•

•

This approval is based on the positive results from the global Phase 3 post‑exposure prophylaxis study, SCORPIO‑PEP, which is the first and only Phase 3 study of an oral antiviral to meet the primary endpoint of preventing COVID‑19 following exposure to an infected individual

这项批准基于全球三期暴露后预防研究 SCORPIO-PEP 的积极结果，该研究是首个也是唯一一个口服抗病毒药物的三期研究，达到了在接触感染者后预防 COVID-19 的主要终点。

1, 2

1, 2

.

。

•

•

XOCOVA

XOCOVA

®

®

is the first and only oral antiviral available for the post-exposure prophylaxis of COVID-19.

是首个也是唯一一个可用于COVID-19暴露后预防的口服抗病毒药物。

OSAKA, Japan, March 23, 2026

日本大阪，2026年3月23日

– Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced that it has received approval in Japan for an expanded indication of XOCOVA

– 盐野义制药株式会社（总部：日本大阪；首席执行官：手代木功博士；以下简称“盐野义”）宣布，已获得日本批准扩大XOCOVA的适应症。

®

®

(generic name: ensitrelvir fumaric acid; hereafter ‘XOCOVA’), an anti SARS-CoV-2 drug, for post-exposure prophylaxis of COVID-19. The approval is based on the

（通用名称：富马酸恩赛特雷韦；以下简称“XOCOVA”），一种抗SARS-CoV-2药物，用于COVID-19的暴露后预防。该批准基于

positive results from the Global Phase 3 Study, SCORPIO-PEP

SCORPIO-PEP全球三期研究的积极结果

.

。

1

1

COVID‑19 remains a public health threat

COVID‑19 仍然是一个公共卫生威胁

2,3

2,3

, While vaccination is considered the foundation of COVID‑19 prevention, declining vaccination rates, waning immunity following vaccination, and the potential emergence of new variants make it difficult to fully prevent SARS‑CoV‑2 infection, symptom onset, or disease severity through vaccination alone..

虽然疫苗接种被认为是预防 COVID-19 的基础，但疫苗接种率的下降、接种后免疫力的减弱以及新变异株的潜在出现，使得仅靠疫苗接种难以完全预防 SARS-CoV-2 感染、症状发作或疾病严重程度。

4,5,6,7

4，5，6，7

Under these circumstances, post‑exposure prophylaxis with an antiviral agent represents an important option for the prevention of COVID‑19, particularly for individuals with risk factors for severe disease who have been exposed to a person with COVID‑19

在这种情况下，使用抗病毒药物进行暴露后预防是预防 COVID-19 的一个重要选择，特别是对于有严重疾病风险因素且已接触过 COVID-19 患者的人群。

8

8

.

。

Ensitrelvir, known as XOCOVA in countries where it is approved,

恩司特韦，在获批的国家被称为XOCOVA，

received emergency regulatory approval

收到紧急监管批准

in Japan in November 2022 and full approval in March 2024 for the treatment of COVID-19. Furthermore, in 2025, based on the positive results from the global Phase 3 post‑exposure prophylaxis study (SCORPIO‑PEP), Shionogi

2022年11月在日本获得批准，2024年3月获得全面批准用于治疗COVID-19。此外，基于全球第三阶段暴露后预防研究（SCORPIO-PEP）的积极结果，Shionogi在2025年...

submitted a supplemental New Drug Application in Japan

在日本提交了补充新药申请

for an expanded indication of ensitrelvir for the post‑exposure prophylaxis of COVID‑19. In addition, a Phase 3 study in Japan in pediatric patients demonstrated favorable safety and tolerability, and showed that the pharmacokinetics of ensitrelvir in pediatric patients were similar to those observed in adults.

用于恩司特韦扩大适应症，针对COVID-19的暴露后预防。此外，在日本进行的一项针对儿科患者的III期研究显示了良好的安全性和耐受性，并表明恩司特韦在儿科患者中的药代动力学与在成人中观察到的相似。

9

9

. Based on these results, Shionogi also

基于这些结果，Shionogi还

submitted an application

提交了一份申请

to expand the approved dosage and administration from the current treatment indication for patients aged 12 years and older to include pediatric patients aged 6 years and older weighing 20 kg or more.

将目前适用于12岁及以上患者的治疗适应症的批准剂量和用法，扩展至包括6岁及以上、体重20公斤或以上的儿科患者。

It became

它变成了

available in Singapore

在新加坡可用

via a Special Access Route application in 2023, and it is currently under regulatory review for the treatment of COVID-19 in Taiwan.

通过2023年的特殊准入途径申请，目前正接受台湾地区用于治疗COVID-19的监管审查。

Ensitrelvir is currently

恩司特韦目前

under review by the U.S. Food and Drug Administration (FDA)

正在接受美国食品药品监督管理局 (FDA) 的审查

for the prevention of COVID‑19 following exposure, with a Prescription Drug User Fee Act (PDUFA) target action date of June 16, 2026. Ensitrelvir is also under regulatory review with the European Medicines Agency for COVID-19 post-exposure prophylaxis and treatment.

用于预防接触新冠病毒后的感染，处方药使用者费用法案（PDUFA）的目标行动日期为2026年6月16日。Ensitrelvir也正在接受欧洲药品管理局的监管审查，用于新冠病毒接触后预防和治疗。

10

10

Product Information

产品信息

Product name

产品名称

XOCOVA

XOCOVA

@

@

Tablets 125mg

片剂 125毫克

Generic Name

通用名称

ensitrelvir fumaric acid

恩司特韦富马酸盐

Indication

适应症

Treatment and post-exposure prophylaxis of SARS-CoV-2 infection

SARS-CoV-2感染的治疗与暴露后预防

Dosage

剂量

Regimen

方案

※

※

The usual dosage for children aged 12 years or older and adults is 375 mg of ensitrelvir orally on Day 1 and 125 mg once daily from Days 2 to 5.

12岁及以上儿童和成人通常的剂量为第1天口服375毫克ensitrelvir，第2至5天每日一次125毫克。

Drug price

药品价格

JPY7,090 per 125mg tablet

每片125毫克的药片7,090日元

Marketing

市场营销

Authorization

授权

Holder

持有者

Shionogi & Co., Ltd.

盐野义制药株式会社

※

※

The dosage and administration of this product are the same for both treatment and post-exposure prophylaxis.

该产品的治疗和暴露后预防的剂量与用法相同。

About ensitrelvir

关于ensitrelvir

Ensitrelvir is a 3CL protease inhibitor created through joint research between Hokkaido University and Shionogi. SARS-CoV-2 has an enzyme called 3CL protease, which is essential for the replication of the virus.

恩赛特韦是由北海道大学和盐野义制药共同研究开发的一种3CL蛋白酶抑制剂。SARS-CoV-2拥有一种名为3CL蛋白酶的酶，这种酶对病毒的复制至关重要。

11

11

Ensitrelvir suppresses the replication of SARS-CoV-2 by selectively inhibiting the 3CL protease.

恩司特韦通过选择性抑制3CL蛋白酶来抑制SARS-CoV-2的复制。

11

11

Shionogi evaluated the safety and efficacy of ensitrelvir through SCORPIO-SR, a Phase 3 study conducted in Asia, during the Omicron-dominant phase of the epidemic.

盐野义制药公司通过在亚洲进行的第三阶段研究SCORPIO-SR，在奥密克戎主导的疫情阶段评估了恩司特韦的安全性和有效性。

12

12

In this study, ensitrelvir showed both clinical symptomatic efficacy (symptom resolution sustained for at least 24 hours) for five typical Omicron-related symptoms (primary endpoint) and antiviral efficacy (key secondary endpoint) in a predominantly vaccinated population of patients with mild-to-moderate SARS-CoV-2 infection, regardless of risk factors..

在这项研究中，恩司特韦表现出对五个典型的奥密克戎相关症状（主要终点）的临床症状疗效（症状缓解持续至少24小时），并在大多数接种疫苗的轻至中度SARS-CoV-2感染患者群体中显示出抗病毒疗效（关键次要终点），且不受风险因素影响。

12

12

Regarding safety, most adverse events were mild in severity and no deaths were seen in the study.

关于安全性，大多数不良事件的严重程度较轻，研究中未出现死亡病例。

12

12

Among the most common treatment-related adverse events were temporary decreases in high-density lipoprotein and increased blood triglycerides, as observed in previous studies.

在最常见的治疗相关不良事件中，高密度脂蛋白暂时减少和血液甘油三酯增加，这与之前的研究结果一致。

12

12

The data from this study were

本研究的数据被

published

已发布

in JAMA Network Open.

在JAMA Network Open上。

Additionally, the Phase 3 SCORPIO-HR study assessed ensitrelvir in a broad range of symptomatic, non-hospitalized participants with COVID-19, regardless of past SARS-CoV-2 infection. The study did not meet its primary endpoint of a statistically significant reduction in time to sustained resolution (symptom resolution sustained for at least 48 hours) of 15 common COVID-19 related symptoms for once-daily ensitrelvir compared to placebo..

此外，三期SCORPIO-HR研究评估了恩赛特雷韦在广泛的症状性、未住院的COVID-19参与者中的效果，无论其过去是否感染过SARS-CoV-2。该研究未达到其主要终点，即与安慰剂相比，每日一次使用恩赛特雷韦未能在统计学上显著减少15种常见COVID-19相关症状持续缓解（症状缓解持续至少48小时）的时间。

13

13

No new safety concerns were identified in the study, and treatment with ensitrelvir was well tolerated, with a similar adverse event profile as placebo.

研究中未发现新的安全问题，且恩赛特韦治疗耐受性良好，不良事件情况与安慰剂相似。

Shionogi recently announced that its global, double-blind, randomized, placebo-controlled Phase 3 study (SCORPIO-PEP) assessing ensitrelvir as oral post-exposure prophylaxis met the primary endpoint of preventing COVID-19.1 SCORPIO-PEP is the first and only Phase 3 study of a COVID-19 oral antiviral as a post-exposure prophylaxis to meet the primary endpoint of preventing COVID-19..

盐野义最近宣布其全球性、双盲、随机、安慰剂对照的3期研究（SCORPIO-PEP）评估了ensitrelvir作为口服暴露后预防药物，达到了预防新冠肺炎的主要终点。SCORPIO-PEP是首个也是唯一一个达到预防新冠肺炎主要终点的新冠肺炎口服抗病毒药物的3期研究。

*

*

SCORPIO-PEP assessed 2,387 study participants aged 12 years and older with a negative screening test for SARS-CoV-2 infection and no symptoms at the time of enrollment, who were exposed to a person living in their household with symptomatic COVID-19. Study participants were randomly assigned in a 1:1 ratio to receive ensitrelvir (125 mg) or placebo, once daily, and began treatment within three days of when the household member with COVID-19 began showing symptoms.

SCORPIO-PEP 研究评估了2,387名12岁及以上、在入组时对SARS-CoV-2感染筛查呈阴性且无症状的研究参与者，这些参与者与家中出现有症状的COVID-19患者共同居住并暴露于该病毒环境。研究参与者以1:1的比例随机分配接受恩赛特雷韦（125毫克）或安慰剂，每日一次，并在家中COVID-19患者开始出现症状的三天内开始治疗。

Participants then continued ensitrelvir or placebo for five days..

参与者随后继续服用恩赛特雷韦或安慰剂五天。

Overall, ensitrelvir was generally well tolerated, with similar rates of adverse events in the ensitrelvir group and the placebo group (15.1% and 15.5%, respectively).

总体而言，恩司特韦通常具有良好的耐受性，恩司特韦组和安慰剂组的不良事件发生率相似（分别为15.1%和15.5%）。

1,

1,

There were no COVID-19 related hospitalizations or deaths.

没有与COVID-19相关的住院或死亡病例。

Forward-Looking Statements

前瞻性声明

This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate.

本公告包含前瞻性陈述。这些陈述是基于当前可用信息的预期，假设存在可能导致实际结果与这些陈述产生重大差异的风险和不确定性。风险和不确定性包括一般国内和国际经济状况，如一般行业和市场状况，以及利率和汇率的变化。

These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations.

这些风险和不确定性尤其适用于与产品相关的前瞻性声明。产品风险和不确定性包括但不限于：临床试验的完成和终止；获得监管批准；对产品安全性和有效性的声明和担忧；技术进步；重要诉讼的不利结果；国内外医疗改革以及法律法规的变化。

Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise..

对于现有产品，也存在生产和营销风险，包括但不限于无法建立产能满足需求、原材料供应不足以及竞争产品进入市场。公司否认有任何意图或义务更新或修改任何前瞻性声明，无论是否由于新信息、未来事件或其他原因。

For Further Information, Contact:

如需更多信息，请联系：

SHIONOGI Website Inquiry Form:

SHIONOGI网站咨询表：

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

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

U.S. Media:

美国媒体：

ShionogiCommunications@shionogi.com

ShionogiCommunications@shionogi.com

EU Media:

欧盟媒体：

pressoffice@shionogi.eu

pressoffice@shionogi.eu

* Literature search conducted January 2026.

* 文献检索于2026年1月进行。

Reference List:

参考文献列表：

[1] Hayden F. Ensitrelvir to Prevent COVID-19 in Households: SCORPIO-PEP Phase III Placebo-Controlled Trial Results. Abstract 200. Presented at CROI 2025, San Francisco, CA: March 9-12, 2025.

[1] 海登 F. 恩西特雷韦预防家庭内新冠病毒感染：SCORPIO-PEP III期安慰剂对照试验结果。摘要200。发表于2025年CROI会议，美国加利福尼亚州旧金山，2025年3月9日至12日。

[2] Current Epidemic Trends (Based on R

[2] 当前流行趋势（基于R

t

t

) for States. Centers for Disease Control and Prevention. Available at:

) 各州。疾病控制和预防中心。可用地址：

https://www.cdc.gov/cfa-modeling-and-forecasting/rt-estimates/index.html?tab=0

https://www.cdc.gov/cfa-modeling-and-forecasting/rt-estimates/index.html?tab=0

[3] Six years after COVID-19’s global alarm: Is the world better prepared for the next pandemic?. World Health Organization. Available at:

[3] 新冠肺炎全球警报发出六年：世界是否为下一次大流行做好了更好的准备？世界卫生组织。可访问：

https://www.who.int/news/item/02-02-2026-six-years-after-covid-19-s-global-alarm-is-the-world-better-prepared-for-the-next-pandemic

https://www.who.int/news/item/02-02-2026-六年后的新冠疫情全球警报-世界是否为下一次大流行做好了准备

[4] Recommendations on COVID-19 Vaccines (11th Edition). Available at:

[4] 关于COVID-19疫苗的建议（第11版）。可访问：

https://www.kansensho.or.jp/uploads/files/guidelines/2509_covid-19_11.pdf

https://www.kansensho.or.jp/uploads/files/guidelines/2509_covid-19_11.pdf

[5] Van Egeren D, Stoddard M, White LF, Hochberg NS, Rogers MS, Zetter B, Joseph-McCarthy D, Chakravarty A. Vaccines Alone Cannot Slow the Evolution of SARS-CoV-2. Vaccines. 2023 Apr 16;11(4):853.

[5] Van Egeren D, Stoddard M, White LF, Hochberg NS, Rogers MS, Zetter B, Joseph-McCarthy D, Chakravarty A. 仅靠疫苗无法减缓SARS-CoV-2的进化。《疫苗》。2023年4月16日；11(4):853。

https://doi.org/10.3390/vaccines11040853

https://doi.org/10.3390/vaccines11040853

[6] Vaccination Trends. Centers for Disease Control and Prevention. Available at:

[6] 疫苗接种趋势。疾病控制与预防中心。可访问：

https://www.cdc.gov/respiratory-viruses/data/vaccination-trends.html

https://www.cdc.gov/respiratory-viruses/data/vaccination-trends.html

[7] Bukke, S. P. N., Prajapati, S., Yadav, S., Thalluri, C., Chettupalli, A. K., Onohuean, H., Yahaya, U.-K. H., Goruntla, N., Janapati, Y. K., Shogar, A. E., & Yadesa, T. M. (2026). Evolving COVID-19 subvariants and waning vaccine-induced immunity: A new public health risk for the African continent.

[7] Bukke, S. P. N., Prajapati, S., Yadav, S., Thalluri, C., Chettupalli, A. K., Onohuean, H., Yahaya, U.-K. H., Goruntla, N., Janapati, Y. K., Shogar, A. E., & Yadesa, T. M. (2026). 不断演变的 COVID-19 亚变种与疫苗诱导免疫力下降：非洲大陆面临的新公共卫生风险。

Vaccine: X, 28, 100777..

疫苗：X，28，100777。。

https://doi.org/10.1016/j.jvacx.2025.100777

https://doi.org/10.1016/j.jvacx.2025.100777

[8] Gentile, I. (2020). COVID-19: Time for post-exposure prophylaxis? International Journal of Environmental Research and Public Health, 17(11), 3997.

[8] Gentile, I. (2020). COVID-19：暴露后预防的时间到了吗？《国际环境研究与公共卫生杂志》，17(11), 3997。

https://doi.org/10.3390/ijerph17113997

https://doi.org/10.3390/ijerph17113997

[9] Japan Registry of Clinical Trials. (2023). A phase 3 study of S-217622 in pediatric participants aged 6 to <12 with SARS-CoV-2 infection (jRCT2031230140).

【9】日本临床试验注册中心。（2023）。S-217622 在 6 至 <12 岁感染 SARS-CoV-2 的儿童参与者中的 III 期研究（jRCT2031230140）。

https://jrct.mhlw.go.jp/en-latest-detail/jRCT2031230140

https://jrct.mhlw.go.jp/zh-latest-detail/jRCT2031230140

[10] 3rd Quarter of Fiscal 2025 Financial Results. January 30, 2026. Accessed March 18, 2026. Available at

[10] 2025财年第三季度财务结果。2026年1月30日发布。2026年3月18日访问。可在

3rd Quarter of Fiscal 2025 Financial Results

2025财年第三季度财务业绩

[11] Unoh Y, et al. Discovery of S-217622, a noncovalent oral SARS-CoV-2 3CL protease inhibitor clinical candidate for treating COVID-19.

[11] Unoh Y, 等。发现S-217622，一种非共价口服SARS-CoV-2 3CL蛋白酶抑制剂，是用于治疗COVID-19的临床候选药物。

Journal of Medicinal Chemistry.

药物化学杂志。

30 Mar 2022;65:9,6499-6512. doi:10.1021/acs.jmedchem.2c00117.

2022年3月30日；65:9，6499-6512。doi:10.1021/acs.jmedchem.2c00117。

[12] Yotsuyanagi H, et al. Efficacy and safety of 5-day oral Ensitrelvir for patients with mild to moderate COVID-19.

[12] 四柳晴树等。口服恩赛特韦5天对轻中度COVID-19患者的疗效与安全性。

JAMA Netw Open.

JAMA网络开放。

9 Feb

2月9日

2024;7(2):e2354991. doi:10.1001/jamanetworkopen.2023.54991.

2024;7(2):e2354991. doi:10.1001/jamanetworkopen.2023.54991.

[13] Luetkemeyer A, et al. Ensitrelvir for the Treatment of Nonhospitalized Adults with COVID-19: Results from the SCORPIO-HR, Phase 3, Randomized, Double-blind, Placebo-Controlled Trial,

[13] Luetkemeyer A, 等。恩赛特雷韦治疗未住院的COVID-19成人患者：SCORPIO-HR三期随机双盲安慰剂对照试验结果，

Clinical Infectious Diseases

临床传染病

, 2025;, ciaf029,

，2025；，ciaf029，

https://doi.org/10.1093/cid/ciaf029.

https://doi.org/10.1093/cid/ciaf029.