– Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) from Shionogi Inc., a New Jersey-based subsidiary of Shionogi, for ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622), an investigational oral antiviral for the prevention of COVID-19 following exposure to an infected individual.

——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，美国食品药品监督管理局 (FDA) 已接受其位于新泽西州的子公司盐野义制药提交的新药申请 (NDA)，该申请针对恩司特韦（通用名：富马酸恩司特韦，编号：S-217622），这是一种研究性口服抗病毒药物，用于在接触感染者后预防 COVID-19。

The FDA has set an action date of June 16, 2026 under the Prescription Drug User Fee Act (PDUFA)..

FDA 根据《处方药使用者费用法案》（PDUFA）设定了 2026 年 6 月 16 日的行动日期。

The NDA is supported by

保密协议由以下内容支持

results

结果

from the global, double-blind, randomized, placebo-controlled Phase 3 study, SCORPIO-PEP, which studied ensitrelvir as post-exposure prophylaxis (PEP). If approved, ensitrelvir would be the first and only oral therapy for the prevention of COVID-19 following exposure to an infected individual.

来自全球、双盲、随机、安慰剂对照的3期研究SCORPIO-PEP，该研究将ensitrelvir作为暴露后预防（PEP）。如果获得批准，ensitrelvir将成为首个也是唯一一个用于暴露于感染者后预防COVID-19的口服疗法。

SARS-CoV-2 remains highly transmissible and up to half of people living with an infected individual may develop COVID-19.

SARS-CoV-2仍然具有高度传染性，与感染者同住的人中多达一半可能会患上COVID-19。

The virus is constantly evolving, with novel symptoms reported.

病毒不断演变，出现新的症状。

COVID-19 continues to impact daily life and may lead to absences from school and work, may cause long COVID, and in some cases, may progress to severe disease.

COVID-19继续影响日常生活，可能导致缺课和缺勤，可能引发长期COVID症状，在某些情况下，还可能发展为重症。

Even patients with mild COVID-19 may experience worsening of preexisting chronic conditions.

即使是轻度 COVID-19 患者，也可能出现原有慢性病的恶化。

Following exposure to COVID-19, the best way to avoid its potentially serious and long-term complications is to stop viral replication, which prevents the development of the disease.

接触新冠病毒后，避免其潜在严重和长期并发症的最佳方法是阻止病毒复制，防止疾病的发展。

There are currently no approved antiviral therapies proven to prevent COVID-19 following exposure.

目前尚无经证实可预防COVID-19的抗病毒疗法获批。

COVID-19 vaccines are received before exposure, and they do not stop viral replication.

COVID-19疫苗是在暴露前接种的，它们并不能阻止病毒复制。

Other COVID-19 antivirals are taken following exposure and diagnosis, after viral replication has occurred and disease is already established.

其他COVID-19抗病毒药物是在接触和诊断后服用的，此时病毒复制已经发生，疾病已经形成。

“Shionogi has a long history of innovation in infectious disease treatment and prevention. Our dedication to this field has led to significant breakthroughs in the development of novel antimicrobials and antivirals for HIV/AIDS, influenza and COVID-19. If approved, ensitrelvir will be the first and only oral therapy to help protect people in the U.S.

“盐野义制药在传染病的治疗和预防方面有着悠久的创新历史。我们对该领域的 dedication 已经促使我们在针对艾滋病、流感以及新冠肺炎的新型抗菌和抗病毒药物开发上取得了重大突破。如果获得批准，恩赛特韦将成为帮助保护美国人民的第一款也是唯一一款口服疗法。

from COVID-19 following exposure,' said Nathan McCutcheon, MBA, President and CEO, Shionogi Inc..

“在接触COVID-19之后，”Shionogi Inc.的总裁兼首席执行官Nathan McCutcheon表示。

About ensitrelvir

关于ensitrelvir

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

恩赛特韦是一种通过北海道大学和盐野义制药联合研究开发的新冠病毒主蛋白酶抑制剂。新冠病毒含有一种称为主蛋白酶（3-CL）的酶，这种酶对病毒的复制至关重要。恩赛特韦通过选择性抑制主蛋白酶来抑制新冠病毒的复制。

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 based on

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

results

结果

from SCORPIO-SR, a Phase 3 study conducted in Asia, during the Omicron-dominant phase of the pandemic.

来自SCORPIO-SR，一项在亚洲进行的第三阶段研究，在疫情的奥密克戎主导阶段。

In SCORPIO-SR, 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SCORPIO-SR研究中，ensitrelvir 在主要接种过疫苗的轻至中度 SARS-CoV-2 感染患者群体中，无论风险因素如何，均显示出对五种典型奥密克戎相关症状（主要终点）的临床症状缓解效果（症状缓解持续至少 24 小时），以及抗病毒效果（关键次要终点）。

Most adverse events were mild in severity and no deaths were seen in the study. Among the most common treatment-related adverse events were temporary decreases in high-density lipoprotein and increased blood triglycerides, as observed in previous studies. Results from this study were .

大多数不良事件的严重程度较轻，研究中未出现死亡病例。最常见的治疗相关不良事件包括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。本研究的结果是。

published

已发布

in JAMA Network Open.

在《JAMA网络开放》上。

In 2025, Shionogi submitted two new drug applications in Japan for

2025年，盐野义制药在日本提交了两种新药的申请

post-exposure prophylaxis

暴露后预防

of COVID-19 and for

关于COVID-19以及

COVID-19 treatment in pediatric patients

儿童患者的 COVID-19 治疗

aged six to under 12 years. The pediatric submission is based on a multicenter, randomized, double-blind, placebo-controlled trial of ensitrelvir in mild-to-moderate COVID-19 patients aged 6 to 12 years in Japan. The study confirmed safety and tolerability and found the pharmacokinetics of ensitrelvir in this age group to be similar to that in adults..

6至12岁以下。该儿科提交资料基于在日本进行的一项多中心、随机、双盲、安慰剂对照试验，研究对象为6至12岁轻至中度COVID-19患者。研究确认了安全性和耐受性，并发现此年龄组中ensitrelvir的药代动力学与成人相似。

Ensitrelvir became

恩司特韦成为

available in Singapore

在新加坡可用

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

用于治疗2019冠状病毒病（COVID-19），通过特别准入途径申请于2023年，目前

under regulatory review in Taiwan f

在台湾处于监管审查之下

or the treatment of COVID-19. Ensitrelvir is also under regulatory review with the European Medicines Agency for COVID-19 post-exposure prophylaxis and treatment.

或用于治疗 COVID-19。Ensitrelvir 也正在接受欧洲药品管理局的监管审查，用于 COVID-19 暴露后预防和治疗。

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.

恩司特韦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。