Fujian Cosunter Pharmaceutical's subsidiary GST-HG131 jointly with GST-HG141 has received an optimized review and approval confirmation letter for the Phase II clinical trial.
10/03/2025
GMT Eight
Fujian Cosunter Pharmaceutical (300436.SZ) announcement: On March 10, 2025, the company's innovative drug holding subsidiary, Fujian Guangsheng Zhonglin Biotechnology Co., Ltd., received a "Confirmation Letter on Optimization of Innovative Drug Clinical Trial Evaluation and Approval Pilot Project" issued by the Beijing Drug Administration, approving the inclusion of the phase II clinical study of GST-HG131 in conjunction with GST-HG141 in the pilot project, which will effectively shorten the clinical evaluation and approval process.
Based on the preclinical and clinical study results of GST-HG131 and GST-HG141, GST-HG131 tablets have a significant inhibitory effect on HBsAg, while GST-HG141 tablets have significant inhibitory and depleting effects on HBV DNA and pgRNA. It is expected that they have a synergistic and complementary effect on the antiviral mechanism. The phase II clinical study of GST-HG131 in conjunction with GST-HG141 aims to explore the safety, tolerability, and effectiveness in chronic hepatitis B patients based on nucleos(t)ide analogs NUC basic therapy, in order to provide more effective treatment options for hepatitis B patients and achieve the company's Hepatitis B Peak Plan.