罕见病药更可及，看国产创新药驶入“快车道”

Core Insights - The emergence of domestic drugs for rare diseases is improving accessibility and affordability for patients, as highlighted by the case of a 14-year-old patient using a new Chinese drug [1][3] - The Chinese government is increasing support for innovative drug development, particularly for rare diseases, through various policy measures and streamlined approval processes [3][4] - The average review time for innovative drug applications in China has significantly decreased, with over 110 domestic innovative drugs approved since the 14th Five-Year Plan, contributing to a market size of 100 billion yuan [4][6] Group 1 - The introduction of domestic drugs is alleviating the long-standing reliance on expensive imported medications for rare diseases [1][3] - The "14th Five-Year Plan" emphasizes support for innovative drugs and medical devices, indicating a multi-faceted approach to enhance local drug development [3] - The establishment of green channels for drug research and approval aims to address the challenges faced by rare disease patients, such as diagnosis difficulties and high drug prices [3] Group 2 - The average review time for innovative drug applications is now 225 working days, with priority-reviewed drugs taking only 162 days, showcasing improved efficiency in the approval process [4] - Since the beginning of the 14th Five-Year Plan, over 110 domestic innovative drugs have been approved, with the number of new drugs in development representing over 20% of the global total [4] - The integration of policy, industry, and technology is expected to facilitate the entry of more domestic innovative drugs into the market, aligning with the vision of ensuring medical access and affordability [6]