“十三五”期间中国肝癌药物临床试验进展

肝癌电子杂志 ›› 2021, Vol. 8 ›› Issue (4): 26-30.

“十三五”期间中国肝癌药物临床试验进展

俞悦^△, 黄慧瑶^△, 吴大维, 王书航, 于安琪, 樊琦, 白颖, 杜静婷, 方元, 江宁, 房虹, 唐玉^*, 李宁

国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院药物临床试验研究中心,北京 100021

收稿日期:2021-10-11 出版日期:2021-12-30 发布日期:2022-10-27
通讯作者: ^*唐玉,E-mail：tangyu_cams@163.com
作者简介:俞悦医师中国医学科学院医院北京协和医学院肿瘤医院药物临床试验研究中心
^△共同第一作者
基金资助:
中国医学科学院医学与健康科技创新工程临床试验及临床试验机构评价体系构建与应用研究（2021-I2M-1-045）; 中国癌症基金会北京希望马拉松专项基金资助（LC2019A10）

Progress on clinical trials of anticancer drug for hepatocellular carcinoma in China during the 13^th Five-Year Plan Period

Yu Yue^△, Huang Huiyao^△, Wu Dawei, Wang Shuhang, Yu Anqi, Fan Qi, Bai Ying, Du Jingting, Fang Yuan, Jiang Ning, Fang Hong, Tang Yu^*, Li Ning

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China

Received:2021-10-11 Online:2021-12-30 Published:2022-10-27

摘要/Abstract

摘要： 目的：了解并展示“十三五”期间中国肝癌药物临床试验发展状况及上市药物概况。
方法：从药物临床试验登记与信息公示平台和国产药品及进口药品数据查询系统提取“十三五”期间肿瘤药物临床试验、涉及试验药品及上市药物信息,分析肝癌相关临床研究及上市药物的数量、年度增长情况及相关影响因素,并与其他癌种进行比较。
结果：“十三五”期间共有110项肝癌药物临床试验进行了登记,年增长率为52%。其中,82项（75%）试验由国内制药企业发起。国内制药企业发起的I期临床试验和等效性试验所占比例高于国际制药企业（分别为27%和18%、33%和0,均P=0.0003）。临床试验共涉及70种肿瘤试验药物,其中54种（77%）由国内制药企业开发。国内制药企业开发的药物中,原研药占比低于国际制药企业（54%和100%,P=0.0002）。原研靶向药的作用靶点以程序性死亡蛋白-1及其配体（programmed cell death protein-1, PD-1/programmed cell death ligand 1, PD-L1）（19种,54%）和抗血管生成多靶点为主（9种,25%）。共有6种肝癌原研药在中国获批上市。
结论：“十三五”期间,中国肝癌药物临床试验蓬勃发展,本土制药企业已成为肝癌药物研发的中坚力量。PD-1/PD-L1和以VEGFR为代表的抗血管多靶点仍是当前研发的热门靶点。以临床为导向、探索新机制的创新性研发将是肝癌药物未来发展的重要方向。

关键词: 肝细胞癌, 药物, 临床试验, 中国

Abstract: Objective: To give a panoramic description of the latest research progress on clinical trials and approved products for hepatocellular carcinoma (HCC) in China in 2016-2020 (13^th Five-Year Plan Period).
Methods: Information Disclosure Platform for Drug Clinical Studies and China Food and Drug Administration Query System for Domestic and Imported Drug were searched for registered clinical trials and approved oncology drugs, respectively. The numbers and growth rates of clinical trials and approved products for hepatic carcinoma were analyzed, as well as the relevant variables. The difference between hepatic cancer and other cancers were also compared.
Results: There were 110 trials for HCC registered in China during 13^th Five-Year Plan Period, with an annual growth rate as 52%. Among them, 82 (75%) were initiated by domestic pharmaceutical enterprises. Compared with global enterprises, the proportion of phase I clinical trials and bioequivalence trials sponsored by domestic companies were higher (27% vs. 18%, 33% vs. 0, P =0.0003), while the proportion of therapeutic innovative drugs was lower (54% vs. 100%, P =0.0002). PD-1/PD-L1(19, 54%) and multi-targets of anti-angiogenesis represented by VEGFR (9, 25%) were the main investigated targets of therapeutic innovative targeted drugs. During 2016 to 2020, 6 therapeutic innovative drugs were approved in China.
Conclusions: Clinical trials on anticancer drugs of HCC in China have ushered a booming era during the 13^th Five-Year Plan Period. Local enterprises played more and more critical roles in clinical research and development. PD-1/PD-L1 and multi-targets of anti-angiogenesis are still hotspots for targeted therapy. Exploring clinical oriented anticancer drugs with novel mechanism is crucial direction of future research and development of HCC.

Key words: Hepatocellular carcinoma, Drug, Clinical trial, China

俞悦, 黄慧瑶, 吴大维, 王书航, 于安琪, 樊琦, 白颖, 杜静婷, 方元, 江宁, 房虹, 唐玉, 李宁. “十三五”期间中国肝癌药物临床试验进展[J]. 肝癌电子杂志, 2021, 8(4): 26-30.

Yu Yue, Huang Huiyao, Wu Dawei, Wang Shuhang, Yu Anqi, Fan Qi, Bai Ying, Du Jingting, Fang Yuan, Jiang Ning, Fang Hong, Tang Yu, Li Ning. Progress on clinical trials of anticancer drug for hepatocellular carcinoma in China during the 13^th Five-Year Plan Period[J]. Electronic Journal of Liver Tumor, 2021, 8(4): 26-30.

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