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GST-HG171, an innovative drug such as an oral small molecule broad-spectrum anti-novel coronavirus 3CL protease inhibitor, a subsidiary of Fujian Guangsheng Tang Pharmaceutical Co.
, Ltd.
(hereinafter referred to as the "Company"), has recently obtained the approval of the ethics committee of the First Affiliated Hospital of Guangzhou Medical University and the Third People's Hospital of Shenzhen on initiating phase II/III clinical trials, marking the II/III of the company's GST-HG171 project A pivotal registration clinical study with seamless design has been fully and substantially launched
.
At the same time, the investigator-initiated clinical study (IIT study) to evaluate the efficacy and safety of the preliminary drug in patients with mild/ordinary new crown has successfully completed the enrollment and administration of all patients, and it is yet to be summarized
.
A randomized, double-blind, placebo-controlled phase II/III seamlessly designed registered clinical study of GST-HG171 tablets in patients with mild and uncommon SARS-CoV-2 infection proposed to enroll 1200 patients with mild and uncommon novel coronavirus infection with placebo as a clinical dosing regimen of 1 GST-HG171 tablet + 1 ritonavir orally twice daily for 5 days
, with the primary endpoint indicator of continuous recovery time of clinical symptoms 。 The phase II/III clinical research protocol has been submitted to the team leader, the First Affiliated Hospital of Guangzhou Medical University and the Ethics Committee of Shenzhen Third People's Hospital for review, and has been formally approved and approved
.
This study was carried out
in Guangdong, Beijing, Shanghai, Wuhan, Fujian and other national clinical medical institutions.