礼来紧急警示风险！替尔泊肽与维生素B12混合被曝产生未知杂质_老虎社区_美港股上老虎

礼来紧急警示风险！替尔泊肽与维生素B12混合被曝产生未知杂质

21世纪经济报道03-12 18:50

3月12日，全球制药巨头礼来公司（Eli Lilly）发布了一项关乎无数使用者安全的公开警示：其明星降糖/减重药物替尔泊肽（Tirzepatide）在与维生素B12混合后，经检测发现了含量显著的未知杂质。　　这一发现不仅让打着“个性化”旗号盛行的复合药物安全性受到严峻拷问，也凸显了监管灰色地带对患者构成的潜在危险。　　礼来在声明中指出，公司对在美国市场销售、含替尔泊肽与B12（包括甲钴胺、羟钴胺或...

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Tilpotide mixed with vitamin B12 was exposed to produce unknown impurities","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"ELIL":0.6,"ELIS":0.6,"LLY":1.98,"LLYX":0.6,"LLYZ":0.6,"LLII":0.6},"content_text":"3月12日，全球制药巨头礼来公司（Eli Lilly）发布了一项关乎无数使用者安全的公开警示：其明星降糖/减重药物替尔泊肽（Tirzepatide）在与维生素B12混合后，经检测发现了含量显著的未知杂质。　　这一发现不仅让打着“个性化”旗号盛行的复合药物安全性受到严峻拷问，也凸显了监管灰色地带对患者构成的潜在危险。　　礼来在声明中指出，公司对在美国市场销售、含替尔泊肽与B12（包括甲钴胺、羟钴胺或氰钴胺）的复合产品开展了专项检测。结果发现，替尔泊肽与B12发生了化学反应，生成了令人担忧的杂质。目前，该杂质对人体的短期与长期效应、对药物原本结合GLP-1和GIP受体的影响、毒性、免疫反应，以及在人体内的吸收、分布、代谢和排泄途径均为未知。　　“替尔泊肽从未与B12联用开展过任何临床研究，且生产这些复方药物的复配药房无需监测或上报不良事件，”礼来在警示中强调，“因此，从复配药房、远程医疗公司、医疗SPA或其他渠道使用这类产品的患者，正在暴露于完全未知的风险之中。”　　礼来此次的警示并非孤立事件。公司发现，B12只是大规模生产复合GLP-1药物时使用的众多未经测试的添加剂之一。为了规避法律并打着“个性化”的幌子，一些大规模配药房和所谓“个性化”服务商还将替尔泊肽与甘氨酸、吡哆醇（维生素B6）、烟酰胺（维生素B3）、肉碱或其他化学物质随意混合，制造出一系列未经任何安全性测试的新型复合药物。　　礼来指出，这些添加剂对服用替尔泊肽的患者没有任何经过证实的临床获益，而由此产生的复合药物却给患者带来了完全未知的风险。　　此外，礼来在持续监测中还发现，复合替尔泊肽仿制品中存在更严重的安全问题，包括细菌污染、高内毒素水平以及礼来公司FDA批准药品中不存在的其他杂质。　　目前，礼来已将上述发现通报美国食品药品监督管理局（FDA），并强烈建议正在使用此类未经检测产品的患者立即联系医生，咨询并讨论替代治疗方案。　　有券商医药行业分析师对21世纪经济报道记者表示，此次事件不仅对依赖复合药物的患者构成直接威胁，也为整个远程医疗和医美行业敲响警钟。随着GLP-1类药物需求激增，复合药物市场迅速膨胀，但其监管却远未跟上。礼来的发现或将推动FDA对复合药物生产采取更严厉的审查，也可能引发一波相关的法律责任追究。　　根据礼来此前发布的2025年第四季度及全年财务业绩，全年总营收达到651.79亿美元，按固定汇率计算同比增长44%。这一业绩的关键在于其GLP-1药物替尔泊肽（商品名包括降糖版Mounjaro和减重版Zepbound）全年贡献了365亿美元收入。　　其中，降糖版替尔泊肽（Mounjaro）全年销售额达到229.65亿美元，同比增长99%；减重版替尔泊肽（Zepbound）全年收入达到135.42亿美元，同比增长175%，两者合计为礼来贡献了365亿美元收入。第四季度，Mounjaro营收达到74.1亿美元，同比增长110%；Zepbound实现42.6亿美元营收，同比增长123%，增长主要由美国市场驱动。　　当前全球GLP-1市场已形成诺和诺德与礼来双雄争霸的格局，2024年两家公司相关产品合计收入已接近500亿美元。诺和诺德2025年营收约为489亿美元，其中司美格鲁肽全系药物贡献了361亿美元销售额。　　另据医药魔方Nextpharma数据库统计，全球共有88款在研小分子GLP-1药物，其中6款已经开展Ⅲ期临床试验，包括礼来的orforglipron、恒瑞医药的HRS-7535等。目前，中国制药企业正加速布局GLP-1仿制药和改良新药，全球GLP-1市场的竞争将进入更加多元化的新阶段。　　此外，日前辉瑞也公布了旗下超长效GLP-1R激动剂PF'3944（MET-097i）的减重IIb期VESPER-3研究结果。PF'3944是Metsera（已被辉瑞收购）开发的一种同类首创的完全偏向、超长效GLP-1受体激动剂（GLP-1RA），具有每月注射1次的给药潜力。　　业内普遍判断，GLP-1赛道的竞争将围绕疗效提升、给药便利性、价格可及性和适应症拓展等多个维度全面展开。　　“对于投资者而言，这一事件短期内可能引发市场对替尔泊肽供应链及仿制版本的担忧，但长期来看，也进一步巩固了通过严格临床试验获得批准的原创药物的安全性与不可替代性。”前述分析师指出，礼来此举不仅是在履行其对患者安全的承诺，也在无形中划清了合规创新药与高风险仿制复合产品之间的界限。（文章来源：21世纪经济报道）","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"-1","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"hasMoreComments":false,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"isCrawlerRequest":true}