By Fineline Cube 
China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) announced that it has received breakthrough therapy designation (BTD) from China’s Center for Drug Evaluation (CDE) for its Category 1 hepatitis B virus (HBV) therapy, GST-HG131. This designation reflects the potential of the drug to address a significant unmet medical need in the treatment of HBV.
Mechanism of Action
GST-HG131 is a novel oral small-molecule inhibitor of hepatitis B surface antigen (HBsAg). It works by destabilizing and degrading HBV mRNA, thereby blocking its expression and effectively suppressing HBsAg synthesis. This innovative mechanism of action represents a promising approach in the ongoing battle against HBV.
Clinical Potential Demonstrated
Preclinical studies and disclosed clinical trial data have shown that GST-HG131 exhibits significant inhibitory effects on HBsAg production. These findings highlight the drug’s potential to effectively control HBV and improve outcomes for patients living with the virus.-Fineline Info & Tech