SHANGHAI,Dec. 12,2024 -- 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 antagonistdeveloped 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."

About CG-0255

CG-0255,a novel antiplatelet therapy,stands out as the world's first thiol prodrug,differing significantly from existing antiplatelet medications. This innovative therapy is metabolized by carboxylesterases,which are ubiquitously expressed enzymes,thus circumventing the reliance on liver enzyme system for activation. This distinctive metabolic pathway addresses prevalent clinical challenges,including drug resistance,low bioavailability,and the risk of adverse drug interactions.

CG-0255's rapid onset of action,achieving peak efficacy within less than 15 minutes,positions it as an optimal treatment for urgent clinical scenarios. It is the only antiplatelet drug available in both injectable and oral formulations,offering healthcare professionals a flexible and dependable method for preventing blood clots across diverse clinical environments. With its swift and robust efficacy,CG-0255 is poised to bridge a critical gap in the current treatment landscape,enhancing patient outcomes with more effective and accessible therapeutic options.

For comprehensive information on CG-0255 and the latest updates,please visit CureGene's official website at https://www.curegene.com.cn/en

About CureGene

Established in 2018,CureGene is China-based,globally oriented biotech company with research and development offices in both China and the United States. The company has developed innovative platforms rooted in core expertise and capabilities,focusing on cardio-cerebrovascular and antiviral disease areas. CureGene has advanced pipelines of novel drugs with significant market potential and fully owned global intellectual property rights. The company,guided by its mission,has attracted a team of distinguished scientists with extensive global pharmaceutical experience. Through a strategic vision,CureGene has transitioned successfully from a research-stage startup into a clinical-stage biotech company,with all pipelines demonstrating First-in-Class or Best-in-Class potential.

For more information,please contact: info@curegene.com.cn

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