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    Recently, SGC001, a world-first novel antibody drug for acute myocardial infarction jointly developed by Sungen Biomedical, a subsidiary of Hotgen Biotech, and Beijing Anzhen Hospital, Capital Medical University, has successfully completed the first patient dosing in its Phase II clinical trial. This study aims to further evaluate the safety and efficacy of SGC001 in the treatment of patients with ST-segment elevation myocardial infarction (STEMI).

     

    SGC001 is a therapeutic antibody developed to target the pathological mechanism of acute myocardial infarction. Positive preliminary outcomes were achieved in the preceding Phase I clinical study. Data indicated that SGC001 delivers remarkable efficacy in reducing myocardial infarct size. The median percentage of infarct size was reduced by 20.5% and 38.1% in the medium and high-dose groups respectively.


    Building on encouraging Phase I findings, the project has advanced smoothly into Phase II research. Led by Peking University First Hospital and Shanghai East Hospital, this multi-center clinical trial involves more than 20 hospitals nationwide. Initiated at Shanghai East Hospital in early 2026, the study completed the first patient enrollment and dosing at Linfen Central Hospital of Shanxi Province on March 9, marking a landmark new stage for the SGC001 program.

     

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    During the multi-center clinical research, the research team screened and randomly enrolled a STEMI patient in strict accordance with trial protocols, and finished drug infusion successfully. Treatment for acute myocardial infarction demands highly time-sensitive intervention. The smooth completion of this dosing session owes to efficient execution and collaboration of clinical researchers, as well as close coordination among emergency, cardiology, imaging and clinical laboratory within the research center.

     

     The ongoing Phase II clinical trial of SGC001 will generate sufficient evidence-based data for comprehensive assessment of the drug’s clinical safety and therapeutic effects. The research team will conduct subsequent patient enrollment and follow-up procedures in full compliance with Good Clinical Practice and trial protocols, ensuring authentic and complete research data. The study results are expected to deepen understanding of innovative therapeutic mechanisms for acute myocardial infarction, and offer new treatment options for clinical practice and patients.


    Updated: May 18, 2026

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