- Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereinafter 'Shionogi') is pleased to announce that it has entered into an exclusive licensing agreement with Link Medical Products Pty Ltd (hereinafter 'Link'), part of Clinigen, the global specialty pharmaceutical services group (Senior Vice President - JAPAC: Dr.

- 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”）欣然宣布，已与Clinigen全球专业制药服务集团（亚太区高级副总裁：Dr. [姓名]）旗下的Link Medical Products Pty Ltd（以下简称“Link”）签订了独家许可协议。

Varun Sethi; hereinafter 'Clinigen') for the development and commercialization of cefiderocol in Australia and New Zealand. The Therapeutic Goods Administration (TGA) regulatory authority in Australia accepted the market authorisation application for cefiderocol in December 2024 and the application is under evaluation.

瓦鲁恩·塞西（Varun Sethi；以下简称“Clinigen”）在澳大利亚和新西兰开发和商业化头孢地罗。澳大利亚治疗用品管理局（TGA）于2024年12月接受了头孢地罗的市场授权申请，目前该申请正在评估中。

Under the terms of the agreement, Link will in-license cefiderocol from Shionogi and obtain exclusive rights for its development and commercialization in Australia and New Zealand. Shionogi will receive an upfront payment, milestone payments based on development progress, and royalties from Link.

根据协议条款，Link将从盐野义制药获得头孢地罗的许可，并获得其在澳大利亚和新西兰的开发和商业化独家权利。盐野义制药将获得预付款、基于开发进展的里程碑付款以及来自Link的特许权使用费。

Shionogi is committed to research and development of innovative treatments for infectious diseases for the benefit of patients around the world and to helping tackle urgent global health challenges such as antimicrobial resistance (AMR).

盐野义制药致力于为全球患者研发传染病的创新疗法，并帮助应对如抗菌素耐药性（AMR）等紧迫的全球健康挑战。

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，头孢地罗酯以商品名 Fetroja 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 (HABP/VABP) and complicated urinary tract infections (cUTIs) caused by certain susceptible Gram-negative microorganisms

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（HABP/VABP）以及由某些敏感的革兰氏阴性微生物引起的复杂性尿路感染（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

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菌株引起的各类感染的生产和上市批准。

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 antibacterial agent for patients in low- 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，正在开展准备工作，以改善低收入和中等收入国家患者获取这种抗菌药物的机会。

About AMR

关于AMR

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) 是指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”，如果不采取应对措施，预计到2050年，每年将导致超过1000万人死亡。

About Link Medical Products Pty Ltd

关于Link Medical Products Pty Ltd

For almost 30 years, Link Healthcare, part of the Clinigen Group, has played a vital role in the Australasian healthcare landscape as a trusted partner providing ethical and compliant pathways to both registered and unregistered medicines. With a team of 58 employees, Link Healthcare offers specialised pharmaceutical services across the product lifecycle, from clinical through to commercial, supporting pharmaceutical and biotech companies and healthcare professionals to address unmet patient needs..

近30年来，作为Clinigen集团的一部分，Link Healthcare在澳大拉西亚的医疗保健领域发挥了重要作用，是提供注册和未注册药物合规途径的可信赖合作伙伴。Link Healthcare拥有58名员工，提供贯穿产品生命周期的专业制药服务，从临床到商业阶段，支持制药和生物技术公司及医疗保健专业人士满足患者的未满足需求。

About Clinigen

关于Clinigen

Clinigen is a global, specialist pharmaceutical services company focused on providing ethical access to medicines. Its mission is to accelerate access to medicines for patients in every corner of the globe. The Group supports pharmaceutical and biotech companies across the medical product lifecycle, from clinical through to commercial and operates from sites in North America, Europe, Africa and the Asia Pacific.

Clinigen是一家全球性的专业制药服务公司，专注于提供药品的道德准入。其使命是加速全球各地患者获得药品的速度。集团支持医药和生物技术公司跨越药品生命周期的各个阶段，从临床到商业运营，并在北美、欧洲、非洲和亚太地区设有站点。

Clinigen has more than 1,100 employees across five continents in 15 countries and provides access in more than 130 countries every year..

Clinigen在五大洲15个国家拥有1100多名员工，每年为130多个国家提供服务。