GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency (EMA) has accepted the company’s regulatory application to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine to include adults from 18 years of age.

GSK plc（LSE/NYSE：GSK）今天宣布，欧洲药品管理局（EMA）已接受该公司扩大其佐剂重组呼吸道合胞病毒（RSV）疫苗使用的监管申请，将包括18岁及以上的成年人。

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was the first RSV vaccine approved in the European Economic Area for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and older, and for those aged 50-59 years who are at increased risk for RSV disease.

是欧洲经济区首个获批的RSV疫苗，用于预防60岁及以上成人以及50-59岁因RSV感染导致下呼吸道疾病（LRTD）的高风险人群。

RSV is a common contagious virus affecting the lungs and breathing passages and impacts an estimated 64 million people of all ages globally every year.

RSV是一种常见的传染性病毒，影响肺部和呼吸道，全球每年约有6400万人受到影响。

RSV can exacerbate certain medical conditions, and lead to severe illness resulting in hospitalisation and even death.

RSV会加重某些健康状况，导致严重疾病，致使患者住院甚至死亡。

A European regulatory decision on this submission is anticipated in H1 2026. GSK is continuing to seek expanded indications for its RSV vaccine in other geographies including the US and Japan.

预计将在2026年上半年对此提交作出欧洲监管决定。GSK将继续寻求在其包括美国和日本在内的其他地区扩大RSV疫苗的适用范围。

About GSK’s RSV vaccine

关于GSK的RSV疫苗

Respiratory Syncytial Virus Vaccine, Adjuvanted, contains recombinant RSV glycoprotein F stabilised in the prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary AS01

呼吸道合胞病毒疫苗（含佐剂）包含稳定在预融合构象的重组RSV糖蛋白F（RSVPreF3）。该抗原与GSK专有的AS01佐剂相结合。

adjuvant.

辅助剂。

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.

该疫苗的使用应遵循官方建议。与任何疫苗一样，并非所有接种者都会产生保护性免疫反应。

The vaccine has been approved for the prevention of RSV-LRTD in individuals 60 years of age and older in more than 60 countries. In addition, it is approved for use in individuals aged 50-59 who are at increased risk due to certain underlying medical conditions in more than 50 markets, including the US, Japan and Europe..

该疫苗已获批准用于预防 60 岁及以上人群的 RSV-LRTD，在 60 多个国家获得批准。此外，它还获准在包括美国、日本和欧洲在内的 50 多个市场中，因某些潜在健康状况而面临较高风险的 50 至 59 岁人群中使用。

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

GSK专有的AS01佐剂系统包含从Antigenics Inc.（Agenus Inc.的全资子公司）授权的STIMULON QS-21佐剂。STIMULON是Agenus子公司SaponiQx Inc.的商标。

About RSV in adults

关于成人RSV

RSV is a common contagious virus affecting the lungs and breathing passages, and impacts an estimated 64 million people of all ages globally every year.

RSV是一种常见的传染性病毒，影响肺部和呼吸道，全球每年约有6400万人受到影响。

Adults can be at increased risk for RSV disease due to certain comorbidities, immune compromised status, or advanced age.

某些合并症、免疫功能受损或高龄可能导致成年人感染 RSV 疾病的风险增加。

RSV can exacerbate conditions, including COPD, asthma, and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalisation, and death.

RSV 可以加剧慢性阻塞性肺病、哮喘和慢性心力衰竭等疾病，并可能导致肺炎、住院甚至死亡等严重后果。

About GSK

关于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.

GSK是一家全球生物制药公司，致力于联合科学、技术和人才，共同战胜疾病。欲了解更多信息，请访问gsk.com。