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礼来公司

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The U.S. Food and Drug Administration approved

美国食品和药物管理局批准了

Eli Lilly

礼来公司

's GLP-1 pill, the company said, a major milestone for the Indianapolis-based drugmaker and one that will test the market for new weight-loss medications.

该公司表示，其GLP-1药丸是这家总部位于印第安纳波利斯的制药公司的一个重要里程碑，这也将测试新型减肥药物的市场反应。

Lilly said the once-daily pill, Foundayo, will start shipping from direct-to-consumer platform LillyDirect on Monday and will be available at pharmacies and on telehealth platforms 'shortly after.' People with insurance coverage could pay $25 a month with a coupon from Lilly, while people paying out of pocket could pay between $149 and $349, depending on the dose.

莉莉表示，这款每日一次的药物 Foundayo 将于周一从直接面向消费者的平台 LillyDirect 开始发货，并将“很快”在药店和远程医疗平台上架。有保险的患者使用礼来提供的优惠券后每月只需支付 25 美元，而自费支付的患者根据剂量不同需支付 149 至 349 美元。

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The approval comes just a few months after Lilly submitted the drug to the FDA as part of a program that grants speedy reviews for drugs that are considered national priority interests. That means Lilly will introduce its Foundayo only about three months behind Novo Nordisk's

该批准是在礼来公司提交药物给FDA的仅仅几个月后，这是属于一个为被认为是国家优先利益的药物提供快速审查的计划。这意味着礼来公司将仅比诺和诺德的Foundayo晚推出约三个月。

Wegovy pill

Wegovy药片

, setting the stage for the next battle between the rival drugmakers in the next frontier for GLP-1 drugs.

，为这两家竞争对手在GLP-1药物的下一个领域中的下一场较量奠定了基础。

'It's a big moment,' Eli Lilly CEO Dave Ricks said in an interview with CNBC. 'We've obviously been working in this category of medicines for a while with the first GLP-1 medication 20 years ago and improving ever since. Here is an option that's not more effective ... but it's more accessible, it's easier to fit into your daily routine.'.

“这是一个重要的时刻，”礼来公司首席执行官戴夫·里克斯在CNBC的采访中表示。“显然，我们已经在这一类药物领域耕耘了一段时间，从20年前第一个GLP-1药物开始，并且一直在不断改进。现在这个选项不仅更有效……而且更容易获取，更容易融入日常生活。”

Lilly licensed the molecule, orforglipron, from Japanese drugmaker Chugai in 2018, paying just $50 million upfront for global rights to the drug. It doesn't produce as much weight loss as Lilly's best-selling shot Zepbound, which raises questions about how big the drug will become when millions of people seem content injecting themselves once a week.

2018年，礼来公司从日本制药商中外制药获得了该分子orforglipron的许可，仅支付了5000万美元的预付款就获得了该药物的全球权利。它产生的减重效果不如礼来最畅销的注射剂Zepbound，这引发了一个问题，即当数百万人似乎满足于每周注射一次时，这种药物的市场规模会有多大。

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Eli Lilly Foundayo GLP-1 Weight loss pill.

礼来公司发现GLP-1减肥药。

Courtesy: Eli Lilly

礼貌：礼来公司

Analysts estimate Foundayo sales will reach $14.79 billion by 2030, according to FactSet. That compares to expectations of $24.68 billion for the weight-loss drug Zepbound and $44.87 billion for Mounjaro, which is marketed for diabetes in the U.S. and obesity and diabetes in the rest of the world.

据FactSet数据，分析师预计Foundayo的销售额到2030年将达到147.9亿美元，相比之下，减肥药物Zepbound的预期销售额为246.8亿美元，而Mounjaro在美国市场用于糖尿病治疗、在其他地区同时用于肥胖和糖尿病治疗，其预期销售额为448.7亿美元。

Ricks said shots haven't been as big of a barrier to uptake as Lilly once thought they would be. He still sees Foundayo as an attractive option for people who would rather take a pill or who are searching for a lower price than the injectables.

里克斯表示，注射剂并没有像礼来公司曾经认为的那样成为阻碍使用的重大障碍。他仍然认为，对于那些更愿意服用药丸或寻找比注射剂更低价格的人来说，Foundayo是一个有吸引力的选择。

He sees it playing a role in maintenance, for people who achieve their goal weight with a shot and want to keep the weight off. And he sees Foundayo as a way to 'reach the planet' without manufacturing constraints or cold-chain requirements that come with Zepbound.

他看到它在维护方面发挥作用，适用于那些通过注射达到目标体重并希望保持体重的人。他还看到Foundayo作为一种“覆盖全球”的方式，没有Zepbound带来的生产限制或冷链要求。

Foundayo is a small molecule whereas Zepbound and Wegovy are peptides, which require more intensive manufacturing processes, a barrier Ricks thinks will hinder generic versions of Wegovy that have

Foundayo 是小分子，而 Zepbound 和 Wegovy 是肽类，需要更密集的生产工艺，里克斯认为这一障碍将阻碍 Wegovy 的仿制药版本。

recently launched

最近推出

in some other countries like India.

在印度等其他国家。

'[Foundayo] does allow for scalability, and that will allow us to launch this globally on the first instance,' Ricks said. 'So today, you can get the oral [Wegovy] in the U.S., but you really can't get it elsewhere. This will be marketed around the world. As soon as we have regulatory approvals, we essentially have as much scale as we need to supply the world with an oral GLP-1 inhibitor.' .

“[Foundayo]确实允许规模化，这将使我们能够在全球首次推出，”里克斯说。“所以今天，你可以在美国获得口服版[Wegovy]，但其他地方基本无法获得。这款药物将会在全球范围内销售。一旦我们获得监管部门的批准，我们基本上可以根据需要扩大规模，为全球提供口服GLP-1抑制剂。”

Lilly expects approval for Foundayo in more than 40 countries over the next year. The company since 2020 has invested more than $55 billion in manufacturing, which includes opening new sites and expanding existing plants to produce the pill.

礼来预计未来一年内将在超过40个国家获得福坦优的批准。自2020年以来，该公司已在生产方面投资超过550亿美元，其中包括开设新厂和扩建现有工厂以生产这种药物。

In the U.S., Lilly will compete with Novo's newly launched Wegovy pill. Early demand for that pill has been stronger than expected, with Novo reporting more than 600,000 prescriptions in March.

在美国，礼来将与诺和新推出的 Wegovy 药片竞争。该药片的早期需求比预期更为强劲，诺和公司报告称三月份的处方量超过了 60 万。

Novo CEO Mike Doustdar

诺沃首席执行官迈克·杜斯特达尔

told CNBC in February

二月告诉CNBC

that one of the earliest takeaways from the launch is that the pill appears to be expanding the obesity treatment market, drawing in new patients rather than converting existing ones from injections. Ricks agreed with that assessment and said Lilly doesn't care whether people take Foundayo or Zepbound.

该药物上市初期最引人注目的结果之一是，这种药片似乎正在扩大肥胖治疗市场，吸引新患者，而不是将现有患者从注射剂转换过来。里克斯同意这一评估，并表示礼来并不在乎人们选择服用福达优还是泽邦。

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'We want people to be on the medicine that meets their health goals,' Ricks said. 'If it has Lilly on the box, that's the goal we have.'

“我们希望人们使用能够满足他们健康目标的药物，”里克斯说。“如果盒子上有礼来的标志，这就是我们的目标。”

Novo plans to argue that the Wegovy pill is more effective than Foundayo. The Wegovy pill showed around 16.6% weight loss on average in a late-stage trial, while Lilly's oral drug caused roughly 12.4% on average in a separate study, when analyzing patients who stayed on treatment. Lilly's Zepbound has consistently shown it can help people lose more than 20% of their body weight.

诺和计划辩称，Wegovy药丸比Foundayo更有效。在一项晚期试验中，Wegovy药丸显示平均减重约16.6%，而礼来的口服药物在另一项研究中显示平均减重约12.4%，分析对象为坚持治疗的患者。礼来的Zepbound始终显示出可以帮助人们减掉超过20%的体重。

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Meanwhile, Lilly plans to tout the fact that Foundayo can be taken any time without any restrictions, while the Wegovy pill needs to be taken first thing in the morning on an empty stomach with only a few ounces of water.

同时，礼来公司计划大肆宣传 Foundayo 可以随时服用且没有任何限制，而 Wegovy 药丸则需要在早晨空腹时用少量水送服。

Where the two drugs are the same is the starting price. The lowest doses of both drugs will cost $149 for cash-paying customers thanks to

两种药物的相同之处在于起始价格。由于得益于某些因素，两种药物的最低剂量对于现金支付的客户来说都将花费149美元。

an agreement

协议

the companies struck with the Trump administration last fall. And price is the most important factor for patients, said Dr. Nidhi Kansal, an obesity medicine doctor at Northwestern Medicine.

去年秋天，这些公司与特朗普政府达成协议。西北医学中心的肥胖症医生尼迪·坎萨尔博士表示，对患者而言，价格是最重要的因素。

'Unfortunately, price is what is driving the decision making between clinicians and patients for these drugs because they're all excellent drugs and we have lots of options now, but it's still a financial decision at the end of the day,' Kansal said.

“不幸的是，价格是推动这些药物在临床医生和患者之间做出决策的因素，因为它们都是非常好的药物，我们现在有很多选择，但最终这仍然是一个财务上的决定，”Kansal 说。

The lower price point and the approachability of a pill versus a shot opens up the market to casually interested patients, said BMO Capital Markets analyst Evan David Seigerman. Seniors on Medicare will be able to access Foundayo and other GLP-1 obesity medicines for $50 a month starting this summer as part of Lilly and Novo's deals with the Trump administration.

BMO资本市场分析师埃文·戴维·塞格尔曼表示，较低的价格和药片相对于注射剂的易用性，使得市场向那些随意感兴趣的患者开放。今年夏天开始，作为礼来和诺和与特朗普政府达成的协议的一部分，使用Medicare的老年人将能够以每月50美元的价格获得Foundayo和其他GLP-1类肥胖症药物。

Ricks expects a 'pretty robust' response to the program, which Lilly built into its financial guidance for the year. .

里克斯预计该计划将获得“相当强劲”的响应，礼来公司已将其纳入今年的财务指导中。

Analysts say a successful launch of Foundayo is key to Lilly's stock recovering from recent weakness. The company's shares have fallen about 14% this year after a meteoric rise that briefly made Lilly the first trillion dollar market cap health-care company. Sales are a lagging indicator, so analysts will be tracking prescriptions to monitor uptake of the pill, said Cantor Fitzgerald analyst Carter Gould.

分析师表示，成功推出Foundayo对礼来公司股票从近期疲软中恢复至关重要。该公司股价在今年早些时候短暂成为首家市值达到一万亿美元的医疗保健公司后，今年已下跌约14%。康托·菲茨杰拉德分析师卡特·古尔德表示，销售是一个滞后的指标，因此分析师将追踪处方情况以监测该药的使用情况。

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'If scripts are going in the right direction, and you're seeing the continued gains, my guess is people will look through any sort of choppiness around [the first or second quarter],' Gould said.

“如果剧本朝着正确的方向发展，并且你看到持续的收益，我的猜测是人们会透过[第一季度或第二季度]的任何波动来看待，”戈尔德说。

Another factor for Lilly's performance this year is a forthcoming readout for its more potent obesity shot, retatrutide. The company has already shared some

今年礼来业绩的另一个因素是其更有效的减肥针剂retatrutide的即将发布的数据。该公司已经分享了一些相关信息。

late-stage data

晚期数据

on that drug, but the most important trial is one studying the treatment specifically for weight loss. If retatrutide lives up to its expectations, Lilly would be on its way to creating a portfolio of obesity medicines.

在这种药物上，但最重要的试验是研究该药物专门用于减肥的治疗。如果雷特鲁肽能达到预期效果，礼来公司将有望打造一系列肥胖症治疗药物。

'The future will be more choices, and that's a great thing,' Ricks said. 'And we hope Lilly is the one presenting those choices.'

“未来会有更多的选择，这是一件好事，”里克斯说。“我们希望莉莉是那个提供选择的人。”

Choose CNBC as your preferred source on Google and never miss a moment from the most trusted name in business news.

将CNBC设置为Google上的首选来源，不错过商业新闻最值得信赖的名字的任何时刻。