Recently, a phase Ib clinical study of SGC001 Injection, the world's first antibody drug for acute myocardial infarction, developed by Sungen, has obtained positive preliminary results. The data showed that SGC001 showed significant efficacy in reducing myocardial infarction area, with the median percentage of myocardial infarction area decreased by 20.5% and 38.1% in the medium and high dose groups, respectively, bringing a breakthrough in the treatment area of acute myocardial infarction worldwide.
The Phase 1b clinical study of SGC001 Injection was conducted in patients with anterior ST-segment elevation myocardial infarction using a randomized, double-blind, placebo-controlled, single-dose escalation design.
SGC001 Injection exhibits an excellent safety profile. No Grade 3 or higher adverse events occurred in any of the low (300 mg), medium (600 mg), and high (900 mg) dose groups, and the safety of the drug was significantly dose-related.
Preliminary efficacy results showed that SGC001 injection showed an effective trend in myocardial protection in both the 600 mg and 900 mg dose groups compared with the placebo group, with a decrease in the percentage of myocardial infarction area, and a shorter time required for high-sensitivity troponin I and high-sensitivity C-reactive protein to return to normal levels.
SGC001 Injection is the first therapeutic antibody drug in the world to enter the clinical study phase for acute myocardial infarction. It was jointly developed by the research and development team of Professor Sun Zhiwei of Sungen in conjunction with Professor Du Jie and Professor Li Yulin of Beijing Institute of Heart, Lung and Blood Vessel Diseases, Capital Medical University. Since its establishment, SGC001 has undergone many years of independent research and development and clinical exploration. In 2024, the clinical trial applications of SGC001 were successively approved by the US FDA and China NMPA, and in 2025 has been certified by the US FDA fast track, and has been included in a number of science and technology and innovation support programs, and its clinical value and innovation potential have been recognized by many parties. At present, no relevant antibody drugs have entered the clinical study stage or been approved for marketing for AMI disease, and the development progress of SGC001 has filled the gap in this field.
Sungen has long been committed to the development of innovator antibody drugs with new targets and new mechanisms worldwide. This periodical achievement of SGC001 is not only a great progress in the field of treatment of myocardial infarction, but also an important embodiment of the deepening of innovation system and the transformation of scientific research layout.
Updated: Nov 27, 2025
