SHANGHAI, June 20, 2026 /PRNewswire/ — CureGene Pharmaceutical today announced that the first participant has been successfully dosed in the U.S. 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 United States 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-hydrolyzing prodrug design, Evategrel is metabolized 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% 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 U.S. 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.
Promising data from previous clinical studies have demonstrated three key advantages of Evategrel:
1. Ultra-Rapid Onset of Action, Ideal for Emergency Setting
Peak antiplatelet effect reached <15 minutes for IV and <30 minutes for oral, rapidly inhibiting the formation of arterial thrombosis. It fills a critical gap in acute ischemic stroke management where rapid action is essential.
2. High Potency at Low Dose with Superior Efficacy
The clinical dose of Evategrel is only 1% of clopidogrel’s standard dose, which significantly reduces medication burden and potential safety risks.
3. Favorable Safety Profile and Broad Applicability
Clinical data confirms a well-tolerated safety profile with low bleeding risk and minimal drug-drug interactions. It is highly suitable for elderly patients with multiple underlying comorbidities on combined medication regimens, offering outstanding clinical flexibility and convenience.
Executive Commentary: Dr. Gongxin He, Founder and CEO of CureGene Pharmaceutical
“The first participant dosing in our U.S. 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 U.S., 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 II trial for ischemic stroke is set to launch soon. The synchronized development in both China and the U.S. 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.”
About Evategrel (CG-0255)
Evategrel (CG-0255) is a new-generation self-developed antiplatelet asset by CureGene. As the world’s first P2Y12 receptor inhibitor designed via thiol-hydrolysis prodrug technology with both intravenous and oral formulations, its innovative molecular structure enables one-step hydrolysis to directly release active metabolites.
It fundamentally overcomes clopidogrel resistance caused by CYP2C19 metabolic enzyme deficiency, featuring rapid onset, potent antiplatelet activity, low inter-individual variability, and minimal drug interaction risks. The intravenous formulation fills a critical clinical gap in emergency settings such as stroke and myocardial infarction, positioning CG-0255 as a potential best-in-class antiplatelet therapy covering full-spectrum clinical scenarios. Currently in late-stage clinical development, the product is expected to gain regulatory approval as early as 2027.
About CureGene Pharmaceutical
Founded in 2018, CureGene Pharmaceutical possesses proprietary core platform technologies and independent high-efficiency innovation capabilities. The Company primarily focuses on therapeutic areas including cardiovascular & cerebrovascular diseases and antiviral therapies, striving to become a China-rooted, globally oriented innovative pharmaceutical enterprise.
Leveraging its proprietary platforms, CureGene has built a robust pipeline of innovative assets with broad market value and global independent intellectual property rights, with multiple candidates actively progressing through clinical development. Driven by its corporate mission and vision, the Company has assembled a high-caliber team of globally minded scientists and overseas returnees. Under its integrated strategic layout, CureGene achieves rapid and efficient R&D translation, with all pipeline candidates demonstrating strong potential to become first-in-class or best-in-class therapies.
SOURCE CureGene