摘要
系统性回顾分析2005—2021年中药有效成分新药(new Chinese herbal active ingredient drugs,NCHAIDs)的临床试验申请、上市申请和临床试验登记情况,结果显示:(1)2005—2021年申请临床试验的39个NCHAIDs中,19个品种获批,批准率为48.7%,其中16个品种已进行临床试验登记。2005—2021年申请生产的5个NCHAIDs中,有1个获得批准。(2)16个已完成临床试验登记新药的平均临床试验所用时间为7年,有1个品种完成了II期临床试验,5个品种完成了I期临床试验。(3)NCHAIDs的适应证相对集中在神经精神、心血管、肿瘤等;对于临床定位与药材功能主治相关性较好的NCHAIDs,临床试验申请获得批准的几率相对较高;有效成分的结构类型较多,其中黄酮、皂苷、内酯等的比例相对较高。建议加强NCHAIDs的成药性研究,控制研发风险;加强NCHAIDs的基础研究;关注NCHAIDs的药动学特性;注重知识产权保护;关注药材资源及制造成本等问题,为今后NCHAIDs的研发提供有益借鉴。
This paper systematically sorted out(investigational new drug,IND)and(new drug application,NDA)date of new Chinese herbal active ingredient drugs(NCHAIDs)from 2005 to 2021.Results showed that:(1)from 2005 to 2021,there were 19 INDs of NCHAIDs approved among 39 INDs of NCHAIDs.The approval rate was 48.7%.Sixteen approved new drugs have been registered for clinical trials.Among five NDAs of NCHAIDs,one had been approved.(2)It has been about seven years since IND was approved for the 16 new drugs that have completed clinical trial registration,of which one has completed phase II clinical trial,and five have completed phase I clinical trial.(3)The indications of NCHAIDs were relatively concentrated in neurological diseases,cardiovascular,tumor and so on;For the NCHAID which clinical indication had good correlation with the function and indication of medicinal material,the probability of obtaining IND approval was relatively high.There were many structural types of NCHAIDs,and the proportion of flavonoids,saponins and lactones was high.This paper suggested that:The research on druggability should be strengthened to control the risk;The basic research of NCHAIDs in stages of new drug discovery should be strengthened;Attention should be paid to pharmacokinetic studies and patent protection of NCHAIDs;In the research of NCHAIDs,the problems of medicinal material resources and manufacturing cost should not be ignored.This paper might provide a useful reference for research and development of NCHAIDs in future.
作者
周刚
周跃华
韩宁
李天泉
ZHOU Gang;ZHOU Yue-hua;HAN Ning;LI Tian-quan(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China;China National Intellectual Property Administration,Beijing 100088,China;Chongqing Kangzhou Big Data Co.,Ltd.,Chongqing 401336,China)
出处
《中草药》
CAS
CSCD
北大核心
2023年第11期3401-3407,共7页
Chinese Traditional and Herbal Drugs
关键词
有效成分新药
临床试验申请
新药上市申请
临床试验用时
成药性
new Chinese herbal active ingredient drugs
investigational new drug
new drug application
clinical trial time
druggability
