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创新药发展进入快车道
Jing Ji Ri Bao· 2025-08-10 21:54
Core Insights - The Chinese pharmaceutical industry has seen a significant increase in overseas licensing deals, with 40 transactions in Q1 2025 alone, amounting to over $38 billion, which is more than half of the total for the entire year of 2024 [4][5] - The number of innovative drugs approved by the National Medical Products Administration (NMPA) has risen sharply, with 48 new approvals expected in 2024, representing more than a fivefold increase since 2018 [2][3] - Recent government policies have provided substantial support for the development of innovative drugs, including measures to streamline clinical trial approvals and enhance market access [6][7] Industry Growth - The number of innovative drugs developed by Chinese companies has reached 40 out of 43 approved drugs in the first half of 2025, indicating a shift from generic to original drug development [3][4] - The global biopharmaceutical market is projected to exceed $1.71 trillion by 2025, with China's market expected to grow at a compound annual growth rate (CAGR) of 14.5%, surpassing 3.5 trillion yuan [5] - The trend of overseas licensing agreements has become a crucial driver for the growth of the innovative drug sector, reflecting China's increasing research and development capabilities on the international stage [4][5] Policy Support - The NMPA has introduced a "30-day fast-track approval channel" for clinical trials to support innovative drug development, aiming to reduce the time required for new drug applications [6][7] - The National Healthcare Security Administration (NHSA) has established a dynamic adjustment mechanism for the medical insurance catalog, facilitating faster inclusion of innovative drugs into the insurance system [6][8] - Various supportive policies have been implemented to encourage innovation across the entire drug development process, from research to commercialization [6][7] Challenges Ahead - Despite the progress, the industry still faces challenges in drug development, including technical difficulties, complex clinical trial processes, and issues related to reimbursement [7][8] - There is a need for a multi-dimensional evaluation system focused on patient benefits to better assess the clinical value of innovative drugs [7][8] - The disconnect between academia and industry remains a significant barrier, particularly in translational medicine, necessitating collaboration between research institutions and pharmaceutical companies [8]