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【医药生物】创新药IND审批缩短至30天,看好国产创新产业链——医药生物行业跨市场周报(202509014)(王明瑞/黄素青)
光大证券研究· 2025-09-15 23:04
Group 1 - The A-share pharmaceutical and biotechnology index fell by 0.36%, underperforming the CSI 300 index by 1.75 percentage points and the ChiNext index by 2.37 percentage points, ranking 28th among 31 sub-industries [4] - The Hong Kong Hang Seng Healthcare Index dropped by 1.43%, underperforming the Hang Seng Index by 4.83 percentage points [4] Group 2 - Recent progress in drug development includes NDA applications for HRS9531 by Heng Rui Pharmaceutical and several other drug applications by companies like Zhi Xiang Jin Tai and Kang Ning Jie Rui [5] - Clinical trials are ongoing for various drugs, including the phase III trial of Velolizumab by Shu Tai Shen and phase II trials for HP515 by Hai Chuang Pharmaceutical and mesutoclax by Nuo Cheng Jian Hua [5] Group 3 - The National Medical Products Administration announced a significant reduction in IND approval time to 30 days, enhancing the efficiency and predictability of clinical research for innovative drugs [6] - The government's support for the entire innovative drug development chain is being implemented, aiming to establish a high-quality development system for innovative drugs in China [6] Group 4 - The investment strategy for 2025 emphasizes structural selection of investment opportunities, focusing on the core contradiction between payment willingness and ability [7] - Three payment channels within the pharmaceutical industry are identified: in-hospital payments, out-of-pocket payments, and overseas payments, with a positive outlook on policy support for in-hospital payments and expanding public demand [8]