If approved, GSK’s RSV vaccine would be the first available in Japan to help protect this group

如果获得批准，GSK的RSV疫苗将成为日本首个可帮助保护该群体的疫苗。

Submission supported by positive Phase IIIb data showing immune response and safety in this population

提交得到了显示该人群免疫反应和安全性的 IIIb 期阳性数据的支持

GSK plc (LSE/NYSE: GSK) today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has accepted the company’s regulatory application to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine to include adults aged 18-49 at increased risk of severe RSV disease.

GSK plc（LSE/NYSE：GSK）今天宣布，日本厚生劳动省（MHLW）已接受该公司扩展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18-49岁患有严重RSV疾病风险的成年人。

Arexvy was the first vaccine approved in Japan for adults aged 60 years and older for the prevention of RSV disease, and for those aged 50 years and older at increased risk for severe RSV disease..

Arexvy是日本首个获批用于60岁及以上成人预防RSV疾病的疫苗，同时也适用于50岁及以上患严重RSV疾病风险增加的人群。

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

RSV是一种常见的、具有传染性的病毒，影响肺部和呼吸道，全球每年约有6400万人受到感染。

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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，造成住院甚至死亡。

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This regulatory submission is supported by positive results from phase IIIb trial NCT06389487

这项监管提交得到了IIIb期试验NCT06389487积极结果的支持。

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which showed a non-inferior immune response in adults aged 18-49 at increased risk for RSV-LRTD due to certain underlying medical conditions, to that observed in adults aged 60 and above. The safety and reactogenicity data were consistent with results from the phase III programme that supported the initial approval of the vaccine in Japan. .

研究表明，对于因某些基础医疗条件而有较高RSV-LRTD风险的18-49岁成年人，该疫苗产生了不劣于60岁及以上成年人的免疫反应。安全性和反应原性数据与支持该疫苗在日本获得最初批准的III期试验结果一致。

GSK is the first company to seek regulatory approval for the vaccine to help protect adults aged 18-49 at increased risk of severe RSV disease in Japan. Regulatory submissions to expand the indications for the RSV vaccine continue in other geographies including the US and Europe.

GSK是首家在日本寻求监管批准该疫苗的公司，以帮助保护18-49岁重症RSV疾病风险增加的成年人。针对RSV疫苗扩大适应症的监管提交正在其他地区进行，包括美国和欧洲。

About Arexvy

关于Arexvy

Respiratory syncytial virus vaccine, adjuvanted, contains recombinant 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，含有在预融合构象中稳定的重组糖蛋白F（RSVPreF3）。该抗原与GSK专有的AS01结合。

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adjuvant.

辅助剂。

The MHLW has approved GSK’s RSV vaccine for the prevention of RSV (respiratory syncytial virus) disease for adults aged 60 years and above and adults aged 50 and older who are considered at increased risk of severe RSV disease. The use of this vaccine should be in accordance with official recommendations.

日本厚生劳动省（MHLW）已批准GSK的RSV疫苗，用于预防60岁及以上成年人以及50岁及以上被认为有严重RSV（呼吸道合胞病毒）疾病风险的成年人的RSV疾病。该疫苗的使用应遵循官方建议。

As with any vaccine, a protective immune response may not be elicited in all vaccinees..

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 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 the NCT06389487 trial

关于NCT06389487试验

NCT06389487 is a phase IIIb open-label study to evaluate the non-inferiority of the immune response and to evaluate the safety of GSK’s RSV vaccine in adults aged 18-49 at increased risk for RSV disease (n=426) compared to adults aged 60 and older (n=429). An additional cohort of 603 participants aged 18-49 were followed up for adverse events separate to safety follow up of the initial cohort.

NCT06389487 是一项 IIIb 期开放标签研究，旨在评估 GSK 的 RSV 疫苗在 18-49 岁（n=426）具有较高 RSV 疾病风险的成年人中的免疫反应非劣效性，并与 60 岁及以上（n=429）的成年人进行安全性比较。另外还有一组 603 名 18-49 岁的参与者被随访以观察不良事件，与初始队列的安全性随访分开。

1,458 participants were enrolled across 52 locations in 6 countries, including 4 sites in Japan..

1458名参与者在6个国家的52个地点注册，其中包括日本的4个站点。

The trial’s co-primary endpoints were RSV-A and RSV-B neutralisation titers expressed as mean geometric titer ratio (relative to older adults over adults at increased risk) and sero-response rate in RSV-A and RSV-B neutralising titers one month post vaccine administration. There were also safety and immunogenicity secondary endpoints..

该试验的共同主要终点是RSV-A和RSV-B中和抗体滴度，以几何平均滴度比表示（相对于高风险成年人群中的老年人），以及疫苗接种一个月后RSV-A和RSV-B中和抗体滴度的血清反应率。此外，还有安全性和免疫原性的次要终点。

About RSV in adults

关于成人RSV

RSV is a common contagious virus affecting the lungs and breathing passages. RSV 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。据估计，全球每年有6400万人受到RSV的影响。

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Adults can be at increased risk for RSV disease due to comorbidities, immune compromised status, or advanced age.2 RSV can exacerbate conditions, including COPD, asthma, and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalisation, and death.

由于合并症、免疫功能受损或高龄，成人患RSV疾病的风险可能会增加。RSV可能加重慢性阻塞性肺病、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。

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Please refer to the updated Product Information (PI) for important dosage, administration, and safety information in Japan at this link: https://www.info.pmda.go.jp/psearch/html/menu_tenpu_base.html

请通过此链接查阅更新后的产品信息（PI），以获取日本地区重要的剂量、管理和安全信息：https://www.info.pmda.go.jp/psearch/html/menu_tenpu_base.html

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。

References

参考文献

National Institute of Allergy and Infectious Diseases, Respiratory Syncytial Virus (RSV). Available at: https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv – last accessed: June 2025

美国国家过敏与传染病研究所，呼吸道合胞病毒 (RSV)。可访问：https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv – 最后访问时间：2025年6月

Falsey, AR et al. Respiratory syncytial virus infection in elderly and high-risk adults, in New Engl J Med 2005; 352:1749-59

Falsey, AR 等。老年人和高危成人中的呼吸道合胞病毒感染，《新英格兰医学杂志》，2005年；352:1749-59

Osei-Yeboah, R et al. Respiratory Syncytial Virus–Associated Hospitalization in Adults with Comorbidities in 2 European Countries: A Modeling Study. J Infect Dis; 2024; 229 (suppl 1): S70-S77

Osei-Yeboah, R 等。伴有合并症的成人呼吸道合胞病毒相关住院在两个欧洲国家的情况：一项建模研究。《感染病学杂志》；2024；229（增刊1）：S70-S77

Atamna A, Babich T, Froimovici D, Yahav D, Sorek N, Ben-Zvi H, Leibovici L, Bishara J, Avni T. Morbidity and mortality of respiratory syncytial virus infection in hospitalized adults: Comparison with seasonal influenza. Int J Infect Dis. 2021 Feb;103:489-493. doi: 10.1016/j.ijid.2020.11.185.

Atamna A, Babich T, Froimovici D, Yahav D, Sorek N, Ben-Zvi H, Leibovici L, Bishara J, Avni T. 住院成人呼吸道合胞病毒感染的发病率和死亡率：与季节性流感的比较。《国际传染病杂志》。2021年2月；第103卷：489-493页。doi: 10.1016/j.ijid.2020.11.185。

Clinicaltrials.gov, “A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above” – available at: https://clinicaltrials.gov/study/NCT06389487.

Clinicaltrials.gov，“一项针对18至49岁呼吸道合胞病毒（RSV）疾病高风险成人与60岁及以上老年人相比的RSV疫苗免疫反应和安全性的研究”——可在以下网址获取：https://clinicaltrials.gov/study/NCT06389487。