[关键词]
[摘要]
分析整理2010—2015年国内获得临床批准的中药品种具体情况,探讨国内中药品种申报审批的规律及其潜在原因。通过检索数据库获得2010—2015年国内获得临床批准的中药品种数量,逐个分析其具体信息,从获批品种的总体数量、注册分类、适应症分布、申报周期、剂型分布情况等多个方面进行分类整理,从各维度对批准趋势进行分析,以进一步阐述中药新药的临床前研发方向和临床批准情况。2010—2015年,中药总体临床批准数量呈下降趋势;中药复方新药(注册分类第6类)的批准数量最多,占比达83.75%;治疗领域方面,呼吸系统、消化系统、心脑血管系统、妇科、肌肉骨骼系统和结缔组织5个治疗领域批准品种数量较多,占总数量的70.03%;平均申报周期为27.36个月,其中内分泌、营养和代谢以及肿瘤领域的品均申报周期最长;剂型方面以片、胶囊、颗粒等口服固体制剂为主,且不同治疗领域对应的制剂剂型存在较大差异。总体而言,临床批准越来越注重新药的临床价值与定位合理性,注册审批情况的分析一定程度上反映了近年中药研发难度逐渐增加,获批形势更加严峻的实际情况,在一定程度上反映出现阶段中药新药研发所面临的主要问题。
[Key word]
[Abstract]
The article provides the references for R&D direction of Chinese materia medica (CMM) by searching and sorting the clinical approval of CMM in China. The overall analysis on CMM includes the total amounts, register classifications, indications, declared periods, formulations of approved herbal medicines, and potential reasons of their regularities. The annual approval amounts during 2010—2015 are obviously decreased in the past 6 years. Approved medicines (83.75%) are compound recipes that belong to the sixth class in register classifications. Involving indications, the total amounts of approved medicines from respiratory system, digestive system, cardio-cerebrovascular system, gynecology, and skeletal musculature system are accounted for 70.03% of total number. The calculated average declared period is 27.36 months, while the applications of endocrine, nutrition, metabolism disease, and cancer system have much longer declared periods than the others. Most formulations of approved medicines are solid oral preparations such as tablets, capsules, granules, and it displays a big difference in formulations between different therapeutic domains. Overall, the registration approval analysis reflects to a certain extent that now is the difficult time of CMM research and development as well as approvals, the new drug R&D should pay more attention on its clinical value.
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[基金项目]
国家科技重大专项(2013ZX09402202)