Shanghai China, January 29,2026, Shanghai CirCode Biomed Co., Ltd. (CirCode), a leading clinical stage circular RNA biopharmaceutical company, announced that its leading pipeline, HM2002, the world's first clinicalstage circular RNA drug, has been granted Fast Track Designation by the U.S.Food and Drug Administration (FDA). This milestone builds on HM2002’s priorclinical approvals，three from China's National Medical Products Administration(NMPA) and one from the FDA, marking a major acceleration in its global R&Dand clinical translation efforts.

The FDA’s Fast TrackDesignation is designed to speed up the development and review of medicationsfor serious diseases where unmet medical needs exist. With this designation,CirCode will have the opportunity for more frequent engagement with the FDA,access to rolling review capabilities, and the ability to apply for priorityreview or accelerated approval once it meets applicable criteria. Thisrecognition will effectively support HM2002, which is currently in Phase Iclinical trials, in accelerating the validation of key clinical endpoints andthe confirmation of therapeutic strategies for target populations,significantly reducing the drug’s R&D and approval timeline.

HM2002 is being developed forthe treatment of ischemic heart disease, the leading cause of death anddisability worldwide. Most patients present in chronic coronary syndrome, and asignificant unmet medical need persists due to the lack of precise andeffective therapeutic options in current clinical practice.

As a pioneer in the circularRNA field, CirCode developed HM2002 based onits proprietary coretechnology platform. Benefiting from its covalently closed-loop structure, thedrug offers key advantages: high stability and low immunogenicity. HM2002 canpromote therapeutic angiogenesis in ischemic myocardial regions throughspecific molecular mechanisms, therefore fundamentally improving myocardialmicrocirculation function.

Meanwhile, CirCode hassuccessfully established a versatile dual-delivery platform encompassing both epicardialand endocardial injection routes. This enables HM2002 to address a broadspectrum of clinical needs, from surgical interventions to minimally invasiveinterventional procedures, providing individualized and differentiatedtreatment plans for patients at different stages and with different conditions,demonstrating broad clinical application prospects.