We are proud to extend our heartfelt congratulations to our partner, CirCode Biomed, on a truly historic achievement: the FDA Investigational New Drug (IND) clearance for HM2002, a novel circular RNA drug to be administered in human patients. This approval marks a pivotal moment in the advancement of RNA-based therapeutics and further validates circular RNA as a transformative modality in medicine.

CirCode announced the FDA clearance on May 30, 2025, following earlier approval from the National Medical Products Administration (NMPA) in China in January. HM2002 now holds the distinction of being the first circular RNA therapy approved for clinical studies in both China and the United States. It is also the only circular RNA drug currently authorized globally for use in patients with ischemic heart disease—a condition that remains the leading cause of death worldwide.

The path to this milestone began in September 2024, when the first patient was dosed in an investigator-initiated trial (IIT) at Ruijin Hospital. Since then, HM2002 has demonstrated remarkable safety and efficacy, showing significant improvements in cardiac function with no drug-related adverse events observed.

Designed to address an urgent unmet medical need, HM2002 leverages the unique advantages of circular RNA, including enhanced stability and low immunogenicity, to deliver sustained expression of vascular endothelial growth factor (VEGF) in myocardial tissue. This promotes angiogenesis, improves myocardial perfusion, and supports cardiac recovery. Unlike traditional VEGF therapies, which struggle with efficient and controlled in vivo expression, HM2002 achieves a precisely timed expression window, ensuring therapeutic impact while minimizing potential safety concerns.

“To promote angiogenesis and relieve ischemia through VEGF overexpression is a well-tested solution, but there is a tremendous challenge to achieve efficient, persistent, and controllable expression of VEGF in vivo,” said Dr. Chenxiang Tang, CEO of CirCode. “We find an excellent match between the need and the properties of circular RNA. A single dose of HM2002 can express VEGF protein long enough for angiogenesis and short enough to ensure safety.”

Dr. Yun Yang, Co-founder, Chairman, and CTO of CirCode, added:

“Thanks to our robust circular RNA platform and integrated AI-driven development process, we accelerated HM2002 from concept to IND approval in less than two years. We’re building a diversified pipeline across therapeutic proteins, vaccines, and in vivo CAR-T technologies, and we remain committed to delivering breakthrough therapies to patients worldwide.”

At XGen Bio, we are honored to support pioneering partners like CirCode, who share our vision of transforming the future of medicine through scientific excellence and bold innovation. This milestone not only represents progress for one company or one product, but for the entire RNA therapeutics ecosystem. We look forward to continuing our close collaboration and supporting CirCode’s journey toward delivering life-changing treatments to patients in need.

Full Press Release:
https://www.prnewswire.com/news-releases/circode-biomed-announces-fda-clearance-for-ind-application-of-hm2002-the-worlds-first-circular-rna-drug-being-administrated-in-patients-302469966.html?tc=eml_cleartime