The efficacy is better than that of Pfizer Paxlovid! The latest research data of Guangshengtang 3CL protease inhibitor was released

On January 9, Guangshengtang issued an announcement that the investigators initiated a clinical trial (IIT) to evaluate the efficacy and safety of its 3CL protease inhibitor GST-HG171 (tyatvir) combined with ritonavir (collectively known as "Taizhongding") in the treatment of new crown patients, and has completed the enrollment and clinical observation of all subjects, and recently obtained a clinical study summary report
.

The results showed that Taizonidine (GST-HG171 tablets/ritonavir tablets) had superior anti-new coronavirus efficacy, and the nucleic acid conversion time of new crown patients was significantly better than that of the positive control Paxlovid and placebo control, and the safety and tolerability were good, which achieved the expected purpose of the trial and provided important supporting
evidence for the later drug marketing.

This is a randomized, placebo/active controlled clinical trial to assess the efficacy and safety
of Taizhongding in adult subjects with mild/common COVID-19.
Subjects were treated twice a day for 5 days in the following three groups to evaluate the nucleic acid conversion time of each group for the main purpose and observe the drug safety and adverse event rate:

1) Test group: test drug taizhonadine (150mg GST-HG171 tablets/100mg ritona tablets)

2) Placebo group: placebo (GST-HG171 analogue/ritonavir tablet)

3) Positive control group: Paxlovid (300 mg nematevir tablets / 100 mg ritonavir tablets)

The study was carried out in the First Affiliated Hospital of Guangzhou Medical University and the Third People's Hospital of Shenzhen, and 61 COVID-19 patients were recruited and treated from November 22 to December 29, 2022, and all subjects have completed 28 days of clinical observation and are out of the group
.

In terms of efficacy, the median time to negative conversion was 8.
4 days for Taizonidine (experimental group), 9.
5 days for Paxlovid (active control group), and 10.
3 days
for the placebo group.
The active ingredient GST-HG171 (150 mg) of Tazhonidine (experimental group) had significantly shorter nucleic acid conversion time than Paxlovid (active control group) and placebo
group at half the dose of only Paxlovid active ingredient nematevir (300 mg).

Taizhongding (test group) began to decrease on nucleic acid positivity on day 5, and all subjects had negative nucleic acid results after day 15
.
The positive rate of nucleic acid began to decrease on day 6 in the Paxlovid positive control and comfort groups, and all subjects had negative nucleic acid results after day 16
.
The nucleic acid positivity rate began to decline earlier than in the Paxlovid positive control group and the placebo group, and all subjects turned negative earlier than the Paxlovid positive control group and the placebo group
.

In terms of safety, there were no serious adverse events, no adverse events leading to discontinuation, no adverse events leading to withdrawal, and no suspicious and unexpected serious adverse reactions
.
The incidence of adverse events and adverse reactions was basically consistent among all groups, and the safety was good
.