Shanghai CirCode Biomed Co Ltd, a Chinese biotech company specialising in circular RNA therapies, announced on Friday that its leading pipeline HM2002 received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for ischemic heart disease on 30 May 2025.

With an investigator-initiated trial (IIT) commenced in September 2024, HM2002 is claimed to be 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 10 January 2025.

HM2002 is 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, CirCode said.

According to the company, 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.