摘要
目的系统分析2013~2022年我国创新生物制品临床试验现状,为我国创新生物制品的研发提供参考和借鉴。方法检索我国政府公示平台相关信息,从临床试验数量及分期、适应证与靶点分布、临床试验的国内外分布、临床试验组长单位与申办方情况对我国药物临床试验状况进行分析。结果2013年1月1日~2022年12月31日共登记了2182项创新生物制品临床试验,以治疗用生物制品为主(95.2%),I期临床试验占比最高(43.4%);适应证主要为抗肿瘤药物(58.9%),抗肿瘤药物的靶点集中于程序性死亡受体1(PD-1)、程序性死亡配体1(PD-L1)、原癌基因人类表皮生长因子受体2(HER2)等靶点;以国内临床试验为主(84.5%),国际多中心临床试验主要由外资制药企业发起;北京、上海、广东三地的临床试验组长单位开展的临床试验数量占比达69.9%,境内制药企业发起的临床试验(85.1%)远高于境外企业(14.9%)。结论我国持续深化审评审批制度改革有力地促进了创新生物制品进入临床试验,国内制药企业已成为创新药物研发的中坚力量,京津冀、长三角、粤港澳大湾区、成渝双城已成为生物医药产业集聚区;但是仍存在适应证和靶点同质化严重、临床资源分布不均衡、国际多中心临床试验能力有待提升等问题。
OBJECTIVE To systematically analyze the clinical trials status of innovative biological products in China from 2013 to 2022,and provide reference for the research and development of innovative biological products in China.METHODS The relevant information of all innovative biological products registered on the platform of drug clinical trial registration and information publicity was retrieved.The current situation of registered drug clinical trials from 2013 to 2022 was analyzed from four aspects:the number and phases of clinical trials,the distribution of indications and targets,the distribution of clinical trials at home and abroad,and the situation of clinical trial leaders and sponsors.RESULTS From January 1,2013 to December 31,2022,a total of 2182 clinical trials of innovative biological products were registered,mainly for therapeutic biological products(95.2%).From the phases of trial stage,the proportion of phase I clinical trials is the highest(43.4%).The main indications are antineoplastic drugs(58.9%),and the targets of antineoplastic drugs are concentrated on programmed death 1(PD-1),programmed cell death-ligand 1(PD-L1),and Human epidermal growth factor receptor2(HER2).Clinical trials are mainly domestic(84.5%),while international multicenter clinical trials are mainly initiated by foreign-capital pharmaceutical enterprises.69.9%of clinical trials were conducted by clinical trial team leaders located in Beijing,Shanghai and Guangdong.Among the types of sponsors,clinical trials initiated by domestic pharmaceutical companies(85.1%)are significantly higher than those initiated by overseas companies(14.9%).CONCLUSION China continues to deepen the reform of the review and approval system,effectively promoting the entry of innovative biological products into clinical trials,domestic pharmaceutical enterprises have become the backbone of innovative drug research and development,The Beijing-Tianjin-Hebei region,Yangtze River Delta region,Guangdong-Hong Kong-Macao Greater Bay Area,Chengdu-Chongqing economic ci
作者
陆静云
李予强
邢花
LU Jingyun;LI Yuqiang;XING Hua(Shenyang Pharmaceutical University,Shenyang,Liaoning 110016,China;Guangzhou Biotech Industry Organization,Guangzhou,Guangdong 510005,China)
出处
《今日药学》
CAS
2023年第6期476-480,共5页
Pharmacy Today
关键词
创新生物制品
药物临床试验
发展趋势
分析
innovative biological products
drug clinical trials
development trend
analysis
