From Refractory Angina Pectoris to Chronic Coronary Syndrome, CirCode's Circular RNA Therapeutic HM2002 has received clinical approval once again!

2025-12-17

SHANGHAI,China, December 17, 2025, Shanghai CirCode Biomed Co., Ltd. (CirCode) announced today that its proprietary circular RNA (circRNA) therapeutic, HM2002 Injection,has received its third Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA).This approval targets Chronic Coronary Syndrome (CCS) and marks the debut of a transcatheter endocardial injection delivery method. This development completes a strategic dual-tracklayout for HM2002,enabling clinical advancement through both surgical and interventional pathwaysfor ischemic heart disease.

Ischemicheart disease is the leading cause of global mortality and disability, with mostcases presenting as CCS. While current standard treatments such as medication,PCI, or CABG are effective for many, a significant number of patients sufferfrom persistent microvascular dysfunction or lack suitable vascular conditionsfor revascularization.Often described as "no options"patients, they endure low quality of life and face a high risk of cardiovascular events. Addressing the needs of this refractory population by promoting angiogenesis to restore myocardial perfusion is a priority incardiovascular innovation.

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As the world's first circular RNA therapeutic, HM2002 was developed based on CirCode's proprietary technology platform and features high stability and low immunogenicity. It promotes therapeutic angiogenesis in ischemic myocardialregions through classic VEGF pathway, thereby improving microcirculation. Distinctfrom previous epicardial injections used in open surgery, this new approval validatesan interventional approach. Using an innovative steerable catheter, the drug is delivered quantitatively and precisely to viable but ischemic myocardial segments without the need for a thoracotomy. This pivot successfully extends theutility of HM2002 from the operating room to the cath lab, greatly improvingpatient access.

HM2002 now boasts a comprehensive delivery platform capable of both epicardial andendocardial injection. This capability ensures coverage for a full spectrum of patientneeds, from complex cases requiring surgery to chronic conditions best managedvia intervention, offering tailored solutions across different stages of thedisease. CirCode continues to drive the frontier of circular RNA therapeutics, dedicated to delivering novel solutions to patients with significant unmet clinical needs.

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