OSAKA, Japan, June 30, 2025

日本大阪，2025年6月30日

– Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced that it has submitted a supplemental New Drug Application (sNDA) in Japan to expand the indication of its investigational oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622, hereafter “ensitrelvir”) for the treatment of COVID-19, from the current approval for patients aged 12 years and older to include pediatric patients aged 6 years and older weighing 20 kg or more.

– 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，已在日本提交了一份补充新药申请（sNDA），以扩大其在研口服抗病毒药物恩司特韦（通用名：富马酸恩司特韦，研发编号：S-217622，以下简称“恩司特韦”）用于治疗COVID-19的适用范围，从目前获批的12岁及以上患者扩展至包括6岁及以上、体重20公斤及以上的儿童患者。

Additionally, Shionogi has filed for approval of a new formulation (25mg tablet) to facilitate easier administration for pediatric patients..

此外，盐野义制药公司已申请批准一种新剂型（25毫克片剂），以方便儿童患者更容易服用。

The sNDA is based on the positive results from the Phase 3 study in pediatric patients aged 6 to under 12 years in Japan (jRCT：

基于日本6至12岁以下儿科患者III期研究的积极结果，提交了补充新药申请（sNDA）（jRCT：

2031230140

2031230140

). The primary objective of this study was to evaluate the safety, tolerability, and pharmacokinetics of ensitrelvir once daily for 5 days in pediatric subjects aged 6 to 12 years. One hundred and seventeen patients were enrolled in this study. The study confirmed safety and tolerability and found the pharmacokinetics of ensitrelvir in this age group was similar to adults.

). 本研究的主要目的是评估恩司特韦每日一次、连续5天在6至12岁儿童中的安全性、耐受性和药代动力学。研究共纳入了117名患者。研究确认了其安全性和耐受性，并发现该年龄段的恩司特韦药代动力学与成人相似。

Furthermore, ensitrelvir demonstrated a potent antiviral effect similar to that observed in adults..

此外，恩司特韦显示出与成人相似的强效抗病毒效果。

COVID-19 remains a public health threat. However, there are no oral antiviral drugs approved for use in pediatric patients under the age of 12. There is a need for the development of safe and convenient oral antiviral treatments for this population. If this application is approved, ensitrelvir is expected to be a new treatment option available for pediatric patients aged 6 years and older weighing 20 kg or more..

COVID-19 仍然是公共卫生威胁。然而，目前尚无批准用于 12 岁以下儿科患者的口服抗病毒药物。亟需为这一群体开发安全且便捷的口服抗病毒治疗方案。如果此申请获批，恩司特韦有望成为适用于 6 岁及以上、体重 20 公斤或以上的儿科患者的新治疗选择。

Ensitrelvir was

恩司特韦

granted Fast Track designation

授予快速通道资格

by the FDA in 2025 for post-exposure prophylaxis of COVID-19 following contact with an individual who has COVID-19 and was

在2025年被FDA批准用于接触过新冠病毒感染者的个体后的暴露后预防

granted Fast Track designation

授予快速通道资格认定

by the FDA in 2023 for the treatment of COVID-19. Shionogi initiated the rolling submission of a new drug application (NDA) with the FDA for Post-Exposure Prophylaxis of COVID-19 in 2025.

2023年获得FDA批准用于治疗COVID-19。Shionogi于2025年启动了向FDA滚动提交用于COVID-19暴露后预防的新药申请（NDA）。

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. In 2025, based on the

2022年11月在日本获得紧急使用授权，2024年3月获得全面批准用于治疗COVID-19。基于此，2025年

favorable outcomes

有利的结果

of the SCORPIO-PEP trial, a global Phase 3 post-exposure prevention study

SCORPIO-PEP试验，一项全球性的3期暴露后预防研究

1

1

, Shionogi submitted

，盐野义提交了

a supplemental New Drug Application for ensitrelvir in Japan

日本恩赛特雷韦的新药补充申请

for the post-exposure prophylaxis of COVID-19 in 2025. It became

用于2025年COVID-19的暴露后预防。它成为了

available in Singapore

在新加坡可用

via a Special Access Route application in 2023, and it is currently

通过2023年的特殊访问途径申请，目前正处于审批过程中。

under regulatory review in Taiwan

在台湾处于监管审查中

. Ensitrelvir is an investigational drug outside of Japan and Singapore. In addition, the brand name Xocova® has not been approved for use outside of Japan and Singapore and pertains only to the approved drug in Japan and Singapore.

Ensitrelvir在日本和新加坡以外的地区属于研究性药物。此外，品牌名称Xocova®尚未获准在日本和新加坡以外地区使用，仅适用于日本和新加坡已批准的药物。

About ensitrelvir

关于恩司特韦

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.

恩赛特韦是通过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病毒含有一种名为3CL蛋白酶的酶，这种酶对其复制至关重要。

2

2

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。

2

2

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赛特韦的安全性和有效性。

3

3

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，恩赛特韦在以接种疫苗为主的轻至中度 SARS-CoV-2 感染患者群体中，无论风险因素如何，均显示出针对五种典型奥密克戎相关症状（主要终点）的临床症状疗效（症状缓解持续至少 24 小时）和抗病毒疗效（关键次要终点）。

3

3

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。

3

3

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，这在之前的研究中也有观察到。

3

3

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并未显著减少15种常见COVID-19相关症状的持续缓解时间（症状缓解至少持续48小时）。

4

4

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，治疗中ensitrelvir的耐受性良好，其不良事件特征与安慰剂相似。

4

4

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 symptomatic COVID-19 through day 10

盐野义制药公司最近宣布其全球双盲、随机、安慰剂对照的3期临床试验（SCORPIO-PEP），评估恩司特韦作为口服暴露后预防药物，达到了在第10天前预防有症状新冠病毒感染的主要终点。

1

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.

SCORPIO-PEP 是第一个也是唯一一个作为暴露后预防的新冠口服抗病毒药物的三期临床研究，成功达到了预防新冠肺炎的主要终点。

*

*

An

一个

investigator-initiated research study

研究者发起的研究

with ensitrelvir is ongoing in hospitalized patients for the management of COVID-19 as part of the Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE) platform protocol. STRIVE was developed under the auspices of NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership. .

恩西特雷韦在住院患者中用于管理 COVID-19 的研究正在作为呼吸道感染和病毒紧急情况策略与治疗（STRIVE）平台协议的一部分进行。STRIVE 是在美国国立卫生研究院（NIH）加速 COVID-19 治疗干预和疫苗（ACTIV）公私合作伙伴关系的支持下开发的。

Shionogi also recently released preliminary results from a multicenter, randomized, double-blind, placebo-controlled trial of ensitrelvir in mild to moderate COVID-19 patients aged 6 to under 12 years in Japan. The study confirmed safety and tolerability and found the pharmacokinetics of ensitrelvir in this age group similar to adults..

盐野义最近还发布了在日本进行的针对6至12岁以下轻中度新冠患者的多中心、随机、双盲、安慰剂对照试验的初步结果。研究证实了安全性和耐受性，并发现该年龄段儿童的恩司特韦药代动力学与成人相似。

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获得的信息和预期，其中的假设受风险和不确定性的影响，可能导致实际结果与这些陈述有重大差异。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主张和担忧；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更。

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，也存在制造和营销风险，其中包括但不限于无法建立足够的生产能力以满足需求、原材料供应不足以及竞争产品的进入。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:

盐野义制药网站咨询表：

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

盐野义通讯@盐野义.com

SEU Press Office:

东南大学新闻办公室：

pressoffice@shionogi.eu

pressoffice@shionogi.eu

* Literature search conducted December 2024.

* 文献检索于2024年12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. Ensitrelvir 用于预防家庭内 COVID-19 感染：SCORPIO-PEP III 期安慰剂对照试验结果。摘要 200。于 2025 年 3 月 9 日至 12 日在美国加州旧金山举行的 CROI 2025 上发表。

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

2.       Unoh Y, 等。发现S-217622，一种用于治疗COVID-19的非共价口服SARS-CoV-2 3CL蛋白酶抑制剂临床候选药物。

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。

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

3.       四谷林 H 等。口服 Ensitrelvir 5 天对轻至中度 COVID-19 患者的疗效与安全性。

JAMA Netw Open.

JAMA网络开放期刊。

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.

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,

吕特克迈尔 A 等。恩赛特雷韦治疗非住院 COVID-19 成人患者的疗效：SCORPIO-HR 第 3 阶段随机、双盲、安慰剂对照试验的结果，

Clinical Infectious Diseases

临床感染病学

, 2025;, ciaf029,

，2025；，ciaf029，

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

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