2025中关村论坛年会|聚焦监管科学，共探生物医药高质量发展新路径

Core Insights - Beijing has positioned the pharmaceutical and health industry as one of the "dual engines" for innovative development, with the industry scale expected to reach one trillion yuan by 2024 [2] - The 2025 Zhongguancun Forum focused on regulatory science and high-quality development in the biopharmaceutical sector, emphasizing the importance of regulatory policies in supporting industry growth [2] - In 2024, a total of 3,332 new drugs were approved nationwide, including 48 innovative drugs, 106 pediatric drugs, and 55 rare disease drugs, indicating a growing focus on innovation and specialized treatments [2] Group 1 - Beijing has implemented the "32 measures" to promote innovative pharmaceutical development, significantly reducing review times for drug applications and clinical trials [3] - The city has established a green channel for urgently needed imported drugs and medical devices, with an import value exceeding 150 billion yuan in 2024, ranking first in the country [3] - Major pharmaceutical companies, including Pfizer and Merck, have established new innovative entities in Beijing, enhancing the city's attractiveness for global pharmaceutical innovation resources [3] Group 2 - The Beijing Drug Administration will continue to optimize review and approval processes to facilitate the rapid application of innovative results and improve regulatory efficiency [4] - Beijing has a natural advantage in building data platforms due to its concentration of top-tier hospitals and national medical research centers, which generate vast amounts of clinical data [5] - The integration of medical and insurance data is seen as beneficial for enhancing drug development capabilities and regulatory cooperation [5] Group 3 - Suggestions have been made to establish a phased submission mechanism for new drug applications, which could shorten the preparation time by 3 to 6 months [6] - Recommendations include reducing the number of required test samples for rare disease drugs and exploring a dynamic regulatory model to streamline the approval process [6]