四中全会精神解读·市场最前沿丨罕见病药更可及,看国产创新药驶入“快车道”
Xin Hua She·2025-11-29 08:12

Core Viewpoint - The article highlights the increasing accessibility of rare disease medications in China, emphasizing the rapid development of domestic innovative drugs and the supportive policies driving this change [1][3]. Group 1: Policy Support and Market Dynamics - The "14th Five-Year Plan" suggests enhanced support for the development of innovative drugs and medical devices, indicating a multi-departmental effort to facilitate local innovative pharmaceutical companies [3]. - The Chinese government has opened green channels for drug research and approval, addressing the challenges faced by rare disease patients, such as difficult diagnosis, medication access, and high drug prices [3][4]. - The national support for innovative drugs, particularly for urgently needed rare disease medications, is unprecedented, according to industry experts [3]. Group 2: Innovation and Development Speed - In 2024, the average review time for innovative drug applications in China is projected to be 225 working days, with priority-reviewed drugs taking only 162 working days, indicating a significant improvement in approval speed [4]. - Since the "14th Five-Year Plan," over 110 domestic innovative drugs have been approved, with a market size reaching 100 billion yuan, and the number of new drugs in development representing over 20% of the global total, positioning China as the second-largest in new drug research and development [4][6]. - The shift from imitation to original innovation in Chinese pharmaceuticals has been marked by enhanced research capabilities and international standards, supported by various initiatives to improve research efficiency and provide robust data for drug evaluation and insurance decisions [6].