- Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter 'Shionogi') is pleased to announce that JEIL PHARMACEUTICAL CO., LTD. (Headquarters: Seoul, South Korea; President: Suk Je Sung ; hereinafter 'JEIL'), its partner in South Korea

- 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”）很高兴宣布其在韩国的合作伙伴杰伊制药株式会社（总部：韩国首尔；总裁：郑锡宰；以下简称“杰伊”）

, has obtained marketing approval from the South Korean regulatory authorities for the gram-negative bacterial infection treatment 'Fetroja

，已获得韩国监管机构对其用于治疗革兰氏阴性菌感染的药物“Fetroja”的上市批准。

Fetroja®/Fetcroja® (cefiderocol), an innovative siderophore cephalosporin, for the treatment of critically ill patients with carbapenem-resistant (CR) Gram-negative (GN) bacterial infections. In South Korea, based on the results of three global clinical trials (a Phase 2 trial [APEKS-cUTI] in patients with complicated urinary tract infections, a Phase 3 trial in patients with carbapenem-resistant gram-negative bacterial infections [CREDIBLE-CR], and a Phase 3 trial in patients with nosocomial pneumonia [APEKS-NP]).

Fetroja®/Fetcroja®（头孢地罗，cefiderocol），一种创新的铁载体头孢菌素，用于治疗患有碳青霉烯类耐药（CR）革兰氏阴性（GN）细菌感染的重症患者。在韩国，该药物的获批基于三项全球临床试验的结果（一项针对复杂性尿路感染患者的二期试验[APEKS-cUTI]，一项针对碳青霉烯类耐药革兰氏阴性细菌感染患者的三期试验[CREDIBLE-CR]，以及一项针对医院获得性肺炎患者的三期试验[APEKS-NP]）。

, JEIL received marketing approval.

，JEIL获得了上市批准。

Antimicrobial resistance (AMR), the phenomenon where bacteria acquire resistance to antibiotics, is one of the most significant global public health threats facing humanity and requires urgent action. AMR has been referred to as a 'silent pandemic,' and without countermeasures, it is projected to result in over 10 million deaths annually by 2050.

抗菌素耐药性（AMR），即细菌对抗生素产生耐药性的现象，是人类面临的最严重的全球公共卫生威胁之一，需要紧急采取行动。AMR被称为“无声的大流行病”，如果不采取对策，预计到2050年每年将导致超过1000万人死亡。

. However, available treatment options remain limited, making this an area of high unmet medical need. With this approval, Fetroja will be a new treatment option for patients in South Korea suffering from infections caused by multidrug-resistant.

然而，可用的治疗方案仍然有限，这使得这一领域存在高度未满足的医疗需求。随着这一批准，Fetroja 将成为韩国由多重耐药菌引起的感染患者的一种新治疗选择。

Shionogi has identified 'Protecting people from the threat of infectious diseases' as a material issue (materiality) to address, and is working toward achieving comprehensive care for infectious diseases. We are committed to protecting the health of people by delivering the necessary infectious disease treatments to patients around the world as quickly as possible, in order to contribute to the successful management of global challenges such as COVID-19 and AMR..

盐野义制药公司将“保护人们免受传染病威胁”确定为需要解决的重要课题（实质性问题），并致力于实现对传染病的全面护理。我们承诺通过尽快向世界各地的患者提供必要的传染病治疗药物，来保护人们的健康，从而为成功应对新冠疫情和抗菌素耐药性等全球挑战做出贡献。

About Shionogi in AMR

关于Shionogi在AMR的情况

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

在欧洲，头孢地罗酯以商品名 Fetcroja 商业销售。

for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options

用于治疗成人中因需氧革兰氏阴性菌引起的感染，且治疗选择有限的情况。

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

在美国，头孢地罗可作为品牌药Fetroja获得。

and is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia (HABP/VABP) and complicated urinary tract infections (cUTIs) caused by certain susceptible Gram-negative microorganisms

适用于18岁及以上患者，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（HABP/VABP）以及复杂性尿路感染（cUTIs）。

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

在日本，头孢地罗酯以商品名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 Escherichia coli, Citrobacter species, Klebsiella pneumoniae, Enterobacter species, Serratia marcescens, Proteus species, Morganella morganii, Pseudomonas aeruginosa, Burkholderia species, Stenotrophomonas maltophilia, and Acinetobacter species.

并获得了日本厚生劳动省对于由对碳青霉烯类抗生素耐药菌株引起的各类感染的制造和销售许可，这些敏感菌株包括大肠埃希菌、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、嗜麦芽寡养单胞菌和不动杆菌属。

Cefiderocol is listed on the World Health Organization's Essential Medicines List

头孢地罗被列在世界卫生组织的基本药物清单上。

, and preparations are underway through a collaborative agreement with The Global Antibiotic Research and Development Partnership (GARDP) and Clinton Health Access Initiative (CHAI) to improve access to this new antibacterial agent for patients in many low- and middle-income countries and high- and middle-income countries.

，根据与全球抗生素研究与开发伙伴关系 (GARDP) 和克林顿健康获取倡议 (CHAI) 的合作协议，准备工作正在进行中，以提高许多低收入和中等收入国家以及高收入和中等收入国家的患者获得这种新型抗菌药物的机会。

About JEIL PHARMACEUTICAL CO., LTD.

关于JEIL制药有限公司。

Founded in 1959 and listed on KOSPI since 1988, JEIL has consistently contributed to the growth and development of South Korea’s pharmaceutical industry by developing and supplying high-quality medicines. Today, JEIL collaborates with pharmaceutical companies worldwide and is recognized as an advanced pharmaceutical company that adheres to international business practices..

成立于1959年，自1988年起在韩国证券交易所上市，JEIL通过开发和供应高质量的药品，持续为韩国制药行业的发展做出了贡献。如今，JEIL与全球制药公司合作，被公认为是遵循国际商业惯例的先进制药公司。