我国创新药获批上市呈井喷效应（大健康观察）

Core Viewpoint - The National Healthcare Security Administration (NHSA) has introduced measures to support the high-quality development of innovative drugs, focusing on enhancing research support, facilitating access to insurance, and encouraging clinical application [1][2]. Summary by Relevant Sections Support for Innovative Drug Development - The NHSA has outlined 16 measures across five key areas to bolster innovative drug development, including support for research, inclusion in insurance directories, and enhancing payment capabilities [1][2]. - Approximately 80% of innovative drugs can be included in the insurance payment scope within two years of market launch [2]. Dynamic Adjustment Mechanism - A dynamic adjustment mechanism for the insurance directory has been established, reducing the adjustment cycle from a maximum of 8 years to 1 year, allowing for a more responsive inclusion of new drugs [2]. - The proportion of new drugs approved within five years that are included in the insurance directory has increased from 32% in 2019 to an expected 98% in 2024 [2]. Negotiation and Renewal Rules - The NHSA has improved negotiation and renewal rules for innovative drugs, focusing on patient clinical benefits to determine pricing [3]. - The number of first-class innovative drugs approved has significantly increased, with 48 new approvals expected in 2024, marking a fivefold increase since 2018 [3]. Encouragement of True Innovation - The measures emphasize the importance of supporting genuine and differentiated innovation in the pharmaceutical industry, addressing challenges such as homogenization and unclear clinical value [4][5]. - Since 2018, 149 innovative drugs have been included in the insurance directory, with total fund expenditures reaching 4.1 trillion yuan, driving significant sales growth [4]. Global Market Development - The NHSA aims to facilitate the global market expansion of innovative drugs, with over 90 overseas licensing transactions completed by Chinese pharmaceutical companies in 2024, totaling over $50 billion [7]. - The measures include building platforms for overseas market access and encouraging commercial health insurance to invest in innovative drugs [7][8]. Clinical Application and Usage - The NHSA encourages timely access to innovative drugs in designated medical institutions and supports the establishment of green channels for procurement [9]. - Measures have been introduced to enhance the capacity of medical institutions to use innovative drugs effectively, including optimizing payment standards and supporting special case applications [10].