动物实验替代方案
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美国大量实验用猴被迫“退休”?真相来了
第一财经· 2025-11-26 10:51
Core Viewpoint - The CDC has issued a directive to end all research projects involving the use of monkeys by the end of this year, marking a significant shift in animal research policy in the U.S. [3][4] Group 1: CDC Directive and Its Implications - The directive affects approximately 200 monkeys used primarily for infectious disease research, including HIV prevention and antiviral treatments [3]. - This is the first time a U.S. government agency has terminated non-human primate research since the NIH initiated a retirement plan for chimpanzees a decade ago [3]. - The future of these monkeys is uncertain, with possibilities including relocation to primate sanctuaries or euthanasia [3]. Group 2: New Methodologies in Research - Advocates for "new methodologies" such as organoids believe this marks the beginning of a "post-animal era" in research [3]. - The CDC's directive is seen as a potential model for transitioning to advanced alternative technologies, although achieving complete replacement of animal models is complex [4]. - The NIH still oversees nearly 7,000 non-human primates, indicating that the CDC's directive does not apply to all research institutions [4]. Group 3: Challenges of Replacement Technologies - Experts caution that while organoids and other new methodologies show promise, they cannot fully replicate the complexity of human diseases [4]. - The current state of recognized alternatives to animal testing remains limited, with few validated methods available [4]. - The debate continues on the extent to which organoids can replace animal models in biomedical research [4]. Group 4: Global Perspective and Future Directions - The focus should be on which countries can effectively implement alternative methodologies in translational medicine and drug evaluation [5]. - The CDC's decision highlights a growing contradiction in biomedical research: the need for new therapies while still relying on animal models for certain critical research areas [5]. - Addressing the balance between ethical considerations and scientific needs is essential for the advancement of both science and ethics [5].
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].