– Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced that it has initiated the rolling submission of a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for its investigational oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622, hereafter “ensitrelvir”).

– 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，已开始向美国食品药品监督管理局（FDA）滚动提交其在研口服抗病毒药物 ensitrelvir（通用名：富马酸恩司特韦，编号：S-217622，以下简称“ensitrelvir”）的新药申请（NDA）。

The rolling submission of ensitrelvir for Post-Exposure Prophylaxis is being made based on the positive results from the Global Phase 3 Study, .

基于全球III期研究的积极结果，ensitrelvir用于暴露后预防的滚动提交正在进行中。

COVID-19 continues to pose a health risk for many people and remains a public health threat, with thousands of hospitalizations and hundreds of deaths each week in the U.S.

COVID-19继续对许多人构成健康风险，并仍然是一个公共卫生威胁，美国每周有数千人住院，数百人死亡。

It can impact quality of life, lead to absence from work, cause long COVID, and progress to severe disease, hospitalization and death.

它会影响生活质量，导致缺勤、引发长期新冠肺炎，并发展为重症、住院甚至死亡。

With continually decreasing vaccination rates, waning immunity after vaccination, and the potential for new variants to emerge, additional treatment and preventive options for COVID-19 are needed.

随着疫苗接种率持续下降、接种后免疫力减弱，以及可能出现新变异株，我们需要更多的治疗和预防新冠的手段。

If this application is approved, ensitrelvir is expected to be the first orally-administered option for the post-exposure prophylaxis of COVID-19

如果该申请获批，恩司特韦预计将成为首个用于新冠暴露后预防的口服药物。

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

恩西瑞韦在2025年被FDA授予快速通道资格，用于接触新冠肺炎患者后的暴露后预防。

granted Fast Track designation

授予快速通道资格

by the FDA in 2023 for the treatment of COVID-19. Shionogi is also in discussions with FDA regarding the treatment indication for COVID-19 with ensitrelvir.

2023年获得FDA批准用于治疗COVID-19。盐野义制药公司也就ensitrelvir治疗COVID-19的适应症与FDA进行了讨论。

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 favorable outcomes of the SCORPIO-PEP trial, a global Phase 3 post-exposure prevention study, an application was submitted in Japan to include additional benefits and efficacy related to the prevention of COVID-19.

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。2025年，基于SCORPIO-PEP试验（一项全球性的III期暴露后预防研究）的良好结果，提交了在日本的申请，以包括与预防COVID-19相关的额外益处和疗效。

Shionogi submitted .

盐野义提交了。

a supplemental New Drug Application for ensitrelvir in Japan

日本恩赛特韦的补充新药申请

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，目前正处于审查阶段。

under regulatory review in Taiwan

在台湾接受监管审查

. 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.

恩司特韦是一种通过北海道大学和盐野义制药共同研究开发的3CL蛋白酶抑制剂。SARS-CoV-2拥有一种叫做3CL蛋白酶的酶，这种酶对病毒的复制至关重要。

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。

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ensitrelvir的安全性和有效性。

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..

本研究中，恩司特韦对五个典型的奥密克戎相关症状（主要终点）表现出临床症状疗效（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，无论风险因素如何，均显示出抗病毒疗效（关键次要终点）。

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。

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，正如之前研究中所观察到的。

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出现症状、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。研究未达到其主要终点，即与安慰剂相比，每日一次服用恩赛特雷韦在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）上没有显示出统计学显著性减少。

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，且恩司特韦治疗耐受性良好，不良事件特征与安慰剂相似。

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 symptomatic COVID-19 through day 10

盐野义最近宣布其全球双盲、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，在第10天前预防有症状的新冠肺炎达到了主要终点。

. 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 是首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，达到了预防新冠肺炎的主要终点。

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参与者，这些人均接触了一位与其同住且出现症状的COVID-19患者。研究参与者以1:1的比例随机分配接受恩司特韦（125 mg）或安慰剂治疗，每日一次，并在家中COVID-19患者开始出现症状后的三天内开始治疗。

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，恩司特雷韦一般耐受性良好，恩司特雷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%）。

There were no COVID-19 related hospitalizations or deaths.

没有与COVID-19相关的住院或死亡病例。

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. .

恩司特韦在住院患者中的应用正在进行，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，用于管理COVID-19。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主持下开发的。

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6至12岁以下轻中度新冠患者中使用ensitrelvir的多中心、随机、双盲、安慰剂对照试验的初步结果。研究确认了安全性和耐受性，并发现该年龄组中ensitrelvir的药代动力学与成人相似。