<p>Hims &amp; Hers Health 正在推出一种与诺和诺德新推出的肥胖药物相似的仿制药，开启了品牌减肥药制造商与药物配制商之间最新的争议战斗。</p>
<p>Hims 周四表示，现已允许医疗服务提供者开处方一种与诺和诺德的口服 Wegovy 相同活性成分的配制药物 semaglutide。该治疗方案的起始价格为每月 49 美元，比诺和诺德与特朗普政府达成的协议价格低 100 美元。Hims 还声称，其治疗方案的配方不同，并采用不同的给药方式，以保护活性成分在消化过程中的稳定性。</p>
<p>在回应 Hims 公告的声明中，诺和诺德发言人 Ambre James-Brown 称 Hims 的举动为 “非法的大规模配制和欺骗性广告”，并威胁采取法律行动。她表示，该配制商正在 “非法” 大规模营销一种 “未经批准、非正品且未经测试的仿制药”。</p>
<p>James-Brown 表示，这一推出 “对患者安全构成重大风险”。“诺和诺德将采取法律和监管行动，以保护我们的患者、我们的知识产权以及美国黄金标准药物审批框架的完整性。这是 Hims &amp; Hers 历史上欺骗美国公众的又一个例子，涉及仿制 GLP-1 产品，[食品药品监督管理局] 之前已警告他们关于其欺骗性广告的行为。”</p>
<p>周四晚上，在一条社交媒体帖子中，FDA 委员 Martin Makary 在没有具体提到任何配制商的情况下表示，该机构 “将迅速对大规模营销非法仿制药的公司采取行动，声称它们与 FDA 批准的产品相似。”</p>
<p>Makary 补充道：“FDA 无法验证未经批准药物的质量、安全性或有效性。”</p>
<p>在过去一年左右的时间里，配制药房利用法律漏洞，抓住了对 GLP-1 减肥药物的广泛需求。他们最初在 Wegovy 和礼来的竞争药物 Zepbound 短缺时开始生产低成本的仿制版本。但即使在之后，尽管面临 FDA 的诉讼和警告，这些努力仍在继续，公司利用量身定制的方法调整和个性化剂量，以寻求遵守既定法律。</p>
<p>药物配制商的存在对诺和诺德产生了特别大的影响，诺和诺德在美国的市场份额已不再领先于礼来。诺和诺德本周刚刚预测，2026 年的销售增长将下降，部分原因是包括药物配制商在内的竞争压力。这一披露抹去了数百亿的市场价值。</p>
<p>诺和诺德一直希望其 Wegovy 药丸能够成为解决方案的一部分。根据早期处方总数，这种上个月推出的药物正以历史上最快的制药推出速度发展。诺和诺德也寄希望于早期销售能够恢复势头，因为礼来的类似药物可能在第二季度获得批准。</p>
<p>Hims 周四的公告对这些计划造成了打击，使其股票以及礼来的股票下跌超过 6%。但诺和诺德努力区分其产品，指出它是 “唯一” 制造 FDA 批准产品的公司，而配制版本 “可能含有杂质、不必要的添加剂和未经测试的剂量”。</p>
<p>瑞银证券分析师 Michael Yee 在周四给客户的报告中指出了这些差异。配方的差异使得 “尚不清楚” 药物在体内的吸收情况以及可能出现的副作用类型。</p>
<p>根据 Yee 的估计，配制处方约占 100 万份，而他公司估计诺和诺德和礼来的 GLP-1 产品线的处方总数约为 1 亿份。他表示：“口服 Wegovy 的动态可能需要进一步发展，诺和诺德还需采取其他措施。” 但他补充说，尽管存在配制的注射型 GLP-1 药物，礼来迄今为止仍能持续超出预期。</p>
<p><em>编辑注：此故事已更新，包含 Martin Makary 的评论。</em></p>

LLYZ

礼来

2 倍做多 HIMS ETF - Defiance

<p>Hims & Hers Health 推出了一款模仿诺和诺德公司肥胖药物 Wegovy 的版本，使用相同的活性成分 semaglutide，但价格更低。诺和诺德对此举表示批评，称其为非法行为，并对患者安全构成威胁，威胁采取法律行动。FDA 已警告针对非法仿制药，强调未经批准的药物风险。此次推出对诺和诺德和礼来的股价产生了负面影响，因为诺和诺德的市场份额受到复合药房的影响。分析师指出，与 FDA 批准的产品相比，复合药物存在潜在的风险和不确定性</p>

<p>Hims &amp; Hers Health is launching a copycat form of Novo Nordisk’s newly launched obesity pill, ushering in the latest contentious battle between the makers of branded weight loss medications and their drug-compounding counterparts.</p>
<div class="lb-trans"><p>Hims &amp; Hers Health 正在推出一种与诺和诺德新推出的肥胖药物相似的仿制药，开启了品牌减肥药制造商与药物配制商之间最新的争议战斗。</p>
</div><p>Hims said Thursday that it’s now enabling healthcare providers to prescribe a compounded pill with the same active ingredient, semaglutide, as Novo Nordisk’s oral Wegovy. That treatment will be sold as part of treatment plans that begin at $49 for the first month — $100 lower than the price Novo is charging under a deal with the Trump administration. Hims also claimed that its treatment is formulated differently and involves a different delivery method to protect the active ingredient during digestion.</p>
<div class="lb-trans"><p>Hims 周四表示，现已允许医疗服务提供者开处方一种与诺和诺德的口服 Wegovy 相同活性成分的配制药物 semaglutide。该治疗方案的起始价格为每月 49 美元，比诺和诺德与特朗普政府达成的协议价格低 100 美元。Hims 还声称，其治疗方案的配方不同，并采用不同的给药方式，以保护活性成分在消化过程中的稳定性。</p>
</div><p>In a statement issued in response to Hims’ announcement, Novo spokesperson Ambre James-Brown called Hims’ move “illegal mass compounding and deceptive advertising” and threatened litigation. The compounder is “unlawfully” mass-marketing an “unapproved, inauthentic, and untested knockoff” of Novo’s medication, she said.</p>
<div class="lb-trans"><p>在回应 Hims 公告的声明中，诺和诺德发言人 Ambre James-Brown 称 Hims 的举动为 “非法的大规模配制和欺骗性广告”，并威胁采取法律行动。她表示，该配制商正在 “非法” 大规模营销一种 “未经批准、非正品且未经测试的仿制药”。</p>
</div><p>The launch “poses a significant risk to patient safety,” James-Brown said. “Novo Nordisk will take legal and regulatory action to protect our patients, our intellectual property and the integrity of the U.S. gold-standard drug approval framework. This is another example of Hims &amp; Hers’ historic behavior of duping the American public with knockoff GLP-1 products, and the [Food and Drug Administration] has previously warned them about their deceptive advertising of GLP-1 knockoffs.”</p>
<div class="lb-trans"><p>James-Brown 表示，这一推出 “对患者安全构成重大风险”。“诺和诺德将采取法律和监管行动，以保护我们的患者、我们的知识产权以及美国黄金标准药物审批框架的完整性。这是 Hims &amp; Hers 历史上欺骗美国公众的又一个例子，涉及仿制 GLP-1 产品，[食品药品监督管理局] 之前已警告他们关于其欺骗性广告的行为。”</p>
</div><p>In a social media post Thursday night, FDA commissioner Martin Makary, without naming any specific compounders, said the agency “will take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products.”</p>
<div class="lb-trans"><p>周四晚上，在一条社交媒体帖子中，FDA 委员 Martin Makary 在没有具体提到任何配制商的情况下表示，该机构 “将迅速对大规模营销非法仿制药的公司采取行动，声称它们与 FDA 批准的产品相似。”</p>
</div><p>“The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs,” Makary added.</p>
<div class="lb-trans"><p>Makary 补充道：“FDA 无法验证未经批准药物的质量、安全性或有效性。”</p>
</div><p>Over the last year or so, compounding pharmacies have used legal loopholes to capitalize on the widespread demand of GLP-1 medicines for weight loss. They first began producing lower-cost, copycat versions of injectable Wegovy and Eli Lilly’s rival Zepbound when those drugs were in shortage. But even afterwards and despite lawsuits and warnings from the FDA, those efforts have continued, with companies using tailored methods of titrating and personalizing doses to seek to comply with established law.</p>
<div class="lb-trans"><p>在过去一年左右的时间里，配制药房利用法律漏洞，抓住了对 GLP-1 减肥药物的广泛需求。他们最初在 Wegovy 和礼来的竞争药物 Zepbound 短缺时开始生产低成本的仿制版本。但即使在之后，尽管面临 FDA 的诉讼和警告，这些努力仍在继续，公司利用量身定制的方法调整和个性化剂量，以寻求遵守既定法律。</p>
</div><p>The presence of drug compounders has been particularly impactful on Novo, which has ceded its once-leading market share in the U.S. to Lilly. Novo just this week predicted a decline in sales growth in 2026, in part due to competitive pressures that include drug compounders. That disclosure erased tens of billions in market value.</p>
<div class="lb-trans"><p>药物配制商的存在对诺和诺德产生了特别大的影响，诺和诺德在美国的市场份额已不再领先于礼来。诺和诺德本周刚刚预测，2026 年的销售增长将下降，部分原因是包括药物配制商在内的竞争压力。这一披露抹去了数百亿的市场价值。</p>
</div><p>Novo has been hoping that its Wegovy pill could be part of the solution. By early prescription totals, the drug, which was launched last month, is off to the fastest pharmaceutical launch in history. Novo is counting on early sales to gain back momentum, too, as a similar pill from Lilly could be approved in the second quarter.</p>
<div class="lb-trans"><p>诺和诺德一直希望其 Wegovy 药丸能够成为解决方案的一部分。根据早期处方总数，这种上个月推出的药物正以历史上最快的制药推出速度发展。诺和诺德也寄希望于早期销售能够恢复势头，因为礼来的类似药物可能在第二季度获得批准。</p>
</div><p>The announcement by Hims on Thursday put a dent in those plans, sinking its shares, as well as Lilly’s, by more than 6%. But Novo took pains to differentiate its product, noting how it’s the “only” company that manufactures an FDA-approved product and the compounded version “may contain impurities, unnecessary additives, and untested doses.”</p>
<div class="lb-trans"><p>Hims 周四的公告对这些计划造成了打击，使其股票以及礼来的股票下跌超过 6%。但诺和诺德努力区分其产品，指出它是 “唯一” 制造 FDA 批准产品的公司，而配制版本 “可能含有杂质、不必要的添加剂和未经测试的剂量”。</p>
</div><p>UBS Securities analyst Michael Yee pointed to those differences in a note to clients Thursday. The differences in formulation leave “unclear” how the drug is absorbed by the body and what type of side effect profile might occur as a result.</p>
<div class="lb-trans"><p>瑞银证券分析师 Michael Yee 在周四给客户的报告中指出了这些差异。配方的差异使得 “尚不清楚” 药物在体内的吸收情况以及可能出现的副作用类型。</p>
</div><p>According to Yee’s estimates, compounding prescriptions account for some 1 million of prescriptions compared to the 100 million or so his firm estimates being written across Novo and Lilly’s GLP-1 franchises. “The oral Wegovy dynamic might need to play out and other efforts on behalf of Novo,” he said, but added that Lilly so far has been able to consistently outperform expectations despite the presence of compounded, injectable GLP-1 drugs.</p>
<div class="lb-trans"><p>根据 Yee 的估计，配制处方约占 100 万份，而他公司估计诺和诺德和礼来的 GLP-1 产品线的处方总数约为 1 亿份。他表示：“口服 Wegovy 的动态可能需要进一步发展，诺和诺德还需采取其他措施。” 但他补充说，尽管存在配制的注射型 GLP-1 药物，礼来迄今为止仍能持续超出预期。</p>
</div><p><em>Editor’s note: This story has been updated with comments from Martin Makary.</em></p>
<div class="lb-trans"><p><em>编辑注：此故事已更新，包含 Martin Makary 的评论。</em></p>
</div>

Novo, Lilly sputter as Hims launches knockoff GLP-1 pill

biopharmadive

Defiance Daily Target 2X Short LLY ETF

2 倍做多 NVO ETF - Defiance

1 倍做空 LLY ETF - Direxion

诺和诺德公司

2 倍做多 LLY ETF - Direxion

TrueShares Structured Outcome Nov ETF

Hims & Hers Health

美国制药 ETF - iShares

2 倍做多 LLY ETF - Defiance

医疗业 ETF - Vanguard

Defiance Leveraged Long +Income HIMS ETF

诺和诺德公司和礼来公司表现不佳，因为 Hims 推出了仿制的 GLP-1 药丸