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创新药的十年:从仿制跟随到全球参与 | 观产业
高毅资产管理· 2025-09-05 07:04
Core Viewpoint - The article reviews the ten-year development of China's innovative drug industry, highlighting significant breakthroughs in quantity, quality, and technology, supported by a complete industrial chain, the growth of CXO, and increased investment in research and development [2][3]. Summary by Sections Development of Innovative Drugs - China's self-developed innovative drugs have ranked first globally, with over 50% of popular target pipelines now accounted for by China, expected to exceed 60% by June 2025 [6]. - The proportion of FIC (First-in-Class) molecules developed by Chinese companies has risen from 9 in 2015 to 120 by 2024, indicating a significant release of potential in original drug research [9]. Technological Breakthroughs - The gap in drug approval times between China and the U.S. has narrowed significantly, from about 8 years before 2015 to less than 2 years post-2015, with some FIC drugs being approved first in China [15][16]. Industrial Chain Advantages - China has a complete industrial chain from raw materials to services, with significant production capabilities in nucleotides and a robust logistics network enhancing the innovative drug sector [18]. - The CXO model has strengthened the industrial foundation for innovative drugs, making China an indispensable part of the global biopharmaceutical industry [19]. - China boasts a large, cost-effective, and younger pool of pharmaceutical engineers, with the number of science and engineering PhD graduates expected to be double that of the U.S. by 2025 [20][21]. Research and Development Growth - The output of biomedical research papers in China has grown rapidly, with a compound annual growth rate (CAGR) of 14.3% from 2015 to 2020, making it the second-largest producer of such papers after the U.S. [22]. - R&D expenditures in the biopharmaceutical sector have increased from 19.2 billion yuan in 2016 to 119.04 billion yuan in 2024, reflecting a CAGR of 29.8% [22]. Market Dynamics - The average time from application to approval for innovative drugs in China has decreased by 57 days, with priority-reviewed drugs seeing an even greater reduction of 189 days [30]. - The market share of domestically developed innovative drugs has increased from 18.7% in 2015 to 27.8% in 2024, indicating a significant breakthrough against foreign competitors [34].