On June 26, the CDE official website showed that the New Drug Application (NDA) for Vcare PharmaTech’s Category 1 antithrombotic novel drug Vicagrel Capsules has been formally accepted.
Vicagrel is an industry-academia collaboration project between Vcare PharmaTech and China Pharmaceutical University. It is a next-generation oral P2Y12 receptor antagonist developed for the treatment and prevention of atherothrombotic events, including acute coronary syndrome (ACS), ischemic stroke (IS), and peripheral arterial disease (PAD). According to the company’s press release, Vicagrel has been selected for four consecutive national-level major science and technology projects. It is a novel antiplatelet agent with faster onset, lower dosage, more stable efficacy, more controllable bleeding risk, lower metabolic burden, and broader application scenarios. It has the potential to become a best-in-class drug in its class. In the future, Vicagrel is expected to more comprehensively meet the growing demand for individualized antithrombotic therapy, disrupting the antithrombotic market landscape, which has seen no new drug targeting the same mechanism in over a decade, and becoming a blockbuster product in the antithrombotic market.
According to the Insight database, the drug first filed for clinical trial in May 2014, officially received clinical trial approval in March of the following year, and initiated its first clinical trial two months later. In January 2024, Vcare PharmaTech announced that it had submitted a New Drug Application to the U.S. FDA for Vicagrel Capsules for the treatment of thrombotic cardiovascular and cerebrovascular diseases, including acute coronary syndrome, ischemic stroke, and confirmed peripheral arterial disease. The submission made today is the first NDA filing for the drug in China.
In terms of licensing partnerships, Everest Medicines and Vcare PharmaTech entered into an exclusive licensing agreement in June 2026, under which Everest Medicines obtained exclusive rights for clinical development, registration, and commercialization of Vicagrel (Sumecigrel, formerly known as Vicagrel) in multiple Asia-Pacific countries and regions, including Southeast Asia, South Korea, Australia, Hong Kong (China), Macau (China), and Taiwan (China).
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