CureGene Pharmaceutical announced that the first participant has been successfully dosed in the US pivotal clinical trial of Evategrel (CG-0255), its proprietary new-generation best-in-class antiplatelet agent. This milestone marks a critical step toward the New Drug Application (NDA) submission in the US and brings new hope to millions of patients with cardiovascular and cerebrovascular diseases worldwide.

Evategrel (CG-0255) is the leading asset developed from CureGene's proprietary A-proX Prodrug Platform. It is the world's first P2Y12 receptor inhibitor available in both intravenous and oral formulations. With an innovative thiol-hydrolysing prodrug design, Evategrel is metabolised and activated by hydrolases—enzymes widely present in human tissues—completely bypassing the CYP450 enzyme pathway.

This unique mechanism fundamentally addresses long-standing clinical challenges, including clopidogrel resistance (affecting nearly 60 percent of East Asian patients), slow onset of action, high inter-patient variability, and significant drug-drug interaction risks, representing a paradigm shift in antiplatelet therapy.

The ongoing US registrational trial is designed to comprehensively evaluate the efficacy and safety of Evategrel (injection and oral capsule) versus clopidogrel in subjects with targeted indications including Acute Coronary Syndrome (ACS), recent myocardial infarction, ischemic stroke, and peripheral arterial disease. The results will provide core clinical evidence for global regulatory submissions.

Dr. Gongxin He, Founder and CEO, CureGene Pharmaceutical, said, "The first participant dosing in our US pivotal trial of Evategrel is a major milestone in CureGene's journey of global innovative drug R&D. Cardiovascular and cerebrovascular diseases remain the leading cause of mortality and disability worldwide, and current treatment options have substantial unmet needs. With its novel mechanism of action and dual-formulation advantages, Evategrel is expected to reshape the global landscape of antiplatelet therapy."

Beyond the US, Evategrel is also advancing efficiently in China. The company has received clinical trial approval from the Center for Drug Evaluation (CDE) of China, and a phase 2 trial for ischemic stroke is set to launch soon. The synchronised development in both China and the US supports future simultaneous NDA filings and provides strong support for seizing the initiative of global market access.

The key clinical progress of Evategrel is not only a milestone for CureGene but also holds the potential to bring faster, safer, and more precise antiplatelet therapy options to hundreds of millions of patients with cardiovascular and cerebrovascular diseases worldwide. We look forward to this innovative medicine, originally developed in China, reaching global patients as soon as possible and truly fulfilling the mission of "bringing benefits to patients."