Detailed results from the CENTERSTONE trial show treatment with Xofluza reduced the odds of transmission, or spread of influenza virus, from an infected person to household members by 32%

CENTERSTONE 试验的详细结果显示，与感染流感病毒的人接触后，使用 Xofluza 治疗可将流感病毒传播给家庭成员的几率降低 32%。

CENTERSTONE is the first global phase III trial that demonstrates the benefit of an antiviral in reducing the spread of a respiratory virus

CENTERSTONE 是首个全球 III 期试验，证明了抗病毒药物在减少呼吸道病毒传播方面的益处。

Reducing the spread of infection within households could help limit transmission within institutions and communities, potentially easing the burden of both seasonal and pandemic influenza on healthcare systems

减少家庭内部的感染传播可能有助于限制机构和社区内的传播，从而可能减轻季节性流感和大流行性流感对医疗系统的负担。

South San Francisco, CA -- April 24, 2025 --

加利福尼亚州南旧金山 -- 2025年4月24日 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the

基因泰克公司（Genentech），罗氏集团（SIX：RO，ROG；OTCQX：RHHBY）的成员，今天宣布

New England Journal of Medicine

新英格兰医学杂志

(NEJM) has published a detailed analysis of the Phase III CENTERSTONE trial of Xofluza

《新英格兰医学杂志》发表了对Xofluza的三期CENTERSTONE试验的详细分析。

®

®

(baloxavir marboxil).

（巴洛沙韦酯）。

The trial met its primary endpoint, showing a single, oral dose of Xofluza taken by people infected with influenza reduced the odds of untreated household members contracting the virus by 32%. For the key secondary endpoint of influenza virus transmission resulting in symptoms, Xofluza showed a clinically meaningful reduction although statistical significance was not reached.

该试验达到了主要终点，结果显示，感染流感的人单次口服Xofluza后，未治疗的家庭成员感染病毒的几率降低了32%。在导致症状的流感病毒传播这一关键次要终点上，Xofluza显示出具有临床意义的减少，尽管未达到统计学显著性。

Xofluza was well tolerated, with no new safety signals identified..

Xofluza 耐受性良好，未发现新的安全信号。

“This trial is the first to demonstrate an antiviral effect that reduces transmission of influenza viruses within a household. This result may potentially have broad-reaching implications for public health,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development.

“这项试验首次证明了抗病毒效果可以减少流感病毒在家庭内的传播。 这一结果可能对公共卫生产生广泛的影响，”罗氏首席医学官兼全球产品开发主管Levi Garraway博士表示。

“This publication reminds us of the ongoing societal need for solutions that can help ease the burden of influenza on society.”.

“该出版物提醒我们，社会仍然需要能够帮助减轻流感对社会负担的解决方案。”

Results from the CENTERSTONE trial have been submitted to health authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

CENTERSTONE 试验的结果已提交给包括美国食品和药物管理局 (FDA) 和欧洲药品管理局 (EMA) 在内的卫生当局。

Influenza poses a significant health and economic burden, particularly for those at high risk of influenza-related complications. Every year, seasonal influenza infects an estimated one billion people worldwide and causes millions of hospitalizations, with up to 650,000 deaths globally. Approximately one-third of all influenza virus transmission occurs within households.

流感带来了严重的健康和经济负担，特别是对那些有流感相关并发症高风险的人群。每年，季节性流感在全球感染约10亿人，并导致数百万人住院，全球范围内多达65万人死亡。大约三分之一的流感病毒传播发生在家庭内部。

As many as 75% of working adults experience approximately two days of absenteeism due to influenza, whether they or someone within their household is sick, with most reporting that they go to work despite exhibiting symptoms. In the event of a pandemic, influenza would likely have a significant impact on the overall functioning of healthcare systems.

多达75%的在职成年人因流感而缺勤约两天，无论他们自己或家中的某个人生病，大多数人都表示尽管出现症状，他们仍然去上班。在发生大流行的情况下，流感可能会对医疗系统的整体运作产生重大影响。

With the co-circulation and burden of multiple respiratory viruses (including COVID-19) infecting individuals within and outside of the winter season, it is more important than ever to have effective options to treat and prevent the spread of influenza..

随着多种呼吸道病毒（包括 COVID-19）在冬季内外的共同传播和感染负担，拥有有效的选择来治疗和预防流感的传播变得比以往任何时候都更加重要。

This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under Other Transaction Agreement number: HHSO100201800036C.

本项目全部或部分得到了美国卫生与公众服务部、战略准备与响应管理局、生物医学高级研究与发展局的联邦资金支持，合作协定编号为：HHSO100201800036C。

About CENTERSTONE

关于CENTERSTONE

The CENTERSTONE study [

中心石研究 [

NCT03969212

NCT03969212

] was a global Phase III trial investigating the efficacy of single-dose Xofluza, taken within 48 hours of symptoms onset, to reduce the onward transmission of influenza within households. The study ran across 272 sites across the globe, with over 4,000 participants, and involved otherwise healthy patients from five to 64 years who had been diagnosed with influenza via a Polymerase Chain Reaction (PCR) or rapid influenza diagnostic test, known as index patients (IPs) and those within their household (known as household contacts, HHCs).

] 是一项全球 III 期试验，研究在症状出现后 48 小时内单剂量服用 Xofluza 在家庭内减少流感传播的有效性。该研究在全球 272 个地点进行，有超过 4,000 名参与者，涉及 5 至 64 岁通过聚合酶链反应 (PCR) 或快速流感诊断测试确诊为流感的健康患者，这些患者被称为索引患者 (IP)，以及与其同住的家庭接触者 (HHC)。

The primary endpoint was the proportion of HHCs who tested positive for influenza within five days after the IP had been treated with either Xofluza or placebo. The secondary endpoint looked at the proportion of HHCs who tested positive for influenza by Day five and developed influenza symptoms. The design of this randomized, placebo-controlled trial was developed with inputs from the U.S.

主要终点是在IP接受Xofluza或安慰剂治疗后五天内检测出流感呈阳性的HHC比例。次要终点是观察在第五天之前检测出流感呈阳性并出现流感症状的HHC比例。这项随机、安慰剂对照试验的设计是在美国的指导下完成的。

Food and Drug Administration and leading experts in influenza.      .

食品和药物管理局和流感方面的权威专家。

About Xofluza

关于Xofluza

®

®

(baloxavir marboxil)

（巴洛沙韦酯）

Xofluza is a first-in-class, single-dose oral medicine with an innovative mechanism of action designed to block viral replication by inhibiting the cap-dependent endonuclease protein, potentially reducing the duration of infectiousness and disease. Xofluza’s mechanism of action has demonstrated efficacy in a wide range of influenza viruses, including in vitro activity against oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies..

Xofluza 是一种首创的、单剂量口服药物，具有创新的作用机制，旨在通过抑制依赖帽状结构的内切核酸酶蛋白来阻断病毒复制，从而可能缩短传染性和疾病持续时间。Xofluza 的作用机制在广泛的流感病毒中显示出效力，包括在非临床研究中对奥司他韦耐药株和禽流感株（H7N9、H5N1）的体外活性。

Xofluza is approved in more than 80 countries for the treatment of uncomplicated influenza types A and B. In the U.S., Xofluza is approved for the treatment of influenza in people five years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications, and to prevent influenza in people five years of age and older following contact with a person who has influenza (post-exposure prophylaxis).

Xofluza 已在 80 多个国家获得批准，用于治疗单纯性 A 型和 B 型流感。在美国，Xofluza 被批准用于治疗年满五岁且症状持续不超过 48 小时的流感患者，这些患者可以是健康的，或是有较高风险发展为流感相关并发症的人群，并用于五岁及以上人群在接触流感患者后预防流感（暴露后预防）。

Xofluza represents the first innovation in mechanism of action for an influenza antiviral approved in almost 20 years for treatment in children five and older, adolescents, and adults..

Xofluza 代表了近 20 年来首个在作用机制上有所创新的流感抗病毒药物，适用于五岁及以上儿童、青少年和成人。

Xofluza was discovered by Shionogi & Co., Ltd. and is being further developed and commercialized globally in collaboration with the Roche Group (which includes Genentech in the U.S.) and Shionogi & Co., Ltd. Under the terms of this agreement, Roche holds worldwide rights to Xofluza excluding Japan and Taiwan, which will be retained exclusively by Shionogi & Co., Ltd..

Xofluza由盐野义制药株式会社发现，并正在与罗氏集团（包括美国的基因泰克公司）和盐野义制药株式会社合作进行全球进一步开发和商业化。根据该协议条款，罗氏拥有Xofluza的全球权利，但日本和台湾的权利将由盐野义制药株式会社独家保留。

Xofluza U.S. Indication

Xofluza美国适应症

XOFLUZA is a prescription medicine used to:

XOFLUZA是一种处方药，用于：

XOFLUZA does not treat or prevent illness that is caused by infections other than the influenza virus.

XOFLUZA 不治疗或预防由流感病毒以外的其他感染引起的疾病。

XOFLUZA does not prevent bacterial infections that may happen with the flu.

XOFLUZA 不能预防可能伴随流感发生的细菌感染。

It is not known if XOFLUZA is safe and effective for the treatment and prevention of the flu in children less than 5 years of age. XOFLUZA is not for use in children less than 5 years of age.

尚不清楚XOFLUZA对5岁以下儿童的流感治疗和预防是否安全有效。XOFLUZA不适用于5岁以下儿童。

Important Safety Information

重要安全信息

Who should not take XOFLUZA?

谁不应该服用XOFLUZA？

What should I tell my healthcare provider before using XOFLUZA?

在使用XOFLUZA之前，我应该告诉我的医疗保健提供者什么？

What are the possible side effects of XOFLUZA?

XOFLUZA可能有哪些副作用？

Serious side effects may include

严重的副作用可能包括

The most common side effects of XOFLUZA for treatment of the flu in adults and adolescents (12 years of age and older) were

在成人和青少年（12岁及以上）中，使用XOFLUZA治疗流感最常见的副作用是

diarrhea, bronchitis, nausea, sinusitis, and headache.

腹泻、支气管炎、恶心、鼻窦炎和头痛。

The most common side effects of XOFLUZA for treatment of the flu in children (5 years of age to less than 12 years of age)

XOFLUZA治疗流感在儿童（5岁至未满12岁）中最常见的副作用

were diarrhea and vomiting.

腹泻和呕吐。

These are not all the possible side effects of XOFLUZA. Call your healthcare provider for medical advice about side effects.

这些并非XOFLUZA的所有可能副作用。如需了解有关副作用的医疗建议，请咨询您的医疗服务提供者。

XOFLUZA is not effective in treating or preventing infections other than influenza. Other kinds of infections can have symptoms like those of the flu or occur along with flu and may need different kinds of treatment. Tell your healthcare provider if you feel worse or develop new symptoms during or after treatment with XOFLUZA or if your flu symptoms do not start to get better..

XOFLUZA 对治疗或预防流感以外的感染无效。其他类型的感染可能具有类似流感的症状，或者与流感同时发生，并且可能需要不同的治疗方法。如果您在使用 XOFLUZA 治疗期间或之后感觉病情加重或出现新的症状，或者您的流感症状没有开始好转，请告知您的医疗保健提供者。

You are encouraged to report side effects to Genentech by calling 1-888-835-2555 or to the FDA by visiting

您可以拨打1-888-835-2555向Genentech报告副作用，或访问FDA网站进行报告。

http://www.fda.gov/medwatch

http://www.fda.gov/medwatch

or calling 1-800-FDA-1088.

或拨打1-800-FDA-1088。

Please see full

请查看完整内容

Prescribing Information

处方信息

, including Patient Product Information.

，包括患者产品信息。

About Genentech in Influenza

关于基因泰克在流感领域

Influenza is a serious infectious disease and represents a significant burden to public health. In the U.S., since 2010, seasonal influenza has infected up to 41 million people and has caused thousands of hospitalizations and 51,000 deaths every year. Genentech has a long history of developing transformative medicines that contribute to public health.

流感是一种严重的传染病，对公共健康造成重大负担。在美国，自2010年以来，季节性流感每年感染多达4100万人，导致数千人住院和51,000人死亡。基因泰克在开发促进公共健康的变革性药物方面有着悠久的历史。

We are committed to bringing innovation in the field of infectious diseases, including influenza. Tamiflu.

我们致力于在包括流感在内的传染病领域带来创新。达菲。

®

®

(oseltamivir) has made a significant difference in the treatment of both, seasonal influenza and pandemic management, and we are proud to have brought this innovative medicine to patients. Genentech, a member of the Roche group, is committed to addressing the unmet need in this area through Roche’s agreement with Shionogi & Co., Ltd.

（奥司他韦）在季节性流感和大流行管理的治疗中都产生了显著的效果，我们很自豪能够将这种创新药物带给患者。罗氏集团成员基因泰克公司（Genentech）通过罗氏与盐野义制药有限公司（Shionogi & Co., Ltd.）的合作协议，致力于满足这一领域的未竟需求。

to develop and commercialize Xofluza.

开发和商业化Xofluza。

®

®

(baloxavir marboxil) in the U.S. market.

（巴洛沙韦酯）在美国市场。

About Genentech

关于基因泰克

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California.

成立40多年以来，基因泰克公司是一家领先的生物技术公司，致力于发现、开发、生产及销售用于治疗重症和威胁生命的疾病药物。该公司是罗氏集团的成员，总部位于加利福尼亚州南旧金山。

For additional information about the company, please visit .

有关公司的更多信息，请访问。

http://www.gene.com

http://www.gene.com

.

。

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