Investment Rating - The industry investment rating is "Outperform the Market" [24] Core Insights - The enthusiasm for the research and development of traditional Chinese medicine (TCM) new drugs continues, with the number of new drug applications exceeding the total for the entire year of 2023. In the first three quarters of 2024, 62 new TCM drugs received IND acceptance, and 31 received NDA acceptance, representing 84.93% and 129.17% of the total for 2023, respectively [1][3][21]. Summary by Sections 1. New Drug Approval Data Tracking - In 2023, a total of 10 new TCM drugs were approved for market, while 8 new drugs have been launched in 2024, including three Class 1.1 new drugs: Ercha Shangqing Wan, Jiuwei Zhike Oral Liquid, and Qinwei Granules. These drugs target conditions such as recurrent aphthous ulcers, acute bronchitis, and acute gouty arthritis [2][11]. 2. IND Acceptance Data Tracking - In the first three quarters of 2024, 62 new TCM drugs received IND acceptance, including 41 Class 1.1 new drugs, 9 Class 1.2 new drugs, and 12 Class 2.3 new drugs. Companies involved include Kangyuan Pharmaceutical, Zuoli Pharmaceutical, and Zhenbaodao [3][13]. 3. NDA Acceptance Data Tracking - A total of 31 new TCM drugs received NDA acceptance in the first three quarters of 2024, including 10 Class 1.1 new drugs and 21 Class 3.1 new drugs. These drugs focus on treating respiratory diseases, oral ulcers, gynecological inflammatory diseases, chronic cholecystitis, and vascular dementia [17][19]. 4. Investment Recommendations - The National Medical Products Administration (NMPA) is promoting the innovation and development of TCM through various measures, including improving regulatory frameworks and reforming review and approval processes. The rich pipeline of new drug research is expected to enhance the revenue of TCM companies, and investors are advised to pay attention to leading companies in TCM new drug development [21].
中药Ⅱ行业跟踪报告：2024年前三季度：中药新药研发热情延续，上市受理数量超2023年全年水平
Wanlian Securities·2024-10-16 10:00