CirCode Biomed gets FDA nod for world's first circular RNA drug HM2002

Shanghai CirCode Biomed Co. Ltd. (CirCode), a clinical-stage biotechnology company, announced that its leading pipeline candidate, HM2002, received Investigational New Drug (IND) clearance from the US FDA for ischemic heart disease on May 30, 2025.

Global First: Circular RNA Drug Used in Humans

HM2002 became the world’s first circular RNA drug ever used in patients when the first administration occurred during an investigator-initiated trial (IIT) in September 2024. It was also approved by China’s National Medical Products Administration (NMPA) on January 10, 2025. This makes HM2002 the first circular RNA therapy with IND clearance in both China and the United States, and the only such therapy globally approved for clinical studies in ischemic heart disease.

Unmet Needs in Ischemic Heart Disease

Ischemic heart disease continues to be the leading cause of death worldwide, especially with a rising elderly population. Existing treatments have limited efficacy in improving myocardial microcirculation and angiogenesis, often resulting in suboptimal long-term outcomes.

How HM2002 Works?

HM2002 uses circular RNA’s properties of enhanced stability and low immunogenicity to deliver vascular endothelial growth factor (VEGF) directly into the myocardium. This promotes angiogenesis, enhances myocardial perfusion, and facilitates cardiac recovery.

Clinical Progress

In the first-in-human IIT at Ruijin Hospital, all participants experienced notable cardiac function improvement without any drug-related adverse events, demonstrating strong initial safety and efficacy.

Statements from CirCode Leadership

Dr. Chenxiang Tang, CEO

“To promote angiogenesis and relieve ischemia through VEGF overexpression is a well-tested solution, but achieving persistent and controllable expression of VEGF in vivo is challenging.

We find an excellent match between this therapeutic need and the properties of circular RNA. A single dose of HM2002 expresses VEGF just long enough for angiogenesis without posing long-term safety risks.”

He emphasized that IND approvals from both NMPA and FDA validate CirCode’s innovation and leadership in circular RNA therapy.

Dr. Yun Yang, Co-founder and CTO

“CirCode’s proprietary circular RNA platform, backed by AI tools, enabled us to move from concept to IND approval in less than two years.

We’ve built a diverse pipeline covering therapeutic proteins, vaccines, in vivo CAR-T, and more — across diseases like cardiovascular, infectious, autoimmune, and oncology.”

About CirCode

CirCode is a clinical-stage biotech company specializing in circular RNA therapeutics. With a proprietary, fully integrated platform protected by a global patent network, the company is developing a range of innovative treatments aimed at improving outcomes across multiple disease areas.

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