国内制药企业高端制剂发展概况及挑战

Development and Challenges of High-End Pharmaceutical Preparations in Domestic Pharmaceutical Enterprises

目的为国内制药企业合理布局高端制剂提供参考。方法基于全球医药产业高端制剂领域的发展现状,分析高端制剂发展面临的挑战,并提出发展策略。结果现阶段,美国、欧盟成员国、日本等国家仍是全球主要的创新药物研发市场。在全球新药产出速率大幅放缓的背景下,高效药物递送系统(DDS)发展迅速,其创新制剂与仿制药规模相当;随着对具有临床使用缺陷的药物领域的渗透,改良型高端制剂具有更大的市场增长空间。高端制剂产业发展面临着巨大挑战,如缺乏创新制剂研究的产业化研究平台,缺乏强大技术支撑的人才团队和复合型领军人才,中国的企业尚未成为创新主体,大多数企业不具备解决高端制剂转化过程中复杂技术问题的能力,缺乏中试转化的配套设备设施。新型高端制剂的发展是中国医药产业发展和转型的必由之路,应建立科学的评价机制及扶植政策;加强药物制剂领域创新技术的研究和转化;加强多学科交融;建立市场化、国际化的制剂研发服务平台;构建系统性创新大环境;以临床需求为依托,开发差异化产品,合理制订临床开发策略;建设高水平、国际化的顶尖人才团队。结论大力发展高端制剂不仅符合国内新药研发趋势,同时也符合我国医药产业结构优化转型、绿色新型和引领性发展的要求。

Objective To provide a reference for the rational overall arrangement of high-end pharmaceutical preparations in domestic pharmaceutical enterprises.Methods Based on the development status of the global pharmaceutical industry in the field of high-end pharmaceutical preparations,the challenges of developing high-end pharmaceutical preparations were analyzed,and the development strategies were put forward.Results At the present stage,the United States,the European Union,Japan and other countries are still the main research and development(R&D)markets of innovative drugs in the world.With a sharp slowdown in the global output of novel drugs,the efficient drug delivery system(DDS)is developing rapidly,and the scale of innovative preparations of DDS is equivalent to that of generic drugs.With the penetration of the drug field with clinical use defects,the modified high-end pharmaceutical preparations have a large space for market growth.The development of the high-end pharmaceutical preparation industry is facing great challenges,such as lack of industrialization research platform for innovative preparation,lack of talent team and compound leading talents with strong technical support,Chinese enterprises have not yet become the main body of innovation,most enterprises cann’t solve complex technical problems in the process of high-end pharmaceutical preparation transformation,and lack of supporting equipment and facilities for the transformation in the intermediate test.The development of new high-end pharmaceutical preparations is the only way for the development and transformation of China’s pharmaceutical industry,we should establish a scientific evaluation mechanism and supporting policies,strengthen the research and transformation of innovative technologies in the field of pharmaceutical preparations,strengthen the integration of multi-disciplines,establish a market-oriented and international service platform for the research and development of pharmaceutical preparations,establish a systematic innovation environment,develop differentiated products based on clinical needs,formulate reasonable clinical development strategies,and build a high-level and international top talent team.Conclusion Vigorously developing high-end pharmaceutical preparations not only conforms to the trend of global new drug research and development,but also meets the requirements of the optimization and transformation of industrial structure,environmental-friendly and leadership development for Chinese pharmaceutical enterprises.