OSAKA, Japan, January 8, 2026 -

日本大阪，2026年1月8日 -

Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter 'Shionogi') announced that its group company, Shionogi China Co., Ltd. (Head Office: Shanghai, China; Chairman: Hirofumi Nagatome), has received approval from the National Medical Products Administration (NMPA) of China for cefiderocol (generic name: Cefiderocol Sulfate Tosylate for Injection; hereinafter “cefiderocol”) for the treatment of complicated urinary tract infections including pyelonephritis.

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”）宣布其集团公司盐野义中国有限公司（总部：中国上海；董事长：长留博史）已获得中国国家药品监督管理局（NMPA）批准，用于治疗包括肾盂肾炎在内的复杂性尿路感染的药物头孢地罗（通用名：注射用头孢地罗硫酸托西酯；以下简称“头孢地罗”）。

caused by Gram-negative bacteria.

由革兰氏阴性菌引起。

This approval is based on positive results from an international multicenter clinical study¹ and a randomized, double-blind, multicenter study² conducted in China. In both studies, which aimed to verify non-inferiority to the comparator drug, cefiderocol demonstrated non-inferiority to imipenem/cilastatin and achieved the primary endpoint.

该批准基于一项国际多中心临床研究¹和一项在中国开展的随机、双盲、多中心研究²的积极结果。在这两项旨在验证非劣效性的研究中，头孢地尔均显示出对亚胺培南/西司他丁的非劣效性，并达到了主要终点。

Furthermore, no new safety concerns were identified, and cefiderocol was well tolerated..

此外，没有发现新的安全隐患，头孢地罗醇耐受性良好。

Antimicrobial resistance (AMR) occurs when bacteria develop resistance to antibiotics, making infections harder to treat. AMR is often referred to as a “silent pandemic” and is recognized as one of the most pressing global public health threats requiring urgent action

抗菌素耐药性 (AMR) 是指细菌对抗生素产生耐药性，导致感染更难治疗。AMR 常被称为“无声的大流行”，并被公认为是全球最紧迫的公共卫生威胁之一，需要立即采取行动应对。

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. In 2021, AMR was estimated to have caused 1.14 million deaths worldwide

2021年，AMR估计在全球范围内导致了114万人死亡。

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. Without coordinated international efforts, it is projected that more than 39 million lives could be lost over the next 25 years

据估计，如果没有协调一致的国际努力，未来25年将有超过3900万人失去生命。

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. Meanwhile, treatment options remain limited, making this an area of high unmet medical need. With this approval, cefiderocol is expected to provide a new treatment option for patients in mainland China suffering

同时，治疗选择仍然有限，使得这一领域存在高度未满足的医疗需求。通过此次获批，头孢地罗预计将为中国大陆遭受此病痛的患者提供一种新的治疗选择。

from difficult-to-treat complicated urinary tract infections.

源自难治性复杂尿路感染。

Shionogi has identified “Protecting people from the threat of infectious diseases” as a material issue and is committed to realizing total care for infectious diseases. We will continue to work toward delivering essential anti-infective treatments to patients worldwide as quickly as possible, contributing to global efforts to combat AMR.

盐野义制药已将“保护人类免受传染病威胁”确定为重要课题，并致力于实现对传染病的全面护理。我们将继续努力尽快向全球患者提供必要的抗感染治疗药物，助力全球抗击抗菌素耐药性（AMR）的努力。

For more information on Shionogi’s initiatives against AMR, please visit..

有关Shionogi对抗AMR的举措的更多信息，请访问。。。。

Clich here

点击这里

to learn more about our efforts to address antimicrobial resistance.

了解更多关于我们应对抗菌素耐药性的努力。

About Cefiderocol

关于Cefiderocol

Cefiderocol is an antibiotic that penetrates the outer membrane of Gram-negative bacteria, including multidrug-resistant strains, to exert its antibacterial activity. As of December 2025, cefiderocol is marketed in 27 countries and regions, including Japan, Europe, U.S., Taiwan and China. It is listed on the WHO Model List of Essential Medicines, demonstrating its continued importance in improving outcomes for patients with some of the most difficult-to-treat Gram-negative infections.

头孢地罗是一种抗生素，能够穿透包括多药耐药菌株在内的革兰氏阴性菌的外膜，发挥其抗菌活性。截至2025年12月，头孢地罗已在27个国家和地区上市，包括日本、欧洲、美国、台湾和中国。它被列入世界卫生组织基本药物标准清单，证明了其在改善一些最难治疗的革兰氏阴性菌感染患者预后方面持续的重要性。

Prior to this approval, the Hainan Provincial Medical Products Administration had authorized its clinical use in the Boao Lecheng International Medical Tourism Pilot Zone in China.

在此获批之前，海南省药品监督管理局曾授权其在中国博鳌乐城国际医疗旅游先行区临床使用。

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References

参考文献

1.

1.

Press release: January 12, 2017

新闻发布：2017年1月12日

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2.

Chinese Clinical Trial Registry: Phase III clinical trial registration number CTR20223300

中国临床试验注册中心：III 期临床试验注册号 CTR20223300

3.       Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet 2022; 399: 629–55.

3.       抗菌素耐药性合作组织。2019年全球细菌抗菌素耐药性负担：系统分析。《柳叶刀》2022；399：629–55。

4.       GBD 2021 Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance 1990-2021: a systematic analysis with forecasts to 2050. Lancet. 2024 Sep 28;404(10459):1199-1226. doi: 10.1016/S0140-6736(24)01867-1. Epub 2024 Sep 16. PMID: 39299261.

4.       GBD 2021 抗微生物药物耐药性合作组。1990-2021年全球细菌抗微生物药物耐药负担：系统分析与2050年预测。《柳叶刀》。2024年9月28日；404(10459):1199-1226。doi: 10.1016/S0140-6736(24)01867-1。电子版发表于2024年9月16日。PMID: 39299261。

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Antimicrobial resistance (who.int) WHO. Antimicrobial resistance. Who.int. Published October 13, 2020.

抗菌素耐药性 (who.int) 世界卫生组织。抗菌素耐药性。Who.int。发布于2020年10月13日。

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Press release: August 5, 2024

新闻发布：2024年8月5日

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；有关产品安全性和有效性的索赔和担忧；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:

SHIONOGI网站咨询表：

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

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