・Real world evidence study carried out in Spain demonstrates 68% clinical cure rate at day 14, and 83% overall survival at day 28, for patients infected with highly resistant metallo-beta lactamase (MBL)-producing pathogens

・在西班牙开展的真实世界证据研究表明，感染高耐药性金属β-内酰胺酶（MBL）产生菌的患者，在第14天的临床治愈率为68%，在第28天的整体生存率为83%。

1

1

・Carbapenem-resistant Enterobacterales pathogens are considered by the World Health Organization to be one of the most critical health threats

・碳青霉烯类耐药肠杆菌目病原体被世界卫生组织认为是最严重的健康威胁之一。

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2

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”) presents new real-world data evaluating Fetroja

盐野义制药株式会社（总公司：日本大阪；首席执行官：手代木功博士；以下简称“盐野义”）发布了评估Fetroja的新的真实世界数据。

®

®

/Fetcroja

/Fetcroja

®

®

(Generic name:cefiderocol), an innovative siderophore cephalosporin, in adults with confirmed MBL-producing Enterobacterales infections at the 36th Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in Munich,17th-21st April, 2026.

（通用名：头孢地罗），一种创新的铁载体头孢菌素，用于治疗确诊为产MBL的肠杆菌目感染的成人患者，于2026年4月17日至21日在慕尼黑举行的第36届欧洲临床微生物学和传染病学会（ESCMID）大会上发布。

1

1

The CIRCE study was a retrospective, observational, multicenter chart review study conducted in Spain between January 2023 and April 2025, designed to describe the effectiveness and safety of real-world cefiderocol use in 232 adult patients with infections caused by MBL-producing Enterobacterales.

CIRCE 研究是一项回顾性、观察性、多中心图表审查研究，于2023年1月至2025年4月在西班牙开展，旨在描述真实世界中使用头孢地罗治疗232名由产MBL肠杆菌目细菌引起的感染成年患者的有效性和安全性。

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1

The analysis found 68% of patients who received cefiderocol were considered clinically cured at day 14 and 82% of patients achieved clinical response at day 14.

分析发现，接受头孢地罗治疗的患者中，68%在第14天被认为临床治愈，82%的患者在第14天达到临床反应。

1

1

The overall rates of survival at days 14 and 28 were 90% and 83%, respectively, in this population.

该群体的第14天和第28天的整体生存率分别为90%和83%。

1

1

At baseline, 29% of patients were immunosuppressed, 27% were in intensive care and 13% presented with septic shock.

基线时，29% 的患者免疫功能低下，27% 的患者在重症监护室，13% 的患者出现感染性休克。

1

1

Drug associated adverse events were collected through routine chart review with no new identified safety signals beyond the established safety profile of cefiderocol.

通过常规图表审查收集了与药物相关的不良事件，未发现超出头孢地罗已知安全特性之外的新安全性信号。

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1

MBL-producing Enterobacterales inactivate almost all beta-lactam antibiotics, including carbapenems - agents typically reserved for severe or high-risk infections, thereby limiting therapeutic options.

产MBL的肠杆菌目几乎能使所有β-内酰胺类抗生素失活，包括碳青霉烯类——通常用于严重或高风险感染的药物，从而限制了治疗选择。

1,3,4

1,3,4

In the CIRCE study, the most frequently identified pathogens were carbapenem-resistant

在CIRCE研究中，最常鉴定出的病原体是耐碳青霉烯类的病原体。

Klebsiella pneumoniae

肺炎克雷伯菌

and

和

Enterobacter

肠杆菌属

spp. respectively,

分别为 spp.

1

1

both classified by the World Health Organization as critical priority pathogens due to their high levels of resistance to currently available therapies.

由于对现有疗法具有高度抗性，这两种病原体都被世界卫生组织列为关键优先级病原体。

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“MBL-producing Enterobacterales infections represent a significant and growing clinical challenge worldwide, particularly in critically ill patients where treatment options are limited,” said Dr Ricard Ferrer, Head of the Intensive Care Department at Vall d’Hebron Hospital in Barcelona, Spain. “These data support the clinical effectiveness of cefiderocol in adult patients with these infections, contributing further real-world evidence to inform future treatment considerations in practice.”.

“产MBL的肠杆菌目感染是全球范围内一个重大且日益严峻的临床挑战，尤其是在治疗选择有限的重症患者中，”西班牙巴塞罗那Vall d’Hebron医院重症监护科主任里卡德·费雷尔博士表示。“这些数据支持了头孢地洛尔在成年患者中的临床有效性，为指导未来实践中的治疗决策提供了更多的真实世界证据。”

Among patients with available follow-up cultures, microbiological eradication rates were reported as 85% in bloodstream infections and 82% in urinary tract infections (UTIs).

在有可用的后续培养的患者中，血流感染的微生物清除率为85%，尿路感染（UTIs）的清除率为82%。

1

1

Approximately half of patients received cefiderocol based on susceptibility testing.

大约一半的患者根据药敏试验结果接受了头孢地罗治疗。

1

1

Additional data presented at ESCMID 2026 evaluated the in vitro* activity of cefiderocol against more than 4,000

在ESCMID 2026上提交的更多数据评估了头孢地罗对4000多株细菌的体外活性。

Stenotrophomonas maltophilia

嗜麦芽寡养单胞菌

clinical isolates collected through the multinational SIDERO-WT (2014–2019) and SENTRY (2020–2024) surveillance programmes.

通过跨国SIDERO-WT（2014-2019）和SENTRY（2020-2024）监测项目收集的临床分离株。

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5

Across this ten-year period, there was no significant change in cefiderocol susceptibility observed before or after market introduction.

在这十年期间，在市场引入之前或之后，均未观察到头孢地罗的敏感性有显著变化。

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6

Stenotrophomonas maltophilia

嗜麦芽寡养单胞菌

is an opportunistic pathogen with high intrinsic resistance to multiple antimicrobial classes, often limiting treatment options in high-risk patients.

是一种对多种抗菌药物具有高内在耐药性的机会性病原体，常常限制了高危患者的治疗选择。

5

5

Data presented at the same congress reinforced cefiderocol’s effectiveness against

在同一大会上提交的数据证实了头孢地罗的有效性。

Stenotrophomonas maltophilia

嗜麦芽寡养单胞菌

, with a subgroup analysis of 119 patients from the PROVE study demonstrating clinical cure in approximately two-thirds of patients, the majority of whom were critically ill and receiving care in intensive care units.

，对来自PROVE研究的119名患者进行的亚组分析显示，约三分之二的患者达到了临床治愈，其中大多数为重症患者，并在重症监护室接受治疗。

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6

“Antimicrobial resistance continues to threaten effective treatment of serious Gram-negative infections globally,” said Mark Hill, Global Head of Medical Affairs, Shionogi & Co. Ltd. “These data add to the growing body of evidence supporting cefiderocol in resistant pathogens and underscores the importance of sustained investment in innovation and evidence generation in antimicrobials.”.

“抗菌素耐药性持续威胁全球范围内对严重革兰氏阴性菌感染的有效治疗，”盐野义制药公司全球医学事务主管马克·希尔表示。“这些数据进一步增加了支持头孢地尔在耐药病原体中的证据，并强调了持续投资于抗菌药物创新和证据生成的重要性。”

*In vitro activity does not necessarily correlate with clinical efficacy.

*体外活性不一定与临床疗效相关。

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，秉承“提供尽可能好的药物，以保护我们服务的患者的健康和福祉”的企业理念，致力于为患者带来益处。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 target 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 https://www.shionogi.com/global/en..

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。欲了解有关盐野义制药株式会社的更多信息，请访问 https://www.shionogi.com/global/en。

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，我们的研发故事已超越抗生素范畴，延伸至包括针对HIV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在研药物，如抗菌素耐药性、COVID-19、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 Global Antibiotic Research and Development Partnership (GARDP) have a license and technology transfer agreement and Shionogi and GARDP have a collaboration agreement with the Clinton Health Access Initiative (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. .

作为我们致力于满足未满足的医疗需求的一部分，盐野义制药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。盐野义制药与全球抗生素研究与开发合作伙伴（GARDP）签订了许可和技术转让协议，并且盐野义制药与GARDP还与克林顿健康获取倡议组织（CHAI）达成了合作协议，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获取抗生素的现状。

Shionogi’s ongoing efforts to address current and emerging health threats includes 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.

盐野义制药持续致力于应对当前和新兴的健康威胁，包括与盐野义集团旗下的Qpex生物制药公司在美国设立药物发现实验室。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 here.

在此处了解更多关于Qpex实验室的信息。

.

。

Shionogi ranked #2 among large research-based pharmaceutical companies in the Access to Medicine Foundation’s 2026 Antimicrobial Resistance (AMR) Benchmark, a global assessment of how leading pharmaceutical companies are tackling antimicrobial resistance and expanding responsible access to antibiotics worldwide..

盐野义制药公司在“获取药物基金会”2026年抗菌素耐药性（AMR）基准评估中，位列大型研究型制药公司的第二名。该基准评估了全球领先的制药公司如何应对抗菌素耐药性问题，并在全球范围内负责任地扩大抗生素的可及性。

About Cefiderocol

关于Cefiderocol

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

在美国，头孢地罗醇以商品名 Fetroja® 上市销售，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和复杂性尿路感染。

3

3

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

在欧洲，头孢地罗醇以商品名 Fetcroja® 上市，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患者。

7

7

In Japan, cefiderocol is commercially available under the brand name Fetroja® 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 Escherichia coli, Citrobacter species, Klebsiella pneumoniae, Enterobacter species, Serratia marcescens, Proteus species, Morganella morganii, Pseudomonas aeruginosa, Burkholderia species, Stenotrophomonas maltophilia, and Acinetobacter species..

在日本，头孢地罗醇以商品名 Fetroja® 上市，并获得厚生劳动省的生产和销售许可，用于治疗由对碳青霉烯类抗生素耐药的敏感菌株引起的多种感染，这些菌株包括大肠杆菌、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、摩根氏菌、铜绿假单胞菌、伯克霍尔德菌属、嗜麦芽寡养单胞菌和不动杆菌属。

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，而这些假设受到风险和不确定性的制约，可能导致实际结果与这些陈述产生重大差异。风险和不确定性包括一般国内和国际经济状况，如总体行业和市场状况，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：临床试验的完成和中止；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..

对于现有产品，也存在生产和营销风险，包括但不限于无法建立满足需求的生产能力、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: https://www.shionogi.com/global/en/contact.html

SHIONOGI官网咨询表：https://www.shionogi.com/global/en/contact.html

Shionogi Europe Press Office: pressoffice@shionogi.eu

盐野义欧洲新闻办公室：pressoffice@shionogi.eu

U.S. Media Contact: ShionogiCommunications@shionogi.com

美国媒体联系人：ShionogiCommunications@shionogi.com

References

参考文献

1.  Boán, J., Aguado, J. M., Soriano-Cuesta, C., Martínez-Sagasti, F., Vidart, N., Hidalgo-Tenorio, C., Sequera, S., Garcia, L., Longshaw, C., & González Calvo, A. J. (2026, April 17–21).

1. 博安，J.，阿瓜多，J. M.，索里亚诺-库埃斯塔，C.，马丁内斯-萨加斯蒂，F.，维达特，N.，伊达尔戈-特尼里奥，C.，塞奎拉，S.，加西亚，L.，朗肖，C.，& 冈萨雷斯·卡尔沃，A. J.（2026年4月17-21日）。

Real-world efficacy of cefiderocol for treatment of infections caused by metallo-beta-lactamase-producing Enterobacterales in Spain

头孢地罗治疗西班牙产金属β-内酰胺酶肠杆菌目细菌感染的真实世界疗效

[Conference poster]. ESCMID Global 2026, Munich, Germany.

[会议海报]. ESCMID 全球 2026，德国慕尼黑。

2.  World Health Organisation. WHO Bacterial Priority Pathogens List, 2024. Available at:

2. 世界卫生组织。WHO细菌重点病原体清单，2024。可访问：

https://iris.who.int/server/api/core/bitstreams/1a41ef7e-dd24-4ce6-a9a6-1573562e7f37/content

https://iris.who.int/server/api/core/bitstreams/1a41ef7e-dd24-4ce6-a9a6-1573562e7f37/content

. Accessed: March 2026.

访问日期：2026年3月。

3.  Fetroja® Prescribing information. Available at:

3. Fetroja®处方信息。可访问：

https://www.shionogi.com/content/dam/shionogi/si/products/pdf/fetroja.pdf

https://www.shionogi.com/content/dam/shionogi/si/products/pdf/fetroja.pdf

. Accessed March 2026.

访问时间：2026年3月。

4.  Vázquez-Ucha, J.C.

4. 瓦斯奎兹-乌查，J.C.

et al.

等。

(2023) ‘Activity of aztreonam in combination with novel β-lactamase inhibitors against metallo-β-lactamase-producing Enterobacterales’,

（2023）‘新型β-内酰胺酶抑制剂联合氨曲南对产金属β-内酰胺酶肠杆菌的活性’，

Journal of Global Antimicrobial Resistance

全球抗菌药物耐药性杂志

. Available at:

. 可在以下地址获取：

https://www.sciencedirect.com/science/article/abs/pii/S0924857923000262

https://www.sciencedirect.com/science/article/abs/pii/S0924857923000262

Accessed March 2026.

访问时间：2026年3月。

5.  Paudel R, et al. Carbapenemase producing Gram negative bacteria.

5. Paudel R, 等。产碳青霉烯酶的革兰氏阴性菌。

Journal of Infection and Public Health

感染与公共卫生杂志

. 2024. Available at:

. 2024. 可在以下地址获取：

https://www.sciencedirect.com/science/article/abs/pii/S0732889324001998

https://www.sciencedirect.com/science/article/abs/pii/S0732889324001998

Accessed March 2026.

访问时间：2026年3月。

6.  Yamano, Y., Longshaw, C., Nguyen, S. T., Maher, J. M., Mendes, R. E., Hackel, M., Yamashiro, S., & DeJong, E. (2026, April 17–21).

6. 山野，Y.，朗肖，C.，阮，S. T.，马赫，J. M.，门德斯，R. E.，哈克尔，M.，山城，S.，& 德容，E.（2026年4月17-21日）。

Activity of cefiderocol against Stenotrophomonas maltophilia clinical isolates collected in multi-national antimicrobial surveillance studies SIDERO-WT (2014–2019) and SENTRY (2020–2024)

头孢地罗对在多国抗菌药物监测研究 SIDERO-WT（2014-2019）和 SENTRY（2020-2024）中收集的嗜麦芽寡养单胞菌临床分离株的活性

[Conference poster]. ESCMID Global 2026, Munich, Germany.

[会议海报]. ESCMID 全球 2026，德国慕尼黑。

7.  Timsit, J.-F., Torre-Cisneros, J. de la, Machuca, I., Kobci, M., Henriksén, A. S., Gill, K., & Nguyen, S. T. (2026, April 17–21).

7. 蒂姆西特，J.-F.，托雷-奇斯内罗斯，J. 德拉，马丘卡，I.，科比，M.，亨里克森，A. S.，吉尔，K.，& 阮，S. T.（2026年4月17-21日）。

Real-world cefiderocol outcomes in the treatment of Stenotrophomonas spp. infections: Data from the PROVE study

头孢地罗在治疗嗜麦芽窄食单胞菌感染中的实际疗效：PROVE研究数据

[Conference poster]. ESCMID Global 2026, Munich, Germany.

[会议海报]. ESCMID 全球 2026，德国慕尼黑。

8.  Fetcroja® Summary of Product Characteristics. Available at:

8. Fetcroja® 产品特性摘要。可访问：

https://www.ema.europa.eu/en/documents/product-information/fetcroja-epar-product-information_en.pdf

https://www.ema.europa.eu/en/documents/product-information/fetcroja-epar-product-information_en.pdf

. Accessed: March 2026.

访问日期：2026年3月。