巨头之战：礼来口服减肥药获批，诺和诺德抛出数据回应

21世纪经济报道04-03

4月3日，就在礼来（Eli Lilly）宣布其口服小分子GLP-1药物Orforglipron（商品名：Foundayo）获得FDA批准仅两天后，诺和诺德（Novo Nordisk）迅速发起了反击。　　这家丹麦制药巨头宣布将在肥胖医学协会年会上公布ORION研究结果。这项间接治疗比较研究显示，其口服版Wegovy（司美格鲁肽片剂25 mg）在减重效果和胃肠道耐受性方面，均显著优于刚刚获批的礼来竞品...

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mg）在减重效果和胃肠道耐受性方面，均显著优于刚刚获批的礼来竞品Orforglipron。　　有券商医药行业分析师对21世纪经济报道记者表示，目前口服GLP-1的竞争已从“诺和诺德单点领先”升级为“礼来追赶+全面对标”的格局。　　“小分子路线在成本和规模化生产上潜力巨大，未来，谁能实现‘高质量+低成本+稳供应’，谁就能掌握市场主动权。”该分析师说。　　这场隔空交锋，正式将全球制药界最吸金的GLP-1赛道从“注射时代”推入了“口服时代”。而随着两大巨头的战火蔓延至口服剂型，一场围绕技术路线、市场定位、产能供应及患者体验的全方位竞赛，已经进入白热化阶段。　　审批竞速　　2025年12月22日，诺和诺德的口服减重版司美格鲁肽在美国获批，成为首款口服GLP-1肥胖治疗药物，率先抢占市场。其上市首周处方量即达1.8万张，远超预期，证明了口服减重药巨大的市场潜力。　　在此情况下，礼来奋起直追，于4月1日，凭借一张特殊的“局长国家优先审评券”（CNPV），创下了自2002年以来新分子实体获批速度的纪录。从提交申请到获批仅用50天，较法定最晚审评日提前了294天。　　Orforglipron的获批不仅标志着全球肥胖症治疗正式迈入小分子口服时代，更意味着礼来与诺和诺德在口服减重药市场正式打响博弈战。　　据礼来方面披露，此次FDA获批主要基于在ATTAIN系列临床研究，证明了orforglipron能帮助肥胖或者伴体重相关合并症的超重患者减轻体重并维持减重效果。　　在ATTAIN-1研究中，持续接受最高剂量orforglipron治疗的参与者，平均减重12.4kg（12.4%），而安慰剂组平均减重1.0kg（0.9%）。无论是否完成试验，orforglipron组参与者平均减重11.3kg（11.1%），而安慰剂组平均减重2.4kg（2.1%）。此外，ATTAIN系列临床研究还显示，orforglipron在所有剂量组中均降低了多项心血管风险指标，包括腰围、非高密度脂蛋白胆固醇、甘油三酯和收缩压。　　礼来方面披露，目前已开展 7 项 Orforglipron 针对肥胖及 2 型糖尿病的Ⅲ期临床研究，全球累计入组患者逾万人。其中，中国患者参与了 6 项全球多中心研究，为全面评估药物在不同人群中的安全性和有效性提供了重要数据支持。　　此外，礼来已向国家药品监督管理局提交orforglipron用于治疗2型糖尿病与肥胖症的上市申请。2026年3月11日，礼来宣布计划未来十年累计投资30亿美元全面扩展在华供应链产能，打造口服固体制剂本土生产与供应体系，着力布局首个申报注册的口服小分子 GLP 1 RA orforglipron 的生产能力。　　机构普遍预测，到2030年，全球减重药市场有望突破1000亿美元，其中口服药占比将达24%-32%（约220-380亿美元）。而从目前形势来看，诺和诺德与礼来这两家公司的口服产品各有侧重，尚未出现绝对的赢家，形成了差异化的竞争格局。　　“隔空回应”　　不过，面对礼来的来势汹汹，诺和诺德迅速将战火拉回到了自己最擅长的领域——临床数据。　　4月3日发布的ORION研究结果，是针对礼来Orforglipron的“精准打击”。这项基于3期OASIS 4和ATTAIN-1临床试验数据的间接比较研究显示，在减重幅度上，司美格鲁肽片剂25 mg实现了显著更大的体重降幅，平均差异达到-3.2个百分点。而在安全性这一患者核心痛点——胃肠道耐受性上，诺和诺德给出的数据更具冲击力：与司美格鲁肽相比，Orforglipron因任何不良事件而中止治疗的发生几率高出约4倍，因胃肠道不良事件中止治疗的几率高出约14倍。　　诺和诺德美国运营部执行副总裁Jamey Millar表示：“这些研究进一步丰富了支持司美格鲁肽临床实力的证据体系，同时突出了患者在选择契合自身生活方式的肥胖治疗药物时所看重的关键特征。自Wegovy®片剂获批以来，我们观察到医疗卫生专业人士以及有肥胖治疗需求的人群均对其保持关注，凸显了我们持续通过不懈创新推动肥胖症治疗领域进步的重要性。”　　实际上，这场围绕口服药的攻防战早在审批前就已埋下伏笔。　　在2025年9月公布的一项针对2型糖尿病患者的头对头研究中，礼来曾公布数据显示Orforglipron在控糖和减重两方面均完胜口服司美格鲁肽。当时的数据显示，Orforglipron 36mg组平均减重9.2%（8.9kg），而口服司美格鲁肽14mg组仅减重5.3%（5.0kg）。　　“如今，诺和诺德通过新的间接比较模型，试图向市场传递一个信息：虽然你的服药更方便，但我的药效更强、肠胃更友好。”前述分析师说，适应症的广度也决定了未来的天花板。目前，除了在疗效上较劲，诺和诺德与礼来都在全力拓展其产品的适应症版图，覆盖心血管疾病、肾脏疾病、睡眠呼吸暂停，甚至阿尔茨海默症。　　“谁能在更多的疾病领域证明其价值，谁就能在医保支付和临床处方中占据主导。”该分析师说，诺和诺德暂时在“疗效-耐受性”上占优，而礼来则在“使用便利性”上构筑了差异化壁垒。未来竞争的关键在于如何在保持疗效和安全性的前提下，持续优化用药体验。　　本土“抢位战”　　对于礼来与诺和诺德而言，围绕双方的疗效战、产能战与成本战一直存在。　　例如，在定价策略上，双方也试图拉开差距。诺和诺德此前为口服Wegovy制定了极具攻击性的起售价——每月149美元，显著低于注射版。目前礼来尚未公布最终定价，但礼来想要抢占市场压力也存在，需要在价格层面下探空间。一旦价格战开打，谁胜谁负也需市场验证。　　而大洋彼岸的双雄对决，也正在深刻影响中国市场的生态格局。作为全球最大的消费市场之一，中国不仅是两家巨头的必争之地，也孕育出了一批具备竞争力的本土挑战者。　　在口服GLP-1领域，中国企业并未缺席。数据显示，国内已有不少于15家药企布局了GLP-1口服制剂赛道。例如，恒瑞医药的HRS-7535是一种新型口服小分子GLP-1R激动剂，已获临床试验批准，拟用于高血压合并超重或肥胖治疗。此外，华东医药的口服小分子GLP-1受体激动剂HDM1002，其体重管理适应症已进入中国临床Ⅲ期研究，预计2026年第三季度获得顶线数据。　　罗氏、阿斯利康、默沙东等跨国药企也正通过收购、BD（商务拓展）等方式加速布局，口服赛道正从“双雄争霸”演变为“群雄逐鹿”。例如，复星医药将自主研发的口服小分子GLP-1受体激动剂YP05002的全球权益授予辉瑞，潜在总金额超20亿美元。　　随着口服剂型的普及，GLP-1赛道的竞争维度正在发生质变。　　首先，竞争焦点从“单纯的减重幅度”转向“长期体重维持”和“身体组分改善”。例如，“减脂增肌”成为新热点。GLP-1类药物常见的副作用是伴随脂肪流失的肌肉量下降。目前，包括来凯医药在内的多家公司正在研发二代产品，试图在减重的同时保住肌肉，提高减重质量。　　2026年的春天，随着礼来Orforglipron的闪电获批与诺和诺德的数据反击，全球减肥药市场正式进入了“口服双雄”时代。　　对于患者而言，这是最好的时代——他们不再需要面对针头，有了更多样的选择，且价格有望在竞争中日渐亲民。对于产业而言，这是一场没有硝烟的残酷战争，谁能在这场战中取胜，也需市场验证。（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":"0","news_tag":"","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 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