GSK plc (LSE/NYSE: GSK) today announced that the European Commission has authorised Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 50-59 who are at increased risk.

葛兰素史克股份有限公司（伦敦证交所/纽约证交所：葛兰素史克）今天宣布，欧盟委员会已授权Arexvy（呼吸道合胞病毒疫苗，重组佐剂）进行主动免疫接种，以预防50-59岁风险增加的成年人因呼吸道合胞病毒（RSV）引起的下呼吸道疾病（LRTD）。

Since June 2023, GSK’s RSV vaccine has been approved in Europe for adults aged 60 and over for the prevention of RSV-LRTD.4.

自2023年6月以来，GSK的RSV疫苗已在欧洲批准用于60岁及以上的成年人预防RSV-LRTD。

Adults with underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes are at increased risk for severe consequences from an RSV infection compared to those without these conditions.5,6 RSV can exacerbate these conditions and lead to pneumonia, hospitalisation or death.6.

与没有这些疾病的人相比，患有慢性阻塞性肺病（COPD），哮喘，心力衰竭和糖尿病等潜在疾病的成年人患RSV感染严重后果的风险增加[5,6]。RSV可加剧这些疾病并导致肺炎，住院或死亡。

It is estimated that there are about 65 million adults aged between 50 and 59 in the European Union/European Economic Area1, with an estimated 20 million of these people (one-third) having at least one underlying medical condition that puts them at increased risk for RSV disease.2,3

据估计，在欧盟/欧洲经济区1中，大约有6500万年龄在50至59岁之间的成年人，其中估计有2000万人（三分之一）至少有一种潜在的疾病，使他们患RSV疾病的风险增加

Tony Wood, Chief Scientific Officer, GSK, said: “Today's approval reflects the importance of broadening the benefits of RSV immunisation to adults aged 50-59 who are at increased risk. RSV infection can have a significant impact on the health of older adults and particularly those with certain existing medical conditions, which can add pressure onto healthcare systems.

葛兰素史克（GSK）首席科学官托尼·伍德（TonyWood）表示：“今天的批准反映了将RSV免疫接种的益处扩大到50-59岁风险增加的成年人的重要性。RSV感染可能对老年人的健康产生重大影响，特别是那些患有某些现有疾病的老年人，这可能会给医疗保健系统带来压力。

As we enter the RSV season, we are pleased to be the first to deliver a vaccine to help protect more people in Europe from RSV-LRTD.”.

随着我们进入RSV季节，我们很高兴成为第一个提供疫苗的人，以帮助保护更多的欧洲人免受RSV-LRTD的侵害。”。

The regulatory application was supported by positive results from a phase III trial evaluating the immune response and safety of GSK’s RSV vaccine in adults aged 50-59, including those at increased risk for RSV-LRTD due to certain underlying medical conditions.7

监管应用得到了一项III期试验的积极结果的支持，该试验评估了GSK RSV疫苗在50-59岁成年人中的免疫反应和安全性，包括由于某些潜在的医疗条件而增加RSV-LRTD风险的成年人

Prof. Dr. Tino F. Schwarz, Klinikum Würzburg Mitte, Würzburg, Germany said: 'There are a great number of patients in the age-group 50-59 years living with certain underlying medical conditions with an increased risk for severe RSV infection. These patients are likely to benefit from the extension of the age indication of the RSV vaccine, helping to reduce the burden of disease of RSV associated LRTDs.

德国维尔茨堡Klinikum Würzburg-Mitte的Tino F.Schwarz教授说：“50-59岁年龄组的大量患者患有某些潜在的疾病，严重RSV感染的风险增加。这些患者可能会受益于RSV疫苗年龄适应症的延长，有助于减轻RSV相关LRTD的疾病负担。

I hope that the NITAGs in Europe will rapidly adapt the indication of RSV vaccination to include these patients'..

我希望欧洲的NITAGs将迅速适应RSV疫苗接种的适应症，以包括这些患者。。

In addition to the US and European approvals, GSK has also filed regulatory submissions to extend the use of this vaccine to adults aged 50-59 at increased risk, including in Japan and other geographies with regulatory decisions undergoing review. Trials evaluating the immunogenicity and safety of the vaccine in adults aged 18-49 at increased risk and immunocompromised adults aged 18 and over are expected to read out in later in 2024..

除了美国和欧洲的批准外，葛兰素史克还提交了监管意见书，将这种疫苗的使用范围扩大到风险增加的50-59岁成年人，包括日本和其他地区，监管决定正在审查中。预计2024年晚些时候将进行评估疫苗在18-49岁风险增加的成年人和18岁及以上免疫功能低下的成年人中的免疫原性和安全性的试验。。

About GSK’s RSV vaccine

关于葛兰素史克的RSV疫苗

Respiratory Syncytial Virus Vaccine, Adjuvanted recombinant, contains recombinant RSV glycoprotein F stabilised in the prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary AS01E adjuvant.

呼吸道合胞病毒疫苗，佐剂重组，含有稳定在融合前构象（RSVPreF3）中的重组RSV糖蛋白F。。

In June 2023, the European Commission approved GSK’s RSV vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. The use of this vaccine should be in accordance with official recommendations. As with any vaccine, a protective immune response may not be elicited in all vaccinees..

2023年6月，欧盟委员会批准葛兰素史克的RSV疫苗用于预防60岁及以上人群中由呼吸道合胞病毒（RSV）引起的下呼吸道疾病（LRTD）。这种疫苗的使用应符合官方建议。与任何疫苗一样，可能不会在所有接种者中引发保护性免疫反应。。

The Arexvy EMA Reference Information, including a full list of adverse events and the complete important safety information in the EU, will be available at this link: www.ema.europa.eu/medicines/human//EPAR/arexvy

Arexvy EMA参考信息，包括欧盟不良事件的完整列表和完整的重要安全信息，将通过以下链接获得：www.EMA.europa.EU/medicines/human//EPAR/Arexvy

The vaccine has also been approved for the prevention of RSV-LRTD in individuals 60 years of age and older in 50 countries, including Europe, Japan and US. Regulatory reviews in multiple countries are ongoing. The proposed trade name remains subject to regulatory approval in other markets.

该疫苗还被批准用于预防欧洲、日本和美国等50个国家60岁及以上人群的RSV-LRTD。多个国家的监管审查正在进行中。拟议的商品名仍需在其他市场获得监管部门的批准。

The GSK proprietary AS01 adjuvant system contains QS-21 STIMULON adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc.

GSK专有的AS01佐剂系统包含QS-21刺激素佐剂，该佐剂由Agenus Inc.的全资子公司Antigenics Inc.许可。

About RSV in adults

关于成年人的RSV

RSV is a common contagious virus affecting the lungs and breathing passages. Adults can be at increased risk for RSV disease due to certain underlying medical conditions, immune compromised status, or advanced age.6 RSV can exacerbate conditions, including COPD, asthma, and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalisation, and death.6 .

RSV是一种常见的传染性病毒，会影响肺部和呼吸道。由于某些潜在的医疗条件，免疫缺陷状态或高龄，成年人患RSV疾病的风险可能会增加[6]。RSV会加剧COPD，哮喘和慢性心力衰竭等疾病，并可能导致严重后果，如肺炎，住院和死亡。

About GSK

GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

葛兰素史克是一家全球性生物制药公司，旨在将科学、技术和人才团结起来，共同战胜疾病。更多信息请访问gsk.com。