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2024-05-30
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！舜景医药心梗抢救抗体药SGC001获得美国食品药品监视治理局（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.).
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q千亿球友会（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视治理局（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、李玉琳教授团队配合开发研制的抢救用单克隆抗体药物，适用于急性心肌梗死（Acute Myocardial Infarction, AMI）患者的抢救治疗。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，海内每年有250万人死于心梗，新增的心梗患者人数可到达百万级，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.
美国心脏协会凭据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盘算：约莫每40秒，就会有一名美国人发生心肌梗死。凭据 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预计为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，据预计有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�。菸尴喙乜固逡┪锝肓俅惭芯拷锥渭吧笈鲜校淳耙揭�SGC001在美国乐成申报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门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，淘汰心肌梗死面积，改善心功效，具有较好的疗效和良好的宁静窗口。SGC001具有成为first-in-class药物的潜力，有望为全球的AMI患者提供一种越发宁静、有效的治疗药物。
Contact us: bd@sungen.net.cn
