CirCode’s Groundbreaking RNA Heart Therapy Gets FDA Approval

SHANGHAI, 2nd June 2025 – Shanghai-based biotech firm CirCode Biomed on May 30, 2025, the U.S. Food and Drug Administration (FDA) approved its Investigational New Drug (IND) application for HM2002 a unique circular RNA therapy designed to treat ischemic heart disease which is considered as one of the world’s deadliest conditions.

HM2002 launched in September 2024 was the first circular RNA drug ever used on a patient during a small clinical trial in China. In early 2025, because of its promising results, it also received approval from China’s National Medical Products Administration (NMPA).

As of now it is the only circular RNA drug in the world to get clinical trial clearance in both the U.S. and China as a medicine to treat this condition.

Ischemic heart disease is a condition that restricts blood flow to the heart & is a leading cause of death worldwide for decades. Current treatments can only do so much. CirCode’s drug, HM2002, uses circular RNA technology to help the heart heal itself by promoting the growth of new blood vessels.

Scientists thought circRNAs didn’t make proteins. CirCode has found they can make useful proteins in a special way, without start signals. Because circRNAs are very stable they don’t trigger strong immune reactions. They can also work in specific cells, they a better option for making new kinds of mRNA medicine in the future.

Dr. Chenxiang Tang, CEO of CirCode, explained that the drug works just long enough to help heal the heart and then naturally fades away, making it both effective and safe.

Co-founder Dr. Yun Yang says

“CirCode’s advanced RNA platform, supported by AI, allowed them to go from idea to FDA approval in under two years. The company is now developing more circular RNA therapies for a wide range of diseases, including cancer, autoimmune disorders, and infections.”

Circular RNA becomes special because is its stable and has a low chance of causing wrong immune reactions. HM2002 delivers a protein called VEGF, which boosts blood vessel growth and heart function. Early trials have shown good results, with patients improving without serious side effects.

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