【摘要】 新药研发是医药创新发展的关键环节，是新一轮生命科技革命和生物经济变革的核心领域，对引领科技创新、带动经济发展、提升人民健康福祉具有战略意义。当前，前沿技术不断革新、学科跨域融合、数字深度赋能驱动新药研发领域创新日趋活跃，国内外创新性小分子药物、抗体药物、免疫细胞治疗、基因治疗与核酸药物等密集获批上市，为未满足的临床需求提供更多选择。文章深入分析新药研发领域发展趋势、全球新药批准情况，以及我国新药研发发展现状与态势，提出发展启示与建议，以期为新药研发领域发展提供参考。更多还原

【Abstract】 As an important component in the pharmaceutical innovation, research and development(R&D) of new drugs stands at the forefront of a new round of life science and technology revolution and bioeconomic reform, which is of strategic significance to leading scientific and technological innovation, driving economic development, and improving people’s health and well-being. At present, continuous innovation in cutting-edge technologies, cross-domain integration of disciplines, and digital depth enablement drive active innovation in the field of new drug R&D. Both domestically and internationally, innovative small molecule drugs,antibody drugs, immune cell therapy, gene therapy and nucleic acid drugs are receiving intensive market approvals, providing a wider range of solutions for unmet clinical needs. This study analyzes the development trend of new drug R&D, the global approval situation of new drug R&D, as well as the current situation and trend of new drug R&D in China. It puts forward development enlightenment and suggestions, in order to provide reference for the development of new drug research and development.更多还原