Prevention of RSV Infection in Infants by Administering Nirsevimab to Infants, With or Without Maternal RSV Vaccination: a Randomised Controlled Trial in France as Part of the Pregnancy and Infant PrEparedness pLatform IN Europe - PIPELINE

RSV (which stands for Respiratory Syncytial Virus) is an infection that causes cold-like symptoms and is most common during winter months. Most people with RSV infection get better by themselves but babies and younger children can become very poorly. About 1 in 15 infants with confirmed RSV within the first 12 months of life will be hospitalised, and a very small proportion will be seriously ill and may die.
Currently there are two different prevention options that can be used to prevent RSV infection in babies. One is a vaccine given to the mother during pregnancy, and the other is a monoclonal antibody given by injection to the baby. Although both prevention options work well on their own and are safe, neither provides 100% protection to the infant. It is not known whether giving both medicines, one to the mother in pregnancy and one to the infant, would provide better protection than giving only one medicine - this is what the PIPELINE-RSV study will look at.
PIPELINE-RSV-France will recruit about 1000 pregnant women in France. A parallel trial, running across Europe (PIPELINE-RSV-International) will recruit about 1500 pregnant women in UK, Switzerland, the Netherlands and Belgium. The protocols will align on key aspects and the data will be analysed together. The study will include two study groups with different prevention options used in each: (1) an injection given to the baby at the beginning of RSV season, or (2) both a vaccine given to the mother in pregnancy and an injection given to the baby at around 4 months of age. Each mother-baby pair will be randomly allocated to group by a computer. The numbers of babies in each of these groups who acquire RSV will be compared. In some countries participating to the International trial, an other study groups may be available : (3) a vaccine given to the mother in pregnancy.
Pregnant women and their babies will be followed until the baby reaches 12 months of age. Information will be collected about medically-important side effects either the mother or the baby had from their medicine(s) and any symptoms of RSV the baby had. Visits with the mother and baby will occur at birth and 12 months later. The mother will complete questionnaires via a Web-based platform to report any non-routine in-person visits, once in pregnancy and after the baby is born twice a month or monthly (more often in the winter), to also report baby's symptoms, to report their trial experience when the baby is 4 and 12 months' old, and to provide their views on vaccination at birth, and when the baby is 4 and 12 months' old. If the baby develops symptoms that might be RSV, their mother or another caregiver will be asked to take a sample using a swab from the baby's nose or mouth, and to send it by post for testing to find out if the baby has RSV.
As well as the main research study, there are also some substudies. A questionnaire will be given to women who consent to take part, to find out their motivations for joining the study and how they prefer to receive information about taking part in studies. A small number of women will be asked to take part in a study to look at how mothers' and babies' immune systems respond to the two different study prevention options , and to investigate different ways of collecting samples from their babies. In addition, researchers will use data from the study to see whether giving both medicines is cost-effective compared with giving just one medicine.

开始日期2026-01-01

申办/合作机构

Centre Hospitalier Annecy Genevois

NCT07097012

/ Recruiting临床4期IIT

Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy - A Pilot Feasibility Trial

The goal of this clinical trial is to learn if the RSV vaccine (protects against respiratory syncytial virus) and Tdap vaccine (protects against pertussis) are most effective in pregnant individuals when taken together at the same visit, or separately at different visits. This clinical trial will also learn about the safety and immune responses of these vaccines in pregnancy.
The Main question:
-Is it possible to run a successful trial that tests how safe and effective it is to give Tdap and RSV vaccines in pregnancy either at the same time or one after the other, at different visits?
The Secondary question:
-To determine how safe and how well the Tdap and RSV vaccines work when given in pregnancy either at the same time or one after the other, at different visits.
The Exploratory (optional participation) questions:
* To measure the levels of antibodies against whooping cough (pertussis) and RSV in mothers at 7 and 19 months after giving birth, depending on whether they got the vaccines at the same time or one after the other during pregnancy.
* To measure whooping cough antibody levels in the babies at 2, 7, and 19 months of age, whose mothers who received the vaccines in pregnancy.
* To measure the levels of RSV antibodies in the mothers' breast milk at 1 week, 2 weeks, 4 weeks, and 2 months after giving birth.
Participants will be randomly assigned to Group 1 (vaccines given at the same time, same visit) or Group 2 (vaccines given one after the other, at different visits).
There are 4 visits as part of the main study, and 6 additional visits as part of the optional study (exploratory questions).
Visit 1-2: Blood collection and vaccines administered Visit 3-4: Blood work (cord blood sample collection from infant, after delivery, if possible) Visit 5-8: Breast milk collection Visit 8-10: Blood collection (infant blood collection only at Visit 8).
Participants will be asked to keep a diary of symptoms throughout the study.

开始日期2025-10-16

申办/合作机构

Canadian Immunization Research Network

[+6]

NCT07041190

/ Not yet recruiting临床3期

PIPELINE-RSV International Trial. Pregnancy and Infant PrEparedness pLatform IN Europe (PIPELINE)- RSV International Immunisation Adaptive Platform Trial.

RSV (which stands for Respiratory Syncytial Virus) is an infection that causes cold-like symptoms and is most common during winter months. Most people with RSV infection get better by themselves but babies and younger children can become very poorly. About 1 in 15 infants with confirmed RSV within the first 12 months of life will be hospitalised, and a very small proportion will be seriously ill and may die.
Currently there are two different prevention options that can be used to prevent RSV infection in babies. One is a vaccine given to the mother during pregnancy, and the other is a monoclonal antibody given by injection to the baby. Although both prevention options work well on their own and are safe, neither provides 100% protection to the infant. It is not known whether giving both medicines, one to the mother in pregnancy and one to the infant, would provide better protection than giving only one medicine - this is what the PIPELINE-RSV study will look at.
PIPELINE-RSV-International will recruit about 1500 pregnant women from across Europe in UK, Switzerland, the Netherlands and Belgium. A parallel trial, PIPELINE-RSV-France, running in France will recruit about 1000 pregnant women in France; the protocols will align on key aspects and the data will be analysed together. The study will include three study groups with different prevention options used in each: (1) a vaccine given to the mother in pregnancy, (2) an injection given to the baby at the beginning of RSV season, or (3) both a vaccine given to the mother in pregnancy and an injection given to the baby at around 4 months of age. Each mother-baby pair will be randomly allocated to group by a computer. The numbers of babies in each of these groups who acquire RSV will be compared. In some countries only two of the three study groups may be available.
Pregnant women and their babies will be followed until the baby reaches 12 months of age. Information will be collected about medically-important side effects either the mother or the baby had from their medicine(s) and any symptoms of RSV the baby had. Visits with the mother and baby will occur at birth, and 4 and 12 months later; these will ideally be in-person at birth and at 12 months. The mother will complete questionnaires via a Web-based platform to report any non-routine in-person visits, once in pregnancy and after the baby is born twice a month or monthly (more often in the winter), to also report baby's symptoms, to report their trial experience when the baby is 4 and 12 months' old, and to provide their views on vaccination at birth, and when the baby is 4 and 12 months' old. If the baby develops symptoms that might be RSV, their mother or another caregiver will be asked to take a sample using a swab from the baby's nose or mouth, and to send it by post for testing to find out if the baby has RSV.
As well as the main research study, there are also some substudies. A questionnaire will be given to women who consent to take part, to find out their motivations for joining the study and how they prefer to receive information about taking part in studies. A small number of women will be asked to take part in a study to look at how mothers' and babies' immune systems respond to the two different study prevention options , and to investigate different ways of collecting samples from their babies. In addition, researchers will use data from the study to see whether giving both medicines is cost-effective compared with giving just one medicine.
The study might be adapted in the future to look at other medicines for preventing RSV infection, when they become available.

开始日期2025-09-01

申办/合作机构

Penta Global Blockchain Foundation, Inc.

100 项与呼吸道合胞病毒疫苗（辉瑞大药厂）相关的临床结果

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2026-01-01·AMERICAN HEART JOURNAL

A pragmatic individually randomized trial to evaluate bivalent RSV prefusion F protein–based vaccine effectiveness for preventing RSV hospitalizations in adults aged 60 years or above (DAN-RSV): Rationale and trial design

Article

作者: Zhang, Pingping ; Skovdal, Mette ; Schwarz, Claudia ; Moulton, Lawrence H ; Modin, Daniel ; Begier, Elizabeth ; Solomon, Scott D ; Gonzalez, Elisa ; Larsen, Lykke ; Gessner, Bradford D ; Biering-Sørensen, Tor ; Skaarup, Kristoffer G ; Lindholm, Matias G ; Dalager-Pedersen, Michael ; Claggett, Brian L ; Christensen, Sine H ; Stæhr Jensen, Jens Ulrik ; Larsen, Carsten S ; Martel, Cyril Jean-Marie ; Wiese, Lothar ; Aliabadi, Negar ; Køber, Lars ; Johansen, Niklas D ; Lassen, Mats C Højbjerg

BACKGROUND:

Respiratory syncytial virus (RSV) can cause serious illness in older adults and those with chronic conditions. While the bivalent RSVpreF vaccine has been shown to protect against RSV-related respiratory tract disease, its impact on severe RSV-related and broader cardiorespiratory hospitalizations remains untested in a fully powered randomized trial. This pragmatic, individually randomized, open-label, parallel-group trial aims to evaluate RSVpreF vaccine effectiveness (VE) in reducing the risk of RSV-related and all-cause cardiorespiratory hospitalizations in adults aged 60 and older.

METHODS:

DAN-RSV is randomizing Danish adults 1:1 to receive either RSVpreF or no RSV vaccine. The trial uses nationwide registries for recruitment, where eligible citizens are identified and invited via the national electronic messaging system and can provide electronic informed consent remotely. Baseline, safety, and outcome data are collected through the national health registries using the civil registration number provided at consent. Up to 130,000 participants will be enrolled during the 2024/2025 winter season. The primary objective is to assess vaccine effectiveness (VE) against RSV-related respiratory tract disease hospitalization. Secondary endpoints include RSV-related and all-cause lower respiratory tract disease hospitalizations, RSV-related and all-cause cardiorespiratory hospitalizations, and all-cause death.

CONCLUSION:

DAN-RSV is an innovative trial combining the gold standard of individual randomization with pragmatic data collection via centralized health records and national health registries. This design offers a feasible approach to assess the impact of RSVpreF on clinically meaningful cardio-respiratory outcomes in adults ≥60 years in a real-world setting - while minimizing bias through use of randomization. The results will support cost-effectiveness analyses and inform future vaccination policies.

TRIAL REGISTRATION:

NCT06684743, registered November 9, 2024 (https://clinicaltrials.gov/study/NCT06684743).

2025-12-31·Human Vaccines & Immunotherapeutics

Budget impact of maternal vaccination with RSVpreF to protect privately insured infants in Dubai against respiratory syncytial virus

Article

作者: Zayed, Mostafa ; Joury, Jean ; Al Dallal, Sara ; Farghaly, Mohamed ; Law, Amy W. ; Kutrieb, Emily ; Averin, Ahuva ; Mendes, Diana ; Quinn, Erin ; Mahendiran, Ramya

Respiratory syncytial virus (RSV) manifesting as lower respiratory tract illness (LRTI; RSV-LRTI) represents a significant healthcare burden among infants in Dubai and worldwide. The novel bivalent stabilized prefusion F subunit vaccine (RSVpreF) for administration among pregnant women to protect infants against RSV-LRTI has been evaluated and approved for use in Dubai. We assessed the budget impact of year-round maternal RSVpreF use to prevent RSV-LRTI among privately insured non-Emirati infants living in Dubai. A deterministic cohort model was built to illustrate clinical and economic outcomes of RSV-LRTI among infants from birth to age 1 year for five annual birth cohorts. Model population comprised infants born to non-Emirati pregnant women; parameter values were estimated principally based on published sources using Dubai-specific data to the extent possible. Model outcomes included cases of disease (hospital, emergency department, outpatient clinic), disease-attributable deaths, and costs of disease and vaccination (in US$). Budget impact was reported in terms of overall cost and per-member per-year (PMPY) cost. With no intervention, there would be 23,267 RSV-LRTI cases (1,960 hospital; 5,655 emergency department 15,652 outpatient) and medical costs would total $11.5 M over 5 years. Targeting 10% of pregnant women with RSVpreF would prevent 855 cases and reduce infant medical care costs by $0.5 M. With vaccination costs estimated at $3.6 M, overall costs would increase by $3.1 M overall and $0.19 PMPY. Findings suggest that RSVpreF use among pregnant women would substantially reduce the clinical and economic burden of RSV-LRTI in infants, requiring an investment of just $0.19 PMPY by private health insurers.

2025-12-31·Expert Review of Vaccines

Public health impact of RSV vaccination among adults aged 60 years and older in the United States using real-world evidence from the initial post-introduction season

Article

作者: Biundo, Eliana ; Verelst, Frederik ; Grace, Mei ; Singer, David ; Graham, Jonathan ; La, Elizabeth M.

BACKGROUND:

Respiratory syncytial virus (RSV) is an important cause of severe respiratory illness in older adults and adults with certain health conditions. Adjuvanted RSVPreF3 and non-adjuvanted RSVpreF vaccines were approved in 2023 for use in adults aged ≥60 years in the United States (US). This study explored the impact of RSV vaccination during the first season of vaccine availability.

RESEARCH DESIGN AND METHODS:

A Markov model was adapted to compare RSV-related outcomes in adults aged ≥60 years with or without RSV vaccination. Analyses were based on real-world RSV vaccination uptake and effectiveness in the 2023-2024 season. Scenario analyses assumed the same higher uptake as for influenza vaccines.

RESULTS:

Over 1 year, real-world RSV vaccinations were estimated to avert 18,326 RSV-related emergency department (ED) visits, 23,630 hospitalizations, and 1,930 deaths versus no vaccination. Assuming the same uptake as for influenza vaccines resulted in considerable additional RSV disease burden averted (avoiding a total of 65,740 RSV-related ED visits, 84,551 hospitalizations, and 6,838 deaths over 1 year vs. no vaccination).

CONCLUSIONS:

Findings suggest that real-world RSV vaccinations have substantially reduced RSV disease burden in the US. Increasing RSV vaccination uptake among eligible adults aged ≥60 years could provide additional public health benefits.

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2025-11-12

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换季就中招？一个喷嚏的“威力”：带你认清呼吸道病毒大家族

换季就中招？一个喷嚏的“威力”：带你认清呼吸道病毒大家族每逢秋冬交替之际，呼吸道疾病的就诊量便迎来“季节性峰值”。在这些季节性高发的隐匿传播链条中，一个看似平常的“喷嚏”，往往是病毒扩散的起点：其所伴随的气溶胶扩散、飞沫沉降等过程，构成病毒实现人际传播的关键载体。因此，我们只有真正摸清病毒的活性、传播路径和致病方式，才能建立起更精准、更有效的防护体系。 NO.1 NO.1 呼吸道病毒的健康冲击呼吸道病毒绝非“小感冒”的代名词，其对人类健康的影响已超越个体层面，成为全球公共卫生体系的长期挑战。数据显示[1]，在所有病原微生物引起的呼吸道疾病中，由病毒所导致的急性呼吸道感染约占80%，是目前世界范围内发病率最高的疾病。呼吸道病毒引起的感染是以呼吸道为侵入门户，在其黏膜上皮细胞内增殖，引起呼吸道局部及以外组织器官病变的疾病。呼吸道感染性疾病病原学复杂、病毒极易发生变异、易在人群中大规模传播从而暴发大流行，是临床中最常见的流行性疾病之一[2]。回溯人类公共卫生史，呼吸道病毒引发的流行早已留下深刻教训：1918 年西班牙流感（H1N1）导致全球数千万人死亡；2003年SARS（冠状病毒属）、2009年甲型H1N1流感（流感病毒属）、2014年MERS（冠状病毒属）、2019年新型冠状病毒（SARS-CoV-2，冠状病毒属）引发的COVID-19疫情，更接连印证呼吸道病毒“家族”的流行风险已成为全球公共卫生的常态化挑战。 NO.2 NO.2 常见呼吸道病毒的 “特征图谱” 呼吸道感染性疾病是由多种呼吸道病毒引起的，常见的呼吸道病毒包括：流感病毒（influenza virus,IV）、人冠状病毒（human coronavirus,HCoV）、副流感病毒（parainfluenza viruses,PIVs）、呼吸道合胞体病毒（respiratory syncytial virus,RSV）、人偏肺病毒（human metapneumovirus,hMPV）、人鼻病毒（ human rhinovirus,HRV）、人腺病毒（human adenoviruses,HAdV）、人博卡病毒（human bocavirus，HBoV）、肠道病毒（enterovirus,EV）等[3]。呼吸道病毒感染的症状差异，本质是“病毒进攻能力”与“人体防御能力”的博弈结果： —— 上呼吸道感染（轻症）病变局限于鼻咽部及咽喉黏膜，主要表现为咽痛、咳嗽、发热、流涕等上呼吸道症状； —— 下呼吸道感染（重症）病毒侵袭气管、支气管及肺组织，表现为下呼吸道感染，甚至可能诱发支气管炎、肺炎、哮喘等呼吸系统疾病以及胃肠道反应，并可引发全身性反应，累及全身各个系统，严重者可引起死亡[4]。（一般来说，呼吸道病毒感染健康成人症状较轻，幼儿、老人、孕妇、有基础疾病患者以及免疫功能低下者等特定人群感染后症状可能较重。）仅凭临床表现、血常规及影像学依然很难区分病原，这时就需要进行呼吸道病原体核酸六联检测，检测的呼吸道疾病类型有：甲型流感病毒、乙型流感病毒、人鼻病毒、腺病毒、呼吸道合胞病毒以及肺炎支原体。 ▲可点击放大查看其他常见呼吸道病毒类型及对应症状如下表：表1 常见呼吸道病毒类型及临床表现[4] 传统理论认为呼吸道病毒的传播方式包括[3]：直接接触感染者或间接接触病毒污染物；飞沫喷溅到口鼻眼等黏膜而发生的短距离（＜1~2m）传播；吸入气溶胶的长距离空气传播。近年来，特别是COVID-19流行以来，气溶胶研究和病毒检测技术飞速发展，对呼吸道病毒传播方式的认识发生了范式转变。越来越多的流行病学、病原学和气溶胶环境学证据表明，SARS-CoV-2、流感病毒、呼吸道合胞体病毒、人鼻病毒等病毒均以气溶胶为主要的传播载体，气溶胶传播是呼吸道病毒传播的主要方式[5-10]。 NO.3 NO.3 呼吸道病毒药物治疗现状[11] 虽然接种疫苗能有效预防大流感的发生，但呼吸道病毒容易发生突变，而疫苗更新速度慢。目前，药物治疗是控制呼吸道病毒传播的主要手段。根据药物作用于病毒发挥抗病毒药效的机制不同，可以将抗病毒药物分为以下几类：M2受体阻断剂类、神经氨酸酶抑制剂类、核苷类、RNA聚合酶抑制剂类、免疫调节剂类、蛋白酶抑制剂类抗病毒药等。表2 治疗呼吸道病毒常见化学药物面对流感威胁，单一的防控手段已难以奏效，需构建环环相扣的全链条防控体系，才能更好地实现从被动应对疫情到主动守护健康的转变。目前治疗呼吸道病毒的西药较少，且具有耐药性、毒副作用大、价格昂贵等特点。市场上早期的金刚烷类抗病毒药因耐药性严重已不适用于临床。中药作为中华民族传统药物，具有来源广泛、价格低廉、多靶点对抗呼吸道病毒的优点，中药单体及中药复方对抗呼吸道病毒也表现出了其独特的优势。中药抗病毒主要从直接抑制病毒和增强机体免疫2个方面达到抗病毒作用。常见的抗呼吸道病毒的中药活性成分有生物碱类、黄酮类、皂苷类、萜类、挥发油类、多糖类、鞣制和其他酚类、蒽醌类、有机酸类、醛类等，具有抗流感病毒、RSV、腺病毒等多种呼吸道病毒的能力。常见的抗呼吸道病毒的中药单药有板蓝根、鱼腥草、白花蛇舌草、败酱草、穿心莲、金银花、绿豆、胖大海、连翘等清热解毒类中药；还有黄芪、人参、刺五加、甘草等补益类中药，以及半夏、远志、黄芩、黄连、肉桂等其他类型的中药。中药复方、中成药与中药单药相比，更具有疗效确切、临床应用范围广、不良反应少等优点。目前用于临床的抗呼吸道病毒的中药复方主要有麻杏石甘汤、小柴胡汤、宣白承气汤、扶正解毒方、桃仁承气汤、沙参麦冬汤、银翘散、大青龙汤、达原饮和麻黄汤等[12]，以及中成药化湿败毒颗粒[12]、金叶败毒颗粒[13]、柴石退热颗粒[14]等。呼吸道病毒传染性强、传播快，易引发大规模流行，日益受到公众关注。在临床治疗中，中西药联合应用日益普遍，合理的联用可发挥增效减毒的作用。同时，生物医药作为研究热点，有望开发出副作用小、不易耐药的抗病毒药物，但其靶向性与作用机制仍有待深入探索。当科学认知、技术手段与防控策略形成合力，秋冬季节的呼吸道健康将从“季节性担忧”转化为“可量化、可保障”的公共卫生目标，为全人群呼吸道健康提供坚实支撑。 -END- 【参考文献】向上滑动阅览 [1] ZHANG N, WANG L, DENG X, et al. Recent advances in the detection of respiratory virus infection in humans[J].J Med Virol, 2020, 92(4): 408-417. [2] WILLIAMS BG, GOUWS E, BOSCHI-PINTO C, et al. Estimates of world-wide distribution of child deaths from acute respiratory infections[J].Lancet Infect Dis, 2002, 2(1): 25-32. [3] 祁贤.呼吸道病毒流行特点及影响因素[J].江苏预防医学,2024,35(01):1-6+20. [4] 周利润,崔晓兰,时宇静.常见呼吸道病毒及抗呼吸道病毒药物研究进展[J].中国药物警戒,2023,20(02):225-230. [5]Tang JW，Marr LC，Tellier R， et al.Airborne transmission of respiratoryviruses including severeacute respiratory syndrome coronavirus 2[J]Curr Opin Pulm Med，2023 ，29(3):191-196. [6]Marr LC ，Tang JW.A paradigm shift to align transmission routes withmechanisms[J.Clin Infect Dis ，2021 ，73( 10):1747-1749. [7]Tang JW，Tellier R，Li Y.Hypothesis ：all respiratory viruses (includingSARSCoV-2)are aerosol-transmitted[J].Indoor Air， 2022，32(1)：e12937. [8]Greenhalgh T，Jimenez JL，Prather KA ，et al.Ten scientific reasons insupport of airborne transmission of SARS-CoV-2[J].Lancet，2021，397(10285)：1603-1605. [9]Morawska L，Allen J， Bahnfleth W，et al.A paradigm shift to combat indoor respiratory infection[J].Science ，2021,372(6543)：689-691. [10] Wang CC，Prather KA，Sznitman J，et al.Airborne transmission of respiratory viruses[J].Science，2021，373( 6558)：eabd9149. [11]中华医学会急诊医学分会,成人急性呼吸道病毒感染急诊诊疗专家共识组.成人急性呼吸道病毒感染急诊诊疗专家共识[J].中华急诊医学杂志,2021,30(12):1417-1428. [12]马旺明,李玮婕,王萍,等.中药复方抗呼吸道病毒性疾病研究进展[J].生物医学转化,2024,5(01):37-47. [13]施春阳,林彤,王文清,等.清热解毒中药金叶败毒颗粒研究概况[J].中草药,2020,51(08):2055-2064. [14]胡淑云.柴石退热颗粒治疗流行性感冒的临床研究[J].中国社区医师,2018,34(04):100-101. 编写 | 银霞、庄庄、文露校对 | 媛大、焯莹插图 | 庄庄、琛琛排版 | 文露 —推荐阅读—

临床研究

2025-11-08

·今日头条

辉瑞豪掷100亿美元赢竞购！Q3 财报藏答案，未来稳了？

在一场堪称《权力的游戏》的生物医药竞购战中，辉瑞笑到了最后。 Metsera最终被辉瑞以每股86.25美元、总估值约100亿美元的报价，成功将生物技术公司Metsera收入囊中，为这场历时数月、波澜起伏的竞购战画上句号。背后，是辉瑞重返增长赛道、押注“下一代爆款疗法” 的雄心。 1 峰回路转的竞购战这场收购故事的剧情反转堪比电视剧。 9月，辉瑞似乎已锁定交易，然而丹麦巨头诺和诺德突然出手，以更高报价插足，让Metsera一度摇摆。市场普遍认为，凭借GLP-1药物的绝对优势，诺和诺德更有胜算。但就在上周，美国联邦贸易委员会（FTC）致信Metsera，指出诺和诺德的提案存在反垄断风险。Metsera最终选择了“风险更低、执行更稳”的辉瑞方案。最终报价：每股86.25美元、总价近百亿美元。较上周五收盘价溢价3.7%，并包含最高20.65美元的额外或有价值权。 Metsera股价随即暴涨近60%，市值突破87亿美元；而诺和诺德宣布退出竞购。这场从华尔街延烧到监管层的对决，也宣告辉瑞在肥胖症治疗领域迎来了“第二次机会”。 2 辉瑞的“减重翻盘计划” 肥胖症治疗，正在成为制药业新的金矿。据分析机构预测，到2030年代初，全球GLP-1类药物市场规模将达到1500亿美元。辉瑞早年在减肥药领域屡战屡败，如今通过Metsera看到了重回赛场的机会。 Metsera的两款核心资产——GLP-1注射剂MET-097i和胰淀素模拟物MET-233i，被认为具备潜在的同类最佳（best-in-class）潜力。Leerink Partners分析师预计，若临床顺利，二者合计峰值销售额有望超过50亿美元。在赢下竞购之前，辉瑞CEO Albert Bourla在财报会上直言：“ 辉瑞认为诺和诺德的提议是虚幻的，根据辉瑞与Metsera的合并协议条款，不能构成更优提案，因为它违反了反垄断法，并且其最终完成的风险更高。 ”“对辉瑞与Metsera合并前景的信念是坚定和毫不动摇的。”“辉瑞已经证明能够通过Eliquis、Lipitor、Norvasc和Vyndaqel系列等关键心血管品牌推动领先的临床、商业和战略势头，辉瑞计划在与Metsera合作时以类似的方式执行，以重振辉瑞的心脏代谢领域影响力。” 3 财报背后的“增长驱动” 在竞购最为激烈的时刻，辉瑞发布了的最新财报显示，其仍处于新冠影响的出清过程中。 2025年前九个月，辉瑞营收 450亿美元，同比 -2% 。主要是美国市场有所下滑（-5%），国际市场继续增长（+4%），最新推出和收购的产品营收73亿美元，同比+9%。 2025年第三季度，辉瑞营收 167亿美元，同比 -7% 。主要是由COVID产品下降驱动。下降主要来自抗新冠口服药物Paxlovid，其次是新冠疫苗Comimaty。非COVID产品表现稳健，同比+4%，主要由Eliquis、Vyndaqel系列和Nurtec驱动。但与此同时，财报也显示出一些新趋，比如在肿瘤与心代谢的双线突破。业务层面，辉瑞分为生物制药（Biopharma）、Centreone、Ignite 。生物制药（Biopharma）占据总营收的98%，分为基础护理（占比42%）、专业护理（28%）、肿瘤（27%）三大板块。具体来看，在2025年前九个月：基础护理（Primary Care）营收188.82亿美元，同比-11%，主要是受新冠药物Paxlovid营收下滑57%的影响。抗凝药物Eliquis以及肺炎球菌疫苗Prevnar family（沛儿家族）是基础护理的板块的支柱产品，前者营收 59.41亿美元，同比+7% ；后者营收 47.86亿美元，同比-1% ，主要是受美国儿科市场上政府大宗订单延迟（约占美国Prevnar收入的60%）的影响。辉瑞的下一代肺炎球菌疫苗（25价）计划在2025年启动针对成人Ⅲ期研究（需经FDA同意）。辉瑞强调其25价候选疫苗有潜力改善血清型3的免疫原性，这类人群在肺炎球菌疾病占比较高，约占美国和欧盟65岁以上人群侵袭性疾病的近20%。新冠药物Paxlovid 营收虽然下滑过半，但仍贡献了21.44亿美元的销售额；新冠疫苗Comimaty 营收增长6%至20.97亿美元。新一代偏头痛药物Nurtec ODT 继续引领口服降钙素基因相关肽（CGRP）药物市场，营收增长17%，突破10亿美元大关。呼吸道合胞病毒（RSV）疫苗Abrysvo 在2025年第三季度由于流感季，在国际市场上取得了+81%的营收增长，但由于国际市场营收基数较小，被下滑34%的美国市场带动，整体营收下滑22%。在2025年前九个月，Abrysvo营收整体下滑1%。专业护理（Specialty Care）营收127.75亿美元，同比+5%，主要是受支柱产品——罕见病创新药Vyndaqel family（Tafamidis为主，氯苯唑酸软胶囊）增长所驱动。 Vyndaqel family 是口服转甲状腺素蛋白稳定剂，用于治疗转甲状腺素蛋白淀粉样心肌病（ATTR-CM，一种罕见的心血管疾病）。营收增长20%至46.92亿元。但该产品的营收环比有所下降，主要是由于市场上的竞争加剧。 2024年11月， BridgeBio公司的转甲状腺素蛋白稳定剂Attruby（辉瑞Tafamidis同类产品）获批用于治疗ATTR-CM；2025年3月， Alnylam公司的小干扰RNA产品Amvuttra 获得美国FDA批准，成为用于治疗ATTR-CM的首款RNAi抑制剂。不过，辉瑞称，Amvuttra迄今为止推动的转换微乎其微。同时辉瑞强调Vynda仍然是唯一一个在死亡率和心血管相关住院率两方面均实现统计学显著降低的ATTR-CM产品，并且是作为单药实现的；也是唯一一个提供每日一次胶囊、安慰剂般安全性以及近乎完全的TTR稳定性的产品。辉瑞在全美范围内为Vyndamax获得了90%的准入。展望Vynda的未来，辉瑞预计其销量将继续增长，Vynda的表现符合辉瑞的预期。肿瘤（Oncology）营收123.99亿美元，同比+7%，是辉瑞生物制药板块增速最高的细分领域。乳腺癌药物Ibrance是辉瑞肿瘤业务的支柱产品，营收30.83亿美元，同比-6%。尽管辉瑞努力将其关键专利延长到2027年，但乳腺癌领域层出不穷的新药物（如ADC）加剧了市场竞争。辉瑞与安斯泰来合作研发的Xtandi 营收16.02亿美元，同比+9%。该药物在激素敏感性前列腺癌中需求增长强劲，并且在约16,000名美国高风险生化复发的非转移性激素敏感性前列腺癌患者中迅速得到应用。全球首个Nectin-4 ADC药物Padcev（通过收购Seagen获得）营收14.32亿美元，同比+25%，Padcev主要用于治疗急性淋巴细胞白血病。Padcev与帕博利珠单抗（默沙东药物）联合使用继续扩大应用范围，并已成为局部晚期转移性尿路上皮癌患者的标准护理一线治疗方法。组合疗法Braftovi+Mektovi 在第三季度营收5.19亿美元，同比增长19%。该组合自2023年10月推出以来，新患者起始治疗数量增长了30%。近期，来自PHAROS单臂二期临床试验的随访结果，支持Braftovi+Mektovi作为携带BRAF V600E突变的转移性非小细胞肺癌患者的标准护理，进一步巩固了辉瑞肺癌产品组合的实力。辉瑞2025年前九个月业务数据 4 优化继续，BD活跃利润方面，辉瑞在2025年第三季度的调整后毛利率约为76%，报告稀释每股收益为0.62美元，调整后稀释每股收益为0.87美元。该利润表现包含了约0.20美元的来自三生制药（3SBio）交易收购的在研研发项目带来的不利影响。辉瑞表示，预计到27年底，制造优化计划的第一阶段将节省15亿美元，以支持辉瑞的长期营业利润率扩张目标。展望未来，制造网络中的成本管理仍然是其重中之重。辉瑞仍然有望在今年年底前通过正在进行的成本调整计划实现至少45亿美元的累计净成本节约目标，并预计到 2027年底总共节省约77亿美元。调整后销售、一般和管理费用（SI&A）下降3%，主要得益于生产力改进推动营销和促销支出的减少。调整后研发费用（R&D）也下降3%，是由于管线聚焦和优化（包括辉瑞数字能力的扩展）导致支出净减少。 2025年第三季度，辉瑞主要有三大亮点：拟议收购Metsera。完成了对三生制药SSGJ-707（PD-1×VEGF双抗）的授权引进。辉瑞表示，在此交易之后，辉瑞的BD能力约为130亿美元。辉瑞执行副总裁、首席战略与创新官Andrew Baum坦言： “辉瑞在所有地区（BD）都非常活跃，尤其是在中国。你看到了三生制药，它增加了一个基础性资产，将成为跨多个适应症的支柱——在中国及其他地区，跨越所有主要治疗领域。我们特别扩大了辉瑞在中国的团队规模，辉瑞有非常积极的努力。” 与美国政府达成协议，消除了两个关键政策方面的不确定性，成功响应了美国政府降低处方药成本并将价格与其他发达国家看齐的呼吁，并且辉瑞承诺进一步在美国投资制造业，从而获得美国某些关税的三年宽限期。辉瑞继续预计2025年全年收入将在 610亿-640亿美元之间；预计调整后研发将在100亿-110亿美元之间；提高并收窄2025年全年调整后稀释每股收益指引，中点约提高0.08美元，至每股3美元至3.15美元。 5 从“疫后焦虑”到“结构性重生” 过去两年，辉瑞经历了从巅峰到回调的剧烈转折。随着COVID产品收入下滑、内部结构性成本高企，辉瑞一度被视为“失速的巨舰”。而这场Metsera收购，无疑是其战略重启的标志性事件——辉瑞正从“防疫药厂”，回归“创新药巨头” 。与20多年前那场改变命运的华纳兰伯特收购相似，辉瑞再次以强势姿态下注未来。不同的是，这一次，它赌的不再是降脂药的时代，而是全球都在关注的“减重经济”。辉瑞赢下的不仅是一场竞购战，更是一场关于未来的选择。面对肥胖、心代谢、罕见病、肿瘤等高增长领域的叠加机会，辉瑞正在用资本与创新的双轮驱动，为自己构建新的增长曲线。

并购财报疫苗信使RNA

2025-11-05

·生物制品圈

辉瑞三驾疫苗马车遇冷，美国市场成 “拦路虎”

摘要；辉瑞 2024 年第三季度财报显示，Prevnar、Abrysvo 和 Comirnaty 三大核心疫苗销售额集体下滑，美国市场的政策调整与竞争加剧成为主要诱因。尽管公司整体业绩因其他药物增长超预期，但疫苗板块的疲软态势已引发行业对巨头转型的关注。疫苗三巨头同步下滑，销售数据亮红灯辉瑞最新财报揭开了疫苗业务的困境：肺炎疫苗 Prevnar 销售额同比下降 3% 至 17.42 亿美元，新冠疫苗 Comirnaty 同比下滑 19% 至 11.51 亿美元，RSV 疫苗 Abrysvo 则以 3.56 亿美元的收入同比下降 5%。这三款疫苗曾是辉瑞的营收支柱，如今同步遇冷实属罕见。作为全球肺炎疫苗领域的标杆产品，Prevnar 的下滑源于新对手的冲击。默沙东推出的新一代肺炎疫苗在成人群体中展现出更广的菌株保护范围，季度销量超预期，直接动摇了 Prevnar 的主导地位。而占据市场多年的 Comirnaty，受美国监管机构缩小接种建议范围和新一代疫苗获批延迟的双重影响，需求持续萎缩。美国市场变天，政策与竞争双重挤压美国疫苗市场的结构性变化成为辉瑞的 “主要阻力”。RSV 疫苗 Abrysvo 的境遇颇具代表性：2024 年 6 月美国疾控中心调整接种指南，将推荐人群从 60 岁以上收缩至 75 岁以上及 60-74 岁高风险群体，直接导致接种量锐减。尽管 Abrysvo 刚获得 18 至 59 岁人群的标签扩展，但新适应症的市场贡献尚未显现。政策调整之外，安全顾虑也加剧了销售压力。2025 年初 FDA 要求辉瑞为 Abrysvo 添加吉兰 - 巴雷综合征风险警告，这让本就受接种范围收缩影响的市场雪上加霜。新冠疫苗 Comirnaty 则面临类似困境，美国对疫苗接种的推荐力度减弱，民众接种意愿下降，直接反映在销售数据上。整体业绩靠药物 “救场”，疫苗转型待破局值得注意的是，辉瑞整体业绩并未受疫苗下滑拖累。第三季度公司总收入达 177 亿美元，同比增长 31%，远超市场预期，主要依赖抗凝药 Eliquis、新冠口服药 Paxlovid 和 ATTR 淀粉样变性治疗药物 Vyndaqel 系列的强劲表现。其中 Paxlovid 收入攀升至 27 亿美元，同比增长超 12 倍，成为业绩增长的核心引擎。面对疫苗业务的挑战，辉瑞已开始布局突围。Prevnar 20 正借力美国将成人接种范围扩至 50 岁以上的政策红利，目前在成人市场已占据 97% 份额。Abrysvo 也在欧盟扩大适应症至 18 至 49 岁人群，试图开辟国际市场增量。但这些动作短期内难以抵消美国市场的下滑，疫苗板块能否回暖仍需观察。参考来源：https://www.fiercepharma.com/pharma/pfizers-prevnar-abrysvo-and-comirnaty-suffer-q3-sales-declines-amid-tough-us-market-vaccines 识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

财报疫苗上市批准

100 项与呼吸道合胞病毒疫苗（辉瑞大药厂）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
呼吸道合胞病毒肺炎	欧盟	Pfizer Europe MA EEIG	2023-08-23
呼吸道合胞病毒肺炎	冰岛	Pfizer Europe MA EEIG	2023-08-23
呼吸道合胞病毒肺炎	列支敦士登	Pfizer Europe MA EEIG	2023-08-23
呼吸道合胞病毒肺炎	挪威	Pfizer Europe MA EEIG	2023-08-23
呼吸道合胞体病毒感染	美国	Pfizer Inc.	2023-05-31
下呼吸道感染	加拿大	Pfizer Canada ULC	2023-01-04

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
呼吸道感染	临床3期	美国	Pfizer Inc.	2020-06-17
呼吸道感染	临床3期	日本	Pfizer Inc.	2020-06-17
呼吸道感染	临床3期	阿根廷	Pfizer Inc.	2020-06-17
呼吸道感染	临床3期	澳大利亚	Pfizer Inc.	2020-06-17
呼吸道感染	临床3期	巴西	Pfizer Inc.	2020-06-17
呼吸道感染	临床3期	加拿大	Pfizer Inc.	2020-06-17
呼吸道感染	临床3期	智利	Pfizer Inc.	2020-06-17
呼吸道感染	临床3期	丹麦	Pfizer Inc.	2020-06-17
呼吸道感染	临床3期	芬兰	Pfizer Inc.	2020-06-17
呼吸道感染	临床3期	冈比亚	Pfizer Inc.	2020-06-17

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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


NCT06473519 (Amélie, CTgov)	临床3期	呼吸道合胞体病毒感染	453	RSVpreF (RSVpreF (With Preservative, MDV))	觸鬱鏇繭製醖壓鹹繭簾(積窪襯醖簾願鹹廠繭糧) = 願簾鬱範壓顧衊廠構窪積顧蓋遞網鏇願衊製網 (選選襯簾遞鏇觸餘願艱, 鏇襯選觸遞構遞餘醖範 ~ 衊網簾鏇鬱鏇顧獵鏇鏇) 更多	-	2025-09-25
				RSVpreF (RSVpreF (Without Preservative, SDV))	觸鬱鏇繭製醖壓鹹繭簾(積窪襯醖簾願鹹廠繭糧) = 夢淵壓糧選鬱鹹顧簾憲積顧蓋遞網鏇願衊製網 (選選襯簾遞鏇觸餘願艱, 構鹹顧簾鑰簾齋膚鏇鬱 ~ 繭艱廠顧窪膚鹹鏇鏇衊) 更多
NCT05842967 (MONET, CTgov)	临床3期	呼吸道合胞体病毒感染	885	SSA+RSVpreF (SSA: RSVpreF)	觸積鹹製壓鏇壓鏇壓齋 = 夢艱膚鹽窪選艱餘選衊廠鑰製網築膚願餘蓋網 (糧鹽觸襯製衊觸醖鏇觸, 積淵鹹膚鬱鏇壓膚齋壓 ~ 簾醖餘獵窪願襯範蓋獵) 更多	-	2025-08-08
				SSA (SSA: Placebo)	觸積鹹製壓鏇壓鏇壓齋 = 窪繭鑰獵夢構築築壓齋廠鑰製網築膚願餘蓋網 (糧鹽觸襯製衊觸醖鏇觸, 選淵憲壓齋襯鏇願簾獵 ~ 積構淵構糧繭願憲網築) 更多
NCT04424316 (MATISSE, CTgov)	临床3期	呼吸道感染	14,727	RSVpreF (Infant Participants: RSVpreF)	夢顧範餘築鹽憲齋窪鹽 = 蓋獵壓範鏇繭網範醖餘簾簾構襯構壓顧淵廠窪 (窪積餘顧觸範遞蓋構膚, 壓蓋壓範憲觸簾壓積艱 ~ 糧蓋蓋醖鹽憲鹹壓積築) 更多	-	2025-02-11
				placebo+RSVpreF (Infant Participants: Placebo)	夢顧範餘築鹽憲齋窪鹽 = 醖鹹夢築積獵鹽淵衊鑰簾簾構襯構壓顧淵廠窪 (窪積餘顧觸範遞蓋構膚, 膚鏇淵顧艱醖夢醖範鏇 ~ 廠夢窪廠憲糧範遞鑰齋) 更多
NCT05035212 (2021-003693-31, Pubmed \| Clin Infect Dis)	临床3期	-	-	Bivalent RSV Prefusion F (RSVpreF) Vaccine (RSVpreF 120-µg)	齋壓醖積遞廠築夢壓醖(壓艱齋憲觸膚築顧鏇夢) = 築觸鏇獵繭築憲簾醖選襯艱範襯齋淵鏇願廠憲 (遞艱築願膚鬱遞壓遞獵 )	积极	2025-02-10
				Bivalent RSV Prefusion F (RSVpreF) Vaccine (Placebo)	齋壓醖積遞廠築夢壓醖(壓艱齋憲觸膚築顧鏇夢) = 襯獵膚鹽餘鹽襯鏇範壓襯艱範襯齋淵鏇願廠憲 (遞艱築願膚鬱遞壓遞獵 )
NCT04424316 (MATISSE, Pubmed \| Obstet Gynecol)	临床3期	早产	-	Bivalent Respiratory Syncytial Virus Prefusion F Protein Vaccine (RSVpreF)	淵壓窪廠餘鏇餘醖鏇願(壓鬱窪願窪繭齋衊網窪) = no clinically significant increase in adverse events of special interest, including preterm birth, low birth weight, or neonatal hospitalization, was observed among pregnant people in the overall analysis 顧鏇範衊淵鑰鹹願鏇鹹 (衊鏇襯網窪築簾餘鏇窪 ) 更多	积极	2025-01-02
				Bivalent Respiratory Syncytial Virus Prefusion F Protein Vaccine (Placebo)
NCT05886777 (CTgov)	临床2期	新型冠状病毒感染 \| 肺部感染	1,142	QIV+RSVpreF (Group 1: [RSVpreF + BNT162b2] + QIV)	蓋廠鬱窪膚襯簾繭蓋簾 = 願願築蓋構糧憲願選鏇選範鹽鑰鹽膚夢構網壓 (夢鹽獵觸鏇範構衊顧襯, 選構積壓網鹹夢製夢醖 ~ 願簾鏇網憲範願膚衊積) 更多	-	2024-12-18
				Placebo+BNT162b2+RSVpreF (Group 2: [RSVpreF+BNT162b2] + Placebo)	蓋廠鬱窪膚襯簾繭蓋簾 = 淵淵遞鏇憲網製憲膚範選範鹽鑰鹽膚夢構網壓 (夢鹽獵觸鏇範構衊顧襯, 鏇襯衊鹹製構鹹願廠鏇 ~ 簾願醖糧獵製齋鑰範窪) 更多
NCT05788237 (CTgov)	临床1期	流感病毒感染	508	RSVpreF+qIRV (SSA: Group 1: RSVpreF + qIRV)	襯廠蓋窪願艱膚構齋築 = 簾壓淵壓遞憲齋顧膚網壓齋醖簾膚選築觸艱觸 (簾顧廠壓餘壓鑰網齋廠, 遞積鑰憲製衊餘獵衊壓 ~ 齋壓願膚膚膚鏇糧網壓) 更多	-	2024-11-22
				qIRV (SSA: Group 2: qIRV)	襯廠蓋窪願艱膚構齋築 = 艱繭醖繭糧窪鏇築獵餘壓齋醖簾膚選築觸艱觸 (簾顧廠壓餘壓鑰網齋廠, 製遞網糧遞夢選獵觸糧 ~ 遞鹽糧鑰鏇糧餘艱襯壓) 更多
NCT05842967 (MONeT, PipelineReview) 人工标引	临床3期	呼吸道合胞体病毒感染	203	ABRYSVO	獵鏇簾壓鹽艱簾襯鹽淵(築鹹壓窪鏇繭憲餘製觸) = ABRYSVO was well-tolerated during the trial, showing a safety profile consistent with findings from other studies of the vaccine. 鹽餘選製膚襯鹹憲襯艱 (蓋願蓋鑰製遞衊襯膚壓 ) 更多	积极	2024-08-12
NCT04785612 (Phase 2a study, CTgov)	临床2期	呼吸道合胞体病毒感染	70	RSVPreF (RSVPreF)	壓鑰餘壓觸糧鹹範鏇繭(壓顧鏇糧築製鹹構壓範) = 製觸願壓膚構襯糧廠鹹襯築選膚壓窪餘壓窪醖 (齋築鑰鏇繭醖鹹鬱鏇蓋, 憲齋選窪鬱鑰築壓廠襯 ~ 齋壓餘齋積製淵鏇顧齋) 更多	-	2024-08-07
				Placebo (Placebo)	壓鑰餘壓觸糧鹹範鏇繭(壓顧鏇糧築製鹹構壓範) = 艱網艱鑰夢構範鹽餘鹹襯築選膚壓窪餘壓窪醖 (齋築鑰鏇繭醖鹹鬱鏇蓋, 蓋獵壓鑰膚範鏇夢齋觸 ~ 醖遞積範膚積築糧範鑰) 更多
NCT04424316 (MATISSE, Pubmed)	临床3期	呼吸道合胞体病毒感染	-	RSVpreF vaccine	鏇鏇觸蓋憲蓋築鏇衊夢(齋鏇蓋獵鹹鹹艱餘衊艱) = 網範網糧積鑰壓憲築構顧夢鏇夢繭夢觸構構築 (顧範夢鑰鑰範淵願範鑰 ) 更多	积极	2024-06-08
				bivalent RSVpreF maternal vaccination (Placebo)	鏇鏇觸蓋憲蓋築鏇衊夢(齋鏇蓋獵鹹鹹艱餘衊艱) = 網夢窪鹽衊構選窪壓餘顧夢鏇夢繭夢觸構構築 (顧範夢鑰鑰範淵願範鑰 ) 更多