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中国生物工程杂志

China Biotechnology
China Biotechnology  2020, Vol. 40 Issue (1-2): 166-173    DOI: 10.13523/j.cb.1905035
Orginal Article     
Current Status and Trend of R&D of Microecological Drugs
GAO Qian1,**(),ZHANG Hong-xiang2,3,JIANG Hong1,YE Mao1
3 Chinese Society of Biotechnology,Beijing 100101, China
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Abstract  

In the recent years, numerous studies highlighted the potential role of microecological drugs in treating multiple diseases and preserving host’s health. In this paper, all the data was extracted from Clarivate via Cortellis. The results of qualitative analysis and expert wisdom were as follows. Up to data, 142 kinds of microecological drugs have been identified and 49 kinds of them have been undergone clinical trials. The United States was far ahead of other countries with 70 percent of the amount in microecological drugs. The drug indications were focused on Clostridium difficile infection, inflammatory bowel disease and ulcerative colitis. The key players have established advanced experimental platforms for discovery and development of novel product candidates, while 4D pharma was a world leader in this field. There were seven drugs in phase 3 clinical development. Access to 303 microecological drugs deal records, the maximum transaction was $2.78 billion. In the future, microecological drugs may make a major breakthrough in cancer and nervous system diseases treatment.



Key wordsMicroecological drugs      Clinical R&D;      Commercial deal     
Received: 16 September 2019      Published: 27 March 2020
ZTFLH:  Q819  
Corresponding Authors: Qian GAO     E-mail: gaoq@mail.whlib.ac.cn
Cite this article:

GAO Qian,ZHANG Hong-xiang,JIANG Hong,YE Mao. Current Status and Trend of R&D of Microecological Drugs. China Biotechnology, 2020, 40(1-2): 166-173.

URL:

https://manu60.magtech.com.cn/biotech/10.13523/j.cb.1905035     OR     https://manu60.magtech.com.cn/biotech/Y2020/V40/I1-2/166

Fig.1 Quantity distribution of microecological drugs in R&D and industrialization
Fig.2 Global countries/regions with the amount of microecological drugs equal to and more than five
Fig.3 Global indications with the amount of microecological drugs equal to and more than five
公司名称 在研药物 最高研发阶段 适应症
4D pharma(10个) MRx-518 临床2期 胰腺肿瘤、前列腺肿瘤、IV期黑色素瘤、转移性膀胱癌、转移性非小细胞肺癌、尿道癌、转移性肾细胞癌、乳腺肿瘤、头颈部肿瘤、子宫肿瘤、卵巢肿瘤
Blautix 临床2期 过敏性肠综合征、肠易激综合征
Thetanix 临床1期 胃肠道炎症、克罗恩病
Rosburix 发现 溃疡性结肠炎、胃肠道炎症
live biotherapeutic preparation (MicroRx, autism) 发现 自闭症
MRx-1299 发现 癌症
MRx-0029 发现 炎症性疾病、神经退行性疾病、癌症
MRx-0005 发现 神经退行性疾病、帕金森病
live biotherapeutic preparation (MicroRx, anxiety/depression) 发现 焦虑症、抑郁症
MRx-0001 发现 哮喘
Seres Therapeutics(8个) SER-109 临床3期 艰难梭菌感染
SER-287 临床2期 炎症性肠病、溃疡性结肠炎、克罗恩病
SER-401 临床1期 3期黑色素瘤、IV期黑色素瘤
microbiome modulators (colorectal cancer) 发现 肝病、代谢紊乱
SER-301 发现 炎症性肠病、溃疡性结肠炎
microbiomes (obesity/ metabolic syndrom) 发现 肥胖、代谢综合征X
SER-155 发现 细菌感染、移植物抗宿主病
SER-262 暂停 艰难梭菌感染
Synlogic(6个) SYNB-1618 临床2期 苯丙酮尿症
microbiome modulator 发现 炎症性疾病、炎症性肠病
synthetic biotic medicines 发现 癌症
SYN-MSUD 发现 槭糖尿病
SYN-STING 发现 晚期实体瘤
SYNB-1020 暂停 内分泌/代谢、胃肠道疾病
Rebiotix(5个) RBX-2660 临床3期 肠球菌感染、肝性脑病、溃疡性结肠炎、多药耐药性感染、艰难梭菌感染
RBX-7455 临床1期 艰难梭菌感染
RBX-8225 临床1期 炎症性肠病、溃疡性结肠炎
RBX-2477 临床前 肝性脑病
RBX-6376 发现 肠球菌感染、多药耐药性感染
BiomX(5个) phage/microbiome immune checkpoint inhibitor-enhancing therapy (cancer) 发现 癌症
phage cocktail (GI tract cancer) 发现 胃肠道肿瘤
phage therapeutics (liver diseases) 发现 肝病
BX-002 发现 炎症性肠病
BX-001 发现 痤疮丙酸杆菌感染
Second Genome(5个) SGM-1019 临床2期 胃肠疾病、非酒精性脂肪性肝炎、溃疡性结肠炎
microbiome modulators (metabolic disease) 发现 代谢紊乱
SG-B (cancer) 发现 癌症
SG-A (cancer) 发现 癌症
SG-2-0776 发现 炎症性肠病
Vedanta Biosciences(5个) VE-416 临床2期 食物过敏、花生过敏症
VE-303 临床2期 艰难梭菌感染
Microbiome-derived program (inflammatory bowel disease) 发现 炎症性肠病
VE-800 发现 癌症
VE-707 发现 多重耐药感染
Table 1 The key players and R&D pipeline with the amount of microecological drugs equal to and more than five
序号 药物名称 在研公司/机构 适应症
1 SER-109 Nestle Health Science、Seres Therapeutics 艰难梭菌感染
2 Oxabact OxThera AB 高草酸尿症
3 IBP-9414 Infant Bacterial Therapeutics AB 坏死性小肠结肠炎
4 植物乳杆菌299V(Lactobacillus plantarum 299v) National Cancer Institute 移植物抗宿主病
5 RBX-2660 Rebiotix Inc 艰难梭菌感染、肠球菌感染、肝性脑病、多药耐药性感染、溃疡性结肠炎
6 RP-G28 Ritter Pharmaceuticals Inc 癌症、乳糖不耐症、代谢综合征X、非酒精性脂肪肝、非酒精性脂肪性肝炎
7 B-244 AOBiome LLC 寻常痤疮、特应性皮炎、湿疹、酒渣鼻、伤口愈合
Table 2 The microecological drugs in phase 3 clinical development
排名 药物名称 委托人 合伙人 交易类型 交易金额
(百万
美元)
已付金额
(百万
美元)
适应症 交易开
始时间
交易时最高
研发状态
1 ABI-M301、ABI-M201、microbiome therapeutics (Gemicel, IBS-D), Allergan、microbiome therapeutics (Gemicel, irritable bowel syndrome with constipation), Allergan Assembly Biosciences Inc Allergan plc 药物-开发/商业化许可 2780 50 便秘主要是肠易激综合征;克罗恩病;腹泻以肠易激综合征为主;胃肠疾病;过敏性肠综合征;溃疡性结肠炎 2017/1/9 发现
2 SER-109、SER-262、SER-287、SER-301 Seres
Therapeutics
Inc
Nestle
Health
Science
药物-开发/商业化许可 1905 180 艰难梭菌感染;克罗恩病;炎症性疾病;溃疡性结肠炎 2016/1/11 临床前
3 sibofimloc Enterome SA Takeda
Pharma-
ceutical
Co Ltd
药物-开发/商业化许可 690 50 克罗恩病;胃肠疾病;肝病 2018/10/23 临床1期
4 - Microbiotica Ltd Genentech Inc 药物-开发/商业化许可 534 - 炎症性肠病 2018/6/6 -
5 JNJ-4447、VE-202-B Vedanta Biosciences Inc Johnson &
Johnson
药物-开发/商业化许可 339 12 炎症性肠病 2013/6/27 发现
6 - Ginkgo BioWorks Glycosyn LLC 技术-其他权利 144 - 免疫紊乱;传染病 2018/11/8 -
7 - Washington University School of Medicine, US Centene
Corp
药物-早期研究/开发 100 - 阿尔茨海默氏病;乳腺肿瘤;糖尿病;肥胖 2019/4/8 -
8 EDP-1503 University of
Chicago
Evelo Biosciences Inc 技术-其他权利 61.40 0.50 癌症 2015/11/9 临床前
9 EDP-1815、EDP-1066 Mayo Clinic
Foundation
Evelo Biosciences Inc 专利-独占许可 56.18 0.225 特应性皮炎;自身免疫性疾病;炎症性疾病;神经系统炎症;银屑病;类风湿关节炎 2017/8/6 发现
10 B-244 AOBiome LLC iCarbonX 药物-资助 30 30 高血压 2017/1/5 临床2期
Table 3 The commercial deals of microecological drugs TOP10
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