CirCode Biomed Announces FDA Clearance for IND Application of HM2002, the world's first circular RNA drug being administrated in patients

SHANGHAI, May 31, 2025 /PRNewswire/ -- Shanghai CirCode Biomed Co. Ltd. (CirCode), an innovative biotech company pioneering circular RNA therapies, recently announced that its leading pipeline HM2002 received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for ischemic heart disease on May 30, 2025.

With the first patient administrated on September of 2024 in an investigator initiated trial (IIT), HM2002 is the world's first circular RNA drug ever being used in patients. It received IND approval from the National Medical Products Administration (NMPA) of China on January 10th, 2025. HM2002 is currently the first circular RNA therapy to receive IND clearance in both China and the United States, and is also the only circular RNA drug globally approved for clinical study on patients with ischemic heart disease.

With the global aging population, ischemic heart disease shows a steadily rising incidence, and has been the leading cause of death globally for the past decades. The current standard of care shows limited effects in promoting myocardial microcirculation reconstruction and angiogenesis, leading to suboptimal efficacy and limited benefit in 10-year survival. There is an urgent unmet medical need for next generation therapies to improve patients' prognosis and quality of life.

With the advantages of improved stability and low immunogenicity from circular RNAs, HM2002 can safely and continuously express vascular endothelial growth factor (VEGF) in the myocardium, which promotes angiogenesis, improves myocardial perfusion, and facilitates cardiac function recovery. It has demonstrated excellent safety and efficacy in the preclinical studies. In the first-in-human IIT at Ruijin Hospital initiated last year, all subjects showed significant cardiac function improvement without any drug-related adverse events.

"To promote angiogenesis and relief ischemia through VEGF overexpression is a well-tested solution, but there is a tremendous challenge to achieve an efficient, persistent, and controllable expression of VEGF in vivo. We find an excellent match between the need and the properties of circular RNA. A single dose of HM2002 can express VEGF protein for a perfect time window in vivo: long enough for efficient angiogenesis, short enough for any safety concerns. Once the microcirculation reformed, it brings long-lasting benefits to patients without the presence of HM2002 or VEGF protein," said Dr. Chenxiang Tang, CEO of CirCode. "The IND clearances from both NMPA and FDA for HM2002 is a strong recognition for our innovation and competitiveness in the circular RNA therapeutic industry.

Dr. Yun Yang, co-founder, chairman, and chief technology officer of CirCode, stated that, "CirCode's robust, proprietary circular RNA platform laid the foundation for the fast IND approval of HM2002. With the help of our AI tools, we were able to leap from a concept to IND approval of HM2002 in less than 2 years. We now have built a strong pipeline portfolio in various fields such as therapeutic proteins, vaccines, and in vivo CAR-T, covering multiple therapeutic areas such as cardiovascular diseases, infectious diseases, autoimmune diseases, and oncology. These pipelines have showed a favorable risk benefit profile with great efficacy and safety data in preclinical settings, many of which will enter the clinical stage within the next year. We are so excited to keep pushing the frontier of circular RNA therapy forward and providing more innovative therapies for patients."

About CirCode

CirCode is a clinical-stage biotechnology company specializing in circular RNA therapeutics. Leveraging strong science and deep know-how, the company has built a fully integrated and proprietary platform, protected by a comprehensive global patent network, paving the way for the development of circular RNA therapeutics. Focusing on unmet medical needs, CirCode has built a robust pipeline targeting vaccines, cardiovascular diseases, autoimmune disorders, and oncology. CirCode is backed by top-tier investors and has received strong recognitions from leading pharmaceutical companies. Circode is committed to promoting the transformation of scientific and technological achievements and realizing the benefit of science and technology for mankind.

More information please visit www.circodebio.com，

Or contact info@circodebio.com for business cooperation.