Jiangsu Vcare Files NDA for Vicagrel Capsules with US FDA
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. This filing marks a significant milestone as Jiangsu Vcare's first NDA submission from its innovative drug pipeline.
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. 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".
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.
*About Vicagrel*
Vicagrel, 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 Vcare*
Founded in 2010, Jiangsu Vcare PharmaTech Co., Ltd. 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, PhD
AmberSight LLC
Rockville, MD 20850
Cell: 01-301-518-5028
Yongheng.zhang@amber-sight.com
*Disclaimer:*
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