/PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, today announced the approval of a novel formulation of the first-of-its-kind, ready-to-infuse formulation of vancomycin, under the brand name TYZAVAN

/PRNewswire/ -- 跨国制药公司Hikma Pharmaceuticals PLC（Hikma）今日宣布，其首创的即用型万古霉素新型制剂已获批准，品牌名为TYZAVAN。

(Vancomycin Injection, USP), by the US Food and Drug Administration (FDA).

（万古霉素注射液，USP），由美国食品药品监督管理局（FDA）批准。

TYZAVAN

TYZAVAN

is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved: (i) septicemia; (ii) infective endocarditis; (iii) skin and skin structure infections; (iv) bone infections; and (v) lower respiratory tract infections..

是一种糖肽类抗菌药物，适用于成人和1个月及以上儿童患者以下感染的治疗，且需能够通过该制剂实现适当剂量：(i) 败血症；(ii) 感染性心内膜炎；(iii) 皮肤及皮肤结构感染；(iv) 骨感染；以及 (v) 下呼吸道感染。

The name TYZAVAN

名称 TYZAVAN

stands for 'time-saving vancomycin,' reflecting its purpose: delivering timely, simplified treatment when every minute counts. TYZAVAN

代表“节省时间的万古霉素”，反映了其目的：在每一分钟都至关重要的时候，提供及时、简化的治疗。TYZAVAN

is the only FDA-approved vancomycin product commercially available for all patients that is available at room temperature and requires no compounding, thawing, activation or dilution—reducing preparation steps and supporting faster treatment

是唯一一种在室温下可获取、无需配制、解冻、激活或稀释的、适用于所有患者的商用万古霉素产品——减少了准备步骤，支持更快的治疗。

According to the Sepsis Alliance, someone in the U.S. is diagnosed with sepsis every 20 seconds, and a sepsis-related death occurs every two minutes.

根据脓毒症联盟的数据，美国每20秒就有人被诊断出患有脓毒症，每两分钟就有一人死于脓毒症相关疾病。

Sepsis is a leading cause of death and hospitalization, often requiring rapid antibiotic administration as a core part of treatment. Independent studies indicate that sepsis survival rate decreases by 15% after 87–113 minutes.

脓毒症是导致死亡和住院的主要原因，治疗的核心部分通常需要快速使用抗生素。独立研究表明，在87到113分钟后，脓毒症的存活率会下降15%。

'The approval of TYZAVAN

“TYZAVAN 的批准

underscores our team's exceptional R&D capabilities in developing innovative healthcare solutions that enhance patient care, particularly in time-sensitive situations,' said Dr Bill Larkins

“这充分体现了我们团队在研发创新医疗解决方案方面的卓越能力，这些解决方案能够提升患者护理质量，尤其是在时间紧迫的情况下，”比尔·拉金斯博士说道。

, President of Hikma Injectables. 'TYZAVAN

，Hikma Injectables 总裁。'TYZAVAN

, available in ready-to-infuse aseptically filled bags, exemplifies our commitment to rethinking essential medicines by making them faster to administer, easier to manage and available when patients need them most. Our dedicated and specialised commercial team will drive the launch of TYZAVAN

，以即用型无菌袋装形式提供，体现了我们对重新思考基本药物的承诺，使其更快速施用、更易于管理，并在患者最需要的时候提供。我们专注且专业的商业团队将推动TYZAVAN的上市。

, ensuring its successful introduction and adoption in US hospitals.'

`, 确保其在美国医院成功引入和采用。'

TYZAVAN

TYZAVAN

provides hospitals with a practical and scalable solution

为医院提供了一个实用且可扩展的解决方案

for improving time to treatment and reducing preparation complexity:

为了缩短治疗时间并降低准备复杂性：

Ready-to-infuse formulation

即用型配方

– removes the need for on-site preparation and IV compounding, reduces strain on pharmacy and nursing staff, minimizes handling risk and reduces risk of medication errors

– 无需现场准备和静脉注射混合，减轻药房和护理人员的压力，最大限度地降低操作风险并减少用药错误的风险。

Seven presentations (0.5g–2g)

七份简报（0.5克–2克）

– supporting flexibility for fixed and weight-based dosing

- 支持固定剂量和基于体重剂量的灵活性

Room-temperature stability

室温稳定性

– shelf life of 16 months; no refrigeration needed

– 保质期16个月；无需冷藏

Automated dispensing cabinet compatible

自动配药柜兼容

– seamlessly fits into hospital workflows

——无缝融入医院工作流程

According to IQVIA, US sales of vancomycin injection were close to

根据IQVIA的数据，美国注射用万古霉素的销售额接近

$200 million

2亿美元

in 2024.

2024年。

This product has been approved for marketing in

该产品已获准上市销售

by the US FDA. This product approval does not confer the right on Hikma, or any other party, to market this product outside

由美国食品药品监督管理局（FDA）批准。该产品批准并不赋予Hikma或任何其他方在境外销售该产品的权利。

About Hikma

关于Hikma

Hikma helps put better health within reach every day for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across

Hikma每天帮助世界各地数百万人实现更好的健康。四十多年来，我们一直致力于生产高质量的药品，并将其提供给需要的人。我们总部位于英国，是一家全球化的公司，在多个国家和地区拥有本地业务。

, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines.

，并且我们运用独特的洞察力和专业知识，将前沿科学转化为创新解决方案，从而改变人们的生活。我们致力于服务我们的客户以及他们所关心的人群，通过创造性思考和务实行动，我们为他们提供广泛的品牌和非品牌仿制药。

Together, our 9,500 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: .

我们的 9,500 名同事共同努力，正在打造一个更加健康的世界，丰富我们所有的社区。我们是领先的授权合作伙伴，并通过我们的风险投资部门，帮助将创新的健康技术带给世界各地的人们。欲了解更多信息，请访问：。