CureGene Pharmaceutical ("CureGene"), a biotechnology company dedicated to innovative treatments for critical unmet medical needs in cardio-cerebrovascular and antiviral disease, proudly announces the approval of its Clinical Trial Application by the China's National Medical Products Administration (NMPA) for the investigational antiplatelet drug Benzenesulfonate CG-0255 for Injection, classified as section 1.1 novel drug, after its announcement of a profound clinical progress in the United States earlier this year. This remarkable milestone marks the progression of CG-0255's development in China, moving it closer to providing a new therapeutic option for patients suffering from coronary artery disease (CAD), a prevalent global health issue.

Coronary artery disease is a leading cause of cardiovascular-related mortality worldwide, accounting for nearly 10 million deaths annually. As the incidence of CAD continues to rise, it poses a formidable challenge to global health. Antiplatelet medications play a crucial role in preventing blood clot formation, thereby mitigating the risk of heart attacks and strokes, which are frequent complications associated with CAD.

CG-0255, an advanced P2Y12 receptor antagonist developed by CureGene as part of its next-generation antiplatelet therapy, features a unique metabolic pathway with the potential to become a Best-in-Class treatment. This drug has successfully completed Phase I clinical trials in the United States for both intravenous and oral formulations, with positive outcomes presented at major cardiology conferences, including the 2023 American Heart Association (AHA) and the 2024 European Society of Cardiology (ESC) annual meetings.

The newly approved CTA of CG-0255 for Injection is specifically designed for patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI), such as angioplasty. The injectable formulation offers several advantages over current oral antiplatelet therapies, including a faster onset of action, enhanced efficacy, and increased bioavailability. Additionally, CG-0255's distinctive metabolic pathway overcomes key challenges in current existing drug therapies, including individual genetic variations in the cytochrome P450 (CYP) 2C19 enzyme system, which can impact the effectiveness of conventional antiplatelet medications. This positions CG-0255 as an ideal choice for emergency care and for patients who may exhibit resistance to other treatments.

Dr. Gongxin He, Founder and CEO of CureGene, stated: "This clinical approval represents a remarkable milestone for CG-0255 and validates the dedication and hard work of our team. We are eager to progress CG-0255 through its clinical development stages in China, and look forward to collaborating with global partners to bring innovative treatments to patients with cardiovascular diseases."