By Fineline Cube 
Shanghai CirCode Biomed Co. Ltd. announced that its self‑developed circular RNA (circRNA) therapeutic HM2002 has received clinical‑trial authorization from the National Medical Products Administration (NMPA) for the treatment of refractory angina. The approval follows earlier clearances in the United States (June 2025) and China (January 2025) for broader ischemic‑heart‑disease indications.
What Is HM2002?
| Feature | Detail |
|---|---|
| Molecule Type | Next‑generation circRNA drug |
| Target | Stable myocardial expression of Vascular Endothelial Growth Factor (VEGF) |
| Mechanism | Promotes angiogenesis and improves myocardial perfusion, accelerating cardiac‑function recovery |
| Advantages vs. Linear RNA | • Higher molecular stability • Lower immunogenicity • Sustained protein expression in the heart |
| Indication | Refractory angina – chronic chest pain unresponsive to conventional therapy |
Regulatory Milestones
| Date | Jurisdiction | Milestone |
|---|---|---|
| Jan 2025 | China (NMPA) | IND clearance for ischemic heart disease |
| Jun 2025 | United States (FDA) | IND clearance for ischemic heart disease |
| Nov 3 2025 | China (NMPA) | Phase I/II trial approval for refractory angina |
The NMPA decision enables CirCode to initiate a first‑in‑human, multicenter trial enrolling up to 120 patients across major Chinese cardiac centers. The study will evaluate safety, dose‑ranging, and preliminary efficacy over a 12‑month follow‑up period.
Market Context
- Unmet Need: Refractory angina affects an estimated 5–7 million patients worldwide, with limited therapeutic options beyond revascularization.
- Size of Opportunity: Bloomberg estimates the global refractory‑angina market could exceed USD 3.2 billion by 2030.
- Competitive Edge: HM2002’s circRNA platform offers a single‑dose, long‑acting VEGF expression strategy, potentially reducing the need for repeated invasive procedures.
Strategic Outlook
- Phase I/II Timeline: First patient dosing expected Q1 2026; interim data read‑out slated for Q4 2026.
- Future Indications: CirCode plans to leverage the same circRNA‑VEGF construct for peripheral‑artery disease and heart‑failure programs.
- Funding: The company disclosed a USD 120 million cash runway, supplemented by a Strategic Collaboration with a leading Chinese biotech that will co‑fund the refractory‑angina trial.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding HM2002’s development timeline, regulatory expectations, and market potential. Actual results may differ materially due to risks including clinical outcomes, regulatory approvals, and competitive dynamics.-Fineline Info & Tech