Workflow
类器官+AI赋能创新药研发
icon
Search documents
FDA新政策下,昭衍新药的猴子白囤了?
Hu Xiu· 2025-04-16 03:04
Core Viewpoint - The FDA has updated its policy to gradually eliminate mandatory animal testing for monoclonal antibody therapies and other drug developments, which has raised significant concerns in the industry, particularly for companies like Zhaoyan New Drug that rely heavily on animal testing [1][2]. Group 1: FDA Policy Changes - The FDA's new policy encourages the use of alternative methods such as computational models, organ-on-a-chip technology, and cross-species data integration to replace animal testing [1][4]. - The FDA's push for alternatives is seen as a potential milestone in drug development, which could impact not only domestic CRO companies but also global pharmaceutical research [4][5]. Group 2: Impact on Zhaoyan New Drug - Zhaoyan New Drug, which derives 95% of its revenue from non-clinical research, faces direct challenges as approximately 70% of its business involves animal testing [10][11]. - The company has a significant portion of its business (78%) from the domestic market, with only 22% from international markets, primarily the U.S. [10][11]. Group 3: Feasibility of Alternatives - The feasibility of AI and organ-on-a-chip technologies as alternatives to animal testing is being explored, with some advancements already noted in clinical trials [5][7]. - The FDA has previously approved a new drug based solely on organ-on-a-chip data, indicating that there is a pathway for these technologies to be integrated into drug development [7]. Group 4: Financial Implications - If animal testing is reduced, the cost of monkeys used in experiments may decline significantly, impacting Zhaoyan New Drug's investments in animal resources [14]. - The company's financial growth may increasingly depend on its clinical business, which is facing intense competition and declining profit margins [15].