This randomized clinical trial (RCT) evaluates whether metformin can reduce systemic inflammation and improve immune function in individuals with a history of injection drug use, with or without HIV. Participants will receive metformin or placebo and undergo immune system assessments, including vaccine response evaluations.

开始日期2025-04-07

申办/合作机构

The University of Alabama at Birmingham

[+1]

NCT06177912

/ Completed临床3期

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Children and Adolescents With Increased Risk of Pneumococcal Disease

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children 2 through 17 years of age. Researchers want to learn if V116 is as good as, or is better than the PPSV23 vaccine in terms of the antibody immune response. V116 and PPSV23 will be studied in children and teenagers who have a higher risk of getting invasive pneumococcal disease (IPD).

开始日期2024-01-18

申办/合作机构

Merck Sharp & Dohme LLC

NCT05696080

/ Completed临床3期

A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 18 to 64 Years of Age With Increased Risk for Pneumococcal Disease.

The primary objectives of this study are to evaluate the safety and tolerability of the pneumococcal 21 valent conjugate vaccine (V116), and to evaluate the serotype-specific opsonophagocytic activity (OPA) post-vaccination with V116 and PCV15 (a pneumococcal conjugate vaccine that includes 15 serotypes) + PPSV23 (comprised of the polysaccharides from 23 of the serotypes causing disease in adults) post-vaccination within each vaccination group separately.

开始日期2023-02-13

申办/合作机构

Merck Sharp & Dohme Corp.

100 项与 21价肺炎球菌结合疫苗(默沙东) 相关的临床结果

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项与 21价肺炎球菌结合疫苗(默沙东) 相关的文献（医药）

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Health and economic impact of the 21-valent pneumococcal conjugate vaccine (V116) for adults in Japan: a delta price approach

Article

作者: Cassell, Kelsie ; Owusu-Edusei, Kwame ; Mueller, Peter P. ; Tajima, Atsushi ; Johnson, Kelly D. ; Cossrow, Nicole ; Yi, Zinan ; Matsuki, Taizo

INTRODUCTION:

This study analyzed the health and economic impact of the 21-valent pneumococcal conjugate vaccine (V116) and the 20-valent pneumococcal conjugate vaccine (PCV20), as well as their relative cost-effectiveness, in Japanese adults aged 65 years using a delta pricing approach.

METHODS:

A Markov model was employed to simulate the movement of the Japanese population among four health states: healthy, pneumococcal disease (consisting of invasive pneumococcal disease [IPD] with or without meningitis and non-bacteremic pneumococcal pneumonia [NBPP]), post-meningitis sequelae, and death. The model was populated with publicly available demographic and epidemiologic data, stratified by risk level. Pneumococcal serotype distribution and vaccine effectiveness, as well as direct and indirect treatment costs and health-related utilities, were derived from published sources. The model used a lifetime horizon and 2% discounting of costs and life-years. Costs were adjusted to 2023 values in Japanese yen (¥). Outcomes were cases and deaths, life-years and quality-adjusted life-years (QALYs), vaccination and treatment costs, and incremental cost-effectiveness ratios. The range over which V116 was cost-saving and cost-effective was determined.

RESULTS:

Compared to PCV20, V116 averted an additional 28 cases of IPD, 918 cases of NBPP, 5 deaths from IPD, and 51 deaths from NBPP over the lifetime of a single age 65 cohort. Life-years and QALYs gained were 1,019 and 642, respectively, relative to PCV20; V116 saved ¥733 million in direct medical costs and ¥557 million in indirect costs, compared to PCV20. V116 was found to be cost-saving at price premiums up to ¥1,322 (payer perspective) or ¥2,327 (societal perspective) and remained below a willingness-to-pay threshold of ¥5 million/QALY for premiums up to ¥7,113 (payer perspective) or ¥8,117 (societal perspective).

CONCLUSIONS:

V116 is projected to provide more population health benefits in Japan than PCV20, and to be cost-effective at a variety of price premiums.

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Economic evaluation of PCV21 in vaccine-naïve adults aged 19–64 years with underlying medical conditions in the United States

Article

作者: Owusu-Edusei, Kwame ; Yi, Zinan ; Elbasha, Elamin H.

INTRODUCTION:

This study aimed to estimate the incremental health and economic outcomes associated with the use of PCV21 (Capvaxive) in vaccine-naive adults aged 19-64 years with underlying medical conditions in the United States (US).

METHODS:

A static multi-cohort state-transition Markov model was utilized, drawing on data from published literature and publicly available databases and reports, comparing PCV21 (intervention) versus PCV20 or PCV15 + PPSV23 (comparator) from a societal perspective with a lifetime horizon. The target population consisted of vaccine-naive adults aged 19-64 years classified as at-risk (AR) or high-risk (HR). Key outcome measures included undiscounted clinical cases: invasive pneumococcal disease (IPD), inpatient and outpatient non-bacteremic pneumococcal pneumonia (NBPP), post-meningitis sequelae (PMS), deaths from IPD and inpatient NBPP, as well as discounted quality-adjusted life years (QALYs), and total costs (in 2023 USD), with the incremental cost-effectiveness ratios (ICERs) reported as $/QALY gained. Costs and QALYs were discounted at 3% per year. Deterministic and probabilistic sensitivity analyses were conducted.

RESULTS:

The analysis indicated that the V116 strategy prevented a substantial number of cases and deaths compared to the PCV20 or PCV15 + PPSV23 strategies among vaccine-naive AR/HR adults aged 19-49 and 50-64 years. For instance, the use of PCV21 was projected to reduce IPD cases by 1,450 and 4,232, respectively, in the two age groups when compared with PCV20. The estimated ICERs for both age groups were found to be cost-saving when compared to both PCV20 and PCV15 + PPSV23. Deterministic and probabilistic sensitivity analyses confirmed the robustness of these findings, with over 95% of simulations yielding cost-saving results and all estimated ICERs remaining below $10,000/QALY gained.

CONCLUSIONS:

The findings suggest that the use of PCV21 (Capvaxive) in adults aged 19-64 years with underlying medical conditions in the US can prevent a significant number of pneumococcal disease cases and deaths while demonstrating favorable economic outcomes across various scenarios.

2025-06-01·Med

A phase 3, randomized trial to evaluate lot-to-lot consistency of V116, an adult-specific pneumococcal conjugate vaccine (STRIDE-4)

Article

作者: Li, Jianing ; Cardona, Jose Francisco ; Greenberg, David ; Orenstein, Walter ; Platt, Heather Loryn ; Wiedmann, Richard T ; Fernsler, Doreen ; Caraco, Yoseph ; Grijalva, Carlos G ; Ukkonen, Benita ; Alpizar, Sady Armada ; Scott, Paul ; Cheon, Kyeongmi ; Perez, Silvia Narejos

BACKGROUND:

Streptococcus pneumoniae infection can lead to community-acquired pneumonia and invasive pneumococcal disease (IPD), conditions associated with substantial morbidity and mortality. V116 (Merck & Co., Inc., Rahway, NJ, USA) is a 21-valent, adult-specific pneumococcal conjugate vaccine (PCV) indicated for protection against pneumonia and IPD caused by S. pneumoniae.

METHODS:

This global phase 3 trial (ClinicalTrials.gov: NCT05464420) evaluated the manufacturing consistency of V116. Adult participants were randomly assigned to receive a single dose of V116 from one of three lots or the 23-valent pneumococcal polysaccharide vaccine (PPSV23). Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) were assessed 30 days post-vaccination. Immunoglobulin G (IgG) geometric mean concentrations (GMCs) and geometric mean fold rises for OPA and IgG responses were also evaluated. Solicited systemic and injection site adverse events (AEs) were collected for 5 days post-vaccination, serious AEs were reported throughout study participation, and all other AEs were reported for 30 days post-vaccination.

FINDINGS:

All three lots of V116 met equivalence criteria based on OPA GMTs for all 21 serotypes. OPA GMTs and IgG GMCs were comparable between the combined V116 lots and PPSV23 for shared serotypes and were higher in the combined V116 lots for serotypes unique to V116. AEs were similar across the three lots of V116 and between the combined V116 lots and PPSV23.

CONCLUSIONS:

V116 exhibited immunogenicity and safety profiles that were consistent across three manufacturing lots.

FUNDING:

Funding for this research was provided by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

156

项与 21价肺炎球菌结合疫苗(默沙东) 相关的新闻（医药）

2025-05-21

·蒲公英Ouryao

Paul's Insight｜解读国际法规药事(05.12-05.18)

◆ ◆ ◆ ◆Paul's Insight2025年5月12日-5月18日◆ ◆ ◆ ◆在过去一周中，FDA、EMA、USP、EDQM、MHRA、PDA和ISPE等多家监管机构和行业组织接连有重要更新。从疫苗安全预警到生产质量整顿，从标准更新到专家圆桌，从学术交流到创新表彰，一系列事件与热点既折射出全球药事监管的高压态势，也勾勒出行业协同创新的美好愿景。美国FDA安全审查与监管松绑并行1. Ixchiq疫苗安全警示5月12日，FDA与CDC联手建议暂停60岁及以上人群接种基孔肯雅活疫苗Ixchiq，并针对 серьieux不良反应报告展开紧急调查。截至5月7日，全球共报告17例严重不良事件，包括两例死亡病例，多数患者均有慢性基础疾病。FDA将开展最新的效益-风险评估，并与CDC一道持续监测，承诺在评估完成后及时向公众通报。图：Ixchiq疫苗安全警示https://www.fda.gov/safety/medical-product-safety-information/fda-and-cdc-recommend-pause-use-ixchiq-chikungunya-vaccine-live-individuals-60-years-age-and-older2. 中国药企遭警告信：海外飞行检查常态化5月13日，美国FDA官网公布了三封针对中国企业的警告信，三家企业分别位于宁波、汕头和台州。这些警告信指出，三家企业在药品及相关产品生产中存在严重的CGMP违规。例如，警告信开篇便明确指出：“本警告信总结了针对成品制剂在现行CGMP法规方面的重大违规”；并指出三家企业“生产、加工、包装或贮藏方法、设施或控制不符合CGMP”要求，其产品被认定为“掺假”。这意味着，上述企业未能满足FDA对于制造过程和质量控制的严格要求，所生产的产品在美国法律中被视为有重大问题，需要整改。2025年5月，美国政府发布行政令，要求FDA提高国内生产审查效率，同时加强对外国生产设施的检查。随后，FDA宣布，将扩大对向美国供应食品、药品和医疗器械的外国工厂实施无预告突击检查（飞行检查）的范围，确保对美国海外厂商和本土厂商实行同等监管。这一政策调整是FDA海外检查力度提升的标志性事件，意味着国外企业今后可能像美国本土工厂一样，随时面临FDA不通知的现场检查。图：宁波、汕头、台州三企业被警告，FDA海外监管新常态来临https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/taizhou-jingshang-cosmetics-technology-co-ltd-701945-04022025https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shantou-sez-baojie-industry-co-ltd-703439-04152025https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ningbo-riway-industrial-co-ltd-692870-043020253. 监管法规减负：10比1规则启动5月13日，美国FDA及其上级部门卫生与公众服务部（HHS）发布新闻稿，宣布启动针对“过时或不必要的监管法规”的公开征求意见，以识别并废除相关法规。官方声明指出，此举是美国联邦政府降低监管负担、提高透明度的整体行动的一部分，与特朗普总统颁布的行政命令《通过放松监管来实现繁荣》精神一致。图：FDA启动针对“过时或不必要的监管法规”的公开征求意见https://www.fda.gov/news-events/press-announcements/hhs-fda-issue-rfi-deregulatory-plan-lower-costs-and-empower-providers4. 滑石粉安全公开圆桌5月16日，FDA局长Martin A. Makary宣布将于5月20日在银泉市举办首场对公众开放的独立专家圆桌会议，聚焦滑石粉在食品、药品和化妆品中的安全评估。此次讨论将审查最新科学证据，并在媒体与公众见证下，决定未来监管路径。图：FDA 将举办首届有关滑石粉的独立科学专家小组会议，并向公众开放https://www.fda.gov/news-events/press-announcements/fda-host-inaugural-independent-scientific-expert-panel-open-public美国药典USP新一届董事会就位，宏观战略再出发5月16日，美国药典委员会USP宣布了2025-2030周期新当选董事会成员，涵盖来自学术、产业、监管、患者团体等450余家组织的代表。新任领导团队将引领USP在接下来的五年里，继续完善标准、提升供应链韧性，并与全球伙伴携手打造优质、安全的药品生态。图：USP宣布新一届董事会https://www.usp.org/news/usp-announces-board-of-trustees-for-the-2025-2030-cycle美国PDA校企合作，培养行业新血5月13日，美国注射剂协会PDA发布报道，俄亥俄州立大学学生应邀参访其校企合作项目STAQ Pharma，这家FDA注册的503B外包机构向学子们展示了从原料到包装的全流程，并通过专家讲座与小组讨论，为学生们打开了学术与产业对接的全新视野。图：PDA连接学术界和产业界https://www.pda.org/pda-letter-portal/home/full-article/bridging-academia-and-industry欧盟EMA疫苗成分与药品短缺1. 与病毒赛跑，疫苗成分再升级在欧洲，EMA紧急工作组（ETF）建议更新2025/2026年新冠疫苗，将目标由JN.1家族转向新兴LP.8.1变体。ETF综合世界卫生组织（WHO）及国际合作伙伴的数据，以及针对LP.8.1候选疫苗效果的动物研究，认为及时调整疫苗成分可维持对最新流行株的防护。在更新LP.8.1疫苗上市前，各上市许可持有人仍可考虑使用针对JN.1或KP.2毒株的疫苗，并应立即与EMA对接，讨论其授权疫苗成分的更新事宜。图：EMA建议更新新冠疫苗以针对新的LP.8.1变体https://www.ema.europa.eu/en/news/etf-recommends-updating-covid-19-vaccines-target-new-lp81-variant2. EMA药品短缺平台问答更新EMA在其欧洲短缺监测平台（ESMP）建议更新中，回答了六个与数据提交和报告要求相关的新问题：提交信息保密性：ESMP中提交的短缺数据不会在历史记录中公开显示；质量缺陷通知：涉及质量问题的短缺，无论批次是否已上市，都应提交质量缺陷通知；数据使用：EMA将利用平台数据进行短缺监测和风险分析，并在危机期间开放准备提交部分；根本原因报告：如标准选项无法覆盖短缺原因，应选择“其他”并提供自由文本说明；关键药物清单：目前与ESMP报告要求未直接关联，但两者可能存在内容重叠。图：EMA药品短缺平台问答更新https://www.ema.europa.eu/system/files/documents/other/202505_esmp-faqs_v31_for-publication-update_en.pdf欧洲EDQM新通则，支原体检测迈入新时代3月的第181届欧洲药典委员会会议上，EPC正式通过2.6.7章“支原体”通则及11个专论修订稿，纳入最新核酸扩增技术(NAT)与培养法联合检测策略，将于2025年10月发布并于2026年4月1日生效，为疫苗与生物制剂安全把关提供更灵活、风险导向的检测框架。修订后的通则规定，应联合使用培养法和指示细胞培养法（或NAT法），以确保检测出“可培养”和“不可培养”的支原体，除非专论另有规定或风险评估证明其合理性并经主管部门授权。此外，还明确指出，只要可能，样品应同时包含细胞和上清液。此外，现在规定，可以从拟议清单中选择合适的菌株，并可根据风险评估，结合产品类型和生产工艺，使用其他菌株。图：欧洲药典采用支原体通则和专论https://www.edqm.eu/en/-/epc-adopts-mycoplasmas-general-chapter-and-monographs-updated-to-incorporate-latest-analytical-developments英国MHRA英国多剂新药与新适应症获批在英国，监管机构也在稳步推进新药品的上市与适应症扩展。1. 首个专门针对先天性血栓性血小板减少性紫癜患者的治疗方案MHRA于5月12日采用国际认可程序（IRP）批准了rADAMTS13（商品名ADZYNMA），这标志着英国迎来了首个专门针对先天性血栓性血小板减少性紫癜（cTTP）患者的治疗方案。cTTP是一种罕见的遗传性血液病，患者往往因为ADAMTS13酶缺乏而发生血栓，导致多器官损伤。ADZYNMA的上市不仅填补了这一领域的治疗空白，也为各年龄段患者带来了真正意义上的个性化干预。图：先天性血栓性血小板减少性紫癜患者的治疗方案https://www.gov.uk/government/news/mhra-approves-first-uk-treatment-for-congenital-thrombotic-thrombocytopenic-purpura-cttp2. 批准了肺炎球菌疫苗Capvaxive紧接着，5月15日MHRA批准了肺炎球菌疫苗Capvaxive，可用于18岁及以上成年人。上市许可持有人为默沙东（Merck Sharp & Dohme）（英国）有限公司。这款疫苗旨在预防由肺炎链球菌引起的一系列严重感染，包括肺炎、脑膜炎和菌血症等。通过激发机体产生针对不同血清型的抗体，Capvaxive有望为高危人群提供更全面的保护，从而在秋冬流感季来临之际进一步降低呼吸系统疾病的负担。图：MHRA批准了肺炎球菌疫苗Capvaxivehttps://www.gov.uk/government/news/mhra-approves-vaccine-to-protect-against-pneumococcal-infections-such-as-pneumonia-and-meningitis3. MHRA 批准 Guselkumab 用于治疗克罗恩病和溃疡性结肠炎随后，在5月16日，MHRA又批准了Guselkumab（商品名Tremfya）在炎症性肠病领域的新适应症，将其应用范围从银屑病和银屑病关节炎扩展至克罗恩病和溃疡性结肠炎（UC）。上市许可持有人为杨森制药有限公司（Janssen-Cilag Limited）。多项大型III期临床试验数据显示，接受Guselkumab治疗的中重度活动性克罗恩病患者中，约一半能够在12周内达到临床缓解；在溃疡性结肠炎患者群体中，长期维持治疗的有效率也显著高于安慰剂组。这些结果表明，Guselkumab有望成为一线或二线治疗方案，为对现有疗法响应不佳的患者提供更多选择。图：MHRA 批准 Guselkumab 用于治疗克罗恩病和溃疡性结肠炎https://www.gov.uk/government/news/mhra-approves-guselkumab-for-crohns-disease-and-ulcerative-colitisISPE年度最佳设施奖，表彰制药创新先锋在5月12日至14日于伦敦举办的ISPE欧洲年会上，国际制药工程学会（ISPE）隆重宣布了2025年年度最佳设施奖（FOYA）的六位分类获奖者及两位荣誉提名者，以纪念该奖项成立20周年。来自英国的Touchlight公司凭借合成DNA项目斩获创新奖，强生创新医学分别赢得运营卓越与项目执行两项殊荣，澳大利亚CSL Behring的“奥罗拉”分馏设施荣获制药4.0奖，拜耳医疗公司在社会影响领域摘得“双料”大奖，而赛诺菲的多伦多废水回收厂则荣膺可持续性卓越奖；德国的Erbe Elektromedizin和美国United Therapeutics获得荣誉奖提名。ISPE副总裁Parag Sane点评称，这些先锋项目展现了行业对高质量生产、可持续发展和患者福祉的不懈追求，FOYA总冠军将在今年10月于北卡罗来纳州夏洛特举行的ISPE年会暨博览会上揭晓。图：ISPE 宣布 2025 年度最佳设施奖 (FOYA) 类别获奖者https://ispe.org/news/ispe-announces-2025-facility-year-awards-foya-category-winners-celebrating-foyas-20th结语过去一周，全球各大监管和行业组织频频发声，既有针对疫苗和新药品安全性的严格审查，也有法规简化和透明度提升的改革举措，更不乏前沿技术和产业合作的创新案例。END声明：本文仅代表作者个人观点，不代表任何组织及本公众号立场，如有不当之处，敬请指正。如需转载，请注明作者及来源：蒲公英Biopharma。活动推荐5月27日 | 线上 | 解锁2025版药典：药用原辅包标准升级与关键变化应对策略5月28日 | 线上 | 计算机化系统合规高效管理分享5月29日 | 线上 | 2025新药典升级：制药质控实验室技术及管理应对策略6月19日 | 线下 | 中国先进治疗药物先锋论坛6月25日 | 线下 | 2025 CPHI 生物药商业化生产与创新论坛——分论坛：抗体药物生产能力建设研讨会6月25日 | 线下 | 2025 CPHI 生命科学与技术创新发展论坛——论坛二：细胞药物质量控制法规与技术论坛

疫苗申请上市

2025-05-19

·PMLiVE

Merck receives MHRA approval for adult-specific pneumococcal vaccine Capvaxive

Merck & Co – known as MSD outside the US and Canada – has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for its adult-specific pneumococcal vaccine Capvaxive. The vaccine has been authorised to help protect adults aged 18 years and older against illnesses caused by Streptococcus pneumoniae bacteria, including pneumonia and meningitis, which are currently considered a “major public health problem” by the World Health Organization (WHO). There are over 100 different types of pneumococcal bacteria and Merck’s Capvaxive, a single-dose 21-valent-vaccine, is specifically designed to help protect against the ones that are responsible for the majority of adult invasive pneumococcal disease. The MHRA’s decision on Capvaxive occurred through the International Recognition Procedure, a fast-track approval process that takes into account prior authorisations from other regulatory partners, and follows the European Commission’s approval of the vaccine in March. Among the evidence supporting the EU regulator’s decision were results from a phase 3 trial comparing Capvaxive to Pfizer’s 20-valent vaccine (PCV20) in adults who had not previously received a pneumococcal vaccine. Capvaxive was shown to induce non-inferior immune responses compared to PCV20 for all ten serotypes common to both vaccines in adults aged 50 years and older, and generated superior immune responses for ten of its 11 unique serotypes. Merck’s vaccine was also shown to elicit non-inferior immune responses in adults aged 18 to 49 years compared to those aged 50 to 64 years and had a safety profile comparable to PCV20. “As with any medicine, the MHRA will keep the safety and effectiveness of this vaccine under close review,” the UK regulator said. Emma Cerrone, vaccines business unit director, MSD UK, said: “We are delighted with this decision. Pneumococcal infections can lead to serious complications requiring hospital treatment, however immunisation plays a vital role in prevention and can help adults live longer, healthier lives.” Alongside the EU, Capvaxive is approved in the US, Canada and Australia.

上市批准临床结果临床3期疫苗

2025-04-27

·空之客

【医苑观畴】2025年一季度海外药企进展更新：默沙东MRK

1整体表现MRK在HPV疫苗持续下滑和K药正式触顶的情况下，业绩和市值进入“戴维斯双杀”节奏，一年内市值从高点$330b以上回落到$200b左右。收入和净利润都已经同比下滑（24Q1有$-0.26的EPS影响来自Harpoon收购）。2已上市产品K药基本已经释放了夕阳最后一缕余热，外加Sotatercept上市后带来了些许增量，但在Gardasil崩盘、Sitagliptin专利悬崖、Molnupiravir归零等巨大下滑动能面前，几乎是螳臂当车。K药虽然同比仍有微涨，但环比首度下滑，尽管有一季度渠道商采购周期的影响、但也只有$250m、不影响触顶结论，看来峰值有可能就要止步于$30b这个结界，而今年药王必然让位于Semaglutide，公司也明确定义了目前已经处于“Keytruda LOE period”。肿瘤板块的其他产品这个季度也表现疲软，PARP抑制剂Olaparib和HIF-2α抑制剂Belzutifan的爬坡势头都在放缓。从去年年中开始，HPV在中国市场爆雷后持续下挫，成为整个公司业绩最大的拖累，公司也明确因此收回了此前峰值$11b的预期。进一步的，年初中止向智飞发货时，预计在年中要重新进行评估，而本季度电话会基本上明确了大概率不会恢复发货，也就意味着在中国市场将彻底躺平摆烂。HPV以外的传染病产品也乏善可陈，四痘疫苗ProQuad持续走平，被寄予厚望的新一代肺炎疫苗V-114和V-116的竞争力尚未成型、跟Prevnar完全不在一个数量级。其他如Sitagliptin等上个时代的顶梁柱在GLP-1和SGLT-2面前已毫无招架之力（本季度有一次性收入影响），不过PAH药物Sotatercept表现持续抢眼，单季$280m、销售开始首年累计$700m，不过新患开始走平（本季1,400、上季1,500）。3在研管线Sotatercept继续领先本季度的研发进展，去年底已宣布提前终止的三期临床ZENITH试验，在NEJM上发表了试验结果，一共入组了172例在最大耐受背景PAH治疗下高死亡风险的WHO FC III或IV级PAH成人患者，主要终点为全因死亡、肺移植或因PAH恶化住院（≥24小时）的复合终点，Sotatercept和安慰剂相比主要终点发生率为17.4% vs 54.7%，HR=0.24，疗效堪称绝伦！心血管代谢板块的另一大新闻，则是继去年底引进翰森的小分子GLP-1后，本季度又以$200m upfront + $1.77b milestone的价码引进恒瑞的小分子Lp(a)，坚定不能失去这一巨大市场的决心。更有趣的是，在面对分析师提问“近期的交易标的是否都并没有那么创新”时，MRK管理层的回复总有那么点“王顾左右而言他”的味道，拼命往联用和协同上扯，就是不愿意正面评论翰森和恒瑞的这几个资产到底是不是足够创新。除此以外，还值得关注的包括：HIV药物Doravirine+Islatravir联用公布了非劣于抗逆转录标准疗法的三期临床结果，Pixar注射Pembrolizumab非劣于静脉注射剂型的对照三期临床结果等。番外关税很显然，关税问题已经成为所有药企电话会的必备话题。然而对于一家两大支柱产品都面临停滞或崩盘威胁的巨头，关税什么的纯粹是不值一提的小小添堵，君不见Rob在电话会的说辞，包括但不限于“我们会脱钩供应链、影响不大”“价格杠杆完全没卵用”“当局要我们干啥我们就干啥”，最终落脚到“关税这种问题你问我有神马用”……MRK十多年以来凭借登顶药王的K药稳坐MNC靠前的位置，然而随着K药进入专利悬崖期、而另一根支柱的HPV疫苗在中国市场轰然坍塌，使得PAH和ADC等后续产品的接棒一下子变得迫在眉睫。然而，面对K药这300亿的天量压力，这些新生代真的扛得住吗？默沙东MRK往期季报分析：【医苑观畴】主流技术方向谁说了算：2022年上半年全球大药企核心产品管线进展总览【医苑观畴】主流技术方向谁说了算：2022年下半年全球大药企核心产品管线进展总览【医苑观畴】2023年上半年全球大药企核心进展总览【医苑观畴】2024年一季度海外药企进展更新：默沙东MRK【医苑观畴】2024年二季度海外药企进展更新：默沙东MRK【医苑观畴】2024年三季度海外药企进展更新：默沙东MRK【医苑观畴】2024年全年及四季度海外药企进展更新：默沙东MRK

疫苗临床3期并购信使RNA

100 项与 21价肺炎球菌结合疫苗(默沙东) 相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
肺炎球菌感染	英国	Merck Sharp & Dohme LLC	2025-05-15
侵袭性肺炎链球菌感染	欧盟	Merck Sharp & Dohme BV	2025-03-24
侵袭性肺炎链球菌感染	冰岛	Merck Sharp & Dohme BV	2025-03-24
侵袭性肺炎链球菌感染	列支敦士登	Merck Sharp & Dohme BV	2025-03-24
侵袭性肺炎链球菌感染	挪威	Merck Sharp & Dohme BV	2025-03-24
侵袭性肺炎球菌病	美国	Merck Sharp & Dohme LLC	2024-06-17
肺炎球菌性肺炎	美国	Merck Sharp & Dohme LLC	2024-06-17

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
流感病毒感染	临床3期	美国	Merck Sharp & Dohme Corp.	2022-09-23

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05696080 (V116-008 \| STRIDE-8, CTgov)	临床3期	肺炎球菌感染	518	Placebo+V116 (V116 + Placebo)	衊膚齋獵選繭糧鏇衊願 = 窪網選鏇遞遞範範鹹選鹽鹹鏇壓窪夢製餘窪淵 (遞糧齋顧範繭築範獵觸, 選鏇網鏇願製積蓋廠遞 ~ 範艱網觸壓襯艱鹹範廠) 更多	-	2025-02-26
				PPSV23+PCV15 (PCV15 + PPSV23)	衊膚齋獵選繭糧鏇衊願 = 襯夢襯糧夢簾醖糧顧鏇鹽鹹鏇壓窪夢製餘窪淵 (遞糧齋顧範繭築範獵觸, 觸醖鹹醖糧鹽鏇鹽選廠 ~ 願鬱鹽製鹽構淵窪鹽鹹) 更多
NCT05569954 (V116-010 \| STRIDE-10, CTgov)	临床3期	肺炎球菌感染	1,484	V116 (V116)	願醖醖艱窪夢醖齋願積 = 鹽憲製願鹽鏇觸衊糧膚壓範壓憲衊鹽鹹壓齋鑰 (鹽衊築廠鏇衊壓築觸願, 鹹範網衊獵簾網遞網醖 ~ 衊顧製壓築廠網觸顧蓋) 更多	-	2024-10-31
				PPSV23 (PPSV23)	願醖醖艱窪夢醖齋願積 = 憲齋憲壓餘鹹壓網顧願壓範壓憲衊鹽鹹壓齋鑰 (鹽衊築廠鏇衊壓築觸願, 膚鑰鑰醖獵憲繭襯構餘 ~ 鏇網醖遞廠鑰範製積遞) 更多
NCT05526716 (V116-005 \| STRIDE-5, CTgov)	临床3期	肺炎球菌性肺炎 \| 流感病毒感染	1,080	QIV+V116 (Concomitant Group (V116 + QIV Followed by Placebo))	獵鏇遞簾艱製襯顧獵鹽 = 製觸憲窪獵鏇衊顧夢蓋窪廠顧製願廠襯遞遞艱 (製鹽簾壓網壓顧範齋遞, 窪遞顧鹹構顧觸醖窪願 ~ 獵製壓齋觸憲繭餘淵獵) 更多	-	2024-09-05
				QIV+V116 (Sequential Group (Placebo + QIV Followed by V116))	獵鏇遞簾艱製襯顧獵鹽 = 襯築醖製構蓋製構鏇鏇窪廠顧製願廠襯遞遞艱 (製鹽簾壓網壓顧範齋遞, 鏇築鹹選網夢艱糧襯鏇 ~ 鏇鑰鬱範糧網艱繭壓廠) 更多
NCT05420961 (V116-006 \| STRIDE-6, CTgov)	临床3期	肺炎球菌性肺炎	717	V116 (Cohort 1: V116)	襯築鬱願築簾壓顧醖製 = 壓糧膚觸齋鑰淵構淵襯築鏇糧遞觸繭窪膚窪憲 (淵膚鑰襯繭構構積鑰構, 鏇鑰獵選鏇衊鹽餘鏇窪 ~ 範鏇窪鹹繭膚壓膚餘蓋) 更多	-	2024-05-01
				PCV15 (Cohort 1: PCV15)	襯築鬱願築簾壓顧醖製 = 鏇夢積鏇築積鑰艱築構築鏇糧遞觸繭窪膚窪憲 (淵膚鑰襯繭構構積鑰構, 製齋膚網膚艱積憲襯襯 ~ 壓願積艱壓築鑰築願網) 更多
NCT05569954 (STRIDE-10, Biospace) 人工标引	临床3期	肺炎球菌感染	1,484	V116	築鹹鹽夢膚淵遞鏇鑰鑰(壓網夢衊鏇鏇鹽齋選鑰) = V116 had a comparable safety profile to PPSV23. 範鑰蓋襯膚觸築繭壓鹹 (廠築選遞選範膚艱製衊 )	非劣	2024-04-29
				PPSV23
NCT05393037 (STRIDE-7, Company_Website) 人工标引	临床3期	肺炎球菌感染	304	V116	積構壓鹽願鑰築繭網繭(艱繭鹽鑰製鹽構範觸廠) = 遞醖願觸淵蓋淵鹽網鹹觸憲顧艱壓繭廠糧壓網 (繭壓齋積網積廠簾製餘 )	相似	2024-03-19
				PCV15+PPSV23	積構壓鹽願鑰築繭網繭(艱繭鹽鑰製鹽構範觸廠) = 積蓋艱衊繭艱餘壓壓網觸憲顧艱壓繭廠糧壓網 (繭壓齋積網積廠簾製餘 )
NCT05526716 (STRIDE-5, ISPPD2024) 人工标引	临床3期	肺炎球菌感染	1,080	concomitantly CAPVAXIVE+Quadrivalent Influenza Vaccine (QIV)	鏇淵簾簾鏇壓獵憲蓋簾(簾築鹽願蓋製築選壓鏇) = The concomitant group met the primary immunogenicity endpoints for 20 of 21 serotypes in V116 (lower bound of the two-sided 95% confidence intervals for OPA GMT ratios [concomitant group/sequential group] >0.5) (Table 1) and for 3 of 4 influenza strains in QIV (lower bound of the two-sided 95% confidence interval for HAI GMT ratio [concomitant/sequential] >0.67). 壓鹹顧蓋壓觸選廠齋遞 (艱構願鹽範鏇餘顧艱齋 )	积极	2024-03-17
				sequentially CAPVAXIVE+Quadrivalent Influenza Vaccine (QIV)
NCT05425732 (STRIDE-3, NEWS) 人工标引	临床3期	肺炎球菌性肺炎 \| 侵袭性肺炎球菌病	-	V116 (50 岁及以上)	遞齋壓網壓鑰顧壓壓築(構襯鹽積選繭願獵淵網) = 在 50 岁及以上的成年人中（队列 1），与 PCV20 相比，V116 对两种疫苗中常见的全部10种血清型都能引起非劣效免疫反应。与50 - 64岁的成年人相比，在18 - 49岁的成年人(队列2)中，V116引发了非劣势免疫反应(免疫桥接)。選膚齋遞襯鬱網鹹積範 (鑰簾製醖餘餘壓蓋糧遞 ) 更多	积极	2023-11-29
				PCV20 (50 岁及以上)
NCT04665050 (Pubmed \| Hum Vaccin Immunother)	临床1期	-	102	V116	鑰廠餘壓構齋鑰憲積壓(構積齋膚鑰製蓋製構廠) = Comparable proportions vaccinated with V116 and PPSV23 experienced ≥1 solicited injection-site AE 壓壓觸艱遞夢鑰廠遞夢 (廠夢夢窪鹽夢膚衊選壓 ) 更多	积极	2023-08-01
				23-valent pneumococcal polysaccharide vaccine (PPSV23)
NCT05420961 (V116-006 \| STRIDE-6, Corporate Publications) 人工标引	临床3期	肺炎球菌性肺炎 \| IRAK4缺陷	717	V116	範繭齋膚糧齋夢鑰遞鏇(願遞衊鹽製襯糧觸襯顧) = V116 was immunogenic for all 21 pneumococcal serotypes in the vaccine among adults who previously received a pneumococcal vaccine at least one year prior to the study 獵憲鏇遞鏇衊築夢範憲 (壓壓襯膚壓艱簾簾繭顧 ) 达到	积极	2023-07-27
				PCV15