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全球首款!舜景醫藥心梗急救抗體藥SGC001獲得美國食品藥品監督管理局(FDA)新藥研究申請(IND)許可
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!舜景醫藥心梗急救抗體藥SGC001獲得美國食品藥品監督管理局(FDA)新藥研究申請(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,www.dtsyr.com). This marks a breakthrough in innovative drug development of Sungen Biomedical and the overall biopharmaceutical industry. 

美國時間2024年05月23日,由AG 尊龙凯时生物(SH.688068)孵化的創新藥公司北京舜景生物醫藥技術有限公司(以下簡稱舜景醫藥)研製的全球首款創新藥SGC001臨床試驗申請(IND)獲得美國食品藥品監督管理局(FDA)批准許可,在創新藥物開發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是一款由舜景醫藥孫志偉研發團隊聯合首都醫科大學北京市心肺血管疾病研究所杜傑教授團隊共同開發研製的急救用單克隆抗體藥物,適用於急性心肌梗死(Acute Myocardial Infarction, AMI)患者的急救治療。AMI是由於冠脈急性閉塞造成的心肌壞死,具有較高的發病率、死亡率和致殘率,併發症多且嚴重。

 

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.

據專業機構數據統計,國內每年有250萬人死於心梗,新增的心梗患者人數可達到百萬級,心梗患者的發病有着明顯的「年輕化」趨勢。2020年發表的一項中國患者心臟事件評估的前瞻性AMI研究PEACE(Patient-centered Evaluative Assessment of Cardiac Events)結果顯示,預計到2030年,中國的AMI患者數量或可達2300萬。


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.

美國心臟協會根據NHLBI(國家心臟、肺和血液研究所)的ARIC(社區動脈粥樣硬化風險)研究的發病數據進行計算:大約每40秒,就會有一名美國人發生心肌梗死。根據 NHLBI從2005年到2014年ARIC研究所列出的數據,心肌梗死的年發病率估計為605,000次新發作和 200,000次復發。在這805,000個首次和復發事件中,據估計有170,000 例是無症狀的。

 

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AMI疾病,暫無相關抗體藥物進入臨床研究階段及審批上市,舜景醫藥SGC001在美國成功申報INDSGC001項目的重要里程碑,也是舜景醫藥在國際化創新藥物開發道路上邁出的重要一步。臨床前藥效學模型研究和毒理學研究結果揭示SGC001對心梗後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

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