Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug BAT2094 (Betagrin). The drug is indicated for use in patients with acute coronary syndrome who are undergoing percutaneous coronary intervention (PCI), including coronary stent placement. BAT2094 is designed to mitigate the risk of acute occlusion, stent thrombosis, no reflow, and slow blood flow.
BAT2094 is characterized as a peptide mimetic beta3 integrin (αIIbß3, αvß3) antagonist that curbs platelet aggregation by obstructing fibrinogen binding to the GP IIb/IIIa. Additionally, it can bind to integrin αvß3 on endothelial and smooth muscle cells, potentially preventing integrin αvß3-induced adhesion and spreading of platelets and endothelial cells, which could lead to the prevention of restenosis in blood vessels.
In a pivotal Phase III clinical trial, the objective was to diminish the occurrence of severe PCI-related complications/endpoints, such as death within 30 days of PCI, myocardial infarction, acute target vessel revascularization, and the need for antithrombotic treatment including acute occlusion. The trial demonstrated that BAT2094 treatment significantly reduced the risk of such endpoint events by over 43% compared to existing standard treatments.- Flcube.com
