2023年2月21日格林尼治时间07:00
贝福图斯继续对
通过RSV季节感染RSV疾病
新的加拿大分析表明，Synagis具有很高的成本效益
29-35周胎龄婴儿
AstraZeneca will showcase new data across its 疫苗和免疫疗法 Respiratory Syncytial Virus (RSV) portfolio at the 7th Respiratory Syncytial Virus Foundation (ReSViNET) Conference in Lisbon, 葡萄牙，2023年2月22日至24日, 加强其帮助保护婴儿免受呼吸道合胞病毒感染的承诺. 该公司将在此次活动中展示五份摘要和海报，包括新的数据特色 Beyfortus (nirsevimab)和 Synagis (palivizumab).
Iskra Reic, 执行副总裁, 疫苗和免疫疗法, AstraZeneca, said: “I am proud of AstraZeneca’s commitment to respiratory syncytial virus (RSV) and our continued focus on innovating antibodies to provide protection to the most vulnerable. 澳门葡京赌博游戏相信 Beyfortus 有潜力 改变医学界预防婴儿呼吸道合胞病毒感染的方法, 这一点尤其重要，因为在刚刚过去的冬季，婴儿中病毒数量激增.”
强调继续需要RSV防护
AstraZeneca is working with the global clinical community to advance the understanding of RSV and is partnering with the ReSViNET Foundation to create the first global RSV surveillance dashboard set to launch in March 2023. 呼吸道合胞病毒是一种高度传染性的病毒，可引起婴儿呼吸道疾病, 包括肺部感染，如细支气管炎和肺炎.1 This seasonal respiratory virus is the most common cause of lower respiratory tract infections and a leading cause of hospitalisation in infants.1-5
Dr. Louis Bont, 乌得勒支大学医学中心威廉敏娜儿童医院的儿科医生, 荷兰, 也是ReSViNET的创始人和董事长, said: “The ReSViNET Foundation’s new dashboard will make it easier and more accessible to track worldwide changes in RSV seasonality, 帮助临床医生保护婴儿，防止呼吸道合胞病毒可能导致的住院率上升.”
寻求广泛预防呼吸道合胞病毒的突破
澳门葡京网赌游戏公布了III期MELODY临床试验全队列的安全性和有效性结果 Beyfortus 健康晚期早产儿和足月婴儿(35周孕龄或更大)进入第一个RSV季节. 这些数据加强了 Beyfortus’ consistent efficacy across endpoints and studies with approximately 70-80% efficacy against medically attended RSV lower respiratory tract infections vs placebo, 包括住院治疗上.6-10
保护高危婴儿的新成本效益数据
Synagis 在ReSViNet上展示了一项新的成本效益分析，继续建立在25年的实际使用基础上. 该分析首次纳入了国际风险评分工具, 如何帮助临床医生识别住院风险最高的早产儿.
澳门葡京网赌游戏在ReSViNet 2023会议上的主要演讲
摘要标题 |
展示细节 |
|---|---|
Safety and efficacy of nirsevimab for prevention of medically attended RSV lower respiratory tract infection in all infants enrolled in the Phase III MELODY trial |
Oral presentation #35; Session III: (Thursday 23 February, 11:40am- 1:00) EPIC SANA里斯本酒店, Morus Hall |
Safety and pharmacokinetics of nirsevimab for prevention of RSV disease in children with congenital heart disease or chronic lung disease of prematurity |
Poster #127; EPIC SANA Lisboa Hotel, Foyer |
Fc mediated function of nirsevimab complements direct RSV neutralisation but is not required for optimal protection in preclinical models |
Poster #184; EPIC SANA Lisboa Hotel, Foyer |
MEDLEY地区RSV感染的基因型和表型特征, 一项随机双盲III期研究，研究对象是患有严重疾病高风险的儿童 |
Poster #170; EPIC SANA Lisboa Hotel, Foyer |
New cost-effectiveness analysis of palivizumab for the prevention of RSV infection in otherwise healthy Canadian infants born 29-35 weeks’ gestational age (wGA) |
Poster #155; EPIC SANA Lisboa Hotel, Foyer |
Notes
RSV
呼吸道合胞病毒是下呼吸道感染的最常见原因, 包括婴儿的细支气管炎和肺炎.1 它也是所有婴儿住院的主要原因.1-5 Globally, in 2019, 大约有3300万例急性下呼吸道感染，导致300多万人住院, 据估计有26只,300名五岁以下儿童在医院死亡.11 rsv相关的直接医疗费用, 全球-包括医院, 门诊和随访护理-估计为4欧元.2017年820亿美元.12
Beyfortus (nirsevimab)
Beyfortus 单剂量长效抗体吗, 由澳门葡京网赌游戏和赛诺菲合作开发和商业化，使用澳门葡京网赌游戏的YTE技术. It is designed to protect infants entering or during their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
Beyfortus 通过一种抗体为新生儿和婴儿提供直接的RSV保护，以帮助预防由RSV引起的下呼吸道感染. 单克隆抗体不需要免疫系统的激活，及时提供帮助, 快速和直接预防疾病.14
Beyfortus has been granted regulatory and other designations to facilitate expedited development by several major regulatory agencies around the world. These include 突破性疗法认定 by the China Center for Drug Evaluation under the National Medical Products Administration; 突破性疗法认定 from the US Food and Drug Administration; access granted to the European Medicines Agency (EMA) 优先级的药品 (PRIME) scheme; and named “a medicine for prioritized development” under the Project for Drug Selection to Promote New Drug Development in Pediatrics by the Japan Agency for Medical Research and Development (AMED). 2022年11月， Beyfortus 已获得欧盟委员会和英国药品和保健产品监管局(MHRA)的批准.15-16
赛诺菲安万特联盟
2017年3月，澳门葡京网赌游戏和赛诺菲宣布合作 agreement 开发和商业化nirsevimab. 根据协议条款, 澳门葡京网赌游戏领导所有的开发和制造活动, 赛诺菲领导商业化活动并记录收入. 根据全球协议的条款, 赛诺菲支付了1.2亿欧元的预付款, has paid a development milestone of €30m and will pay up to a further €465m upon achievement of certain development and sales-related milestones. 这两家公司分担成本和利润. 该协议的收入在公司财务报表中报告为合作收入.
索比协议
相关报道，2018年11月，澳门葡京网赌游戏同意出售美国商业权利 Synagis (palivizumab) to Swedish Orphan Biovitrum AB (publ) (Sobi) in addition to the right to participate in payments that may be received by AstraZeneca from the US profits or losses for nirsevimab. Under the agreement, 澳门葡京网赌游戏获得了预先考虑, 2019-2021年期间nirsevimab的非或有付款, 随后FDA接受了nirsevimab的生物制品许可申请(BLA), 会收到1.75亿美元的现金支付吗. 澳门葡京网赌游戏也有权获得nirsevimab的某些其他里程碑付款, 其中包括在BLA在美国获得批准之日之后支付的9000万美元现金. AstraZeneca will continue to manufacture and supply nirsevimab globally and is entitled to an additional royalty from Sobi if profits from nirsevimab in the US exceed a pre-specified level.
Synagis (palivizumab)
Synagis (palivizumab) is an RSV F protein inhibitor monoclonal antibody indicated for the prevention of serious lower respiratory tract disease caused by RSV in paediatric patients with a history of premature birth (less than or equal to 35 weeks gestational age) and who are 6 months of age or younger at the beginning of the RSV season, with bronchopulmonary dysplasia (BPD) that required medical treatment within the previous 6 months and who are 24 months of age or younger at the beginning of the RSV season, or with hemodynamically significant congenital heart disease (CHD) and who are 24 months of age or younger at the beginning of the RSV season.13
AstraZeneca
澳门葡京网赌游戏(LSE/STO/Nasdaq: AZN)是一家全球性制药公司, 以科学为主导的澳门葡京赌博游戏公司，专注于发现, development, 以及肿瘤学处方药的商业化, Rare Diseases, 和澳门葡京赌博游戏, 包括心血管, Renal & 代谢与呼吸 & Immunology. 总部设在剑桥, UK, 澳门葡京网赌游戏在100多个国家开展业务，其创新药物被全球数百万患者使用. Please visit sunzixuan.com 并在Twitter上关注公司 @AstraZeneca.
Contacts
References
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13. Synagis SmPC. http://www.ema.europa.欧盟/ en /文件/澳门葡京网赌游戏/ synagis-epar-product-information_en.pdf. 2023年2月访问.
14. 疾病控制和预防中心. Vaccines & Immunizations. 2017年8月18日. http://www.cdc.gov / / vac-gen / immunity-types疫苗.htm. 2023年2月访问.
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16. Medicines & 保健产品监管机构. http://assets.publishing.service.gov.英国/政府/上传/系统/上传/ attachment_data /文件/ 1119040 / Marketing_authorisations_granted_1_ -_14_November_2022.pdf. 2023年2月访问.