First in the world Sungen Biomedical obtains FDA's clinical trial approval of IND SGC001 as an emergency use antibody drug for AMI

On May 23rd, 2024, Eastern Standard Time, US Food and Drug Administration (FDA) approved the clinical trial application for the world's first AMI antibody drug, SGC001, as an investigational new drug (IND). The drug is developed by Beijing Sungen Biomedical Technology Co., Ltd. (Sungen Biomedical), an innovative biopharmaceutical company incubated by Beijing Hotgen Biotech Co., Ltd. (SH.688068,www.hotgen.com.cn). This marks a breakthrough in innovative drug development of Sungen Biomedical and the overall biopharmaceutical industry.

SGC001 is a monoclonal antibody indicated for emergency treatment of acute myocardial infarction (AMI). The drug is developed by Professor Zhiwei Sun's team from Sungen Biomedical, in collaboration with Professor Jie Du's team from Beijing Institute of Heart, Lung and Blood Vessel Diseases, Capital Medical University. AMI is a condition characterized by death of myocardia due to acute occlusion of coronary arteries, resulting in high morbidity, mortality, disability rate, and various serious complications.

It is estimated that there are 2.5 million deaths from heart attacks annually in China. While millions of new myocardial infarction patients are diagnosed yearly, this group are getting significantly younger. A prospective AMI study PEACE (Patient-centered Evaluative Assessment of Cardiac Events) in 2020 suggests that the number of AMI patients in China could reach 23 million by 2030.

Based on incidence data from the ARIC (Atherosclerosis Risk In Communities) study of NHLBI (National Heart Lung and Blood Institute), AHA (American Heart Association) indicates that approximately every 40 seconds, one American will have an MI. The 2005 to 2014 ARIC study estimates that there are 605,000 new attacks and 200,000 recurrent attacks each year in the US. And 170,000 of these are silent, without significant symptoms.

Till now, there is no antibody therapy for AMI approved for clinical or commercial stage. The successful clinical trial application in the United States is an important milestone of SGC001 and a huge step towards the internationalization of innovative drugs developed by Sungen Biomedical. Preclinical pharmacodynamic and toxicological studies reveales that SGC001 has obvious therapeutic effects on heart failure and pathological remodeling of the heart after AMI, with significantly decreased mortality rate, reduced infarction size, improved cardiac functions, good efficacy and a reliable therapeutic window. SGC001 has the potential to become a first-in-class drug, providing safer and more effective therapies for AMI patients worldwide.

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Company Name: Beijing Sungen Biomedical Technology Co., Ltd
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Country: China
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