On November 16, 2024, the "The first China Pharmaceutical Valley • Future Biological Innovative Drugs Conference" was successfully held in Beijing, which was sponsored by the Management Committee of Daxing Bio-pharmaceutical Industry Base of Zhongguacun Science and Technology Park and hosted by Beijing Hotgen Biotech Co., Ltd. and other enterprises. This event is supported by leaders at all levels in Daxing District. Industry experts, outstanding entrepreneurs and investment institutions were gathered to discuss the frontier development of the industry through thematic reports, roundtable discussions and other forms, to promote the deep integration of the medical and health industry, and to further enhance the influence of Daxing District in the field of innovative drugs.
Professor Du Jie from Beijing Institute of Cardiovascular and Vascular Diseases, Capital Medical University was invited to share at the meeting. In a presentation entitled "The world's first anti-myocardial infarction drug: Sungen Biomedical SGC001", Professor. Du pointed to data released by the World Health Organization showing that about 17.5 million people died of cardiovascular diseases worldwide in 2012, accounting for 31% of all deaths worldwide. According to statistics, the number of patients with cardiovascular diseases in China was about 290 million in 2018, and the prevalence and mortality rate were still on the rise, accounting for more than 40% of the disease deaths of residents. Cardiovascular disease can be called the "No.1 Killer" of human beings. Heart failure is the end stage of cardiovascular diseases such as myocardial infarction. Heart failure caused by cardiovascular diseases after treatment will continue to affect the survival of patients.
In the target discovery stage of the study, Professor Du Jie's team studied through multi-omics databases such as transcriptome, proteome and phenome based on large-scale multi-center cardiovascular disease (myocardial infarction, etc.) cohort samples. It is found that CXCR2+ cells are key cells to sense cardiac injury. S100A8/A9 secreted by CXCR2+ granulocytes promotes the expression of chemokines, recruits inflammatory cells, and initiates adverse myocardial remodeling and heart failure. S100A8/A9 are key molecules that sense injury and initiate heart failure. Blocking S100A8/A9 can effectively inhibit heart failure. Subsequently, the team successfully innovated and developed a monoclonal antibody drug to target S100A8/A9, which is the world's first FIC drug SGC001 injection, for the emergency treatment of patients with Acute Myocardial Infarction (AMI).
Preclinical studies have found that SGC001 injection (Dukiprubart) can inhibit the inflammatory response of immune cells and has an anti-apoptosis effect. It was found that Dukiprubart could reduce the mortality rate and infarction volume, improve cardiac function, and alleviate myocardial lesions in the humanized mouse model of complete infarction. There was a clear dose-effect relationship in the model animals.
The in vivo efficacy study of Dukiprubart in rhesus monkey model with complete infarction found that a single intravenous administration of Dukiprubart at low, medium and high doses could reduce the degree of myocardial tissue lesions, reduce the size of myocardial infarction and improve cardiac function. In conclusion, SGC001 injection (Dukiprubart) is the world's First (First in Class) fully human mAb for the treatment of myocardial infarction, with good proprietary characteristics, stable process and reliable quality. Dukiprubart is safe and effective in preclinical studies, and its efficacy in animals is consistent with theoretical expectations. The successful development of Dukiprubart will bring revolutionary changes in the emergency treatment of AMI. At present, Sungen Biomedical's SGC001 injection (Dukiprubart) has obtained IND approval in China and the United States, and the clinical research is progressing well.
Updated: Dec 17, 2024
