Key Milestone Achieved! NDA for Sumecigrel Capsule, an Antiplatelet Innovative Drug by Vcare PharmaTech, Officially Accepted

　　Recently, the NDA for Sumecigrel Capsule (formerly known as Vicagrel), a Class 1 innovative antiplatelet drug developed by Jiangsu Vcare PharmaTech Co.,Ltd. (Vcare PharmaTech), has been officially accepted by the NMPA. The drug has now entered the NDA stage. As a global pioneer in novel antiplatelet agents, Sumecigrel is expected to provide a new and improved treatment option to tens of millions of patients with cardiovascular and cerebrovascular diseases.

　　Sumecigrel Capsule is a new-generation oral P2Y12 receptor antagonist, clinically indicated for the treatment and prevention of atherosclerotic thrombotic events, including Acute Coronary Syndrome (ACS), Ischemic Stroke (IS) and Peripheral Arterial Disease (PAD). Designed to address the boxed warning regarding clopidogrel resistance, this drug innovatively optimizes the metabolic pathway of clopidogrel while retaining the molecular discovery pathway of its active metabolite. It aims to strike a better balance between the therapeutic benefits and bleeding risks of antiplatelet medications.

　　A series of completed clinical studies, including Phase I, Phase II, China-US PK/PD bridging study and Phase III trials, have fully validated the clinical efficacy and safety of Sumecigrel Capsule. It boasts multiple advantages including faster onset of action, lower dosage, more stable therapeutic effect, better control of bleeding risks, reduced metabolic burden and broader application scope. The Phase III clinical studies have now been completed. Sumecigrel demonstrated a trend of superior performance over clopidogrel in reducing the risk of MACCE, with more prominent benefits observed in elderly patients, those complicated with anemia, chronic kidney disease and patients undergoing complex PCI with multiple stents, especially high-risk elderly patients aged 75 and above. The drug also shows favorable safety profiles: its major bleeding risk is comparable to that of clopidogrel and better than data from similar studies, with no new unexpected safety signals identified.

　　Against the backdrop of population aging, clinical challenges such as high bleeding risks and complicated combined medication use among elderly cardiovascular patients have become increasingly prominent. Approximately 30% to 40% of patients struggle to achieve a balance between efficacy and safety, leading to huge unmet clinical needs. Sumecigrel effectively addresses the shortcomings of existing drugs and offers a new therapeutic breakthrough for patients with high-risk and complex conditions.

　　Dr. Gong Yanchun, Co-founder, Chairman and CEO of Vcare PharmaTech, stated: "Sumecigrel Capsule is an achievement from the industry-university-research cooperation between our company and China Pharmaceutical University in the early stage. After years of intensive R&D efforts, the NDA has now been accepted, marking a critical milestone. The field of cardiovascular and cerebrovascular disease treatment is in urgent need of high-quality innovative drugs with balanced efficacy and safety to cater to increasingly personalized antiplatelet treatment scenarios. We look forward to the successful launch of Sumecigrel Capsule to benefit patients with cardiovascular and cerebrovascular diseases worldwide."

　　Following the achievement of this key regulatory milestone in China, Vcare PharmaTech will fully advance the subsequent review and approval procedures for marketing. Meanwhile, the company continues to prepare for marketing applications in the United States, the European Union and other countries and regions. In addition, Vcare PharmaTech has entered into an exclusive regional licensing agreement with Everest Medicines for the Asia-Pacific market of Sumecigrel. The company is accelerating the global strategic layout of this product in an all-round manner.

　　About Sumecigrel

　　Sumecigrel is the world’s first new-generation P2Y12 receptor antagonist developed on the premise of retaining the same active metabolite as clopidogrel and optimizing its metabolic pathway to mitigate clopidogrel’s heavy reliance on CYP2C19 genetic polymorphism. It is indicated for atherosclerotic thrombotic events including Acute Coronary Syndrome (ACS), Ischemic Stroke (IS) and Peripheral Arterial Disease (PAD). It stands as one of Vcare PharmaTech’s representative achievements under the philosophy of "differentiated original design to address unmet clinical needs".

　　The molecular design findings of the drug were published in Journal of Medicinal Chemistry (JMC), a top journal of the American Chemical Society, and highlighted by SciBX under Nature Portfolio, being recognized as "one of the most commercially promising projects in the field of new antiplatelet drugs". Currently, its NDA has been accepted in China, and NDA preparations are underway in the United States, the European Union and other regions. With Best-in-Class potential and broad commercial prospects, Sumecigrel is poised to reshape the antithrombotic drug market, which has seen no innovative drugs targeting the same mechanism launched for more than a decade.

　　About Cardiovascular and Cerebrovascular Diseases

　　Cardiovascular and cerebrovascular diseases refer to a group of functional and organic disorders of the circulatory system, covering diseases related to the heart, blood vessels and neurohumoral systems regulating blood circulation. According to lesion locations and pathological characteristics, they are generally divided into heart diseases, cerebrovascular diseases (such as stroke) and peripheral vascular diseases, forming a multi-level disease spectrum across the whole circulatory system.

　　Atherosclerosis is the major pathological basis of these diseases. Lipid deposition, vascular endothelial injury, inflammatory response and thrombosis may cause vascular stenosis, occlusion or decreased elasticity, further leading to severe conditions such as myocardial ischemia, myocardial infarction, cerebral infarction and cerebral hemorrhage. These diseases are featured by high morbidity, disability, mortality, recurrence rate and numerous complications. Major risk factors include hypertension, hyperlipidemia, hyperglycemia, smoking, excessive drinking, sedentary lifestyle, obesity and advanced age. Mostly developing chronically with acute episodes, they rank as the top chronic diseases threatening the health of middle-aged and elderly people.

　　Cardiovascular and cerebrovascular diseases have become one of the leading causes of death worldwide. The related death toll rose to 17.9 million in 2019, accounting for about 32% of all global deaths in that year, among which around 85% were caused by myocardial infarction (a major type of Acute Coronary Syndrome) and stroke. The latest epidemiological studies show that the death toll from cardiovascular and cerebrovascular diseases further increased to 19.2 million in 2023.