NANJING, China, Jan. 4, 2024 /PRNewswire/ -- On December 28, 2023, Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare) successfully submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Vicagrel capsule, which is indicated to treat a range of thrombotic cardiovascular and cerebrovascular diseases, including acute coronary syndrome, ischaemic stroke, and peripheral arterial disease.

南京，中国，2024年1月4日/PRNewswire/--2023年12月28日，江苏威卡雷制药科技有限公司（江苏威卡雷）成功向美国食品和药物管理局（FDA）提交了维卡格雷胶囊的新药申请（NDA），该胶囊用于治疗一系列血栓性心脑血管疾病，包括急性冠状动脉综合征，缺血性中风，和外周动脉疾病。

This filing marks a significant milestone as Jiangsu Vcare's first NDA submission from its innovative drug pipeline. .

这一申请标志着江苏Vcare从其创新药物渠道首次提交NDA，这是一个重要的里程碑。。

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This NDA filing builds on continuous dialogues with the FDA and is supported by robust nonclinical data and clinical studies conducted in both China and US. Vicagrel, a novel oral P2Y12 receptor antagonist, represents Jiangsu Vcare's commitment to addressing unmet clinical needs with innovative approaches.

这份NDA文件建立在与FDA持续对话的基础上，并得到了中国和美国进行的强有力的非临床数据和临床研究的支持。Vicagrel是一种新型口服P2Y12受体拮抗剂，代表了江苏Vcare致力于以创新方法解决未满足的临床需求。

Its mechanism of action involves the same active metabolite as clopidogrel that effectively inhibits platelet activation and aggregation, while addressing the issue of 'clopidogrel resistance'..

其作用机制涉及与氯吡格雷相同的活性代谢物，可有效抑制血小板活化和聚集，同时解决“氯吡格雷抵抗”的问题。。

This NDA filing reflects more than ten years of persistent innovation and dedication by Jiangsu Vcare. Once approved, Vicagrel promises to offer a new treatment option for the estimated 27.6 million US patients with coronary heart disease and stroke.

这份保密协议文件反映了江苏创投十多年来的持续创新和奉献精神。一旦获得批准，维卡格雷承诺将为美国约2760万冠心病和中风患者提供新的治疗选择。

About VicagrelVicagrel, a product of the collaboration between Jiangsu Vcare and China Pharmaceutical University, is under the exclusive ownership of Jiangsu Vcare. The early R&D breakthroughs were published in prestigious journals including the American Chemical Society's Journal of Medicinal Chemistry (2012) and Nature-affiliated SciBX (2012).Vicagrel stands out among antithrombotic treatments, offering key advantages in both pharmacogenomics and pharmacokinetics over clopidogrel due to its unique structural design. Recent Pharmacokinetics/Pharmacodynamics data positions vicagrel as a superior version of clopidogrel, eliminating the Black Box Warning associated with clopidogrel use and reducing drug interaction concerns, all achievable at a much lower daily dose.About Jiangsu VcareFounded in 2010, Jiangsu Vcare PharmaTech Co., Ltd.

关于VicaGravelVicagrel，是江苏Vcare与中国药科大学合作的产物，由江苏Vcare独家所有。早期的研发突破发表在著名期刊上，包括美国化学学会的《药物化学杂志》（2012）和自然附属SciBX（2012）。维卡格雷在抗血栓治疗中脱颖而出，由于其独特的结构设计，在药物基因组学和药代动力学方面均优于氯吡格雷。最近的药代动力学/药效学数据将维卡格雷定位为氯吡格雷的高级版本，消除了与氯吡格雷使用相关的黑匣子警告，并减少了药物相互作用的担忧，所有这些都可以在较低的日剂量下实现。关于江苏威凯成立于2010年的江苏威凯制药科技有限公司。

is a high-tech enterprise specializing in innovative drug development, with over 700 employees, mostly technical staff, and operates a major R&D center in Nanjing Biomedical Valley. The company's research portfolio encompasses a range of clinical assets and preclinical projects, targeting key areas such as cardiovascular and cerebrovascular diseases, oncology, and autoimmune disorders.The company features a start-of-art drug discovery platform and partners with China Pharmaceutical University for postdoctoral and graduate research in Nanjing. Having raised nearly 1 billion yuan through three financing rounds between 2021 and 2023, the company aims to leverage its decade-long experience to develop innovative drugs addressing unmet medical needs.Jiangsu Vcare is seeking worldwide commercialization partner(s) for Vicagrel, and welcomes interested parties to contact us.Contact person: Eric Zhang, PhDAmberSight LLCRockville, MD 20850Cell: 01-301.

是一家专门从事创新药物开发的高科技企业，拥有700多名员工，其中大部分是技术人员，并在南京生物医学谷运营着一个主要的研发中心。该公司的研究组合包括一系列临床资产和临床前项目，针对心脑血管疾病，肿瘤学和自身免疫性疾病等关键领域。该公司拥有一个启动art药物发现平台，并与南京中国药科大学合作进行博士后和研究生研究。该公司在2021年至2023年间通过三轮融资筹集了近10亿元资金，旨在利用其十年的经验开发创新药物，以满足未满足的医疗需求。江苏Vcare正在为Vicagrel寻求全球商业化合作伙伴，欢迎有兴趣的各方与我们联系。联系人：Eric Zhang，PhDAmberSight LLCRockville，MD 20850Cell:01-301。