/PRNewswire/ -- Shanton Pharma, a clinical-stage biotech company developing a novel treatment for gout, today announced that FDA has designated its Investigational New Drug SAP-001 as a Fast Track product for treatment of hyperuricemia in adult patients with gout who are refractory to conventional therapy..

/PRNewswire/ -- 专注于开发痛风新型疗法的临床阶段生物技术公司Shanton Pharma今日宣布，美国食品药品监督管理局（FDA）已将其在研新药SAP-001指定为快速通道产品，用于治疗对常规疗法无效的成年痛风患者的高尿酸血症。

'We are excited about the Fast Track designation for SAP-001' says Dr.

“我们对SAP-001的快速通道指定感到兴奋”，博士说。

Wenfeng Miao

文峰庙

, Shanton's CMO. 'Refractory gout is a serious condition for which there are considerable unmet medical needs, requiring the development of new treatments. We are pleased to tap into the opportunity for faster regulatory reviews provided by this designation to speed up the availability of a much-needed solution for gout patients who do not respond to or cannot tolerate Standard-of-Care treatment with conventional Urate Lowering Therapies.'.

，Shanton的首席营销官。'难治性痛风是一种严重的疾病，存在相当多未满足的医疗需求，需要开发新的治疗方法。我们很高兴能够利用这一指定带来的快速监管审查机会，加快为那些对传统降尿酸疗法（ULT）无反应或不能耐受标准治疗的痛风患者提供迫切需要的解决方案。'

FDA's decision to grant the Fast Track designation for SAP-001 was based in part on Shanton's recent efficacy and safety outcomes in a Phase

FDA决定授予SAP-001快速通道资格，部分是基于Shanton在近期的二期临床试验中的有效性和安全性结果。

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clinical study in which SAP-001 demonstrated the potential to meaningfully improve on currently available Urate Lowering Therapy for refractory gout patients.

SAP-001在临床研究中展现了对难治性痛风患者有意义地改进现有降尿酸疗法的潜力。

About Fast Track

快速通道简介

Fast Track is an FDA expedited review program which includes more frequent meetings with FDA, early and ongoing feedback from FDA, rolling review of NDA sections as they become available, and the possibility of priority review and accelerated approval. The purpose is to get important new drugs to patients earlier..

快速通道是FDA的一个加快审查程序，包括与FDA更频繁的会议、FDA早期和持续的反馈、在NDA章节可用时进行滚动审查，以及优先审查和加速批准的可能性。其目的是让患者早日获得重要的新药。

About SAP-001

关于 SAP-001

SAP-001 is Shanton's lead investigational compound for once-a-day oral urate-lowering therapy that targets refractory gout. SAP-001's urate lowering properties are based on a unique, First-in-Class mechanism-of-action and the product has shown Best-in-Class efficacy and safety in gout patients with hyperuricemia refractory to Standard of Care Xanthine Oxidase Inhibitor therapy in a recent Phase .

SAP-001是Shanton公司用于治疗顽固性痛风的每日一次口服降尿酸疗法的主要研究化合物。SAP-001的降尿酸特性基于一种独特的一类新机制，并且在最近的一项二期临床研究中，该产品在对标准黄嘌呤氧化酶抑制剂治疗无效的高尿酸血症痛风患者中展现了同类最佳的疗效和安全性。

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study.

学习。

About Shanton Pharma

关于Shanton Pharma

Shanton Pharma is a privately held, clinical-stage biotech founded in 2016 by experienced pharma entrepreneurs, with a research focus on unmet needs associated with hyperuricemia and gout. The company is headquartered in

Shanton Pharma是一家私人控股的临床阶段生物技术公司，由经验丰富的制药企业家于2016年创立，研究重点是与高尿酸血症和痛风相关的未满足需求。公司总部位于