April 2026 – Shanghai CirCode Biomed Co., Ltd. (CirCode)today announced that its core circular RNA therapeutic candidate, HM2003Injection, has been granted Fast Track Designation (FTD) by the U.S. Food andDrug Administration (FDA), further accelerating its global clinicaldevelopment.
HM2003 has now secured four key U.S. regulatorydesignations: FDA IND clearance, Rare Pediatric Disease Designation (RPDD), OrphanDrug Designation (ODD) for thromboangiitis obliterans (TAO), and Fast TrackDesignation. This robust regulatory package significantly expedites clinicalprogression and potential approval.
The Fast Track program enables benefits includingrolling review, eligibility for priority review, and frequent FDA interactions,supporting accelerated development of HM2003 for the treatment of critical limbischemia, an area with high unmet medical need.
Built on CirCode’sproprietary circular RNA platform, HM2003 demonstrates superior stability andlow immunogenicity. It promotes collateral vessel formation and improves limbperfusion, offering an innovative treatment approach for ischemic vasculardiseases.