Daratumumab

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。 8月27-29日 敬请期待 第十届「MMC医学市场年会」 点击 阅读原文 了解更多

Over the next five years, several blockbuster oncology drugs from leading pharmaceutical companies will lose patent protection, ushering in a wave of patent cliffs that pose significant revenue and strategic risks. This concentrated wave of oncology losses of exclusivity (LOEs) stems from a historic surge in immuno-oncology approvals during the mid-2010s, particularly in checkpoint inhibitors and targeted therapies. Many of these blockbuster assetslaunched between 2014 and 2017were granted expedited pathways, bringing them to market faster but also aligning their exclusivity periods. These cliffs, historically associated with revenue drops that can exceed 50% within two years of LOE, present a critical inflection point, especially for sponsors heavily reliant on a few oncology assets [1].What happens when the cliff hits? The historical signalsHistorical signals from Avastin, Gleevec and Revlimid, illustrate the disruptive nature of such events. Each saw rapid revenue declinesAvastin dropped over 40% post biosimilar entry, Gleevec lost more than 50% of U.S. sales within a year of generic launch, and Revlimid faced a projected 50% erosion despite staggered generic entryunderscoring the urgent need for proactive lifecycle and pipeline strategies [1,2]. Sponsors unprepared for the transition faced valuation declines, market share loss and delayed R&D pivots, either in the reprioritization of promising clinical assets or in investing in registrational-stage ones. Conversely, sponsors with diversified pipelines or aggressive acquisition strategies managed to absorb the impact and maintain momentum. Oncology, due to its high-value therapies and pricing premiums, is particularly vulnerable to erosion once biosimilar and generic competition enters the scene. We took a closer look at the waters ahead to understand how well-positioned companies are to navigate the looming patent cliffs. Drugs like Keytruda, Opdivo and Darzalex approaching LOE represent tens of billions in annual revenue at risk. While some companies have fortified pipelines or pursued lifecycle management strategies, others remain overexposed or delayed in their planning. This snapshot aims to highlight strategic posture as of today, while recognizing that these positions are dynamicand that sponsors still have time to improve their trajectories.Oncology LOE risk and readiness lensTo better understand which companies are strategically positioned to weather the impact of oncology patent cliffs, we developed a readiness framework that assesses both impact exposure and pipeline momentum. The framework incorporates two metrics:An Impact Absorption Score, which evaluates how dependent a company is on a soon-to-expire drug and whether it maintains a broader commercial presence in oncology; and A Clinical Launch Momentum Score, which measures the strength of a company's near-term clinical oncology portfolio, especially the number of late-stage assets with a high likelihood of approval.To complement these, we included a Revenue at Risk metricreflected in the bubble size on the accompanying chartcapturing the absolute dollar value of oncology revenue exposed to LOE. This provides an at-a-glance sense of the potential financial magnitude each company must contend with as they approach key cliff events.Permission granted by Intelligencia AIFrom our perspective at Intelligencia AIthrough access to a comprehensive clinical trial database and regular analysis of the competitive positioning of pharma pipelinesthe current snapshot of patent cliffexposed companies comes as little surprise. We've seen early signals across trial activity, pipeline robustness, and business development behavior. For instance, weve observed that sponsors with consistently high trial initiation rates in post-LOE indications, coupled with targeted in-licensing of late-stage assets, tend to rank higher in readinesspatterns we've seen reflected in companies like Merck Sharp & Dohme (MSD). At the same time, companies with fewer late-stage trials and limited BD&L activity in oncology subtypes where exclusivity is expiring may face a more challenging transition unless strategic adjustments are made. By continuously integrating clinical data in real time with deal flow analytics, sponsors can improve situational awareness and act well before cliff-side impacts become visible in earnings.Our analysis, represented in the graph above, highlights both existing strengths and areas where renewed focus may be required. Some companies already show strong signs of preparation, while others have the opportunity to enhance their resilience through targeted action.Facing the cliff: Whos ready to leap, and whos looking down? To bring this framework to life, we highlight three illustrative sponsorseach occupying a distinct quadrant:Genentech (Roche): Safe harborsPositioned in the upper right quadrant, Genentech combines strong momentum with the ability to absorb impactmaking it a clear example of a Safe Harbor. Despite facing near-term LOEs for Kadcyla and Perjeta, Genentech retains exclusivity for more than fifteen oncology therapies. Notably, almost half of its pipeline has progressed to late-stage development, supporting future revenue continuity. Its relatively balanced revenue distribution across assets limits vulnerability, reducing the size of its Revenue at Risk bubble despite upcoming expiries. Astellas: Storm frontIn the lower left quadrant, Astellas exemplifies the Storm Frontlow absorption capacity paired with limited momentum. With Xtandi approaching LOE and few other oncology products or late-stage candidates to offset the loss, Astellas faces concentrated risk with little in the near-term pipeline to relieve pressure. Its Revenue at Risk is moderate in absolute terms but highly concentrated, amplifying its strategic vulnerability. The window for action remains open, but its narrowing.MSD: Rising tidesMSD is a classic example of a Rising Tidea company with strong clinical momentum but high exposure to a single anchor product. With Keytruda accounting for nearly half of its oncology revenue, MSD carries one of the largest Revenue at Risk profiles in the landscape. However, the company has taken deliberate steps to accelerate its pipeline, with multiple late-stage assets progressing toward approval. This momentum signals a clear effort to offset future erosion and positions MSD to ride the tide of clinical progress, even as it faces a sharp LOE drop from a heavily concentrated revenue base. From Analysis to actionable strategy: Staying ahead of the oncology patent cliffThe oncology patent cliff presents a complex and urgent challenge. As blockbuster therapies approach loss of exclusivity, the consequences for unprepared sponsors can be steepranging from sharp revenue erosion to delayed R&D pivots and weakened market positions. But while the risks are significant, the window for action remains open.Companies best positioned to weather the cliff are those that actively invest in late-stage pipelines, accelerate clinical execution, and pursue external innovation with a sense of urgency. This challenge touches all parts of the organization. Portfolio strategy leaders must reassess timelines and resource allocations with LOE pressure in mind. Search & evaluation teams are racing to identify high-fit external assets amid fierce competition. And BD&L professionals must act decisively to close value-driving deals before the window narrows.This current snapshot reflects where companies stand today, not where they ultimately need to be. Strategic posture in this environment is inherently dynamic. Companies can still shift course by reprioritizing clinical assets, tightening portfolio governance, identifying whitespace for in-licensing, and building partnerships that close therapeutic or modality gaps. Success will hinge on the ability to translate pipeline and market foresight into coordinated, data-driven action.At Intelligencia AI, we equip sponsors to do exactly that drive smarter decisions with the right data, insights and AI. Our solution brings together predictive analytics, clinical data in real-time, and business development intelligence to help teams evaluate risk precisely, monitor competitive activity continuously, and uncover strategic opportunities earlybefore cliff-side impacts appear in earnings.The patent cliff is real and fast approachingbut its outcome is not yet written. For those willing to act decisively, there is still time not only to mitigate the fallout but to emerge stronger, more focused, and better positioned for the next era of oncology innovation.ReferencesKim, M. S., Haslam, A., & Prasad, V. (2025). Trend of sales revenue by year for top-selling cancer drugs in the US and the effect of loss of market exclusivity. Journal of Cancer Policy, 43, 100533. https://doi.org/10.1016/j.jcpo.2024.100533FirstWord Pharma. (2021, April 21). Roche confirms outlook despite drug sales falling 14% in Q1. Retrieved from https://firstwordpharma.com/story/5279321 '