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May 16, 2025 7:45 am ET P reliminary results from a pooled analysis of clinical trial data evaluating the long-term safety and favorable benefit-risk profile of WINREVAIR™ to be featured as a late-breaking presentation RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced new clinical and outcomes research data on pulmonary arterial hypertension (PAH) to be presented at the American Thoracic Society’s (ATS) 2025 International Conference in San Francisco from May 16-21. Data from nine presentations demonstrate Merck’s commitment to advancing research for patients with this disease. Merck will present pooled data from participants who have completed the PULSAR, SPECTRA, or STELLAR studies and have continued in the ongoing open-label extension study, SOTERIA, evaluating the long-term safety, tolerability and efficacy of WINREVAIR™ (sotatercept-csrk) when added to background therapy for the treatment of PAH. These results represent the largest analysis of WINREVAIR to date. "The results from this pooled analysis add to the growing body of evidence for WINREVAIR,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “We remain confident in the long-term potential for WINREVAIR for patients with PAH and look forward to sharing findings as we continue to evaluate WINREVAIR." Merck will also present an overall survival analysis for WINREVAIR leveraging data from the pivotal Phase 3 study, STELLAR, and interim data from participants who have continued in the ongoing open-label SOTERIA study, as well as additional outcomes research on the burden and impact of PAH in various patient populations. Details on Merck abstracts at ATS: PAH Long-term safety and exposure-adjusted incidence rates of adverse events from pooled sotatercept studies (PULSAR, SPECTRA, STELLAR, and SOTERIA). I. Preston. Session B96 Crossing the Golden Gate Bridge: clinical trials, targeted therapies and novel approaches in pulmonary arterial hypertension on Monday, May 19, 5:15 – 7:15 p.m. ET/2:15 – 4:15 p.m. PT Overall survival of patients on sotatercept: an analysis of STELLAR and SOTERIA trials. T. Thakur. Session B96 Crossing the Golden Gate Bridge: clinical trials, targeted therapies and novel approaches in pulmonary arterial hypertension on Monday, May 19, 5:15 – 7:15 p.m. ET/2:15 – 4:15 p.m. PT Long-term safety of MK-5475 in pulmonary arterial hypertension (PAH): Results from the phase 2 INSIGNIA-PAH extension period. P. Hassoun. Poster Board #505; D28 Fisherman’s Wharf: Clinical and epidemiological insights into pulmonary hypertension: trends, treatments, and outcomes on Wednesday, May 21, 11:15 a.m. – 1:15 p.m. ET/8:15 – 10:15 a.m. PT Quantifying the impact of pulmonary arterial hypertension (PAH) on health-related quality of life (HRQOL), work productivity, and economic stability for patients and their caregivers. H. Black. Poster Board #1018; B23 Diffuse lung disease and pulmonary hypertension: clinical perspectives on Monday, May 19, 12:15 –2:15 p.m. ET/9:15 –11:15 a.m. PT Comparing the burden of pulmonary arterial hypertension (PAH) among women across regions: a patient survey. T. Thakur. Poster Board #1021; B23 Diffuse lung disease and pulmonary hypertension: clinical perspectives on Monday, May 19, 12:15 – 2:15 p.m. ET/9:15 – 11:15 a.m. PT Perceptions, attitudes and behaviors among women of childbearing and childrearing age with pulmonary arterial hypertension. T. Thakur. Poster Board #1020; B23 Diffuse lung disease and pulmonary hypertension: clinical perspectives on Monday, May 19, 12:15 –2:15 p.m. ET/9:15 – 11:15 a.m. PT The impact of cardiopulmonary comorbidities on the economic burden and mortality of pulmonary arterial hypertension in the United States. H. Black. Poster Board #P253; A36 Pulmonary hypertension patient experience, health services and outcomes on Sunday, May 18, 12:15 – 7:15 p.m. ET/9:15 a.m. – 4:15 p.m. PT Caregiver network and caregiving needs in women with pulmonary arterial hypertension (PAH). T. Thakur. Poster Board #P254; A36 Pulmonary hypertension patient experience, health services and outcomes on Sunday, May 18, 12:15 – 7:15 p.m. ET/9:15 a.m. – 4:15 p.m. PT Acute inpatient utilization among Medicaid patients treated for pulmonary arterial hypertension. A. Watanabe. Poster Board #P251; A36 Pulmonary hypertension patient experience, health services and outcomes on Sunday, May 18, 12:15 – 7:15 p.m. ET/9:15 a.m. – 4:15 p.m. PT About WINREVAIR ™ (sotatercept-csrk) for injection, for subcutaneous use, 45 mg, 60 mg WINREVAIR is FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1) to increase exercise capacity, improve WHO functional class (FC) and reduce the risk of clinical worsening events. WINREVAIR is the first activin signaling inhibitor therapy approved to treat PAH. WINREVAIR improves the balance between pro-proliferative and anti-proliferative signaling to modulate vascular proliferation. In preclinical models, WINREVAIR induced cellular changes that were associated with thinner vessel walls, partial reversal of right ventricular remodeling, and improved hemodynamics. WINREVAIR is the subject of a licensing agreement with Bristol Myers Squibb. Selected Safety Information for WINREVAIR in the U.S. WINREVAIR may increase hemoglobin (Hgb). Severe erythrocytosis may increase the risk of thromboembolic events or hyperviscosity syndrome. Monitor Hgb before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter, to determine if dose adjustments are required. WINREVAIR may decrease platelet count. Severe thrombocytopenia may increase the risk of bleeding. Thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion. Do not initiate treatment if platelet count is <50,000/mm3. Monitor platelets before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter to determine whether dose adjustments are required. In clinical studies, serious bleeding (e.g., gastrointestinal, intracranial hemorrhage) was reported in 4% of patients taking WINREVAIR and 1% of patients taking placebo. Patients with serious bleeding were more likely to be on prostacyclin background therapy and/or antithrombotic agents, or have low platelet counts. Advise patients about signs and symptoms of blood loss. Do not administer WINREVAIR if the patient is experiencing serious bleeding. WINREVAIR may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment with WINREVAIR and for at least 4 months after the final dose. Pregnancy testing is recommended for females of reproductive potential before starting WINREVAIR treatment. Based on findings in animals, WINREVAIR may impair female and male fertility. Advise patients on the potential effects on fertility. The most common adverse reactions occurring in the phase 3 clinical trial (≥10% for WINREVAIR and at least 5% more than placebo) were headache (24.5% vs 17.5%), epistaxis (22.1% vs 1.9%), rash (20.2% vs 8.1%), telangiectasia (16.6% vs 4.4%), diarrhea (15.3% vs 10.0%), dizziness (14.7% vs 6.2%), and erythema (13.5% vs 3.1%). Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with WINREVAIR, and for 4 months after the final dose. About PAH Pulmonary arterial hypertension (PAH) is a rare, progressive and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation. Approximately 40,000 people in the U.S. are living with PAH. The disease progresses rapidly for many patients. PAH results in significant strain on the heart, leading to limited physical activity, heart failure and reduced life expectancy. The five-year mortality rate for patients with PAH is approximately 43%. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov ). Please see Prescribing Information for WINREVAIR (sotatercept-csrk) at http://www.merck.com/product/usa/pi_circulars/w/winrevair/winrevair_pi.pdf , Patient Information for WINREVAIR at http://www.merck.com/product/usa/pi_circulars/w/winrevair/winrevair_ppi.pdf , and Instructions for Use for WINREVAIR (1-vial kit, 2-vial kit) at https://www.merck.com/product/usa/pi_circulars/w/winrevair/winrevair_ifu_1-vial_2-vial_kits.pdf . Media Contacts: Julie Cunningham (617) 519-6264 Courtney Ronaldo (908) 442-5695 Investor Contacts: Peter Dannenbaum (732) 594-1579 Steven Graziano (732) 594-1583 Source: Merck & Co., Inc.

编者按：本文来自新康界，作者Fariy；赛柏蓝授权转载，编辑yuki 近日，JPM医疗健康大会再次证明了其作为生物医药健康领域顶礼膜拜的地位。这场全球医疗投资与产业交流合作的顶级盛宴，短短数日内汇聚了无数信息流。它们在这里被剖析、被热议，参与者们在这股信息洪流中搜寻着每一个潜在的价值信号... 01 阿斯利康：2030年收入有望达到800亿美元 在JPM大会上，阿斯利康披露2024年前9个月公司收入已达到392 亿美元（YOY +19%），主要涉及肿瘤、心血管、肾脏和代谢疾病（CVRM）、呼吸与免疫（R&I）、疫苗和免疫疗法 (V&I)、罕见病五大治疗领域。 来源：阿斯利康2025JPM大会资料 截至2024年，该公司有91个后期研发项目正在进行中，阿斯利康预测这些项目的平均年收入高峰有望超过10亿美元。目前，阿斯利康已为其后续增长布局了强大的在研产品管线。 同时，在体重管理和健康风险、ADC 和放射性偶联药物、下一代 IO 双特异性抗体、细胞治疗和 T 细胞接合剂、基因治疗和基因编辑五大领域，阿斯利康已取得了重要进展，这些项目将驱动阿斯利康在2030年以后保持持续的增长。 阿斯利康预测，到2030年，公司将推出至少20个NMEs 上市，并有望实现800亿美元的总收入。 02 礼来：2025多款新药计划上市 “大家对礼来的增长期望非常高，任何小失误都会被放大，他们几乎没有犯错的余地。” 美东时间1月14日，就在2025JPM大会的第2天，美国市值最大的制药公司——礼来发布重磅消息，预计2024年第四季度营收约为135亿美元，同比增长45%，低于分析师平均预期的140亿美元。 受这一消息影响，礼来股价一度跌至每股729美元，为去年11月以来的最低水平，日内跌幅最大时达到8.58%，创自2021年3月以来的最大盘中跌幅。 礼来董事长兼首席执行官戴文睿也在会上承认，在去年最后三个月，替尔泊肽的市场增长速度并没有原先预计的那么快，库存也低于预期，计划在2025年上半年投产更多产能，预计GLP-1类药物的可销售剂量将比2024年上半年增加至少60%。 尽管如此，礼来对2025年的增长前景保持乐观，预计2024年全年收入将达到450亿美元，同比增长32%，这一增长主要得益于其糖尿病和减肥药物的强劲表现，以及肿瘤、免疫和神经科学药物的良好业绩。预计2025年的销售额预测在580亿美元至610亿美元之间，甚至略高于分析师的预期。 为了实现这一乐观目标，礼来寄希望于增加药物供应量，以及其他产品组合药物，如淋巴瘤和白血病治疗药物Jaypirca、皮炎药物Ebglyss、溃疡性结肠炎治疗Omvoh 以及最近批准的阿尔茨海默病治疗药物Kisunla等。 此外，公司还预计2025年将有新药上市，包括Jaypirca、Ebglyss、Omvoh和Kisunla，这些新药将为营收增长做出贡献。 03 吉利德：计划推出九款HIV产品 在JPM大会上，吉利德首席执行官Dan O'Day表示，在经历了2021年至2023年连续两年收入小幅下滑之后，吉利德将在 2024 年扭转这一趋势，并在未来延续积极势头，原因是过去的投资正在转化为商业利益。 同时，吉利德科学预计在其强效药物Biktarvy在2033年失去市场独占权之前，有望推出九款HIV产品，由此抵消市场独占权消失时所带来的冲击。 目前，吉利德科学在HIV领域最核心的产品是每年两次注射的lenacapavir，该款药物于2022年在欧美获批用于治疗HIV-1感染，并被《科学》杂志评选为 2024年度重大突破药物之一。此外，lenacapavir预计将于2025年夏季获批用于HIV-1感染的暴露前预防（PrEP）。 除了抗病毒领域，吉利德在肿瘤领域和炎症性疾病领域均有布局和突破。目前，Anito - cel针对4L + R/R MM展现出强大的治疗潜力，在临床试验中表现出高总体反应率和良好的安全性，且有望在2026年商业化上市；seladelpar（ Livdelzi）在PBC领域需求旺盛，并已获得FDA批准上市。seladelpar是吉利德于2024年以43亿美元收购CymaBay时获得的肝病药物。 此外，目前，吉利德科学有超过100项创新的IND前和临床实验项目，涵盖多个治疗领域与作用机制。Daniel O'Day表示，现有产品能够每年稳定产生数十亿美元的收入，因而吉利德可以进行“适当的并购及构建合作伙伴关系”来补充管线。在JPM2025大会开展期间，吉利德也达成了一笔交易，以17亿美元的总交易额引进Leo Pharma的STAT6抑制剂。 04 默沙东：2024年预计达到639亿美元 在2025JPM大会上，默沙东公布最新的业务进展和研发管线，展现了公司在肿瘤、心血管代谢疾病、传染病/疫苗、免疫学、眼科等领域的强劲势头和未来发展方向。 默沙东自2021年以来取得了强劲的业绩增长，总营收持续增长，2024年预计达到639亿美元。3期临床项目数量几乎翻了两番，达到26个，其中包括已上市产品在其他适应症的研究。公司在战略业务发展方面投入了近400亿美元，以增强其管线。 2024年，默沙东取得了多项监管和商业里程碑，包括多个关键数据的公布、重要产品的批准和成功上市，例如Keytruda在宫颈癌、子宫内膜癌等适应症的批准，以及针对RSV的mAb药物clesrovimab的上市。2025年，默沙东计划在多个治疗领域取得重大进展，并推动一系列创新疗法的获批和上市。 肿瘤领域： Keytruda的拓展：默沙东将继续拓展PD-1抑制剂Keytruda的适应症，使其覆盖更多类型的癌症，为更多患者带来希望。 ADC药物的开发：公司正在开发一系列靶向HER3、B7H3、CDH6、TROP2等靶点的抗体偶联药物（ADC），例如patritumab deruxtecan、ifinatamab deruxtecan和sacituzumab tirumotecan，以治疗多种肿瘤。 心血管代谢疾病领域： 口服PCSK9抑制剂：默沙东正在开发口服PCSK9抑制剂enlicitide decanoate，以降低胆固醇水平，预防心血管疾病。 GLP-1/Glucagon受体共激动剂：公司正在开发GLP-1/Glucagon受体共激动剂efinopegdutide，以治疗肥胖和2型糖尿病。 其他药物：默沙东还在开发靶向activin信号通路和sGC的药物，例如WINREVAIR和MK-5475，以治疗心血管疾病。 传染病/疫苗领域： RSV疗法：默沙东正在开发针对呼吸道合胞病毒（RSV）的单克隆抗体（mAb）药物clesrovimab，以预防或治疗RSV感染。 HIV疗法：公司正在开发核苷逆转录酶易位抑制剂（NRTTI）药物islatravir，以及其与其他药物的组合疗法，例如islatravir + doravirine和islatravir + lenacapavir，以治疗HIV感染。 05 BMS：未来五年推出10款新药 2025年，BMS将面临Revlimid（来那度胺）、Pomalyst（泊马度胺）和Sprycel（达沙替尼）带来的专利危机，尤其是Revlimid。BMS预计，Revlimid的2025年销售额将缩减至20-25亿美元之间，最少下滑42%。 不过，BMS并不担心，其五大“明星产品”：obenfy、Opdivo、Reblozyl、Breyanzi 、Camzyos，预计在2025年将撑起公司半壁江山。 尤其是精神分裂症药物Cobenfy（KarXT）在2024年取得了不错的开端，销售峰值预计可达数十亿美元，将成为BMS的关键增长产品之一。 BMS首席执行官Chris Boerner表示：“BMS预计在未来五年内有望推出10款新药，并获得30项药品新适应症扩展。” 06 辉瑞：未来五年推出10款新药 在今年的JPM大会上，辉瑞（Pfizer）首席执行官Albert Bourla再次强调了发挥近年来并购交易的价值的目标，称“收购所得产品将在2030年贡献200亿美元的收入，这足以抵消多款核心产品未来失去市场独占期带来的损失——这部分损失可能高达170-180亿美元”。 收购Seagen的这笔交易已经在为辉瑞的肿瘤业务带来收益。自进入辉瑞管线以来，Padcev（维恩妥尤单抗）和Adcetris（维布妥昔单抗）均取得了重要进展，前者已在美国、欧洲和中国等主流市场覆盖尿路上皮癌的一线治疗和后线治疗，后者在2024年顺利完成了针对弥漫性大B细胞淋巴瘤（DLBCL）的III期ECHELON-3研究。这两款ADC产品在2024年前三季度为辉瑞创造了近20亿美元的收入。 此外，其他在研ADC的开发也在推进中，其中靶向整合素β6（ITGB6）的首创产品sigvotatug vedotin在2023年进入了III期临床阶段。与此同时，辉瑞对自研产品也充满信心。辉瑞的一代CDK4/6抑制剂哌柏西利在2023年失去了专利保护，下一代产品——选择性CDK4抑制剂atirmociclib已在路上，该药物正在HR阳性且HER2阴性的转移性乳腺癌人群中开展III期研究。 来源：辉瑞2025JPM大会资料 在本次的JPM大会中，辉瑞宣布其在2025年的关键优先事项是提高股东价值，并通过聚焦重点领域以改进研发效率、扩大利润率、实现商业卓越和优化资本配置来实现这一目标。 此外，辉瑞首席执行官Albert Bourla表示，公司正在为未来几年将席卷而来的“LOE 浪潮”做准备，LOE 指的是畅销药品独占权的丧失。Bourla表示，专利损失浪潮可能会导致每年约 170亿- 180亿美元的销售额损失。 END 内容沟通：郑瑶（13810174402） 左下角「关注账号」，右下角「在看」，防止失联