预约演示
更新于：2026-10-22
Palivizumab
帕利珠单抗
更新于：2026-10-22
概要
基本信息
药物类型 单克隆抗体 |
别名 Palivizumab (Genetical Recombination)、Palivizumab (genetical recombination) (JAN)、Palivizumab (USAN/INN) + [4] |
作用方式 抑制剂 |
作用机制 呼吸道合胞病毒F蛋白抑制剂 |
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (1998-06-19), |
最高研发阶段(中国)- |
特殊审评- |
登录后查看时间轴
结构/序列
Sequence Code 15486L
来源: *****
Sequence Code 508599H
来源: *****
关联
17
项与 帕利珠单抗 相关的临床试验CTRI/2025/11/098082
A Multicentre, Interventional, Phase IV, Open-label, Study to Evaluate the Safety of Palivizumab in Children Less than 24 Months of Age With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease - NA
NCT06851806
A Multicentre, Interventional, Phase IV, Open-label, Study to Evaluate the Safety of Palivizumab in Children Less Than 24 Months of Age With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease
NCT05816863
Clinical Study of Pabolizumab for Neoadjuvant Immunotherapy of Locally Advanced Microsatellite-unstable Gastric Adenocarcinoma
100 项与 帕利珠单抗 相关的临床结果
登录后查看更多信息
100 项与 帕利珠单抗 相关的转化医学
登录后查看更多信息
100 项与 帕利珠单抗 相关的专利（医药）
登录后查看更多信息
805
项与 帕利珠单抗 相关的文献（医药）2026-12-31Human Vaccines & Immunotherapeutics
Meta-analysis of the efficacy of palivizumab versus nirsevimab at preventing medically attended respiratory syncytial virus infections in non-hospitalized preterm infants
Review
作者: Waghorne, Nicola ; Carbonell-Estrany, Xavier ; Keary, Ian ; Paes, Bosco ; Fullarton, John ; Rodgers-Gray, Barry
Palivizumab has >27 y of proven effectiveness in the prevention of severe respiratory syncytial virus (RSV) infection in high-risk infants. However, there remains limited data on its efficacy at preventing medically attended, non-hospitalized RSV infections (MARI). A systematic literature review was undertaken to identify randomized, placebo-controlled studies of prophylactic interventions against MARI and RSV-related hospitalization in healthy infants born ≤35 weeks' gestational age (wGA). The findings informed a meta-analysis of three studies (N = 2,464) that found palivizumab significantly reduced MARI by 70.5% compared with placebo in 29-35 wGA infants, with broadly similar efficacy to nirsevimab.
2026-12-31Human Vaccines & Immunotherapeutics
Nirsevimab for respiratory syncytial virus prevention: A comprehensive product review
Review
作者: Martinon-Torres, Federico ; Razzini, Josefina L.
Infant RSV prevention is undergoing a public-health paradigm shift toward scalable, broad-eligibility passive immunization. This review examines nirsevimab (Beyfortus®), a long-acting recombinant IgG1κ monoclonal antibody targeting the conserved site Ø of prefusion RSV F protein. Its extended half-life enables season-long protection with a single dose, overcoming key limitations of palivizumab. A validated manufacturing platform and stringent release specifications ensure consistent quality and potency. Pivotal trials demonstrated high efficacy against RSV-associated lower respiratory tract infection hospitalization (RSVH), while the pragmatic HARMONIE trial confirmed an 83.2% reduction in RSVH under routine conditions. Postlicensure studies across multiple countries report 70-90% effectiveness against RSVH and substantial reductions in intensive care admissions. Comparative 2024-2025 data further suggest greater protection than maternal RSVpreF vaccination. Nirsevimab represents a scalable public-health intervention that can be used alone or complement maternal RSV vaccination, warranting continued surveillance of effectiveness, safety, and viral escape.
2026-09-01Lancet Child & Adolescent Health
A national programme of bivalent prefusion F vaccination in pregnancy and protection against respiratory syncytial virus hospitalisation in infants until age 6 months in the UK: a multicentre, prospective, test-negative, case–control study
Article
BACKGROUND:
In late summer, 2024, the UK introduced the maternal bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine for all pregnant individuals at a gestation of 28 weeks or more. After an initial catch-up phase, the maternal RSVpreF programme transitioned to year-round delivery, and in late summer, 2025, nirsevimab replaced palivizumab for infants at high risk of severe RSV disease. We aimed to estimate the protection provided by maternal RSVpreF against hospital admission with RSV in infants up to the age of 6 months, and to assess the overall performance of the UK RSV prevention programme once this had entered a steady state.
METHODS:
We conducted a national, multicentre, prospective, test-negative, case-control study at 37 BronchStop hospital sites in the UK. Patient and public involvement from a group of parents informed study protocol design. Included patients were prospectively enrolled infants aged 6 months or younger at the time of hospital admission with acute lower respiratory tract infection (ALRI) and tested for RSV. Test-positive infants (case patients) were defined as those admitted with a positive RSV test. Test-negative infants (control patients) were defined as those who tested negative for RSV. Infants were followed up until hospital discharge or death while an inpatient. The primary outcome was infant hospital admission with RSV-associated ALRI in infants born at a gestation of 28 weeks or more who did not receive nirsevimab postnatally. Primary vaccine effectiveness was calculated with the use of a conditional logistic regression model adjusted by site, calendar month of attendance, gestational age at birth, socioeconomic status, age at admission, and breastfeeding status. This study was registered with ClinicalTrials.gov, NCT04959734.
FINDINGS:
Between Sept 2, 2025, and Jan 31, 2026, 1356 infants were admitted to participating sites and screened for eligibility, 694 of whom were included in the primary analysis (429 RSV-positive infants and 265 RSV-negative infants). Median age was 2·2 months (IQR 1·3-3·9) for RSV-positive infants and 1·7 months (1·0-3·3) for RSV-negative infants. 394 (57%) of 694 infants were male and 300 (43%) were female. Ethnicity data were available for 693 mothers, of whom 538 (78%) identified as being of White ethnicity. The mothers of 161 (38%) RSV-positive infants and 175 (66%) RSV-negative infants had received the RSVpreF vaccine before delivery. The adjusted vaccine effectiveness of maternal RSVpreF vaccination for preventing infant hospital admission was 61% (95% CI 38-75) for infants aged up to 6 months, and 76% (54-87) for infants aged up to 3 months. The overall effectiveness of the UK RSV prevention programme was 61% (39-75) through to age 6 months.
INTERPRETATION:
In the real-world setting of the UK's maternal vaccination programme, RSVpreF vaccination was effective up until the age of 6 months in reducing the risk of hospital admission with RSV-associated ALRI, as was the UK's infant RSV prevention programme. These data could help decision makers to evaluate whether RSVpreF or an anti-RSV infant monoclonal antibody best serves the needs of their infant population.
FUNDING:
National Institute for Health and Care Research, The Wellcome Trust, Imperial College London, the Public Health Agency Northern Ireland, the Belfast Health and Social Care Trust Charitable Trust Funds, the Edinburgh Children's Hospital Charity, and the Respiratory Syncytial Virus Consortium in Europe.
100 项与 帕利珠单抗 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 支气管肺发育不良 | 澳大利亚 | 2015-09-24 | |
| 呼吸道合胞体病毒感染 | 欧盟 | 1999-08-13 | |
| 呼吸道合胞体病毒感染 | 冰岛 | 1999-08-13 | |
| 呼吸道合胞体病毒感染 | 列支敦士登 | 1999-08-13 | |
| 呼吸道合胞体病毒感染 | 挪威 | 1999-08-13 | |
| 下呼吸道感染 | 美国 | 1998-06-19 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 主动脉缩窄 | 临床3期 | 俄罗斯 | 2009-11-01 | |
| 动脉导管未闭 | 临床3期 | 俄罗斯 | 2009-11-01 | |
| 先天性心脏缺损 | 临床3期 | 俄罗斯 | 2009-11-01 | |
| 心房中隔缺损 | 临床3期 | 俄罗斯 | 2009-11-01 | |
| 早产 | 临床3期 | 俄罗斯 | 2009-11-01 | |
| 慢性肺疾病 | 临床2期 | 澳大利亚 | 2006-04-01 | |
| 慢性肺疾病 | 临床2期 | 智利 | 2006-04-01 | |
| 慢性肺疾病 | 临床2期 | 新西兰 | 2006-04-01 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
N/A | 222 | 餘願獵願壓觸壓鬱遞繭(製廠構衊壓廠鹹艱觸簾) = 蓋衊廠鬱窪襯鹽衊鏇窪 壓獵鹹鏇衊網網鹹艱繭 (觸鏇蓋夢窪選壓鬱製鏇 ) 更多 | 积极 | 2023-09-09 | |||
临床3期 | 50 | 鏇鹽醖壓夢齋範餘淵鹹 = 糧窪醖積積壓憲築範壓 遞鏇蓋糧製構網願夢範 (憲築鏇觸襯願鑰製繭構, 積願淵顧齋艱憲衊獵鏇 ~ 製顧膚網選夢蓋遞窪窪) | - | 2018-03-13 | |||
N/A | - | Premature infants receiving palivizumab | 築鏇鏇構繭範鏇繭憲鏇(膚膚鏇鹽鏇繭鏇網鑰夢) = 鹹窪獵築範艱遞遞範選 齋鑰餘鬱壓簾築願衊衊 (衊製願壓網衊鏇膚鏇鬱 ) | - | 2017-01-01 | ||
築鏇鏇構繭範鏇繭憲鏇(膚膚鏇鹽鏇繭鏇網鑰夢) = 襯鹹糧網壓夢艱築範願 齋鑰餘鬱壓簾築願衊衊 (衊製願壓網衊鏇膚鏇鬱 ) | |||||||
N/A | - | 觸鏇醖獵醖艱艱窪齋鬱(壓廠遞廠鹽壓蓋積製憲) = a fever which led to the discontinuation of the infusion 選廠壓簾遞構觸獵衊壓 (鏇壓窪廠觸鑰鑰窪鏇艱 ) 更多 | - | 2016-03-01 | |||
No palivizumab prophylaxis | |||||||
N/A | - | - | - | 2015-09-01 | |||
临床3期 | 28 | 衊淵獵憲顧衊膚壓觸襯(鏇鹹鬱顧積鬱鏇遞艱壓) = 築壓獵廠艱繭鏇構製夢 製遞鏇繭鹹鏇襯壓網壓 (觸積憲選齋壓窪糧廠廠, 0) 更多 | - | 2013-06-17 | |||
临床2期 | 260 | (Motavizumab (MEDI-524) Followed by Palivizumab) | 觸糧鑰鬱繭襯窪觸顧簾 = 構鬱衊糧獵製夢鹹網鑰 鑰積選顧製衊餘餘鹹獵 (構壓憲膚窪膚鹽糧膚築, 觸繭遞願築艱鏇願壓衊 ~ 遞構繭襯製窪夢憲糧選) 更多 | - | 2012-12-11 | ||
(Palivizumab Followed by Motavizumab (MEDI-524)) | 觸糧鑰鬱繭襯窪觸顧簾 = 簾遞襯窪窪顧獵構鬱廠 鑰積選顧製衊餘餘鹹獵 (構壓憲膚窪膚鹽糧膚築, 窪憲艱膚壓廠艱獵窪鹹 ~ 鏇選獵鹽觸鹽夢醖範淵) 更多 | ||||||
N/A | - | - | 獵鹹觸餘襯窪繭鬱簾構(獵鹽顧齋積鹹鏇築構夢) = 築選願網選製選餘鑰遞 範蓋齋餘鹹鹹壓築膚鬱 (鬱鬱廠獵製鬱淵艱廠鬱 ) 更多 | 积极 | 2012-09-01 | ||
獵鹹觸餘襯窪繭鬱簾構(獵鹽顧齋積鹹鏇築構夢) = 積網遞積願製範憲鑰簾 範蓋齋餘鹹鹹壓築膚鬱 (鬱鬱廠獵製鬱淵艱廠鬱 ) 更多 | |||||||
临床2/3期 | 100 | 鬱糧壓憲網醖遞鏇廠獵 = 餘衊憲糧獵繭選廠觸鹽 觸簾蓋衊選積醖醖膚選 (襯壓觸顧構觸願鏇鹽積, 築窪顧繭積鹹鬱製獵衊 ~ 廠鏇壓製範顧簾築遞鹽) 更多 | - | 2011-07-19 | |||
临床4期 | 417 | (Liquid Palivizumab) | 窪壓憲齋觸壓構夢夢醖 = 繭壓醖獵醖餘製鑰築鏇 鹽鏇夢壓構願餘築鹽選 (鏇觸網簾齋鹹憲醖淵顧, 衊艱顧淵鹽壓觸築積夢 ~ 範網築製鏇製壓網鹽繭) 更多 | - | 2008-10-28 | ||
(Lyophilized Palivizumab) | 窪壓憲齋觸壓構夢夢醖 = 糧鹹鹽鏇選膚糧積範淵 鹽鏇夢壓構願餘築鹽選 (鏇觸網簾齋鹹憲醖淵顧, 網艱鏇顧網餘夢築鏇願 ~ 窪範廠積構壓鏇膚憲觸) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
生物类似药
生物类似药在不同国家/地区的竞争态势。请注意临床1/2期并入临床2期，临床2/3期并入临床3期
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
提出任何生物医药研究问题
让每一步生物医药决策都精准制胜
基于十亿级生物数据与全球情报的精准 AI，赋能早期药物发现
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即接入生物医药数据包
智慧芽新药库数据也通过智慧芽开放平台，以MCP或API服务形式对外开放。立即使用我们的MCP服务定制您的LLM智能体。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用