Tirzepatide

Wikimedia /White House The Trump administration’s ever-changing tariffs and Most Favored Nation drug pricing are part of a blizzard of unclear, potentially illegal tactics that leave observers throwing their hands in the air. Never before has the pharmaceutical industry had to consider international trade agreements in its daily business. The matter was settled in 1994, until Donald Trump returned to the White House with a blizzard of confusing policy proposals, from tariffs to Most Favored Nation Drug pricing. This has left the industry in a collective state of confusion. But instead of adding up individually, experts say Trump’s policies are like levers being pulled to achieve a different goal: a trade war. “I had never considered, nor had to consider, the impact of tariffs on pharmaceuticals of any kind on the U.S., or the E.U., or Switzerland, or Canada for that matter, because of the Pharma Agreement ,” Barry Appleton, an international trade lawyer at Appleton & Associatestold BioSpace in an interview. In 1994, World Trade Organization Member states the U.S., European Union., Canada, U.K., Switzerland, Norway, Japan, and Macao all signed a “zero-for-zero initiative” that eliminated tariffs on pharmaceutical products and ingredients for all signatories. The U.S. in 2025 is still a signatory to that agreement. “The U.S. has signed on to this agreement saying that they would not do this,” Appleton said, referring to Trump’s pharmaceutical tariffs. “That agreement is still there, the U.S. is just ignoring it. I can understand why pharma companies don’t know what to do. I can’t believe we’re having this conversation. It’s kind of like Alice down the rabbit hole.” Monet Stanford, senior vice president for health care policy at the financial intelligence firm CFRA, agreed, suggesting that the tariffs are a way to move the broader global trade war forward by leveraging pharmaceutical companies. “The threat of MFN is a tool for a geopolitical trade conversation,” Stanford told BioSpace in an interview. “And that’s where tariffs come in.” Stanford pointed to companies based in Ireland and Switzerland, where corporate tax rates are friendlier than in the U.S., as an example. If these companies don’t want to change their prices to align with MFN, the U.S. might then step in and place a tariff on those countries instead. “[A company that] previously exported a drug on a 12.5% corporate tax rate now has a tariff slapped on top of that. It basically equals what the new U.S. corporate tax rate is. Does that change your calculus as a pharma?” Stanford asked. Corporate tax havens like Ireland are critical to pharmaceutical trade policy. There, large pharma companies can shield themselves from more onerous corporate tax rates in the U.S., even making manufacturing cheaper for those companies. Novo Nordisk’s Wegovy or Eli Lilly’s Zepbound are so popular, for instance, that the manufacturers have been loading planes with $36 billion worth of peptides and hormones that take off from Ireland bound for the U.S. in an effort to stockpile cheap ingredients before tariffs potentially hit. At this point, the U.S.’s trade deficit with Ireland is second only to China’s. I can understand why pharma companies don’t know what to do. I can’t believe we’re having this conversation. It’s kind of like Alice down the rabbit hole. Barry Appleton, Appleton & Associates If anything, according to observers like Stanford and Appleton, the threat of tariffs and MFN pricing might, at best, induce companies to alter their tax practices, or at worst, unilaterally stop selling critical drugs in nations that desperately need them. In late July, Trump sent letters to 17 Big Pharmas like Lilly, Pfizer and AbbVie, asking them to extend MFN drug pricing to Medicaid recipients. That demand is hard to understand, according to Stanford, “because there’s already the best price in Medicaid.” Medicaid has a Best Price Rule in place where recipients get the lowest possible price for a drug. Instead, it may end up harming patients in other countries. For instance, in a scenario posed by Appleton, if GSK, one of the recipients of Trump’s 17 letters, decided that it did not want to reduce the price of its HIV PrEP drug cabotegravir, it could withdraw that drug from countries like Rwanda, where the drug is offered for free , in order to avoid lowering its prices in the U.S. Experts believe there are other more realistic and applicable policy avenues that the administration could pursue to more directly target pharma companies and drug prices. Brad Setser, a senior fellow at the Council on Foreign Relations, told BioSpace in an interview that a better, more realistic target would be to close the tax incentive for “roundtripping,” the practice of pharma companies routing revenue from sales of products in the U.S. through internationally-based subsidiaries, essentially offshoring profits and avoiding U.S. corporate taxes. Removing that loophole would potentially reshore billions in lost tax revenue back to the U.S. A group of Democratic senators introduced a bill in June to close that loophole, though it hasn’t advanced. “That would have been a very sensible thing to do from the Trump admin’s perspective,” Setser said, “I was disappointed that it wasn’t a part of the [One Big Beautiful] tax bill.” With so much uncertainty, some companies are already making moves in response, even as significant questions remain as to the legality of these tactics and enforcement capabilities. Eli Lilly announced on Aug. 14 that it would raise prices on its drugs in the EU in response to MFN drug pricing in the U.S., even though doing so wouldn’t lower or even effect prices in the U.S. It’s becoming a battle between nations, where the U.S. is acting as an aggressor, using the country’s inherent advantage as a large, wealthy market to pressure pharmaceutical companies and, in turn, other nations. “It’s a type of ‘policy laundering,’” Appleton said, “where we’re essentially assaulting other countries’ drug prices. Yes, the US may get lower prices, but the cost will be to create unbelievably bad relations with a lot of countries all over the world.”

来源：经济观察网 作者：王丽颖 8月以来，各大跨国药企（MNC）已经相继公布2025年上半年成绩单。强生(Johnson & Johnson)以456.36亿美元营收领跑，罗氏、默沙东依然位列前三。礼来凭借火爆的减重产品替尔泊肽实现业绩增长41%，一举跳跃至第六位。整体看，你追我赶的激烈竞争态势明显。 专利悬崖下的亮眼成绩单 未来几年，将有近200种药物失去专利保护，其中包括至少69种年销售额超10亿美元的重量级药物。这些专利悬崖对跨国药企的业绩冲击很大，预计累计损失销售额会超过3000亿美元。而这也是今年以来，跨国药企疯狂在中国创新药领域“淘金”的缘故。 根据药时代统计，MNC面临专利悬崖的百亿级别药物共计9款，包括辉瑞的阿哌沙班、默沙东的K药、BMS的O药、强生的达雷妥尤单抗、赛诺菲的度普利尤单抗、诺和诺德的司美格鲁肽、艾伯维的利生奇珠单抗、礼来的替尔泊肽以及Vertex的Trikafta。然而，即便压力较大，但是营收排名前十的企业在2025年上半年依然有很多亮点值得剖析。 根据已公布的数据，按照营收高低排名依次是：强生、罗氏、默沙东、艾伯维、辉瑞、礼来、阿斯利康、诺华、拜耳、诺和诺德、BMS。与2024年排名相比，营收前三甲依然是强生、罗氏、默沙东。第四名至第八名的药企营收很接近，竞争较为激烈。 领跑者强生：双引擎提速 今年上半年，强生在全球斩获456.36亿美元收入，同比增长4.1%。其中，创新药板块收入290.75亿美元，同比增长3.6%；医疗科技板块收入165.61亿美元，同比增长5.0%。总体看，二季度业绩增长较快。 强生董事会主席兼首席执行官杜安卿（Joaquin Duato）表示，第二季度业绩出色得益于创新药板块和医疗科技双引擎得天独厚的综合实力。基于上半年业绩表现，强生上调了今年全年的经营收入指引，预计为927美元至931亿美元，同比增长4.5%-5%。 强生的创新药产品主要涵盖肿瘤、免疫、神经科学、肺动脉高压、感染性疾病、心血管与代谢等领域。上半年肿瘤业务一马当先，为强生带来119.9亿美元的收入，同比增长21.1%。这些收入主要来自于达雷妥尤单抗（Darzalex）、阿帕他胺（Erleada）和伊布替尼（Imbruvica），三者分别录得67.76亿美元、16.79亿美元、14.44亿美元的收入。 失意者默沙东：启动瘦身计划 上半年，默沙东总营收为313.35亿美元，同比下降2%。默沙东制药业务收入276.88亿美元，同比下降3%。其中，中国区收入同比下滑70%至10.75亿美元，占据默沙东全球制药业务3.9%的份额。“药王”帕博利珠单抗（Keytruda）的销售额达151.61亿美元，不过增势已趋缓，同比增长7%。另一核心产品HPV疫苗Gardasil/Gardasil 9上半年销售额为24.53亿美元，同比下降48%。 值得注意的是，默沙东还在半年报公布之际宣布启动一项新的多年期优化计划，旨在通过生产力行动预计每年节省30亿美元的成本来实现其产品组合的转型，这些成本将全部再投资以支持新产品的发布及其跨多个治疗领域的产品线。 未来五年，默沙东的K药、西格列汀/二甲双胍、来特莫韦等重磅产品均将面临专利悬崖，如何找到“接班”产品对默沙东而言至关重要。根据近两年的BD交易金额发现，默沙东共计338亿美元牵手科伦博泰与第一三共，重金押入ADC领域。这意味着默沙东将继续为K药续命，所以对联合疗法重重加码。 黑马礼来：“药王”之争正酣 上半年，礼来营收达282.862亿美元，同比增长41%。中国市场收入9.17亿美元，同比增长20%。其中，降糖版替尔泊肽Mounjaro同比增长85%至90.407亿美元。减肥版替尔泊肽Zepbound在上半年大卖56.933亿美元，增速高达223%。 “药王”之争从未如此激烈。就在一季度业内普遍预期诺和诺德的司美格鲁肽将问鼎“药王”宝座时，二季度礼来却后发制胜，上半年两款替尔泊肽总销售额达到了147.34 亿美元，几乎追平司美格鲁肽上半年的166.83 亿美元总收入。按此强劲势头，替尔泊肽极有可能卫冕2025年度“药王”桂冠。 狠人阿斯利康：中国区“榜一大哥” 年初还在“风暴中心”的阿斯利康算是自救成功了，重仓中国让其起死回生。上半年总营收280.45亿美元，同比增长11%。其中，中国区营收为35.15亿美元，增长5%，成为2025年上半年中国区营收“榜一大哥”。 进入2025年，医药领域资本寒冬、国谈集采、医疗反腐升级以及特朗普政府的关税政策调整等多重因素交织，多家MNC公司中国区业务增速下滑。不过，在遇到成长的烦恼时，跨国药企并未选择放弃，而是更加重视在华市场，并纷纷调整了发展战略。 最为显著的变化是，今年上半年MNC增加了与国内创新药企的合作节奏，对外BD（商务拓展）异常火爆。据统计，2025上半年，已达成52项出海交易，其中18项总额超10亿美元，披露的总金额超过647亿美元。 近半年多来，阿斯利康中国架构至少已经进行4次调整。一方面，大刀阔斧改革中国区业务架构。另一方面，加速与中国创新药企合作开发未来重磅药物。目前阿斯利康居2025中国区BD交易榜首，总共完成4笔BD交易。 惯性增长的旧时代已经过去，相比阿斯利康的快速增长，罗氏制药在中国区的增速也高达9%；诺华次之，增速为8%；赛诺菲中国区业绩增速仅0.1%，部分原因是受全球原料供应问题，以及公司心血管市场策略和管线优化；诺和诺德排名上移，14.62亿美元的营收仅次于赛诺菲；礼来则是以19%的高增速，领涨头部MNC。 MedTrend医趋势分析称，MNC在中国区的格局正在悄然发生变化。运营多年的成熟产品出现战略性撤退，比如默沙东的HPV疫苗销售大滑坡，赛诺菲降脂药波立达也选择退出中国市场。相比之下，在未来重磅新药的布局方面，MNC却又看好中国市场，在半年报中，MNC几乎均在反复强调加快推动创新研发，以及中国创新药上市速度。