The biomedical industry is developing at an unprecedented speed and the establishment and improvement of a digital infrastructure for biomedical research and development (R&D) is crucial for biotechnology innovation and Health China construction. This study analyzes the implication, classification, and systematic framework of the digital infrastructure for biomedical R&D in the new era. It summarizes the strategic layouts and development paths of the digital infrastructures for biomedical R&D in the United States, the European Union, and China, and examines the gap between China and European and American countries in terms of international influence and authority, development model design and efficiency, sustainability, and management organization construction. Moreover, it presents the challenges faced by the digital infrastructure of China regarding top-level design, management, and governance. Furthermore, we suggest that the following aspects should be strengthened: top-level framework design, coordination of biomedical and healthcare resources, clustered construction and governance of the platform, and capacity building and operationguarantee of the open platform.