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].

Core Viewpoint - The FDA has announced a significant policy change that will gradually eliminate the mandatory requirement for animal testing in the development of certain new drugs, particularly monoclonal antibody therapies, which has raised concerns in the pharmaceutical industry and led to stock price declines for companies reliant on traditional animal testing methods [1] Group 1: Policy Changes - The FDA's new policy aims to encourage the use of alternative methods, such as AI algorithms and organoid technology, to reduce or replace animal testing in drug development [1] - This policy shift is seen as a more concrete approach compared to previous efforts, providing a clear example for the industry to follow [1] Group 2: Industry Impact - The cost and time associated with animal testing have been significant issues, with the price of experimental monkeys increasing dramatically from approximately 6,500 yuan per monkey in 2014 to 150,000 yuan per monkey in 2022 [1] - Leading domestic companies have previously invested in experimental animals, and the new FDA policy may disrupt their business models [1] Group 3: Future Considerations - Industry experts indicate that while the FDA's policy provides a foundation for reducing animal testing, more clinical data is needed to demonstrate that organoids can effectively predict toxicity and potentially surpass the efficacy of animal testing [1]