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中国生物工程杂志

China Biotechnology
China Biotechnology  2018, Vol. 38 Issue (5): 104-111    DOI: 10.13523/j.cb.20180514
    
The Development Situation and Suggestions of mmune Cell Therapy Industry
Yan SU1,Li XU1,Li-wei WANG2,Yue WANG1,Ping XU1,*()
1 Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences, Shanghai 200031, China
2 Bureau of Frontier Sciences and Education, Chinese Academy of Sciences, Beijing 100864, China
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Abstract  

Immunotherapy has been successfully applied in the treatment of many kinds of tumors, and significantly improved the quality of life of patients. Immune cell therapy is one of the focus directions in the development of immunotherapy. The development of immune cell therapy has gone through the stage of development of non-specific immunity to non-differentiated specific immunity and to differentiated specific immunity. Several immune cell therapy products have launched, and the industrial system has been preliminarily formed, including treatment/drug development and related services/equipment production. By analyzing the immune cell therapy industry development situation at home and abroad and the technology development bottleneck, main problems of the development of the industry in China are pointed, some suggestions were put forward so as to provide reference for the development of immune cell therapy industry in China.



Key wordsImmune cell therapy      Industry situation      Development bottleneck     
Received: 23 January 2018      Published: 05 June 2018
ZTFLH:  Q354  
Corresponding Authors: Ping XU     E-mail: xuping@sibs.ac.cn
Cite this article:

Yan SU,Li XU,Li-wei WANG,Yue WANG,Ping XU. The Development Situation and Suggestions of mmune Cell Therapy Industry. China Biotechnology, 2018, 38(5): 104-111.

URL:

https://manu60.magtech.com.cn/biotech/10.13523/j.cb.20180514     OR     https://manu60.magtech.com.cn/biotech/Y2018/V38/I5/104

Fig.1 The number of immune cell therapy trials
产品名称 原研公司 适应证 细胞类型 上市地点/时间
Kymriah 瑞士诺华 前体B细胞急性淋巴细胞白血病 CAR-T 美国(2017)
Yescarta 美国凯特医药(Kite Pharma) 特定类型大B细胞淋巴瘤 CAR-T 美国(2017)
Sipuleucel-T 疫苗 美国Dendreon 前列腺癌 树突状细胞 美国(2010)
DCVax-Brain疫苗 美国西北生物制药公司 脑癌 树突状细胞 瑞士(2007)
HybriCell 疫苗 巴西Genoa Biotecnologia SA 黑色素瘤、肾细胞癌 树突状细胞与肿瘤细胞融合 巴西(2005)
CreaVax-RCC 疫苗 韩国JW CreaGene Inc 肾细胞癌 树突状细胞 韩国(2007)
Immuncell-LC 疫苗 韩国Green Cross Cell Corp 肝细胞癌 树突状细胞 韩国(2008)
APCEDEN 印度APAC Biotech 前列腺癌、卵巢癌、结肠直肠癌和非小细胞肺癌 树突状细胞 印度(2017)
 
Fig.2 Immune cell therapy industry system
排名 机构 临床试验数量(项)
1 美国国立癌症研究所 116
2 美国杜克大学 23
3 美国H.Lee莫菲特癌症研究中心 20
3 美国加州大学洛杉矶分校 20
5 美国匹兹堡大学 18
Table 2 Global top 5 institutions most abundant in the number of DC therapy trials
Fig.3 Analysis of Novartis CAR-T patents
公司 合作单位 靶点 产品名称 适应证 研发状态
瑞士诺华 美国宾夕法尼亚大学、
美国费城儿童医院
CD19 CTL019 前体B细胞急性淋巴
细胞白血病
上市
美国朱诺治疗
(Juno
Therapeutics)
圣裘德儿童研究医院、美国纪念斯隆-凯特林癌症中心、弗雷德-哈金森癌症研究中心、西雅图儿童医院、Celgene CD19 JCAR014 非霍奇金淋巴瘤 临床Ⅰ期
CD19 JCAR017 非霍奇金淋巴瘤 临床Ⅰ期
CD22 JCAR018 非霍奇金淋巴瘤、小儿急
性淋巴细胞白血病
临床Ⅰ期
BCMA 多发性骨髓瘤 临床Ⅰ期
WT1 JCAR016 急性髓性白血病、非小细
胞肺癌、间皮瘤
临床Ⅰ/Ⅱ期
L1CAM JCAR023 小儿神经母细胞瘤 临床Ⅰ期
MUC16 JCAR020 卵巢癌 临床Ⅰ期
ROR1 JCAR024 非小细胞肺癌、乳腺癌 临床Ⅰ期
LeY 肺癌 临床Ⅰ期
美国凯特医药
(Kite Pharma)
NCI、基因泰克、安进 CD19 Axicabtagene ciloleucel
(ZUMA-1/5/6/7)
弥漫大B细胞淋巴瘤等
多种血液肿瘤
ZUMA-1(Yescarta)
进度最快,已上市
CD19 KTE-C19(ZUMA-2/
3/4/8)
套细胞淋巴瘤等多种
类型的血液肿瘤
ZUMA-2进度最快,
进入临床Ⅱ/Ⅲ期
CD19 Human anti-CD19
(2nd Gen)
血液系统恶性肿瘤 临床Ⅰ期
CD19 Humanized anti-CD19
Control CAR(3rd Gen)
血液系统恶性肿瘤 临床前
BCMA KITE-585 多发性骨髓瘤 临床Ⅰ期
CLL-1 KITE-796 急性髓性白血病 临床前
Table 3 CAR-T R&D pipeline of Novartis, Juno Therapeutics, Kite Pharma
公司组建模式 代表性公司
新兴CAR-T
研发企业
海外CAR-T公司生产技术和管理输入 药明巨诺、复星凯特
在海外完成技术研发向国内进行技术转化 Eureka、ProMab
在国内开展CAR-T生产和临床研发 科济生物、斯丹赛、优卡迪、恒润达生、吉凯基因、南京传奇
干细胞公司转型做CAR-T 中源协和、博雅控股、西比曼
Table 4 Domestic CAR-T enterprise formation mode
公司 靶点 适应证 临床疗效 核心专利
南京传奇 BCMA 多发性骨髓瘤 病情客观缓解率达到100%(35人) WO2017025038
科济生物 GPC3 肝细胞癌 13名患者未出现剂量限制性毒性(DLT)或3级以上不良反应。5名可进行疗效评估的患者中,1名患者出现部分缓解,2名患者疾病稳定 WO2015172339
斯丹赛 CD19 复发难治性
白血病
共完成了41例复发难治性白血病的临床研究,其中34例患者达到完全缓解,完全缓解率达83% -
Table 5 CAR-T clinical data disclosed by some domestic enterprises
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