全球化研发背景下中药新药研发面临的形势和机遇  

Situations and opportunities of new drugs of Chinese materia medica under background of globalized research and development

作　　者：李鸿彬[1] 丁文侠 陆文亮[1] LI Hong-bin;DING Wen-xia;LU Wen-liang(Academy of Tasly Holding Group Co.,Ltd.,Tianjin 300410,China)

机构地区：[1]天士力控股集团有限公司研究院,天津300410

出　　处：《中草药》2020年第15期4092-4097,共6页Chinese Traditional and Herbal Drugs

摘　　要：自2017年我国加入人用药品注册技术要求国际协调会议(ICH)组织以来,新药研发标准正式与国际接轨,中国化学药和生物药创新发展进入全新时代。然而,与化学药和生物药对比,中药新药研发略显不足,新药申报数量和批准数量不多,工业产值增长放缓,这是由于全球经济放缓的大背景及中国加入ICH之后研发规则和标准提高造成的。目前中医药得到国家政策支持,同时大健康时代来临带给中医药重大发展机遇。中药企业应顺势而为,努力提高中药产品的供给侧水平。同时应正确认识中药发展困境、挑战和机遇,加大中药创新力度和上市产品二次研发的力度。分析目前全球化研发背景下中药新药研发面临的形势,剖析中药新药研发和申报出现的困局及存在的机遇和挑战,对新时代下中药产业健康发展具有重要意义。Since China joined International Conference on Harmonization(ICH)in 2017,the research and development standards of new drugs have been formally in line with the international standards,and the innovation and development of chemical and biological drugs in China have entered a new era.However,compared with chemical drugs and biological drugs,the research and development of new drug of Chinese materia medica(CMM)is slightly insufficient,the number of new drug applications and approvals is not large,and the growth of industrial output is slowing down,which is caused by the global economic slowdown and the improvement of research and development rules and standards with China’s accession to ICH.At present,CMM is supported by national policies,and the coming of the era of great health has brought great opportunities for the development of traditional Chinese medicine(TCM).Pharmaceutical enterprises should follow the trend and strive to improve the supply side level of pharmaceutical products of TCM.At the same time,we should correctly understand the difficulties,challenges and opportunities in the development of CMM,and strengthen the pharmaceutical innovation and secondary research and development of CMM.It is of great significance for the healthy development of CMM industry in the new era to analyze the situation faced by the research and development of CMM under the background of globalization,and analyze the difficulties,opportunities and challenges in the research and application of new drugs of CMM.

关 键 词：全球化研发 中药 新药 研发 申报 挑战 机遇 

分 类 号：R288[医药卫生—中药学]