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以动物安评业务为主的昭衍新药4月11日开盘直接跌停,港股最高跌幅逾18%。从消息面上看,昭衍新药的股价大跌或与美国食品和药物管理局(FDA)近期宣布计划逐步取消单克隆抗体和其他药物的动物实验要求有关。

FDA在公告中表示,将通过一系列方法减少、优化或可能替代动物实验要求,包括基于AI的毒性和细胞系计算模型以及实验室环境中的类器官毒性测试。FDA称该方案将立即开始实施,适用于新药研究申请(IND),鼓励纳入新替代方法计划(NAMs)数据,并在同步发布的路线图中进行了概述。

昭衍新药在回应投资者时表示,公司股价大跌的确是与FDA发布的公告有关,但FDA的公告对公司影响不大。一方面,该政策已推出好几年,但进展比较缓慢;另一方面,目前在毒理测试中,AI和类器官技术替代不了试验猴,公司已布局AI和类器官,现阶段其技术不太成熟,公司在持续跟进中。

根据最新年报,药物非临床研究服务在2024年为昭衍新药贡献了19.17亿元的营收,占总营收比重近95%。由于市场竞争加剧,昭衍新药的药物非临床研究服务已比去年同期相比下降16.96%。对于医药合同研发(CRO)企业而言,拥有猴源的多寡是其核心竞争力的体现。在新药研发火热、猴价高涨之际,昭衍新药、康龙化成、药明康德、益诺思等皆以并购或入股上游供应企业的形式,锁定实验猴原材料成本。但随着市场泡沫逐渐消散,国内的猴价逐渐趋于理性。根据中国政府采购网公示的最新一轮实验猴招标公告,实验用猴中用量最大的品种食蟹猴已经跌破10万元/只。这也反映在昭衍新药的年报中,2024年的生物资产公允价值变动为其带来了1.14亿元的净损失。

据业内人士介绍,药物在动物实验上的安全性、有效性、和毒理数据,和人体临床研究的相关性其实不高。此外,动物实验花费高,实验周期长、动物实验室的管理和运营也相当繁琐。FDA的政策不是要彻底取消动物实验,而是鼓励更高效、更人道的替代方法。技术的进步必然带来大浪淘沙。从实验动物切换到器官芯片,这种转型考验每一家CRO公司。动物实验短期内仍将在药物开发复杂系统验证中保留一席之地,但替代技术的渗透率将逐年提升。这提醒CRO等相关企业加快构建“混合验证体系”,整合类器官、AI和有限动物实验,同时密切关注监管机构的政策动向。

中山大学药学院一位专家表示,在FDA新规指引下,非动物数据占比或将持续提升,未来可能形成“动物实验+替代技术”的混合验证体系。尽管完全替代仍面临复杂系统模拟的技术瓶颈,但相关企业需要未雨绸缪。对于制药公司而言,计算机模拟总归是要比动物实验要高效。革命性工具的出现意味着研发流程的重构和效率的提升。对于患者而言,这可能带来更多创新药物、更低的药价和更个性化的治疗方案。

广发证券的行业研究员认为,投资者需要重新审视产业链上的各个环节,关注那些能够提供创新替代方法的企业,因为它们将成为下一个增长的引擎。传统CRO公司也并非没有出路,关键在于能否及时转型,将AI、类器官等新技术纳入自身业务体系。

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