2020年中国肿瘤药物临床试验进展

Progress on clinical trials of cancer drugs in China,2020

目的了解2020年中国肿瘤药物临床试验的进展及上市肿瘤药物情况,探讨新型冠状病毒肺炎(COVID-19)对肿瘤药物临床试验进展的影响。方法从中国国家食品药品监督管理总局药物临床试验登记与信息公示平台登记数据库和国产药品及进口药品数据查询系统提取2020年肿瘤药物临床试验、涉及试验药品及上市药物信息,与2019年进行比较分析,同时比较2020年国内制药企业和全球制药企业在试验范围、试验分期及药物类型、作用和机制等方面的差异。结果2020年共有722项肿瘤药物临床试验在中国注册,年增长率为52.3%,占同期全部药物临床试验的28.3%。其中由国内制药企业发起603项(83.5%),国际多中心试验105项(14.5%),Ⅰ期临床试验所占比例(44.5%)最高。722项肿瘤药物临床试验共涉及肿瘤药物458种,年增长率为36.7%。其中361种(85.8%)由国内制药企业开发,原研药是常见药物类型(77.1%),肿瘤治疗药物多见(92.8%)。作用机制方面以靶向药为主(76.6%),程序性死亡蛋白1(PD-1)和表皮生长因子受体(EGFR)是最常见的靶点。2020年共有17家制药企业的19种抗肿瘤新药或生物类似药在中国获准上市,其中10种来自国内制药企业。不论是肿瘤药物临床试验,还是上市药物,肺癌和乳腺癌均为最常见的适应证。在肿瘤药物临床试验申办方分布、试验范围分布和试验分期分布方面,以及试验药物申办方分布、药物类型分布、药物作用分布方面,2020年与2019年差异均无统计学意义(均P>0.05)。结论疫情防控期间,中国肿瘤药物临床试验仍保持高水平增长。国内制药企业在2020年取得了一系列关键性成果,是推动中国肿瘤药物临床试验发展的中坚力量。

Objective To explore the latest progress of oncology drug clinical trials in China under COVID-19,as well as to provide decision-making evidence for related stakeholders.Research progress of oncology drug trials and approved cancer drugs in China in 2020 were systematically summarized and compared with 2019.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 trial scope,stage,drug type,effect and mechanism of domestic and global pharmaceutical enterprises were compared between 2019 and 2020.Results A total of 722 cancer drug trials registered in China in 2020,with an annual growth rate of 52.3%,accounting for 28.3%of all registered trials.Among them,603(83.5%)trials were initiated by domestic pharmaceutical enterprises,and 105(14.5%)were international multicenter trials,phase I trials accounted for 44.5%.For all those trials,there were 458 cancer drug varieties,with an annual growth rate of 36.7%,and 361(85.8%)were developed by domestic enterprises.Most of the investigational products were therapeutic innovative drugs(77.1%),major in tumor treatment(92.8%).In terms of mechanism,targeted drugs were the most popular,accounting for 76.6%,and programmed cell death-1(PD-1)and epithelial growth factor receptor(EGFR)were the most common targets.In addition,there were 19 anticancer drugs from 17 companies approved in China in 2019,with 10 drugs from domestic companies.Lung cancer and breast cancer are the most common indications for both registered trials and marketed drugs.No statistically significant differences were found between 2020 and 2019 in terms of the distribution of trial sponsor,scope and stage,as well as the distribution of drug type,effect and mechanism(P>0.05).Conclusions During the Covid-19 epidemic period,clinical trials of oncology drugs in China progress smoothly and maintain a high growth rate.Series of innovative products obtained by domestic enterprises in 2020 is the main driving force of development of oncology drug clinical trials in China.