Shanghai CirCode Biomed Co. Ltd. (CirCode), an innovative biotech company pioneering circular RNA therapies, recently announced that its leading pipeline HM2002 received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for ischemic heart disease on May 30, 2025..

上海环码生物有限公司（CirCode），一家致力于开发环状RNA疗法的创新生物技术公司，近日宣布其主要管线HM2002于2025年5月30日获得美国食品药品监督管理局（FDA）针对缺血性心脏病的新药临床试验（IND）批准。

With the first patient administrated on September of 2024 in an investigator initiated trial (IIT), HM2002 is the world's first circular RNA drug ever being used in patients. It received IND approval from the National Medical Products Administration (NMPA) of China on January 10th, 2025. HM2002 is currently the first circular RNA therapy to receive IND clearance in both China and the United States, and is also the only circular RNA drug globally approved for clinical study on patients with ischemic heart disease..

2024年9月，首个患者在一项研究者发起的试验（IIT）中接受给药，HM2002成为世界上首款用于患者的环状RNA药物。该药物于2025年1月10日获得中国国家药品监督管理局（NMPA）的IND批准。HM2002是目前唯一一款在中美两国均获得IND许可的环状RNA疗法，同时也是全球唯一获批进入缺血性心脏病患者临床研究的环状RNA药物。

With the global aging population, ischemic heart disease shows a steadily rising incidence, and has been the leading cause of death globally for the past decades. The current standard of care shows limited effects in promoting myocardial microcirculation reconstruction and angiogenesis, leading to suboptimal efficacy and limited benefit in 10-year survival.

随着全球人口老龄化，缺血性心脏病的发病率稳步上升，且在过去几十年中一直是全球主要的死亡原因。目前的标准治疗在促进心肌微循环重建和血管生成方面效果有限，导致疗效欠佳，10年生存率的提升也较为有限。

There is an urgent unmet medical need for next generation therapies to improve patients' prognosis and quality of life..

存在一个迫切的未满足医疗需求，需要新一代疗法来改善患者的预后和生活质量。

With the advantages of improved stability and low immunogenicity from circular RNAs, HM2002 can safely and continuously express vascular endothelial growth factor (VEGF) in the myocardium, which promotes angiogenesis, improves myocardial perfusion, and facilitates cardiac function recovery. It has demonstrated excellent safety and efficacy in the preclinical studies.

利用环状RNA稳定性好、免疫原性低的优点，HM2002能够在心肌中安全、持续表达血管内皮生长因子（VEGF），促进血管新生，改善心肌供血，促进心脏功能恢复。在临床前研究中展现了良好的安全性和有效性。

In the first-in-human IIT at Ruijin Hospital initiated last year, all subjects showed significant cardiac function improvement without any drug-related adverse events..

去年在瑞金医院开展的首次人体IIT中，所有受试者心脏功能均有显著改善，且没有任何与药物相关的不良事件。

'To promote angiogenesis and relief ischemia 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. We find an excellent match between the need and the properties of circular RNA. 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.

“通过VEGF过表达促进血管生成和缓解缺血是一种经过充分验证的解决方案，但在体内实现高效、持久且可控的VEGF表达存在巨大挑战。我们发现环状RNA的特性与这一需求非常匹配。单剂量的HM2002可以在体内表达VEGF蛋白达到一个理想的时间窗口：足够长以实现高效的血管生成，又足够短以避免任何安全性问题。

Once the microcirculation reformed, it brings long-lasting benefits to patients without the presence of HM2002 or VEGF protein,' said Dr. Chenxiang Tang, CEO of CirCode. 'The IND clearances from both NMPA and FDA for HM2002 is a strong recognition for our innovation and competitiveness in the circular RNA therapeutic industry..

一旦微循环重建，即使在没有HM2002或VEGF蛋白的情况下，也会为患者带来持久的益处。” CirCode公司首席执行官唐陈翔博士表示，“HM2002获得NMPA和FDA的IND批准，这充分证明了我们在环状RNA治疗领域的创新能力和竞争力。”

Dr. Yun Yang, co-founder, chairman, and chief technology officer of CirCode, stated that, '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 2 years.

环码生物联合创始人、董事长兼首席技术官杨云博士表示：“环码生物强大的环状RNA平台为HM2002的快速IND获批奠定了基础。借助我们的AI工具，我们能够在不到2年的时间里从概念跃进到HM2002的IND获批。

We now have 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. These pipelines have showed a favorable risk benefit profile with great efficacy and safety data in preclinical settings, many of which will enter the clinical stage within the next year.

我们在治疗性蛋白、疫苗和体内CAR-T等多个领域建立了强大的研发管线组合，覆盖了心血管疾病、传染病、自身免疫疾病和肿瘤学等多个治疗领域。这些研发管线在临床前研究中显示出良好的风险收益特征，具有显著的有效性和安全性数据，其中许多将在明年进入临床阶段。

We are so excited to keep pushing the frontier of circular RNA therapy forward and providing more innovative therapies for patients.'.

我们非常兴奋能够继续推动环状RNA疗法的前沿发展，并为患者提供更多的创新疗法。

About CirCode

关于CirCode

CirCode is a clinical-stage biotechnology company specializing in circular RNA therapeutics. Leveraging strong science and deep know-how, the company has built a fully integrated and proprietary platform, protected by a comprehensive global patent network, paving the way for the development of circular RNA therapeutics.

CirCode是一家临床阶段的生物技术公司，专注于环状RNA疗法。凭借强大的科学实力和深厚的专业知识，公司构建了一个完全集成且独有的平台，并受到全球全面专利网络的保护，为环状RNA疗法的开发铺平了道路。

Focusing on unmet medical needs, CirCode has built a robust pipeline targeting vaccines, cardiovascular diseases, autoimmune disorders, and oncology. CirCode is backed by top-tier investors and has received strong recognitions from leading pharmaceutical companies. Circode is committed to promoting the transformation of scientific and technological achievements and realizing the benefit of science and technology for mankind..

专注于未满足的医疗需求，CirCode建立了针对疫苗、心血管疾病、自身免疫疾病和肿瘤学的坚实管线。CirCode得到了顶级投资者的支持，并获得了领先制药公司的高度认可。CirCode致力于推动科技成果的转化，实现科技造福人类的目标。