SGC001 Injection is the world’s first therapeutic antibody drug targeting myocardial infarction(AMI) entering clinical stage. After years of independent research and clinical exploration, SGC001 project received dual approvals for clinical trial applications from both the US FDA and China’s NMPA in 2024. In 2025, this FIC-potential pipeline received Fast Track designation from the US FDA and was included in multiple science and technology innovation support programs. Its clinical value and innovation potential have been recognized by various parties.
In October 2025, Sungen announced that the Phase Ib clinical study of SGC001 had achieved positive preliminary results. The data showed that SGC001 demonstrated significant efficacy in reducing the myocardial infarction area. With the median percentage reduction in infarction area being 20.5% in the mid-dose group and 38.1% in the high-dose group, the pipeline represents a groundbreaking advancement in the global treatment of acute myocardial infarction.
Currently, no antibody drugs have been approved for myocardial infarction treatment. The development of SGC001 could fill a significant gap in this field.
SGT003 is an innovative bispecific antibody drug designed to selectively deplete regulatory T cells (Tregs) within tumor tissues while significantly improving the therapeutic safety window of the CTLA-4 target.
Preclinical data show that SGT003 can significantly reduce the proportion of intratumoral Tregs and tumor-associated macrophages (TAMs), with superior antitumor activity at equivalent or even lower doses compared to YERVOY (Ipilimumab) and anti-PD-1 monoclonal antibodies. Unlike the broad peripheral immune activation caused by YERVOY, SGT003 has a more limited impact on peripheral immune cells, demonstrating a better efficacy-safety balance. At lower doses, SGT003 exhibits more significant tumor inhibition and substantially improved safety compared to anti-PD-1 and anti-CTLA-4 monoclonal antibodies, showcasing excellent therapeutic advantages in tumor treatment. Furthermore, SGT003 treatment induces durable antitumor immune memory, effectively inhibiting tumor recurrence in animal models. These findings further support the potential of SGT003 to become a more effective and safer next-generation backbone drug for first-line tumor immunotherapy.
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