·         Statistically Significant Reduction in Viral Load Confirmed in Clinical Trial

·临床试验证实病毒载量在统计学上显着降低

·         Primary Endpoint Achieved

·达到主要终点

·         In the highest dose group, there was an 88.94% reduction in viral load (P<0.0001)

·在最高剂量组中，病毒载量减少了88.94%（P<0.0001）

OSAKA, Japan, Jan 30, 2025

日本大阪，2025年1月30日

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Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) is pleased to announce that its novel investigational respiratory syncytial virus (RSV) oral antiviral candidate S-337395, which is being jointly developed with UBE Corporation (Head office: Minato-ku, Tokyo; President and Representative Director: Masato Izumihara; hereafter “UBE”),has achieved its primary endpoint in a Phase 2 clinical trial..

Shionogi＆Co.，Ltd.（总部：日本大阪；首席执行官：Isao Teshirogi，Ph.D.；以下简称“Shionogi”）很高兴地宣布，其新型研究性呼吸道合胞病毒（RSV）口服抗病毒候选药物S-337395正在与UBE Corporation（总部：东京Minato ku；总裁兼代表董事：Masato Izumihara；以下简称“UBE”）联合开发，已在2期临床试验中达到其主要终点。。

This trial was a randomized, placebo-controlled, double-blind human challenge study conducted in healthy adults who were actively inoculated with RSV. The antiviral efficacy and safety of S-337395 were evaluated when administered orally once daily for five days. The S-337395 treatment group showed a statistically significant reduction in viral load compared to the placebo group, achieving the primary endpoint.

该试验是一项在积极接种RSV的健康成年人中进行的随机，安慰剂对照，双盲人类攻击研究。当每天口服一次，持续五天时，评估S-337395的抗病毒功效和安全性。。

In the highest dose group of S-337395, there was an 88.94% reduction in viral load (P<0.0001), and also a statistically significant improvement in clinical symptom scores. Additionally, S-337395 was generally safe and well tolerated, there were no serious or severe adverse events, and no dose-dependent increase in incidence or severity of adverse events.

在最高剂量组S-337395中，病毒载量降低了88.94%（P＜0.0001），临床症状评分也有统计学意义的改善。此外，S-337395通常安全且耐受性良好，没有严重或严重的不良事件，并且不良事件的发生率或严重程度没有剂量依赖性增加。

No participants discontinued due to adverse events..

没有参与者因不良事件而停药。。

S-337395 is an investigational oral antiviral candidate for RSV infection that inhibits the activity of the L protein, which is essential for virus replication.

S-337395是RSV感染的研究性口服抗病毒候选药物，可抑制L蛋白的活性，L蛋白对病毒复制至关重要。

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Furthermore, this drug has received

此外，这种药物已经收到

Fast Track

快速通道

designation from the U.S. Food and Drug Administration (FDA).

美国食品和药物管理局（FDA）指定。

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RSV is a common respiratory virus that infects the nose, throat, and lungs, and can also cause severe illness such as bronchiolitis and pneumonia in children younger than 1 year of age.

呼吸道合胞病毒（RSV）是一种常见的呼吸道病毒，可感染鼻子、喉咙和肺部，也可引起1岁以下儿童的毛细支气管炎和肺炎等严重疾病。

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In recent years, there has been a growing awareness that RSV also causes high rates of hospitalization and mortality amongst individuals aged 60 and older. It is estimated that there are over 3 million patients with RSV infection annually in the U.S.

近年来，人们越来越意识到RSV还会导致60岁及以上人群的高住院率和死亡率。据估计，美国每年有300多万RSV感染患者。

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Effective antiviral treatment options for RSV remain limited, and there continues to be a significant unmet medical need in this area.

RSV的有效抗病毒治疗选择仍然有限，这方面的医疗需求仍然没有得到满足。

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We are accelerating the development of S-337395 to provide it to patients suffering from RSV infections as soon as possible.

我们正在加速S-337395的开发，以尽快为RSV感染患者提供S-337395。

Shionogi is committed to the principle “Protecting people worldwide from the threat of infectious diseases” as our key focus, and is working on the realization of total care for infectious diseases. In response to acute respiratory infections driving epidemics (such as influenza and COVID-19, RSV), we are working to build a new business model with an expanded portfolio of treatments achieving stable revenue..

Shionogi致力于将“保护全世界人民免受传染病威胁”的原则作为我们的重点，并致力于实现传染病的全面护理。。。

【About S-337395】

【关于S-337395】

S-337395 is a novel investigational oral treatment for RSV infection discovered through joint research with UBE. It is a low-molecular-weight compound with a novel mechanism that inhibits the RNA-dependent RNA polymerase activity of the L protein possessed by the RSV , thereby inhibiting the transcription and replication of the viral genome.

S-337395是通过与UBE联合研究发现的一种新型RSV感染研究性口服治疗方法。它是一种低分子量化合物，具有抑制RSV拥有的L蛋白的RNA依赖性RNA聚合酶活性的新机制，从而抑制病毒基因组的转录和复制。

Unlike F protein inhibitors, which exert their effect by preventing new viral infection of cells extracellularly, S-337395 works by preventing viral proliferation within infected cells, thus potentially offering higher efficacy and a more rapid reduction in viral load. Currently, under the joint development agreement.

与通过防止细胞外新病毒感染而发挥作用的F蛋白抑制剂不同，S-337395通过阻止感染细胞内的病毒增殖而起作用，因此可能提供更高的功效和更快的病毒载量降低。目前，根据联合开发协议。

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with UBE, Shionogi is advancing the global clinical development, while UBE is responsible for the development and manufacturing of the active pharmaceutical ingredient. By leveraging each company's strengths, we are advancing the joint development of this drug.

与UBE一起，Shionogi正在推动全球临床开发，而UBE负责开发和制造活性药物成分。通过利用每家公司的优势，我们正在推进这种药物的联合开发。

【About the Phase 2 Human Challenge Trial】

A human challenge trial is a clinical study in which healthy subjects are intentionally infected with a pathogen, such as a virus, to investigate the onset of disease and the progression of symptoms, including the viral load, after administration of a treatment or placebo. This trial was a randomized, placebo-controlled, double-blind human challenge study conducted to verify the efficacy and safety of S-337395.

人类挑战试验是一项临床研究，其中健康受试者故意感染病原体，如病毒，以调查疾病的发作和症状的进展，包括服用治疗或安慰剂后的病毒载量。该试验是一项随机，安慰剂对照，双盲人类挑战研究，旨在验证S-337395的有效性和安全性。

It involved 114 healthy adults who were actively inoculated with RSV. Participants were administered S-337395 or placebo for five days. The primary endpoint was the area under the curve (AUC) of the viral load over time..

它涉及114名积极接种RSV的健康成年人。参与者服用S-337395或安慰剂五天。主要终点是病毒载量随时间变化的曲线下面积（AUC）。。

【About RSV infection】

【关于RSV感染】

RSV is present worldwide without any geographical or climatic bias. It is characterized by having the greatest impact on vulnerable infants in all regions and by recurring annually, especially in urban areas. Each year in the U.S., RSV leads to approximately: 2.1 million outpatient (non-hospitalization) visits among children younger than 5 years old, 58,000–80,000 hospitalizations among children younger than 5 years old.

RSV在世界范围内存在，没有任何地理或气候偏见。它的特点是对所有地区的弱势婴儿影响最大，每年都会复发，尤其是在城市地区。在美国，RSV每年导致约210万名5岁以下儿童门诊（非住院）就诊，5岁以下儿童住院58000-80000次。

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and approximately 0.63 million-2.3 million outpatient (non-hospitalization) visits among adults 60 years and older, 70,555–168,130 hospitalizations among adults 60 years and older, and 3,813-15,739 deaths among adults 60 years and older

60岁及以上的成年人约有63万至230万次门诊（非住院），60岁及以上的成年人约有70555-168130次住院，60岁及以上的成年人约有3813-15739人死亡

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【About UBE Corporation】

【关于UBE公司】

UBE encompasses a group of specialty chemicals businesses, of which the pharmaceuticals business comprises the core of its life sciences portfolio, progressing beyond its track record of discoveries in small molecule therapeutics into high added-value products such as ADCs (antibody-drug conjugates).

UBE涵盖了一组特种化学品业务，其中制药业务是其生命科学投资组合的核心，超越了其在小分子疗法中发现的跟踪记录，发展成为高附加值产品，如ADC（抗体-药物偶联物）。

Alongside is a CDMO (contract development and manufacturing organization) business, which is strengthening its existing small molecule production capacity while also acquiring capabilities in novel modalities such as oligonucleotide therapeutics. UBE's life science businesses will continue to offer solutions that enhance and protect human life and health  .

此外还有一家CDMO（合同开发和制造组织）业务，该业务正在加强其现有的小分子生产能力，同时还获得了寡核苷酸治疗等新型方式的能力。UBE的生命科学业务将继续提供增强和保护人类生命和健康的解决方案。

https://www.ube.com/ube/en/

https://www.ube.com/ube/en/

[References]

[参考文献]

1.

1.

Press release on December 10, 2018

2018年12月10日新闻稿

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2.

Press release on February 28, 2022

2022年2月28日新闻稿

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3.

Press release on October 24, 2024.

2024年10月24日的新闻稿。

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U.S. Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV). Accessed January 23, 2025. Available at

U、 美国疾病控制和预防中心。呼吸道合胞病毒感染（RSV）。2025年1月23日访问。可在

https://www.cdc.gov/rsv/causes/index.html

https://www.cdc.gov/rsv/causes/index.html

.

.

5.       Drysdale SB, Broadbent L. Respiratory syncytial virus (RSV): over 60 years of research but still so many unanswered questions.

5.Drysdale SB，Broadbent L.呼吸道合胞病毒（RSV）：60多年的研究，但仍有许多悬而未决的问题。

Ther Adv Infect Dis.

Ther Adv感染Dis。

2023;10:20499361231159991. doi:10.1177/20499361231159991.

2023;10:20499361231159991.doi:10.1177/20499361231159991。

6.       U.S. Centers for Disease Control and Prevention. Surveillance of RSV. Accessed January 23, 2025. Available at

6、美国疾病控制与预防中心。RSV监测。2025年1月23日访问。可在

https://www.cdc.gov/rsv/php/surveillance/index.html

https://www.cdc.gov/rsv/php/surveillance/index.html

.

.

7.       Miloje Savic et al. Respiratory syncytial virus disease burden in adults aged 60 years and older in high‐income countries: A systematic literature review and meta‐analysis.

7.Miloje-Savic等人。高收入国家60岁及以上成年人的呼吸道合胞病毒疾病负担：系统文献综述和荟萃分析。

Influenza Other Respir Viruses.

流感其他呼吸道病毒。

2022 Nov 11;17(1):e13031. doi: 10.1111/irv.13031

2022年11月11日；17（1）：e13031。doi:10.111/irv.13031

For Further Information, Contact:

欲了解更多信息，请联系：

SHIONOGI Website Inquiry Form:

SHIONOGI网站查询表：

https://www.shionogi.com/global/en/contact.html

https://www.shionogi.com/global/en/contact.html

U.S. Media:

U、

ShionogiCommunications@shionogi.com

ShionogiCommunications@shionogi.com

SEU Press Office:

SEU新闻办公室：

pressoffice@shionogi.eu

pressoffice@shionogi.eu