Shanghai,China, October 24, 2025, Shanghai CirCode Biomed Co., Ltd. announced that its innovativecircular RNA therapeutic, HM2003 injection（Hereinafterreferred to as HM2003）, has been grantedOrphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA)for the treatment of Thromboangiitis Obliterans (TAO).

TheFDA's Orphan Drug Designation is intended to encourage the development ofinnovative therapies for rare diseases, defined as those affecting fewer than200,000 people in the United States. With this designation, HM2003 will qualifyfor a range of incentives, including a 25% tax credit on clinical trial costs,exemption from Biologics License Application (BLA) fees—potentially waiving upto $3 million in fees—and 7 years of market exclusivity in the U.S. uponapproval.

ThromboangiitisObliterans (TAO), also known as Buerger's disease, is a segmental, non-atherosclerotic,inflammatory vascular disease primarily affecting small and medium-sizedarteries and veins in the limbs. Its pathological featureis characterized by intense inflammatory thrombus formation, leading tovascular lumen occlusion, and subsequent distal limb ischemia. TAO is asignificant cause of Chronic Limb-Threatening Ischemia (CLTI), which can resultinsevere limb pain, ulceration, and gangrene, posing a very high risk of amputation.Given that there are currently no fundamental therapeutic options globallytargeting the pathological mechanism of TAO, there is a high medical unmet needin this field.

HM2003 aims toprovide an innovative potential therapeutic option for patients with CLTI, andTAO represents one of the therapeutic's key target indications. This OrphanDrug Designation represents a critical milestone in the global clinicaldevelopment of HM2003 and lays a solid foundation for addressing thelong-standing unmet medical needs in this field. The accompanying incentivesare expected to accelerate the therapeutic’s development and regulatory approval process, ultimately benefiting TAOpatients worldwide.