创新药再迎利好政策，临床试验申请审评审批将开启30日通道

Core Insights - The approval of 37 innovative drugs in China by May 29 this year is approaching the total expected for 2024, with 11 approved on a single day, indicating a significant acceleration in the domestic pharmaceutical sector [1] - The new policy to shorten the clinical trial review and approval process from 60 to 30 days is expected to enhance the efficiency of drug development and boost China's pharmaceutical innovation capabilities [1][2] - The number of innovative drugs under development in China has surged, positioning the country as the second-largest in the world for new drug development, with projections of 48 approved innovative drugs in 2024, an increase of 8 from 2023 [2] Group 1 - The new 30-day review channel will apply to Class 1 innovative drugs, including traditional Chinese medicine and biopharmaceuticals, aimed at enhancing clinical trial efficiency and international competitiveness [2] - The reform in the review and approval system is expected to alleviate the backlog and stimulate innovation, leading to increased R&D investments from domestic companies [3] - The trend of domestic pharmaceutical companies collaborating with foreign firms for drug registration in Europe and the U.S. reflects the growing international recognition of China's technological innovation [3] Group 2 - The overall investment in R&D and the number of companies engaged in new drug development have seen explosive growth, with a notable increase in the number of innovative drugs being developed [2] - The increasing interest from multinational pharmaceutical companies in acquiring or licensing Chinese innovative drugs indicates a growing market presence and cash flow for domestic firms [3] - Despite the progress, challenges remain in original innovation, with a tendency towards following existing models rather than pioneering new targets, and a need for improved commercialization processes [3]