Biotechnology company CureGene Pharmaceutical announced on Thursday that it has secured approval from China's National Medical Products Administration for a Clinical Trial Application of its investigational antiplatelet drug, CG-0255 Benzenesulfonate for Injection.

This milestone advances CG-0255's development in China as a potential treatment for coronary artery disease (CAD), a leading cause of cardiovascular mortality globally. CAD accounts for approximately 10 million deaths annually and presents an escalating global health challenge.

CG-0255 is an innovative P2Y12 receptor antagonist developed as a next-generation antiplatelet therapy. The drug's unique metabolic pathway, activated by carboxylesterases instead of liver enzymes, enhances bioavailability and mitigates resistance issues linked to genetic variations in CYP2C19. Unlike existing therapies, CG-0255 features both oral and injectable formulations, achieving peak efficacy within 15 minutes and providing flexibility for acute and emergency care scenarios.

Designed specifically for acute coronary syndrome patients undergoing percutaneous coronary intervention, CG-0255 offers faster onset and greater reliability than current oral treatments. Successful Phase I trials in the United States showcased positive outcomes, solidifying CG-0255's position as a potential Best-in-Class therapeutic option to address unmet needs in cardiovascular care.