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产业深观察|中国创新药的全球竞争力到底有多强?
新华网财经·2025-08-14 02:26

Core Viewpoint - The article highlights the rapid growth and transformation of China's innovative drug development sector, emphasizing its shift from quantity to quality and its increasing global competitiveness [2][8][20]. Summary by Sections Innovative Drug Approvals - In the first half of 2025, China approved 43 innovative drugs, a 59% increase year-on-year, nearing the total of 48 approvals in 2024 [2]. - The innovative drug sector is benefiting from favorable policies that support the entire industry chain, showcasing China's growing global competitiveness in biopharmaceuticals [2]. Clinical Development and Regulatory Efficiency - The average time for innovative drug approval has decreased from 420 working days in 2017 to 235 days [5]. - Measures have been implemented to improve access to rare disease medications, with several rare disease drugs approved in the first half of 2025 [5][7]. Shift in Drug Development Focus - Chinese innovative drug development is transitioning from "Me-too" drugs to "Best-in-class" drugs, with a focus on unmet clinical needs [8]. - The industry is enhancing its research capabilities and internationalization, with a notable increase in original innovations [8][20]. International Collaboration and Market Expansion - Chinese companies are exploring various models for international recognition, including licensing, joint development, and independent market entry [10][12]. - Notable collaborations include agreements between companies like 3SBio and Pfizer, and Heng Rui Pharma with GSK, aimed at accelerating drug development and market entry [11][12]. Global Registration and Recognition - Chinese innovative drugs are achieving global recognition, with products like Zepzelca and others gaining approval in major markets [16]. - Companies are focusing on high-quality clinical research and compliance with international standards to enhance their global competitiveness [18][19]. Challenges and Future Directions - Despite progress, challenges remain in areas such as platform technology accumulation and global commercialization experience [23]. - The industry needs to enhance its capabilities in original innovation and market access strategies to improve the commercialization of new drugs [23][24]. Policy Support and Industry Development - The government is actively supporting true innovation and differentiated innovation through various policies [21][24]. - Future industry development requires collaboration across multiple sectors, including regulatory improvements and talent development [24][25].