Program Includes Establishing Pharmaceutical Manufacturing in the U.S., Procurement and Development of Treatment for Infections Caused by Biothreat Pathogens

计划包括在美国建立制药生产、采购和开发针对生物威胁病原体引起的感染的治疗方法

OSAKA, Japan, April 8, 2026

日本大阪，2026年4月8日

–

–

Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced that Shionogi Inc., a New Jersey-based subsidiary of Shionogi, has been awarded a contract through the Biomedical Advanced Research and Development Authority’s (BARDA) Project BioShield related to Fetroja® (cefiderocol) as a critical countermeasure against difficult-to-treat Gram-negative bacterial infections and pathogens that present a high-priority biothreat to national health security.

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，其位于新泽西的子公司盐野义有限公司通过生物医学高级研究与发展管理局 (BARDA) 的 Project BioShield 计划，获得了一份与 Fetroja®（头孢地罗）相关的合同，作为应对难以治疗的革兰氏阴性菌感染和对国家健康安全构成高优先级生物威胁的病原体的关键对策。

The contract is initially funded at $119 million with multiyear options for a total of up to $482 million..

合同初期资金为1.19亿美元，多年期权总计高达4.82亿美元。

The contract will bolster the U.S. government’s ability to respond to national health security threats and strengthen domestic manufacturing capabilities and supply readiness by funding Shionogi Inc. to:

该合同将通过资助Shionogi公司来增强美国政府应对国家安全威胁的能力，并加强国内制造能力和供应准备：

·       Establish a U.S. drug product manufacturing site for Fetroja.

·       为Fetroja建立美国药品生产场地。

·       Support procurement of Fetroja.

·       支持采购Fetroja。

·       Advance Fetroja for the treatment of infections caused by high priority biothreat pathogens, including

·       推进Fetroja用于治疗由高优先级生物威胁病原体引起的感染，包括

Burkholderia pseudomallei

假鼻疽伯克霍尔德菌

(melioidosis) and

（类鼻疽）和

Yersinia pestis

鼠疫耶尔森菌

(plague).

（瘟疫）。

·       Expand the utility of Fetroja for HABP/VABP in pediatric patients with a U.S. Food and Drug Administration (FDA) Supplemental New Drug Application (sNDA).

通过美国食品药品监督管理局（FDA）的补充新药申请（sNDA），扩大Fetroja在儿科患者中用于HABP/VABP的效用。

“Since the 1950s, Shionogi has been researching, developing and partnering to deliver innovative antibiotics to patients worldwide,” said John Keller, Ph.D., Director of the Board, Senior Vice President, R&D Supervisory Unit, Shionogi. “Fetroja, the world’s first siderophore cephalosporin antibiotic, is a prime example of our in-house innovation and this contract is a continuation of the way we collaborate with global government and non-governmental organizations to drive innovation.”.

“自20世纪50年代以来，盐野义一直致力于研究、开发并与各方合作，将创新的抗生素带给全球患者，”盐野义董事会董事、研发监管部高级副总裁约翰·凯勒博士表示。“Fetroja是全球首个铁载体头孢菌素类抗生素，是我们内部创新的典型例子，而该合同延续了我们与全球政府和非政府组织合作推动创新的方式。”

“Shionogi is proud of our ongoing commitment to combating antimicrobial resistance, as shown by the continued investment in Fetroja since its introduction in 2020, expanding our portfolio with the acquisition of Qpex Biopharma, Inc. in 2023, and further investing in Qpex to establish a new research facility dedicated to advancing antimicrobial research and development in 2025,” said Nathan McCutcheon, MBA, President and CEO, Shionogi Inc.

“盐野义制药为我们在对抗抗菌素耐药性方面的持续承诺感到自豪，这一承诺体现在自2020年Fetroja上市以来的持续投资、2023年通过收购Qpex生物制药公司扩大我们的产品组合，以及进一步投资于Qpex，计划在2025年建立一个专注于推动抗菌药物研发的新研究设施。”盐野义制药总裁兼首席执行官Nathan McCutcheon表示。

“This contract complements our existing work with the U.S. government and enables us to advance our ongoing expansion efforts in the U.S. at greater pace and scale.”.

“该合同补充了我们与美国政府的现有工作，并使我们能够以更快的速度和更大的规模推进我们在美国的持续扩展努力。”

This project has been funded with Federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50126C00004.

本项目由美国卫生与公众服务部、战略准备与响应管理局、生物医学高级研究与发展局根据合同编号75A50126C00004提供联邦资金支持。

BARDA’s Project BioShield accelerates the research, development, procurement and availability of effective medical countermeasures against chemical, biological, radiological and nuclear (CBRN) agents.

BARDA的Project BioShield加速了针对化学、生物、放射性和核（CBRN）制剂的有效医疗对策的研究、开发、采购和可用性。

In the U.S. Fetroja is approved by the FDA for the treatment of hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), and complicated urinary tract infections caused by certain susceptible Gram-negative microorganisms. In Japan cefiderocol is commercially available under the brand name Fetroja.

在美国，Fetroja 已获 FDA 批准用于治疗医院获得性细菌性肺炎 (HABP)、呼吸机相关细菌性肺炎 (VABP) 以及由某些敏感的革兰氏阴性微生物引起的复杂尿路感染。在日本，头孢地罗以商品名 Fetroja 上市销售。

®

®

for various infections caused by strains resistant to carbapenem antibiotics. In Europe cefiderocol is commercially available under the brand name Fetcroja

对于由对碳青霉烯类抗生素耐药的菌株引起的各类感染。在欧洲，头孢地罗肟以商品名 Fetcroja 上市销售。

®

®

for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options. See Fetroja U.S. full indications and important safety information below in the About Cefiderocol section.

用于治疗因需氧革兰氏阴性菌引起的感染，适用于治疗选择有限的成人。有关 Fetroja 在美国的完整适应症和重要的安全信息，请参见下文“关于 Cefiderocol”部分。

For Full U.S. Prescribing Information for Fetroja

有关 Fetroja 的完整美国处方信息，请参阅

®

®

(cefiderocol), including approved indications and safety information, please visit

（头孢地罗），包括已批准的适应症和安全信息，请访问

Fetroja Prescribing Information

Fetroja处方信息

.

。

About Shionogi in Infectious Disease

关于盐野义在传染病领域

Over the past 70 years, Shionogi has discovered and commercialized six novel antibiotics. Today, our R&D story extends beyond antibiotics to include novel medications for HIV and influenza. Our global pipeline includes investigational agents to address global health challenges including antimicrobial resistance, COVID-19, influenza, rare fungal diseases and respiratory syncytial virus..

在过去的70年里，盐野义制药发现了六种新型抗生素并将其商业化。如今，我们的研发工作已超越抗生素范围，扩展到包括针对艾滋病毒和流感的新型药物。我们的全球研发管线包括应对全球健康挑战的试验性药物，如抗菌素耐药性、新冠肺炎、流感、罕见真菌病以及呼吸道合胞病毒等。

As part of our commitment to addressing unmet medical needs, Shionogi partners with several non-governmental organizations to increase equitable access to our medications worldwide. Shionogi and

作为我们致力于满足未被满足的医疗需求的一部分，盐野义与多个非政府组织合作，以增加我们的药物在全球范围内的公平获取。盐野义和

Global Antibiotic Research and Development Partnership (GARDP)

全球抗生素研究与开发伙伴关系 (GARDP)

have a license and technology transfer agreement and Shionogi and GARDP have a collaboration agreement with the

拥有许可和技术转让协议，盐野义制药公司和GARDP与之有合作协议

Clinton Health Access Initiative (CHAI)

克林顿健康访问倡议（CHAI）

that aim 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.

旨在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抗生素获取状况的格局。

Shionogi’s ongoing efforts to address current and emerging health threats include a U.S.-based drug discovery laboratory in the U.S. with Qpex Biopharma, Inc., a Shionogi Group Company. Through Qpex, we are advancing a robust portfolio of potential best-in-class, clinical-stage antimicrobial compounds.

Shionogi持续致力于应对当前和新兴的健康威胁，包括与Shionogi集团旗下的Qpex Biopharma公司在美国建立药物发现实验室。通过Qpex，我们正在推进一系列潜在的同类最佳、处于临床阶段的抗菌化合物的强大组合。

Learn more about the Qpex lab .

了解有关 Qpex 实验室的更多信息。

here

这里

.

。

Shionogi ranked #2 among large research-based pharmaceutical companies in the Access to Medicine Foundation’s

盐野义制药在药品可及性基金会的大型研究型制药公司中排名第二。

2026 Antimicrobial Resistance (AMR) Benchmark

2026年抗菌素耐药性（AMR）基准

, a global assessment of how leading pharmaceutical companies are tackling antimicrobial resistance and expanding responsible access to antibiotics worldwide.

，全球评估领先的制药公司如何应对抗菌素耐药性并在世界范围内扩大对抗生素的负责任获取。

About Shionogi & Co. Ltd.

关于盐野义制药株式会社

Shionogi & Co., Ltd. is a 148-year-old global, research-driven pharmaceutical company headquartered in Osaka, Japan, that is dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.” The company currently markets products in several therapeutic areas including anti-infectives, pain, CNS disorders and cardiovascular diseases.

盐野义制药株式会社是一家拥有148年历史的全球性研究驱动型制药公司，总部位于日本大阪，致力于根据其“提供尽可能好的药物来保护我们服务的患者的健康和福祉”的企业理念为患者带来益处。该公司目前在多个治疗领域销售产品，包括抗感染药、镇痛药、中枢神经系统疾病和心血管疾病。

Shionogi’s research and development currently targets two therapeutic areas: infectious diseases and diseases with unmet medical needs in pain/CNS, including Alzheimer’s disease, oncology, rare diseases, and sleep apnea. For more information on Shionogi & Co., Ltd., please visit .

盐野义制药当前的研发目标锁定在两大治疗领域：传染病以及在疼痛/中枢神经系统方面存在未满足医疗需求的疾病，包括阿尔茨海默病、肿瘤学、罕见病和睡眠呼吸暂停。如需了解更多关于盐野义制药株式会社的信息，请访问。

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

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

.

。

About Cefiderocol

关于Cefiderocol

In the U.S., cefiderocol is commercially available under the brand name Fetroja

在美国，头孢地罗醇以商品名 Fetroja 商业销售。

®

®

and is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia and complicated urinary tract infections caused by certain susceptible Gram-negative microorganisms. In Europe, cefiderocol is commercially available under the brand name Fetcroja.

并且适用于18岁或以上的患者，用于治疗由某些敏感的革兰氏阴性微生物引起的医院获得性细菌性肺炎、呼吸机相关性细菌性肺炎以及复杂的尿路感染。在欧洲，头孢地罗科尔以商品名Fetcroja上市销售。

®

®

for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options. In Japan, cefiderocol is commercially available under the brand name Fetroja

用于治疗因需氧革兰氏阴性菌引起的感染，适用于治疗选择有限的成人。在日本，头孢地罗以商品名Fetroja上市销售。

®

®

and received manufacturing and marketing approval from the Ministry of Health, Labour and Welfare for various infections caused by strains resistant to carbapenem antibiotics among sensitive strains of

并获得了厚生劳动省对敏感菌株中由耐碳青霉烯类抗生素的菌株引起的各类感染的生产和上市许可。

Escherichia coli, Citrobacter species, Klebsiella pneumoniae, Enterobacter species, Serratia marcescens, Proteus species, Morganella morganii, Pseudomonas aeruginosa, Burkholderia species, Stenotrophomonas maltophilia,

大肠埃希菌、柠檬酸杆菌属、肺炎克雷伯菌、肠杆菌属、粘质沙雷氏菌、变形杆菌属、摩根摩根菌、铜绿假单胞菌、伯克霍尔德菌属、嗜麦芽寡养单胞菌，

and

和

Acinetobacter species

鲍曼不动杆菌属物种

.

。

U.S. INDICATIONS

美国适应症

Fetroja

菲尔特罗亚

®

®

(cefiderocol) is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis caused by the following susceptible Gram-negative microorganisms:

（头孢地罗）适用于18岁及以上患者的复杂性尿路感染（cUTIs），包括由以下敏感革兰氏阴性微生物引起的肾盂肾炎：

Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa,

大肠埃希菌、肺炎克雷伯菌、奇异变形杆菌、铜绿假单胞菌，

and

和

Enterobacter cloacae

阴沟肠杆菌

complex.

复杂。

Fetroja is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by the following susceptible Gram-negative microorganisms:

Fetroja 适用于 18 岁或以上的患者，用于治疗由以下敏感革兰氏阴性微生物引起的医院获得性细菌性肺炎和呼吸机相关细菌性肺炎（HABP/VABP）：

Acinetobacter baumannii

鲍曼不动杆菌

complex

复杂

, Escherichia coli, Enterobacter cloacae

，大肠杆菌，阴沟肠杆菌

complex

复杂

, Klebsiella pneumoniae, Pseudomonas aeruginosa,

`, 肺炎克雷伯菌, 铜绿假单胞菌,`

and

和

Serratia marcescens

粘质沙雷氏菌

.

。

USAGE

用法

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Fetroja and other antibacterial drugs, Fetroja should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

为了减少耐药菌的发展并保持Fetroja和其他抗菌药物的有效性，Fetroja应仅用于治疗或预防那些已证实或高度怀疑由细菌引起的感染。

IMPORTANT SAFETY INFORMATION

重要安全信息

CONTRAINDICATIONS

禁忌症

Fetroja is contraindicated in patients with a known history of severe hypersensitivity to cefiderocol or other beta-lactam antibacterial drugs, or any other component of Fetroja.

Fetroja 禁用于已知对头孢地罗或其他β-内酰胺类抗菌药物或Fetroja任何其他成分有严重过敏史的患者。

WARNINGS AND PRECAUTIONS

警告和注意事项

Increase in All-Cause Mortality in Patients with Carbapenem-Resistant Gram-Negative Bacterial Infections

碳青霉烯类耐药革兰氏阴性菌感染患者的全因死亡率增加

An increase in 28-day all-cause mortality was observed in Fetroja-treated nosocomial pneumonia, bloodstream infections, or sepsis patients compared to those treated with best available therapy (BAT) in a clinical study (

在一项临床研究中，与接受最佳可用治疗（BAT）的患者相比，使用Fetroja治疗的医院获得性肺炎、血流感染或败血症患者观察到28天全因死亡率增加。

NCT02714595

NCT02714595

). Most BAT regimens contained colistin. All-cause mortality remained higher in patients treated with Fetroja than in patients treated with BAT through Day 49.

）。大多数BAT方案包含粘菌素。在第49天之前，使用Fetroja治疗的患者全因死亡率仍高于使用BAT治疗的患者。

Generally, deaths were in patients with infections caused by Gram-negative organisms, including non-fermenters such as

通常，死亡病例为由革兰氏阴性菌（包括非发酵菌）引起的感染患者。

Acinetobacter baumannii

鲍曼不动杆菌

complex,

复杂，

Stenotrophomonas maltophilia

嗜麦芽寡养单胞菌

, and

，以及

Pseudomonas aeruginosa

铜绿假单胞菌

, and were the result of worsening or complications of infection, or underlying comorbidities. The cause of the increase in mortality has not been established. Closely monitor the clinical response to therapy in patients with cUTI and HABP/VABP.

，并且是感染恶化或并发症，或基础合并症的结果。死亡率增加的原因尚未确定。密切监测 cUTI 和 HABP/VABP 患者对治疗的临床反应。

Hypersensitivity Reactions

超敏反应

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Hypersensitivity was observed with Fetroja. Before Fetroja is instituted, inquire about previous hypersensitivity to cephalosporins, penicillins, or other beta-lactam drugs.

接受β-内酰胺类抗菌药物的患者报告过严重且偶见致命的超敏（过敏性）反应和严重皮肤反应。使用Fetroja时也观察到超敏反应。在使用Fetroja之前，应询问患者是否对头孢菌素、青霉素或其他β-内酰胺类药物有过敏史。

If an allergic reaction occurs, discontinue Fetroja.  .

如果发生过敏反应，请停止使用 Fetroja。

Clostridioides difficile

艰难梭菌

-associated Diarrhea (CDAD)

相关性腹泻 (CDAD)

CDAD has been reported with nearly all systemic antibacterial agents, including Fetroja. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, antibacterial drugs not directed against.

几乎所有全身性抗菌药物（包括Fetroja）都有报道出现艰难梭菌相关性腹泻（CDAD）。详细的病史询问是必要的，因为有报道称在使用抗菌药物后超过2个月仍可能发生CDAD。如果怀疑或确认CDAD，不应使用针对该病原体无效的抗菌药物。

C. difficile

艰难梭菌

may need to be discontinued.

可能需要停止使用。

Seizures and Other Central Nervous System (CNS) Adverse Reactions

癫痫发作和其他中枢神经系统（CNS）不良反应

Cephalosporins, including Fetroja, have been implicated in triggering CNS adverse reactions such as seizures. Encephalopathy, coma, asterixis, and neuromuscular excitability have been reported with cephalosporins, particularly in patients with a history of epilepsy and/or when recommended dosages of cephalosporins were exceeded due to renal impairment.

包括Fetroja在内的头孢菌素类药物曾被发现会引发中枢神经系统不良反应，如癫痫发作。已有关于使用头孢菌素导致脑病、昏迷、扑翼样震颤和神经肌肉兴奋性的报告，尤其是在有癫痫病史的患者中，或因肾功能损害导致头孢菌素推荐剂量被超过时。

Adjust Fetroja dosing based on creatinine clearance. If focal tremors or seizures occur, evaluate patients to determine whether Fetroja should be discontinued.  .

根据肌酐清除率调整Fetroja的剂量。如果出现局部震颤或癫痫发作，评估患者以确定是否应停用Fetroja。

Development of Drug-Resistant Bacteria

耐药菌的发展

Prescribing Fetroja in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

在没有确诊或高度怀疑的细菌感染，或预防性用药指征的情况下开处方使用Fetroja，不太可能给患者带来益处，并且会增加产生耐药菌的风险。

ADVERSE REACTIONS

不良反应

The most common adverse reactions occurring in ≥2% of patients receiving Fetroja in the cUTI trial were: diarrhea (4%), infusion site reactions (4%), constipation (3%), rash (3%), candidiasis (2%), cough (2%), elevations in liver tests (2%), headache (2%), hypokalemia (2%), nausea (2%), and vomiting (2%).

在cUTI试验中，接受Fetroja治疗的患者中发生率≥2%的最常见的不良反应为：腹泻（4%）、输注部位反应（4%）、便秘（3%）、皮疹（3%）、念珠菌感染（2%）、咳嗽（2%）、肝功能测试值升高（2%）、头痛（2%）、低钾血症（2%）、恶心（2%）和呕吐（2%）。

The most common adverse reactions occurring in ≥4% of patients receiving Fetroja in the HABP/VABP trial were: elevations in liver tests (16%), hypokalemia (11%), diarrhea (9%), hypomagnesemia (5%), and atrial fibrillation (5%).  .

在HABP/VABP试验中，接受Fetroja治疗的患者中至少4%出现的最常见的不良反应为：肝功能测试值升高（16%）、低钾血症（11%）、腹泻（9%）、低镁血症（5%）和心房颤动（5%）。

Please click

请单击

here

这里

for Full U.S. Prescribing Information for Fetroja® (cefiderocol).

有关 Fetroja®（头孢地罗）的完整美国处方信息，请参阅。

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，这些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的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. .

此外，对于现有产品，存在生产和营销风险，其中包括但不限于无法建立产能以满足需求、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。

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