·

·

Data from five European countries demonstrates the effectiveness of cefiderocol against Gram-negative pathogens considered as high or critical priorities by the WHO, including high rates of clinical cure and day 28 survival across patients with limited treatment options.

来自五个欧洲国家的数据证明了头孢地罗对被世界卫生组织列为高或关键优先级的革兰氏阴性病原体的有效性，包括在治疗选择有限的患者中表现出较高的临床治愈率和第28天存活率。

1,2

1,2

·

·

New European cohort data from the largest real-world evidence study of cefiderocol indicates a lower clinical cure rate trend among patients who received cefiderocol as salvage therapy compared with patients who received documented or empirical treatment.

来自最大规模的真实世界证据研究的新欧洲队列数据显示，与接受过记录在案或经验性治疗的患者相比，接受头孢地罗作为补救治疗的患者的临床治愈率趋势较低。

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OSAKA, Japan, 8

日本大阪，8

th

th

April , 2025 –

2025年4月 –

Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President & CEO: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) presents new European data from its largest real-world evidence study of Fetroja

盐野义制药株式会社（总公司：日本大阪；总裁兼首席执行官：手代木功博士；以下简称“盐野义”）展示了其规模最大的Fetroja真实世界研究中的新欧洲数据。

®

®

/Fetcroja

/Fetcroja

®

®

(cefiderocol), an innovative siderophore cephalosporin at the 35th Congress of the European Society of Clinical Microbiology and Infectious Diseases in Vienna on 11th-15th April 2025.

（头孢地罗），一种创新的铁载体头孢菌素，将于2025年4月11日至15日在维也纳举行的第35届欧洲临床微生物学和传染病学会大会上展示。

The PROVE (Retros

证明（回顾

p

p

ective Cefide

有效的Cefide

ro

罗马尼亚语

col Chart Re

图表重新生成

v

v

i

我

e

e

w) study is a five-year international, retrospective, observational medical chart review study, conducted between November 2020 and July 2024 designed to describe the efficacy and safety of real-world cefiderocol use in adult patients with serious Gram-negative (GN) bacterial infections.

w) 本研究是一项为期五年的国际性、回顾性、观察性病历回顾研究，于2020年11月至2024年7月期间进行，旨在描述真实世界中使用头孢地罗治疗成人严重革兰氏阴性（GN）细菌感染的有效性和安全性。

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Analysis of the European cohort found a higher clinical cure rate trend among patients who received cefiderocol for a documented infection (67.4%) or as empiric therapy (64.6%) as compared to those who received it as salvage therapy (58.2%).

对欧洲队列的分析发现，接受头孢地罗治疗的患者中，用于确诊感染（67.4%）或作为经验性治疗（64.6%）的临床治愈率趋势高于将其作为补救治疗（58.2%）的患者。

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Professor Oliver Cornely, Director of Translational Research, University of Cologne, said: “These data suggest a trend towards worse clinical outcomes when the use of cefiderocol to treat Gram-negative bacterial infections is reserved as a last line treatment option compared with those who received the treatment earlier.

科隆大学转化研究主任奥利弗·科内利教授表示：“这些数据表明，与较早接受治疗的患者相比，将头孢地罗用作治疗革兰氏阴性菌感染的最后一道治疗手段时，临床结果可能会更差。”

This trend may offer clinicians new evidence to justify the early and effective use of cefiderocol in patients with suspected resistant infections.”.

这一趋势可能为临床医生提供新的证据，证明在疑似耐药感染的患者中早期有效使用头孢地罗是合理的。

The study analysed data from 567 patients hospitalised with confirmed GN bacterial infections, who were treated with cefiderocol for the first time for ≥72 hours across Spain, France, Italy, Germany and the United Kingdom.

该研究分析了来自西班牙、法国、意大利、德国和英国的567名因确诊GN细菌感染住院并首次接受头孢地罗治疗≥72小时的患者的数据。

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Carbapenem resistance rate was >70% among patients enrolled in the study.

研究中纳入的患者碳青霉烯类耐药率超过70%。

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55.9% of patients were critically ill in the intensive care unit and 41.3% were receiving organ support at the point of cefiderocol initiation.

55.9%的患者在重症监护室处于病危状态，41.3%的患者在开始使用头孢地罗时正在接受器官支持治疗。

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Respiratory tract infection (RTI) was the most frequent infection site, reported in over 50% patients (299), followed by urinary tract infection in over 12% of patients (73).

呼吸道感染（RTI）是最常见的感染部位，超过50%的患者（299人）报告了该情况，其次是尿路感染，占12%以上的患者（73人）。

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Patients in the study receiving cefiderocol across all pathogens achieved an overall clinical cure rate of 65.3%.

研究中接受头孢地罗治疗的所有病原体患者的总体临床治愈率为65.3%。

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The most frequent pathogens observed were

最常见的病原体是

Pseudomonas aeruginosa

铜绿假单胞菌

(41.3%),

（41.3%），

Acinetobacter baumannii

鲍曼不动杆菌

(15.0%), and Enterobacterales (14.6%)

(15.0%)，和肠杆菌目 (14.6%)

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1

, which are identified as priority pathogens by the World Health Organisation

，这些病原体被世界卫生组织确定为优先病原体

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. A clinical cure rate of 73.1% was observed among patients with a

临床治愈率为73.1%的患者中观察到

Pseudomonas aeruginosa

铜绿假单胞菌

infection.

感染。

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Takuko Sawada, Board Director and Vice Chair, Shionogi & Co Ltd., said: “Antimicrobial resistance is one of the most pressing global health challenges of this century, resulting in the deaths of millions of people around the world each year. In order to support better patient outcomes, it is imperative that clinicians have access to the innovative treatments they need for appropriate use with the right patient at the right time.

泽田拓子，盐野义制药有限公司董事会董事兼副董事长表示：“抗菌素耐药性是本世纪最紧迫的全球健康挑战之一，每年导致全球数百万人死亡。为了支持更好的患者治疗效果，临床医生必须能够及时获取所需的创新疗法，以便在正确的时间为正确的患者进行适当使用。”

We remain committed to the research and development of essential medicines that will help tackle the growing threat of drug-resistant infection.”.

我们仍然致力于研发有助于应对日益严重的耐药性感染威胁的基本药物。

-  Ends –

——结束——

About Shionogi & Co. Ltd.

关于盐野义制药株式会社

Shionogi & Co., Ltd. is a 147-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, cardiovascular diseases and gastroenterology.

日本大阪的盐野义制药株式会社是一家拥有147年历史的全球性研究驱动型制药公司，致力于根据“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、心血管疾病和胃肠病学。

Shionogi’s research and development currently target two therapeutic areas: infectious diseases, and pain/CNS disorders..

盐野义制药目前的研发目标锁定在两个治疗领域：传染病，以及疼痛/中枢神经系统疾病。

For more information on Shionogi & Co., Ltd., please visit

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

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

.

。

About Shionogi in AMR

关于盐野义制药在抗菌药物耐药性方面的工作

Shionogi has a strong heritage in the field of anti-infectives and has been developing antimicrobial therapies for more than 60 years. Shionogi is proud to be one of the few large pharmaceutical companies that continues to focus on R&D in anti-infectives.

盐野义制药在抗感染领域有着深厚的积淀，并已致力于开发抗菌疗法超过60年。盐野义制药自豪于成为少数几家继续专注于抗感染药物研发的大型制药公司之一。

About Cefiderocol

关于Cefiderocol

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（cefiderocol）以商品名 Fetcroja® 上市，用于治疗成人中因需氧革兰氏阴性菌引起的感染，适用于治疗选择有限的患者。

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In the US, cefiderocol is commercially available under the brand name Fetroja® for the treatment of 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（cefiderocol）以商品名 Fetroja® 上市，用于治疗 18 岁及以上患者的医院获得性细菌性肺炎、呼吸机相关性细菌性肺炎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。

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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

在日本，头孢地罗酯以商品名Fetroja®上市，并获得了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菌株引起的各类感染。

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

埃希氏菌属、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

, and

，以及

Acinetobacter species.

鲍曼不动杆菌属。

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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。这些声明是基于当前可获得的信息和预期，但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声明有重大差异。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..

对于现有产品，也存在生产和市场风险，其中包括但不限于无法建立生产能力以满足需求、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。

For Further Information, Contact:

如需更多信息，请联系：

SHIONOGI Website Inquiry Form:

SHIONOGI网站咨询表：

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

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

Shionogi Europe Press Office:

盐野义欧洲新闻办公室：

pressoffice@shionogi.eu

pressoffice@shionogi.eu

U.S. Media Contact:

美国媒体联系人：

ShionogiCommunications@shionogi.com

ShionogiCommunications@shionogi.com

References

参考文献

[1] Fetcroja® Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/fetcroja-epar-product-information_en.pdf . Accessed: March 2024.

[1] 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 。访问时间：2024年3月。

[2] Fetroja® Prescribing information. Available at:

[2] Fetroja®处方信息。可访问：

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209445s000lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209445s000lbl.pdf

. Accessed: March 2024.

访问日期：2024年3月。

[3]

[3]

Press release on November 30, 2023.

2023年11月30日新闻稿。

Regarding the Acquisition of Manufacturing and Marketing Approval for the New Siderophore Cephalosporin Antibiotic Fetroja

关于新型铁载体头孢菌素类抗生素Fetroja的生产和上市许可的获取

Ⓡ

®

(cefiderocol) Intravenous Infusion 1g vial in Japan

（头孢地罗）静脉输注1克瓶装，在日本