Venus Remedies Limited (NSE: VENUSREM, BSE: 526953), a leading pharmaceutical company specializing in critical care injectables, today announced that its investigational product

金星制药有限公司（NSE：VENUSREM，BSE：526953），一家专注于重症护理注射剂的领先制药公司，今天宣布其研究性产品

VRP-034

VRP-034

has been granted

已被授予

Qualified Infectious Disease Product (QIDP)

合格的传染病产品 (QIDP)

designation by the

指定由

United States Food and Drug Administration (US FDA)

美国食品药品监督管理局 (US FDA)

for the treatment of bloodstream infections caused by polymyxin B (PMB)-susceptible strains in adults.

用于治疗由多粘菌素B（PMB）敏感菌株引起的成人血流感染。

Developed by

由...开发

Venus Medicine Research Centre (VMRC)

金星药物研究中心 (VMRC)

, the R&D division of Venus Remedies, VRP-034 is a novel supramolecular cationic (SMC) formulation of polymyxin B sulphate, uniquely developed to address the nephrotoxic effects associated with conventional polymyxin B therapy.

，金星制药的研发部门，VRP-034 是一种新型的超分子阳离子（SMC）硫酸多粘菌素 B 制剂，独特开发以应对与传统多粘菌素 B 治疗相关的肾毒性效应。

The QIDP designation, granted under the

QIDP 指定，根据以下规定授予

Generating Antibiotic Incentives Now (GAIN) Act

《促进抗生素激励法案》（GAIN）

, provides VRP-034 with significant regulatory benefits, including priority review, eligibility for fast track designation, and an additional five years of market exclusivity upon approval in the United States.

，为VRP-034提供了显著的监管优势，包括优先审查、快速通道资格认定，以及在美国获批后额外五年的市场独占期。

“Receiving QIDP designation for VRP-034 is a pivotal milestone in our efforts to combat antimicrobial resistance,” said

“VRP-034获得QIDP资格认证是我们对抗抗菌素耐药性工作中的一个关键里程碑，”

Saransh Chaudhary

萨兰什·查达里

, CEO, Venus Medicine Research Centre. “QIDP recognition for VRP-034 underscores the urgent global need for safer polymyxin-based therapies and validates the strength of our scientific approach.”

，首席执行官，金星医学研究中心。“VRP-034获得QIDP认可，突显了全球对更安全的多粘菌素类疗法的迫切需求，并验证了我们科学方法的实力。”

Venus Remedies’ has developed the novel polymyxin-B formulation, VRP-034, using its proprietary Renal Guard technology. The company utilized kidney-on-a-chip technology (based on Organ-on-a-Chip model) to study established kidney injury biomarkers, including KIM-1, cystatin C, NAG, and NGAL, in response to polymyxin-B, an antibiotic used against multidrug-resistant Gram-negative bacteria.

维纳斯制药公司利用其专有的肾脏保护技术开发了新型多粘菌素B制剂VRP-034。该公司利用基于器官芯片模型的肾脏芯片技术，研究了已知的肾脏损伤生物标志物（包括KIM-1、胱抑素C、NAG和NGAL）对多粘菌素B的反应，多粘菌素B是一种用于对抗多重耐药革兰氏阴性菌的抗生素。

These insights directly contributed to the refining of its Renal Guard technology, forming the foundation of the novel formulation, VRP-034, designed specifically to minimize nephrotoxicity while preserving therapeutic efficacy..

这些见解直接促成了其肾保护技术的改进，为新型制剂 VRP-034 的开发奠定了基础，该制剂专门设计用于在保持治疗效果的同时最大限度地减少肾毒性。

Polymyxins, particularly PMB and colistin, are among the last-resort antibiotics used against Multidrug resistance (MDR) infections. However, their clinical use is severely limited by nephrotoxicity, which affects up to 60% of patients. VRP-034 offers a novel solution by preserving the pharmacokinetics and pharmacodynamics of PMB while significantly reducing oxidative stress and renal cell injury, as demonstrated in multiple .

多粘菌素，尤其是PMB和粘菌素，是对抗多重耐药（MDR）感染的最后手段抗生素之一。然而，它们的临床应用因肾毒性而受到严重限制，这种毒性会影响高达60%的患者。VRP-034通过在保持PMB的药代动力学和药效动力学的同时显著减少氧化应激和肾细胞损伤，提供了新颖的解决方案，这一点在多项研究中得到了证明。

in vitro

体外

and

和

in vivo

体内

studies.

研究。

Key preclinical findings for VRP-034 include:

VRP-034的关键临床前研究结果包括：

Up to 70% reduction in nephrotoxicity compared to marketed PMB

与上市的PMB相比，肾毒性降低高达70%

Robust efficacy against resistant pathogens in both

对两种耐药病原体均具有强劲疗效

in vitro

体外

and animal models

动物模型

Favorable safety profile across multiple toxicity studies using advanced renal biomarkers and human organ-on-a-chip models

在使用先进的肾脏生物标志物和人体器官芯片模型的多项毒性研究中，显示出良好的安全性

This recognition by the US FDA strengthens Venus Remedies’ commitment to innovation in the fight against

美国食品药品监督管理局的这一认可进一步坚定了金星制药公司在抗击疾病方面的创新承诺，

AMR

自适应多速率音频编码 (AMR)

and underlines the company’s dedication to addressing unmet needs in infectious disease therapy.

并强调了公司在解决传染病治疗领域未满足的需求方面的 dedication。