#China #Shanghai #circular RNA #CirCode Biomed #HM2002

CirCode Biomed Secures Groundbreaking FDA Approval for HM2002

Shanghai CirCode Biomed Co. Ltd., a frontrunner in the emerging field of circular RNA therapies, has recently achieved a significant milestone with the FDA granting Investigational New Drug (IND) clearance for its innovative treatment, HM2002. This extraordinary drug is designed to address ischemic heart disease, a condition that has plagued the global population for decades due to its increasing prevalence as an aging population grows. The announcement, made on May 30, 2025, sets a new benchmark as HM2002 becomes the first circular RNA drug authorized for patient treatment worldwide.

A New Era in Cardiovascular Treatment

The journey of HM2002 began with its administration to patients in a pioneering investigator-initiated trial (IIT) back in September 2024. Following this, it received additional regulatory approval from the National Medical Products Administration (NMPA) of China on January 10, 2025. This dual-indication status, approved both in China and the United States, underlines the revolutionary nature of HM2002 in the therapeutic landscape.

Ischemic heart disease, responsible for a substantial number of deaths globally, presents a critical unmet medical need. Current treatments prove ineffective at promoting myocardial microcirculation and enhancing the vascular network—problems contributing to poor patient outcomes. Therein lies the promise of HM2002, which utilizes the unique properties of circular RNAs to safely and sustainably overexpress Vascular Endothelial Growth Factor (VEGF) in patient myocardium. This not only facilitates angiogenesis—the creation of new blood vessels—but also improves myocardial perfusion and cardiac recovery.

Unprecedented Safety and Efficacy Results

Preclinical research has already demonstrated promising results regarding the safety and efficacy of HM2002. In the initial human trial conducted at Ruijin Hospital, participants exhibited significant improvements in cardiac function, all while reporting no adverse side effects related to the drug. These results are a testament to the concept that effective VEGF expression can yield substantial health benefits post-ischemia.

Dr. Chenxiang Tang, CEO of CirCode, emphasized the potential of HM2002 by stating, “To promote angiogenesis and relieve ischemia through VEGF overexpression is a well-tested solution. However, achieving a controllable and persistent expression of VEGF in vivo has been a hurdle. HM2002’s single-dose administration allows for optimal VEGF expression without prolonged risks.”

With the clearances from both major regulatory bodies, CirCode’s innovative approach has gained recognition in the circular RNA therapeutic industry for its competitiveness and scientific rigor.

CirCode’s Future Prospects

In tandem with these developments, Dr. Yun Yang, co-founder and chief technology officer, highlighted the robust platform that supports the rapid development of HM2002. He noted that through the application of advanced AI tools, CirCode bridged the gap from concept to IND approval in less than two years. The company is now poised to expand its pipeline, eyeing applications in therapeutic proteins, vaccines, and in-vivo CAR-T treatments across several therapeutic domains including not only cardiovascular diseases but also infectious and autoimmune disorders, as well as oncology.

The advancements in HM2002 encapsulate the promises vitally needed to meet unmet medical demands, especially in light of the rising rates of heart diseases globally. CirCode is not only transforming the direct therapeutic strategies but also reshaping the future landscape of disease management.

Conclusion

With rigorous research driving their innovations and a commitment to addressing significant health concerns, CirCode Biomed stands at the forefront of biotechnological advances. As they continue to navigate this evolving field, their focus remains on providing new therapeutic options that can translate scientific breakthroughs into real-world applications for patients, invigorating hope in cardiac care and beyond.

For further information, visit CirCode or contact via email at info@circodebio.com for potential collaborations and business inquiries.