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CureGene Receives Clinical Trial Approval in China for the in-house Developed Innovative Drug Evategrel (CG-0255) via Oral Administration

2025-01-10 08:08:09

CureGene Pharmaceutical (“CureGene”) announces that its in-house developed innovative antiplatelet drug evategrel oral gel has been officially approved as an Investigational New Drug (IND) from the Center for Drug Evaluation (CDE) of China. This marks another significant breakthrough following the clinical trial approval of evategrel via intravenous injection by the Center for Drug Evaluation (CDE) of China. It signifies that the clinical development of evategrel in China has fully entered the fast lane, solidifying the foundation for accelerating the drug’s eventual market launch, which is anticipated to offer an improved treatment option for patients with coronary artery disease.

Evategrel is a next-generation revolutionary antiplatelet drug innovatively designed by CureGene, available in both intravenous injection and oral  formulation. It is being developed for clinical treatment options for indications such as acute coronary syndrome, myocardial infarction, stroke, and peripheral artery disease to address unmet medical needs and provide a better antiplatelet treatment option for a wide range of patients with cardio-cerebrovascular diseases. In clinical applications, evategrel is potent with a high safety window, minimal individual variability, and low drug-drug interactions. Given all available data, It has the potential to become the best-in-class P2Y12 receptor antagonist drug, fully addressing clinical demands across various treatment scenarios.

In recent years, cardio-cerebrovascular disease has become one of the leading causes of death worldwide. Among them, coronary artery disease (CAD) is the most common type of cardiovascular disease, with nearly 10 million deaths annually due to acute and chronic coronary syndromes and a patient population reaching hundreds of millions, posing a severe threat to human health and life. To prevent and treat coronary heart disease, antiplatelet drugs play a critical role in clinical management and prevention of cardio-cerebrovascular diseases.

About CureGene 
CureGene was founded in 2018. Based in China, we strive to become a globally focused innovative biopharmaceutical company. We have established innovative platforms based on our core expertise and capability. Currently we are focused on cardio-cerebrovascular and antiviral disease areas. We have developed a number of pipelines of drugs with huge market potential and fully owned global IP rights and are actively moving these projects forward. Guided by our shared mission statement, we have assembled a group of talented and highly accomplished scientists with global pharmaceutical experience from China and overseas. With a comprehensive strategic vision, CureGene has successfully and highly efficiently moved from research stage startup into a clinical stage company, with all pipelines capable of First-in-Class or Best-in-Class potential.

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