GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the approval of GSK’s respiratory syncytial virus (RSV) vaccine for the prevention of lower respiratory tract disease (LRTD) caused by RSV from adults aged 60 and above to include adults aged 50-59 years at increased risk for RSV disease.    .

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，欧洲药品管理局人类使用药品委员会（CHMP）建议扩大葛兰素史克呼吸道合胞病毒（RSV）疫苗的批准范围，以预防由60岁及以上成年人的RSV引起的下呼吸道疾病（LRTD），包括50-59岁的RSV疾病风险增加的成年人。。

Today’s positive opinion is the first time that an indication for adults aged 50-59 has been recommended by CHMP for a RSV vaccine, one of the final steps prior to the extension of the marketing authorisation by the European Commission. The European Commission’s final decision is expected by September 2024.

今天的积极意见是CHMP首次建议50-59岁成年人接种RSV疫苗，这是欧盟委员会延长上市许可之前的最后一步。欧盟委员会的最终决定预计将于2024年9月作出。

Since June 2023, Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) has been approved in Europe for adults aged 60 and over for the prevention of RSV-LRTD.   .

自2023年6月以来，欧洲已批准Arexvy（呼吸道合胞病毒疫苗，重组佐剂）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 failure1 and diabetes2 are at increased risk for severe consequences from an RSV infection compared to those without these conditions. RSV can exacerbate these conditions and lead to pneumonia, hospitalisation or death.1  .

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1和糖尿病2等潜在疾病的成年人患RSV感染严重后果的风险增加。RSV可加剧这些情况，并导致肺炎，住院或死亡。

Each year, RSV causes approximately 270,000 hospitalisations and 20,000 in-hospital deaths in adults 60 years of age and older in Europe.3 The burden of RSV disease in at increased risk adults aged 50-59 is similar to that of the overall population aged 60 and above.4

每年，RSV在欧洲60岁及以上的成年人中导致约270000例住院治疗和20000例住院死亡[3]。50-59岁高风险成年人的RSV疾病负担与60岁及以上总人口的RSV疾病负担相似

The positive opinion is supported by results from a phase III trial [NCT05590403]5 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.

一项III期临床试验[NCT05590403]5的结果支持了这一积极观点，该试验评估了GSK的RSV疫苗在50-59岁成年人中的免疫反应和安全性，包括那些由于某些潜在的医疗条件而导致RSV-LRTD风险增加的人。

GSK’s RSV vaccine was approved by the US FDA for adults aged 50-59 at increased risk on 7 June 2024. GSK has also filed regulatory submissions to expand the use of its RSV vaccine to adults aged 50-59 at increased risk 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 due to certain underlying medical conditions and in immunocompromised adults aged 18 and over are expected to read out in H2 2024.   .

2024年6月7日，美国FDA批准葛兰素史克的RSV疫苗用于50-59岁风险增加的成年人。葛兰素史克还提交了监管意见书，将其RSV疫苗的使用范围扩大到日本和其他地区风险增加的50-59岁成年人，监管决定正在接受审查。预计2024年下半年将公布评估疫苗在18-49岁成年人中的免疫原性和安全性的试验，这些成年人由于某些潜在的医疗条件而风险增加，并且在18岁及以上的免疫功能低下的成年人中。

About GSK’s RSV Vaccine

关于葛兰素史克的RSV疫苗

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

呼吸道合胞病毒重组佐剂疫苗含有稳定在融合前构象（RSVPreF3）中的重组RSV糖蛋白F。该抗原与GSK专有的AS01E佐剂结合。

The vaccine was approved in Europe for adults aged 60 and over for the prevention of RSV-LRTD in June 2023. 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，该疫苗在欧洲被批准用于60岁及以上的成年人预防RSV-LRTD。这种疫苗的使用应符合官方建议。。

The vaccine has also been approved for the prevention of RSV-LRTD in individuals 60 years of age and older in over 45 countries, including the 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包括美国在内的45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 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Agenus Inc的全资子公司Antigenics Inc.许可的STIMULON QS-21佐剂。STIMULON是Agenus的子公司SasioQX Inc.的商标。

RSV is a common contagious virus affecting the lungs and breathing passages. Adults can be at increased risk for RSV disease due to comorbidities, immune compromised status, or advanced age. RSV can exacerbate conditions, including COPD, asthma, and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalisation, and death.1 Each year RSV causes approximately 470,000 hospitalisations and 33,000 deaths in adults aged 60 and older in high-income countries.3 .

RSV是一种常见的传染性病毒，会影响肺部和呼吸道。。RSV可加剧COPD，哮喘和慢性心力衰竭等疾病，并可导致严重后果，如肺炎，住院和死亡[1]。在高收入国家，每年RSV导致60岁及以上成年人约470000例住院和33000例死亡。

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。