By Fineline Cube 
China-based Shanghai CirCode Biomed Co. Ltd., a specialist in circular RNA therapies, announced that its HM2002 drug for ischemic heart disease has received approval from the U.S. Food and Drug Administration (FDA) to proceed with Investigational New Drug (IND) clinical trials.
HM2002 Mechanism and Advantages
HM2002 is a next-generation circular RNA (circRNA) drug developed using CirCode Bio’s proprietary technology platform. It works by stably expressing vascular endothelial growth factor (VEGF) in myocardial tissue, promoting angiogenesis and myocardial perfusion to accelerate cardiac function recovery. Compared to traditional linear RNA, HM2002’s circRNA technology offers greater stability and lower immunogenicity.
Clinical Progress
Previously, HM2002 demonstrated favorable safety and preliminary efficacy in investigator-initiated trials (IITs). In January 2025, the drug also received clinical trial approval from China’s National Medical Products Administration (NMPA), making it the world’s first circRNA-based therapeutic to enter clinical stages with regulatory clearance from both the U.S. and China.-Fineline Info & Tech