | 1 | — | — | — | — | 2 |
| Wilms肿瘤蛋白 | — | 1 | — | — | 1 | — | — | — | — | 2 |
Fig.3
The type distribution of mRNA vaccine products"
Fig.4
The type distribution of mRNA drug products"
Fig.5
Distribution of mRNA product application in disease fields"
Table 3
Mainly indications and development status of mRNA products"
| 适应症 | 临床前 阶段 | 初步发现 阶段 | 临床 Ⅰ期 | 临床 Ⅱ期 | 临床 Ⅲ期 | 预注册 | 注册 | 上市 | 产品 总数 |
|---|---|---|---|---|---|---|---|---|---|
| COVID-19感染 | 38 | 8 | 9 | 16 | 8 | 2 | 1 | 5 | 87 |
| 流感病毒感染 | 7 | 1 | 6 | 3 | 1 | — | — | — | 18 |
| HIV感染 | 4 | — | 5 | 1 | — | — | — | — | 10 |
| 胰腺癌 | 3 | 1 | 3 | 2 | — | — | — | — | 9 |
| 呼吸道合胞病毒感染 | 3 | 1 | 3 | — | 1 | — | — | — | 8 |
| 乳腺癌 | 3 | — | 1 | 3 | — | — | — | — | 7 |
| 卵巢癌 | 2 | — | 2 | 3 | — | — | — | — | 7 |
| 结肠直肠癌 | 1 | — | 1 | 3 | — | — | — | — | 6 |
| 黑色素瘤 | 1 | — | 1 | 4 | — | — | — | — | 6 |
| 转移性非小细胞肺癌 | 1 | — | — | 3 | 1 | — | — | — | 5 |
| 囊性纤维化 | 3 | — | — | 1 | — | — | — | — | 4 |
| 肝炎 | 2 | — | 2 | — | — | — | — | — | 4 |
| EB病毒病毒感染 | 2 | — | 1 | — | — | — | — | — | 3 |
| 胶质母细胞瘤 | 1 | — | — | 1 | 1 | — | — | — | 3 |
| Kartagener综合征 | 3 | — | — | — | — | — | — | — | 3 |
| 鸟氨酸转氨酶缺乏症 | 2 | — | — | 1 | — | — | — | — | 3 |
| 乳头瘤病毒感染 | 1 | 2 | — | — | — | — | — | — | 3 |
| 呼吸窘迫综合征 | 2 | 1 | — | — | — | — | — | — | 3 |
| 水痘带状疱疹病毒感染 | 2 | 1 | — | — | — | — | — | — | 3 |
Fig.6
Mainly R&D countries/regions of mRNA products in the field of infectious diseases"
Fig.7
The clinical research stages of mRNA products in field of infectious diseases in China and the United States"
Table 4
Mainly R&D institutions of mRNA products in field of infectious diseases in China and the United States (Number≥2)"
| 研发机构 | 机构所属国家 | 临床前阶段 | 初步发现阶段 | 临床Ⅰ期 | 临床Ⅱ期 | 临床Ⅲ期 | 预注册 | 注册 | 上市 | 产品总数 |
|---|---|---|---|---|---|---|---|---|---|---|
| Moderna | 美国 | 9 | 1 | 9 | 8 | 7 | — | — | 3 | 37 |
| Pfizer | 美国 | 3 | — | 1 | 1 | 1 | 1 | 1 | 2 | 10 |
| 斯微（上海）生物科技有限公司 | 中国 | 3 | 2 | — | — | 1 | — | — | — | 6 |
| National Institutes of Health | 美国 | 1 | — | 5 | — | — | — | — | — | 6 |
| Arcturus Therapeutics | 美国 | 1 | — | — | 2 | — | 1 | — | — | 4 |
| 云顶新耀有限公司 | 中国 | 2 | — | — | 1 | — | — | — | — | 3 |
| Translate Bio MA | 美国 | 2 | — | 1 | — | — | — | — | — | 3 |
| 上海复星医药集团 | 中国 | — | — | 1 | — | — | — | — | 1 | 2 |
| 西藏药业公司 | 中国 | 1 | — | — | — | 1 | — | — | — | 2 |
| 云南沃森生物技术股份有限公司 | 中国 | — | 1 | — | — | 1 | — | — | — | 2 |
| International AIDS Vaccine Initiative | 美国 | — | — | — | — | — | — | — | — | 2 |
| Merck | 美国 | 1 | 1 | — | — | — | — | — | — | 2 |
| RNA Immune | 美国 | 2 | — | — | — | — | — | — | — | 2 |
| Sorrento Therapeutics | 美国 | 2 | — | — | — | — | — | — | — | 2 |
| Tiba Biotech | 美国 | — | 2 | — | — | — | — | — | — | 2 |
Fig.8
Mainly R&D countries/regions of mRNA products in the field of neoplasm"
Fig.9
The clinical research stages of mRNA products in field of neoplasm in China and the United States"
Table 5
Mainly R&D institutions of mRNA products in field of neoplasm (Number≥2)"
| 研发机构 | 机构所属国家 | 临床前阶段 | Discovery | 临床I期 | 临床II期 | 产品总数 |
|---|---|---|---|---|---|---|
| BioNTech | 德国 | 2 | — | 3 | 4 | 9 |
| Moderna | 美国 | 1 | 1 | 3 | 4 | 9 |
| 斯微（上海）生物科技有限公司 | 中国 | 6 | — | — | — | 6 |
| Nutcracker Therapeutics | 美国 | 1 | 2 | — | — | 3 |
| Astra Zeneca | 英国 | 1 | — | 1 | — | 2 |
| CureVac | 德国 | 1 | 1 | — | — | 2 |
| Sanofi | 法国 | 1 | — | 1 | — | 2 |
| Strand Therapeutics | 美国 | 1 | 1 | — | — | 2 |
Fig.10
Mainly R&D countries/regions of mRNA products in the field of endocrine/metabolism"
Fig.11
The clinical research stages of mRNA products in field of endocrine/metabolic in the United States"
Table 6
Mainly R&D institutions of mRNA products in field of endocrine/metabolic"
| 研发机构 | 机构所属 国家 | 临床前阶段 | 初步发现阶段 | 临床 Ⅰ期 | 临床 Ⅱ期 | 上市 | 产品总数 |
|---|---|---|---|---|---|---|---|
| Moderna | 美国 | 6 | 1 | — | 3 | — | 10 |
| Arcturus Therapeutics | 美国 | 1 | — | — | 1 | — | 2 |
| Giddi Pharma | 中国 | — | — | — | — | 1 | 1 |
| Ionis Pharmaceuticals | 加拿大 | — | — | — | 1 | — | 1 |
| Maastricht University | 荷兰 | 1 | — | — | — | — | 1 |
| Modema Therapeutics | 美国 | 1 | — | — | — | — | 1 |
| Nexturn Bio | 韩国 | — | — | 1 | — | — | 1 |
| PTC Therapeutics | 美国 | — | — | — | — | 1 | 1 |
| Radboud Centre for Mitochondrial Medicine | 全球性组织 | 1 | — | — | — | — | 1 |
| The Institute for Life Changing Medicines | 美国 | 1 | — | — | — | — | 1 |
| University of Navarra | 西班牙 | — | 1 | — | — | — | 1 |
| University of Pittsburgh | 美国 | 1 | — | — | — | — | 1 |
| University of Utah | 美国 | 1 | — | — | — | — | 1 |
Fig.12
The clinical research stage of mRNA products"
Table 7
mRNA COVID-19 vaccines in the clinical stage II/III"
| 名称 | 临床阶段 | 研发机构 | 递送技术 |
|---|---|---|---|
| LVRNA-009 | 临床Ⅱ期 | 珠海丽凡达生物技术有限公司 | LNP |
| SARS-CoV-2 vaccine (mRNA vaccine, COVID-19, Omicron variant), Suzhou Abogen Biosciences | 临床Ⅱ期 | 苏州艾博生物科技有限公司 | LNP |
| mRNA-1073 | 临床Ⅱ期 | Moderna | LNP |
| mRNA-1273.351 | 临床Ⅱ期 | Moderna | LNP |
| mRNA-1283 | 临床Ⅱ期 | Moderna | LNP |
| mRNA-1273.211 | 临床Ⅲ期 | Moderna | LNP |
| mRNA-1283.529 | 临床Ⅱ期 | Moderna | LNP |
| mRNA-1273.529 | 临床Ⅲ期 | Moderna | LNP |
| mRNA-1273.213 | 临床Ⅲ期 | Moderna | LNP |
| mRNA-1273.617 | 临床Ⅲ期 | Moderna | LNP |
| mRNA-1283.211 | 临床Ⅱ期 | Moderna | LNP |
| EG-COVID | 临床Ⅱ期 | eyeGENE; PharmCADD | LPX |
| DS-5670 | 临床Ⅲ期 | Daiichi Sankyo Company Limited; University of Tokyo | LNP |
| SYS-6006 | 临床Ⅱ期 | 石药集团有限公司 | LNP |
| ChulaCov19 mRNA vaccine | 临床Ⅱ期 | Chulalongkorn University; University of Pennsylvania | LNP |
| ARCoV | 临床Ⅲ期 | 中国人民解放军军事医学科学院; 云南沃森生物技术股份有限公司 | LNP |
| BNT-162b3 | 临床Ⅱ期 | BioNTech; Pfizer | — |
| BNT-162b2 Omi (BA.1) | 临床Ⅲ期 | BioNTech; Pfizer | LNP |
| BNT-162b5 Bivalent (WT/OMI BA.2) | 临床Ⅱ期 | BioNTech; Pfizer | — |
| PTX-COVID19-B | 临床Ⅱ期 | Biological E; Everest Medicines; Providence Therapeutics Holdings; University of Toronto | — |
| SW-0123 | 临床Ⅲ期 | Biocad; 益诺思; 斯微（上海）生物科技有限公司; 西藏药业; 同济大学 | — |
| mRNA vaccine (COVID-19, delta/omicron variant), Argorna Pharmaceuticals/Guangzhou RiboBio/Guangzhou Institutes of Biomedicine and Health/Guangzhou National Laboratory | 临床Ⅱ期 | 阿格纳生物制药有限公司; 广州生物医药与健康研究院; 广州国家实验室; 锐博制药 | — |
| ARCT-165 | 临床Ⅱ期 | Arcturus Therapeutics | LPX |
| ARCT-021 | 临床Ⅱ期 | Arcturus Therapeutics | — |
Table 8
Other mRNA prophylactic vaccines in the clinical stage II / III"
| 名称 | 研发机构 | 临床阶段 | 适应症 |
|---|---|---|---|
| mRNA-1893 | Moderna | 临床Ⅱ期 | 寨卡病毒感染 |
| HIV-TriMix-mRNA vaccine | Barcelona IDIBAPS Research Institute | 临床Ⅱ期 | HIV病毒 感染 |
| mRNA-1647 | Moderna | 临床Ⅲ期 | 巨细胞病毒感染 |
Table 9
mRNA tumor therapeutic vaccines in the clinical stage II / III"
| 名称 | 研发机构 | 临床阶段 | 适应症 |
|---|---|---|---|
| NCI-4650 | Moderna; National Cancer Institute | 临床Ⅱ期 | 转移性胃肠道癌、转移性泌尿生殖道癌、Ⅳ期黑色素瘤 |
| mRNA-4157 | Merck; Moderna | 临床Ⅱ期 | 黑色素瘤 |
| BNT-112 | BioNTech | 临床Ⅱ期 | 激素难治性前列腺癌 |
| umitrelimorgene autodencel | Duke University; Immunomic Thera-peutics | 临床Ⅱ期 | 胶质母细胞瘤 |
| dendritic cell vaccine transfected with hTERT-, survivin- and tumor cell derived mRNA (cancer), | University of Oslo | 临床Ⅲ期 | 胶质母细胞瘤 |
| WT1-targeted autologous dendritic cell vaccine (cancer) | University of Antwerp | 临床Ⅱ期 | 间皮瘤 |
| autogene cevumeran | BioNTech; GeneTech | 临床Ⅱ期 | 转移性膀胱癌、转移性乳腺癌、转移型大肠癌、转移性头颈癌、转移非小细胞肺癌、转移性肾癌、胰腺癌、Ⅳ期黑色素瘤 |
| mRNA-4359 | Moderna | 临床Ⅱ期 | 基底细胞癌、转移性膀胱癌、转移乳腺癌、转移结直肠癌、转移头颈癌、转移非小细胞肺癌、鳞状细胞癌、Ⅲ期黑色素瘤、Ⅳ期黑色素瘤 |
Table 10
mRNA drugs in the clinical stage II / III"
| 名称 | 研发机构 | 研发阶段 | 适应症 |
|---|---|---|---|
| LUNAR-OTC | Arcturus Therapeutics | 临床II期 | 鸟氨酸转氨酶缺乏症 |
| BNT-142 | BioNTech | 临床II期 | 宫内膜样癌、转移性非小细胞肺癌、转移性卵巢癌|转移睾丸癌 |
| BNT-141 | BioNTech | 临床II期 | 胆道癌、转移性结直肠癌、转移食管癌、转移卵巢癌、转移胰腺癌、转移胃癌 |
| mRNA based immunotherapies (TriMix, breast cancer), eTheRNA | eTheRNA immunotherapies | 临床II期 | 乳腺肿瘤 |
| sapablursen | Ionis Pharmaceuticals | 临床Ⅱ期 | β地中海贫血、真性红细胞增多症 |
| ISTH-0036 | Isarna Therapeutics | 临床Ⅱ期 | 糖尿病性黄斑水肿、青光眼、湿龄相关性黄斑变性 |
| mRNA-1030 | Moderna | 临床Ⅱ期 | 流感病毒A感染、流感病毒B感染 |
| mRNA-2416 | Moderna | 临床Ⅱ期 | 转移性卵巢癌、T细胞淋巴瘤 |
| mRNA-3745 | Moderna | 临床Ⅱ期 | 糖原贮积病 |
| mRNA-3927 | Moderna | 临床Ⅱ期 | 丙酸血症 |
| mRNA-1020 | Moderna | 临床Ⅱ期 | 流感病毒A感染、流感病毒B感染 |
| mRNA-1010 | Moderna | 临床Ⅲ期 | 流感病毒A感染、流感病毒B感染 |
| mRNA-3705 | Moderna | 临床Ⅱ期 | 甲基丙二酸血症 |
| mRNA-1345 | Moderna | 临床Ⅲ期 | 呼吸道合胞病毒感染 |
| AZD-8601 | Moderna/AstraZeneca | 临床Ⅱ期 | 心肌梗死 |
| PTC-518 | PTC Therapeutics | 临床Ⅱ期 | 亨廷顿舞蹈症 |
| mRNA-DC-CTL | 上海比昂生物医药科技有限公司 | 临床Ⅲ期 | 转移性非小细胞肺癌 |
| MRT-5005 | Translate Bio MA | 临床Ⅱ期 | 囊性纤维化 |
Table 11
Various types of mRNA products in clinical stage II / III in China and the United States"
| mRNA产品类型/国家 | 中国 | 中国 | 美国 | 美国 |
|---|---|---|---|---|
| 临床Ⅱ期 | 临床Ⅲ期 | 临床Ⅱ期 | 临床Ⅲ期 | |
| 处于临床Ⅱ/Ⅲ期的新冠病毒mRNA疫苗 | 5 | 2 | 8 | 5 |
| 处于临床Ⅱ/Ⅲ期的其他mRNA预防性疫苗 | — | — | 1 | 1 |
| 处于临床Ⅱ/Ⅲ期的mRNA肿瘤治疗性疫苗 | — | — | 6 | — |
| 处于临床Ⅱ/Ⅲ期的mRNA药物 | — | 1 | 14 | 2 |
Fig.13
Sales of mRNA products on the market"
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