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.