Shanghai, China, January 10, 2025, Circode Biomed today announced that its leading pipeline HM2002 injection has received Investigational New Drug (IND) Approval from the National Medical Products Administration (NMPA) for the treatment of Ischemic Heart Disease (IHD). This is the first circular RNA therapeutics to obtain IND approval from the NMPA. It serves as a concrete demonstration of the company's vision as "Pioneering circular RNA therapeutics" and further strengthens China's leading role in the field of circular RNA drug development.

Focusing on the unmet medical needs: Ischemic Heart Disease

IHD is a severe cardiovascular condition caused by coronary atherosclerosis, leading to insufficient blood supply to the myocardium due to vascular narrowing or blockage, which can result in myocardial ischemia or even necrosis. With the aging global population and changing lifestyles, the incidence of IHD continues to rise, making it one of the leading public health threats worldwide. However, current treatment options have shown limited efficacy in promoting myocardial microcirculation reconstruction and angiogenesis, highlighting the urgent need for more effective and innovative therapies to improve patient outcomes and quality of life.

HM2002 Injection: breakthrough circular RNA therapeutics

HM2002 Injection is a next-generation circular RNA drug developed using CirCode's proprietary innovative technology platform, specifically designed for the treatment of IHD. It transiently yet stably expresses vascular endothelial growth factor (VEGF) in the myocardium for a perfect time frame, sufficient to promote angiogenesis and myocardial perfusion, thereby accelerating the recovery of cardiac function. Compared with traditional linear RNA, circular RNA offers higher stability and lower immunogenicity, demonstrating unique advantages in therapeutic applications.

In August 2024, an investigator initiated clinical trial (IIT) was launched by Professor Zhao Qiang's team from the Department of Cardiac Surgery at Ruijin Hospital, affiliated with Shanghai Jiao Tong University. The trial aims to explore the safety and preliminary efficacy of intramyocardial administration of HM2002 Injection in IHD patients undergoing coronary artery bypass grafting (CABG). By October 2024, all patients had completed the treatment. Preliminary results showed that cardiac functions for all patients improved significantly, with no drug-related adverse events observed. Patient follow-up is currently ongoing. These findings support a good safety profile and potential efficacy for HM2002 Injection and lay a solid foundation for subsequent clinical trials.

The NMPA clinical trial approval for HM2002 Injection marks a critical milestone for CirCode in the field of circular RNA drug development, setting a new benchmark for Chinese biotech companies piloting in new modalities. CirCode will continue to focus on the research and clinical application of circular RNA therapeutics, advance the clinical development of HM2002 Injection, and explore the potential for other indications. The company aims to develop more breakthrough therapies, bringing hope and benefits to patients worldwide.