中药研发外包产业现状调研与分析  

Current Situation of the Chinese Medicine Research and Development Outsourcing Industry

作　　者：陈子琪 罗菊元 郭明雪 杜守颖[1] 陆洋[1,2] CHEN Ziqi;LUO Juyuan;GUO Mingxue;DU Shouying;LU Yang(Department of Chinese Material Medica,Beijing University of Chinese Medicine,Beijing,China 102488;Shenzhen Research Institute,Beijing University of Chinese Medicine,Shenzhen,Guangdong,China 518000)

机构地区：[1]北京中医药大学中药学院,北京102488 [2]北京中医药大学深圳研究院,广东深圳518000

出　　处：《中国药业》2021年第18期1-5,共5页China Pharmaceuticals

基　　金：北京中医药大学重点攻关项目[2020-JYB-ZDGG-048]。

摘　　要：目的了解中药研发外包产业的发展现状。方法向就职于医药行业人群线上发放调查问卷并回收,分析合同研究组织(CRO)公司、医药企业中药研发外包现状及制约中药CRO发展的原因,并有针对性地提出建议。结果现阶段,中药业务在CRO公司中占比较小,但多数医药企业表明在未来5年内会加大对中药研发的投入;中药研发外包项目类型主要是临床研究;政策对医药企业的影响比CRO公司更明显;医药企业与CRO公司研究的中药药品种类和针对的疾病无明显差异。结论CRO公司可加大对中药业务的准备,选择有经验的某种疾病临床试验,提高研究质量,同时也需加大对自身企业形象及品牌的宣传。Objective To understand the current situation of the Chinese medicine research and development(R&D)outsourcing industry.Methods An online questionnaire survey was conducted among people working in the pharmaceutical industry,and the questionnaire was collected to analyze the current situation of Chinese medicine R&D outsourcing in the contract research organizations(CROs)and pharmaceutical enterprises and the reasons restricting the development of Chinese medicine R&D outsourcing industry,and put forward the targeted suggestions.Results At present,the Chinese medicine business accounts for a small proportion of CROs,but most pharmaceutical enterprises show that they will increase their investment in Chinese medicine R&D in the next five years.At present,the Chinese medicine R&D outsourcing service projects are mainly clinical trials.The impact of policy on pharmaceutical enterprises is more obvious than that on CROs.The types of drugs developed by pharmaceutical enterprises and CROs and the types of diseases targeted by these drugs have no significant difference.Conclusion CROs can improve their ability to undertake Chinese medicine business,select clinicals trials experienced in a certain disease,improve the research quality,and increase the publicity of their corporate image and brand.

关 键 词：中药研发外包 合同研究组织 行业调研 发展建议 

分 类 号：R932[医药卫生—生药学] R288[医药卫生—药学]