医药生物行业点评报告：药审中心发布濒危动物类中药材人工制成品相关试行稿，产业迎来新机遇

Investment Rating - The industry investment rating is "Increase" [8] Core Viewpoints - The release of trial guidelines for artificial products made from endangered animal-based traditional Chinese medicine (TCM) materials presents new opportunities for the industry. The guidelines were published on December 9, 2024, by the Drug Review Center [4] - Continuous policy support for substitutes of rare and endangered TCM materials has been observed throughout the year. The guidelines aim to provide a clear direction for the development of substitutes for endangered TCM materials, which could create significant industrial replacement value if they maintain efficacy and clinical outcomes similar to natural products [5] - The price index for endangered TCM materials has increased from approximately 2344 in January 2018 to about 3018 by December 15, 2024, indicating a growing market for substitutes [5] Summary by Sections Policy Developments - The Drug Review Center has issued detailed guidelines for the research and development of artificial products made from endangered animal-based TCM materials, which includes regulations on pharmacological studies and clinical trials [5] - The guidelines also specify the requirements for substituting or reducing endangered ingredients in existing TCM prescriptions, providing a structured approach to the development of these substitutes [5] Investment Recommendations - The report suggests focusing on two categories of companies: 1) Companies currently developing artificial products from endangered animal-based TCM materials, such as Shanghai Kaibao and Warner Pharmaceutical [6] 2) Major TCM companies that include endangered animal ingredients in their products, such as Tongrentang, Pianzaihuang, and others [6]