Hotgen(SH:688068) Shang Hai Zheng Quan Bao·2025-10-22 19:39Core Viewpoint - Beijing Hotgen Biotech Co., Ltd. announced that its affiliate, ShunJing Biopharmaceutical Technology Co., Ltd., has achieved positive preliminary results in the Phase Ib clinical trial of the innovative drug SGC001, which is aimed at treating acute myocardial infarction [1][2]. Clinical Progress - The Phase Ib clinical trial of SGC001 has been completed, showing good safety and tolerability in patients with anterior ST-segment elevation myocardial infarction (STEMI) [1]. - No grade 3 or higher adverse events were reported across low (300 mg), medium (600 mg), and high (900 mg) dosage groups, indicating a strong safety profile [1][2]. - Pharmacokinetic analysis revealed that the median Tmax for SGC001 ranged from 1.30 to 4.07 hours, with a half-life (t1/2) of approximately 8 to 11 days [2]. Preliminary Efficacy Results - Initial efficacy results indicated that SGC001 at 600 mg and 900 mg doses showed a trend towards myocardial protection compared to the placebo group, with median reductions in myocardial infarction area percentages of 20.5% and 38.1%, respectively [2]. - The time required for high-sensitivity cardiac troponin I (hsTnI) and high-sensitivity C-reactive protein (hs-CRP) to return to normal levels was shorter in the treatment groups compared to the placebo [2]. Drug Overview - SGC001 is a monoclonal antibody developed for emergency treatment of acute myocardial infarction, specifically targeting anterior STEMI [3]. - The drug has received clinical trial approvals from both the U.S. FDA and China's National Medical Products Administration (NMPA), and it was granted Fast Track Designation by the FDA in March 2025 [3]. - The project has also received support from Beijing's Science and Technology Program and is recognized as an innovative pharmaceutical product [3].