OSAKA, Japan, January 22, 2025 -

日本大阪，2025年1月22日-

Shionogi & Co., Ltd.  (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter 'Shionogi') announced that the Taiwan Food and Drug Administration has accepted our new drug application (NDA) for ensitrelvir fumaric acid (hereafter “ensitrelvir”) for the treatment of COVID-19.

Shionogi＆Co.，Ltd.（总部：日本大阪；首席执行官：Isao Teshirogi，Ph.D.；以下简称“Shionogi”）宣布，台湾食品药品监督管理局已接受我们用于治疗COVID-19的恩替雷韦富马酸（以下简称“恩替雷韦”）的新药申请（NDA）。

This NDA was submitted by Taiwan Shionogi & Co., Ltd., (hereafter “Taiwan Shionogi”), the Taiwan subsidiary of Shionogi. Additionally, Taiwan Shionogi and .

本保密协议由Shionogi的台湾子公司Taiwan Shionogi&Co.，Ltd.（以下简称“Taiwan Shionogi”）提交。此外，台湾Shionogi和。

Taiwan Centers for Disease Control have concluded a contract for the purchase of ensitrelvir for stockpiling by the Taiwanese government.

台湾疾病控制中心签订了一份购买恩替雷韦的合同，供台湾政府储存。

Ensitrelvir is an investigational oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.  In Japan, ensitrelvir, known as Xocova

Enstrelvir是一种研究性口服抗病毒药物，可通过选择性抑制病毒3CL蛋白酶来抑制SARS-CoV-2的复制。在日本，Enstrelvir被称为Xocova

®

®

, received emergency regulatory approval in 2022 and full approval in March 2024 for the treatment of COVID-19. Ensitrelvir was also made available in Singapore based on the Special Access Route application in 2023. It remains an investigational drug outside of Japan and Singapore.

，于2022年获得紧急监管批准，并于2024年3月获得全面批准，用于治疗新型冠状病毒肺炎。根据2023年的特殊访问路线应用，Enstrelvir也在新加坡上市。它仍然是日本和新加坡以外的研究药物。

COVID-19 continues to mutate and impact the health and lives of many people worldwide, necessitating the ongoing development of effective and safe treatments. It is estimated that there are approximately 1.7 million COVID-19 patients in Taiwan annually*, and ensitrelvir is expected to contribute as a new treatment option for COVID-19..

新型冠状病毒肺炎继续发生变异，影响着全世界许多人的健康和生活，因此需要不断开发有效和安全的治疗方法。据估计，台湾每年约有170万新型冠状病毒肺炎患者*，而恩替雷韦有望成为新型冠状病毒肺炎的一种新的治疗选择。。

* Cumulative number of patients visiting outpatient and emergency departments in 2024 (Source:

*2024年门诊和急诊累积就诊人数（来源：

Taiwan Centers for Disease Control website

台湾疾病控制中心网站

)

)

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

。SARS-CoV-2有一种称为3CL蛋白酶的酶，它对病毒的复制至关重要。Ensitrelvir通过选择性抑制3CL蛋白酶来抑制SARS-CoV-2的复制。。

The U.S. Food and Drug Administration (FDA)

美国食品和药物管理局（FDA）

granted Fast Track designation to ensitrelvir for COVID-19

被授予针对新型冠状病毒肺炎的恩替雷韦快速通道指定

. FDA Fast Track designation is designed to facilitate the development and expedite the review of potential new therapies that treat serious conditions and fulfill an unmet medical need. Known as Xocova

FDA快速通道指定旨在促进开发并加速审查治疗严重疾病并满足未满足医疗需求的潜在新疗法。被称为Xocova

®

®

in Japan, ensitrelvir

在日本，单向

received emergency regulatory approval

获得紧急监管批准

in 2022 and full approval in March 2024. Ensitrelvir was

2022年，并于2024年3月获得全面批准。Enstrelvir是

made available in Singapore

在新加坡提供

in November 2023 based on the Special Access Route application. Ensitrelvir remains an investigational drug outside of Japan and Singapore. In addition, the brand name Xocova

2023年11月，基于特殊访问路线应用。。此外，品牌Xocova

®

®

has not been approved for use outside of Japan and Singapore and pertains only to the approved drug in Japan and Singapore.

尚未批准在日本和新加坡以外使用，仅适用于日本和新加坡批准的药物。

About Shionogi in Infectious Disease

关于感染性疾病中的Shionogi

Since 1953, Shionogi has been a leader in infectious disease discovery and commercialization. Our R&D story extends beyond antibiotics to include novel medications for HIV and influenza. Today, our global pipeline includes investigational agents developed to address global health challenges including antimicrobial resistance, COVID-19, influenza, rare fungal diseases and respiratory syncytial virus..

自1953年以来，Shionogi一直是传染病发现和商业化的领导者。。今天，我们的全球渠道包括为应对全球健康挑战而开发的研究药物，包括抗菌素耐药性，新型冠状病毒，流感，罕见真菌疾病和呼吸道合胞病毒。。

As part of our commitment to addressing unmet medical needs, Shionogi is partnering with several non-governmental organizations to increase equitable access to our medications worldwide. Shionogi has a landmark license and technology transfer agreement for cefiderocol with

作为我们致力于解决未满足的医疗需求的一部分，Shionogi正在与几个非政府组织合作，以增加全球公平获得我们药物的机会。

Global Antibiotic Research and Development Partnership (GARDP) and a collaboration agreement with the Clinton Health Access Initiative (CHAI)

全球抗生素研究与发展伙伴关系（GARDP）以及与克林顿健康获取倡议（CHAI）的合作协议

to transform the landscape of access to antibiotics in many low-income countries, most lower middle- and upper middle-income countries, and select high-income countries.

改变许多低收入国家，大多数中低收入和中高收入国家以及部分高收入国家获得抗生素的情况。

About the ensitrelvir Clinical Development Program

关于Enstrelvir临床开发计划

Shionogi has a robust clinical development program for ensitrelvir and is committed to making it available to populations worldwide. In addition to

Shionogi有一个强大的Enstrelvir临床开发计划，并致力于将其提供给世界各地的人群。除了

SCORPIO-HR

天蝎座-HR

and

和

SCORPIO-PEP

天蝎座-PEP

, Shionogi evaluated the safety and efficacy of ensitrelvir through SCORPIO-SR, a Phase 2/3 study conducted in Asia, during the Omicron-dominant phase of the epidemic. The data from this study were

，Shionogi通过SCORPIO-SR评估了恩替雷韦的安全性和有效性，SCORPIO-SR是在Omicron流行期在亚洲进行的一项2/3期研究。这项研究的数据是

published

已发布

in JAMA Network Open.

在JAMA网络开放。

Additionally, an

此外，一个

investigator-initiated research study

调查员发起的研究

is ongoing in hospitalized patients for the management of COVID-19 as part of the new 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.

作为呼吸道感染和病毒性紧急情况（STRIVE）平台协议新策略和治疗的一部分，正在住院患者中进行新型冠状病毒肺炎的管理。STRIVE是在美国国立卫生研究院加速新型冠状病毒治疗干预和疫苗（ACTIV）公私合作伙伴关系的支持下开发的。

Shionogi is also studying the safety and efficacy of ensitrelvir in Japan for children between the ages of 6 to 11 years old..

Shionogi还在日本研究Enstrelvir对6至11岁儿童的安全性和有效性。。

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.

本公告包含前瞻性声明。这些声明基于当前可用信息的预期，假设存在风险和不确定性，可能导致实际结果与这些声明存在重大差异。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，以及利率和货币汇率的变化。

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特别适用于与产品相关的前瞻性陈述。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；获得监管部门的批准；关于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；国内外医疗改革和法律法规的变化。

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..

此外，对于现有产品，还存在制造和营销风险，包括但不限于无法建立生产能力以满足需求，缺乏原材料以及竞争产品的进入。无论是由于新信息、未来事件还是其他原因，公司均不打算或有义务更新或修订任何前瞻性声明。。

For Further Information, Contact:

欲了解更多信息，请联系：

SHIONOGI Website Inquiry Form:

SHIONOGI网站查询表：

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

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