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

全球首款！舜景医药心梗急救抗体药SGC001获得美国食品药品监督管理局（FDA）新药研究申请（IND）许可

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. 

美国时间2024年05月23日，由热景生物（SH.688068）孵化的创新药公司北京舜景生物医药技术有限公司（以下简称舜景医药）研制的全球首款创新药SGC001临床试验申请（IND）获得美国食品药品监督管理局（FDA）批准许可，在创新药物开发方面取得全新阶段性突破。

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.

SGC001是一款由舜景医药孙志伟研发团队联合首都医科大学北京市心肺血管疾病研究所杜杰教授、李玉琳教授团队共同开发研制的急救用单克隆抗体药物，适用于急性心肌梗死（Acute Myocardial Infarction, AMI）患者的急救治疗。AMI是由于冠脉急性闭塞造成的心肌坏死，具有较高的发病率、死亡率和致残率，并发症多且严重。

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.

据专业机构数据统计，国内每年有250万人死于心梗，新增的心梗患者人数可达到百万级，心梗患者的发病有着明显的“年轻化”趋势。2020年发表的一项中国患者心脏事件评估的前瞻性AMI研究PEACE（Patient-centered Evaluative Assessment of Cardiac Events）结果显示，预计到2030年，中国的AMI患者数量或可达2300万。

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.

美国心脏协会根据NHLBI（国家心脏、肺和血液研究所）的ARIC（社区动脉粥样硬化风险）研究的发病数据进行计算：大约每40秒，就会有一名美国人发生心肌梗死。根据 NHLBI从2005年到2014年ARIC研究所列出的数据，心肌梗死的年发病率估计为605,000次新发作和 200,000次复发。在这805,000个首次和复发事件中，据估计有170,000 例是无症状的。

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.

目前，针对AMI疾病，暂无相关抗体药物进入临床研究阶段及审批上市，舜景医药SGC001在美国成功申报IND是SGC001项目的重要里程碑，也是舜景医药在国际化创新药物开发道路上迈出的重要一步。临床前药效学模型研究和毒理学研究结果揭示SGC001对心梗后心衰及心脏病理性重塑有明显的治疗作用，可以显著降低心梗的死亡率，减少心肌梗死面积，改善心功能，具有较好的疗效和良好的安全窗口。SGC001具有成为first-in-class药物的潜力，有望为全球的AMI患者提供一种更加安全、有效的治疗药物。

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