On November 3, 2025, Vienna time, Sungen announced the Phase I clinical results of SGC001 Injection, the world's first antibody drug for acute myocardial infarction, at the 31st BIO Europe 2025, held in Vienna. This randomized, double-blind, placebo-controlled study of patients with anterior ST-segment elevation myocardial infarction showed that SGC001 demonstrated significant efficacy in reducing myocardial infarct size, with median percent myocardial infarction area reductions of 20.5% and 38.1% in the medium and high dose groups, respectively. The positive results of its safety and preliminary efficacy bring a new research and development perspective for the treatment of acute myocardial infarction worldwide.
Dr Gao Qi, Vice General Manager of Sungen, said: "BIO Europe, as a global cooperation hub in the field of biopharmaceuticals, provides us with an important platform for in-depth exchanges with international counterparts. The Phase I clinical study of SGC001 is the first clinical study of this target reported globally, and is also the first antibody drug for myocardial protection, which not only validates the feasibility of its innovative mechanism, but also demonstrates the development strength of the Chinese team in the field of innovative drugs. At present, we have completed the preparation for phase II clinical trials, and will systematically assess the efficacy and safety of the drug in different populations.”
Acute Myocardial Infarction (AMI), especially ST-segment elevation Myocardial Infarction (STEMI), is always a major challenge in the global cardiovascular field because of its Acute onset and high mortality. At present, the main clinical percutaneous coronary intervention (PCI) can rapidly restore blood flow, but there are still a large number of patients due to myocardial ischemia-reperfusion injury, resulting in the expansion of infarct size, and then lead to serious complications such as heart failure. Although traditional thrombolytic drugs can be used in patients who cannot undergo PCI in time, there are limitations such as high risk of bleeding and limited recanalization rate. Therefore, there is an urgent need for novel therapeutic methods that can precisely protect myocardium and reduce infarct size. At present, no relevant antibody drugs have entered the clinical study phase or been approved for marketing for AMI disease. With the continuous advancement of clinical study of SGC001, Sungen is expected to bring a new treatment option for AMI patients worldwide.
Updated: Nov 28, 2025
