中药审评审批数据点评：2024年前三季度中药新药报产及上市延续良好态势

Investment Rating - The industry is rated as "Overweight" [5] Core Viewpoints - In the first three quarters of 2024, a total of 7 new traditional Chinese medicine (TCM) drugs were approved for market, with a significant proportion targeting respiratory and gynecological conditions [2] - The approval of new TCM drugs has accelerated since 2021, with 81.4% of the total approvals occurring in this period, driven by increased policy support [2] - There are currently 27 TCM drugs under review, maintaining a strong momentum, with a focus on various disease categories including respiratory, digestive, and gynecological [3] - The development and approval of TCM new drugs have been expedited, particularly for Class 3 new drugs, due to enhanced policy support and simplified registration processes [4] - The TCM industry is facing short-term pressures from high base effects and weak consumption, but the overall trend remains positive due to gradual implementation of TCM procurement policies and macroeconomic policy support [5] - The industry is focusing on innovation and the integration of traditional practices with modern consumption trends, emphasizing the importance of both innovation and heritage in driving high-quality development [5][6] Summary by Sections New Drug Approvals - In 2024, 7 new TCM drugs were approved, with respiratory and gynecological drugs being prominent [2] - Cumulatively, 43 new TCM drugs have been approved from 2017 to September 2024, with a notable acceleration since 2021 [2] Drugs Under Review - 27 TCM drugs are currently under review, with a diverse range of therapeutic areas being targeted [3] - The total number of TCM drugs under review has reached 39 [3] R&D and Market Trends - The pace of R&D and market entry for TCM new drugs has increased, particularly for Class 3 new drugs, reflecting a shift towards modernized practices [4] - The industry is expected to benefit from ongoing reforms in state-owned enterprises, enhancing efficiency and quality [6] Investment Focus - The report suggests focusing on three main investment themes: innovation in TCM drugs, brand TCM products, and state-owned enterprise reforms [5][6]