6 days ago
CirCode Biomed gains clearance from FDA for RNA drug HM2002
CirCode Biomed's circular RNA drug HM2002 has received investigational new drug (IND) clearance from the US Food and Drug Administration (FDA) for the treatment of ischaemic heart disease.
HM2002 has also been approved by China's National Medical Products Administration (NMPA) in January 2025.
This global endorsement allows CirCode to conduct clinical studies in patients suffering from ischaemic heart disease.
HM2002 offers several advantages due to its composition of circular RNAs, which provide improved stability and low immunogenicity.
The drug is designed to safely and continuously express vascular endothelial growth factor (VEGF) within the myocardium. This mechanism promotes angiogenesis, enhances myocardial perfusion and aids in recovering cardiac function.
CirCode CEO Dr Chenxiang Tang stated: 'To promote angiogenesis and relieve ischaemia through VEGF overexpression is a well-tested solution, but there is a tremendous challenge to achieve an efficient, persistent and controllable expression of VEGF in vivo.
'A single dose of HM2002 can express VEGF protein for a perfect time window in vivo: long enough for efficient angiogenesis, short enough for any safety concerns. Once the microcirculation is reformed, it brings long-lasting benefits to patients without the presence of HM2002 or VEGF protein.'
Preclinical studies have shown that HM2002 demonstrates safety and efficacy profiles.
In a first-in-human investigator-initiated trial commenced at Ruijin Hospital, China, in 2024, all subjects exhibited significant improvements in cardiac function without any reported adverse events.
CirCode co-founder, chairman and chief technology officer Yun Yang stated: "CirCode's robust, proprietary circular RNA platform laid the foundation for the fast IND approval of HM2002. With the help of our AI tools, we were able to leap from a concept to IND approval of HM2002 in less than two years.
'We have now built a strong pipeline portfolio in various fields such as therapeutic proteins, vaccines and in vivo CAR-T, covering multiple therapeutic areas such as cardiovascular diseases, infectious diseases, autoimmune diseases and oncology.'
"CirCode Biomed gains clearance from FDA for RNA drug HM2002" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand.
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