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！舜景醫(yī)藥心梗急救抗體藥SGC001獲得美國(guó)食品藥品監(jiān)督管理局（FDA）新藥研究申請(qǐng)（IND）許可

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,meteoiberica.net). This marks a breakthrough in innovative drug development of Sungen Biomedical and the overall biopharmaceutical industry. 

美國(guó)時(shí)間2024年05月23日，由熱景生物（SH.688068）孵化的創(chuàng)新藥公司北京舜景生物醫(yī)藥技術(shù)有限公司（以下簡(jiǎn)稱舜景醫(yī)藥）研制的全球首款創(chuàng)新藥SGC001臨床試驗(yàn)申請(qǐng)（IND）獲得美國(guó)食品藥品監(jiān)督管理局（FDA）批準(zhǔn)許可，在創(chuàng)新藥物開發(fā)方面取得全新階段性突破。

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是一款由舜景醫(yī)藥孫志偉研發(fā)團(tuán)隊(duì)聯(lián)合首都醫(yī)科大學(xué)北京市心肺血管疾病研究所杜杰教授、李玉琳教授團(tuán)隊(duì)共同開發(fā)研制的急救用單克隆抗體藥物，適用于急性心肌梗死（Acute Myocardial Infarction, AMI）患者的急救治療。AMI是由于冠脈急性閉塞造成的心肌壞死，具有較高的發(fā)病率、死亡率和致殘率，并發(fā)癥多且嚴(yán)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.

據(jù)專業(yè)機(jī)構(gòu)數(shù)據(jù)統(tǒng)計(jì)，國(guó)內(nèi)每年有250萬(wàn)人死于心梗，新增的心?；颊呷藬?shù)可達(dá)到百萬(wàn)級(jí)，心?；颊叩陌l(fā)病有著明顯的“年輕化”趨勢(shì)。2020年發(fā)表的一項(xiàng)中國(guó)患者心臟事件評(píng)估的前瞻性AMI研究PEACE（Patient-centered Evaluative Assessment of Cardiac Events）結(jié)果顯示，預(yù)計(jì)到2030年，中國(guó)的AMI患者數(shù)量或可達(dá)2300萬(wàn)。

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.

美國(guó)心臟協(xié)會(huì)根據(jù)NHLBI（國(guó)家心臟、肺和血液研究所）的ARIC（社區(qū)動(dòng)脈粥樣硬化風(fēng)險(xiǎn)）研究的發(fā)病數(shù)據(jù)進(jìn)行計(jì)算：大約每40秒，就會(huì)有一名美國(guó)人發(fā)生心肌梗死。根據(jù) NHLBI從2005年到2014年ARIC研究所列出的數(shù)據(jù)，心肌梗死的年發(fā)病率估計(jì)為605,000次新發(fā)作和 200,000次復(fù)發(fā)。在這805,000個(gè)首次和復(fù)發(fā)事件中，據(jù)估計(jì)有170,000 例是無(wú)癥狀的。

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，針對(duì)AMI疾病，暫無(wú)相關(guān)抗體藥物進(jìn)入臨床研究階段及審批上市，舜景醫(yī)藥SGC001在美國(guó)成功申報(bào)IND是SGC001項(xiàng)目的重要里程碑，也是舜景醫(yī)藥在國(guó)際化創(chuàng)新藥物開發(fā)道路上邁出的重要一步。臨床前藥效學(xué)模型研究和毒理學(xué)研究結(jié)果揭示SGC001對(duì)心梗后心衰及心臟病理性重塑有明顯的治療作用，可以顯著降低心梗的死亡率，減少心肌梗死面積，改善心功能，具有較好的療效和良好的安全窗口。SGC001具有成為first-in-class藥物的潛力，有望為全球的AMI患者提供一種更加安全、有效的治療藥物。

Contact us: bd@sungen.net.cn