对我国医药研发领域新动态的探讨

Exploration of the Updates of Medical Research and Development in China

目的:探讨我国医药研发领域的新动态,为医药企业研发战略和策略的制定提供参考。方法:收集国家统计局、工业和信息化部、国家食品药品监督管理总局等网站上发布的相关数据,并结合国家发布的相关政策与制度,从研发投入、品种数量、品种结构、内在研发质量、研发领域布局等方面分析医药研发的新动态并提出建议。结果与结论:未来医药研发投入强度和增长率将迅速增加;以补充申请形式体现的一致性评价和再评价的注册申请将大量增长;以"抢仿"为主的仿制药开发模式将向以专利挑战为主的国际主流模式转变,研发品种将由仿制向创新转变;药品研发加强质量管理将成为业内共识,传统的粗放式研发将向精细化、科学化研发转变;对创新生物制品和罕见病、儿童用药的研发将越来越受到关注和鼓励,仿制药挑战专利将更常见。基于此,建议医药企业可从上述五方面着手,增加研发投入及提高效率,注重单个在研品种的价值而不是数量,及时调整研发品种结构,开展研发质量管理,优化研发领域的布局,有选择性地开展创新生物制品和罕见病、儿童用药的研发,及时跟踪、分析、评估专利,争取"首仿"上市,抢占市场先机。

OBJECTIVE：To investigate the updates of medical research and development（R＆D）in China,and to provide reference of R＆D strategies for medical enterprises. METHODS：Collected the data issued from the official website of National Bureau of Statistic,Ministry of Industry and Information Technology and China Food and Drug Administration,combined with related policies and systems issued by the states,the updates of medical R＆D were analyzed from the R＆D input,drug varieties, structure of drug products,internal quality of R＆D and R＆D field layout,etc. RESULTS ＆ CONCLUSIONS：The intensity and growth rate of medical R＆D expenditures will increase rapidly in the future. The amount of applications and approvals for drug consistency evaluation and reevaluation based on supplementary application will get bigger. The development model of generic drug will be transformed from“rushing for imitation”to the global mainstream strategy of patent challenge. R＆D varieties will change from imitation to innovation. That drug R＆D enhance quality management will become the consensus of the industry. The past extensive drug R＆D will be upgraded to go ahead the intensive and science-oriented way. Orphan drugs,pediatric drugs and innovative biological products will be paid more attention in the R＆D. That generic drugs challenge patents will be more common. Based on this,it is suggested that pharmaceutical enterprises should carry out work from the above five aspects,increase R＆D investment and improve efficiency,pay attention to the value of individual R＆D varieties rather than quantity,timely adjust the structure of R＆D varieties,carry out R＆D quality management,and optimize the layout of R＆D fields. The pharmaceutical enterprises should selectively carry out R＆D of innovative biological products,orphan drugs and pediatric drugs,timely follow-up, analysis and evaluation of patents,strive for the“first generic drug”of the market,and seize market opportunities.