Qilu Pharmaceutical Launches Phase III Clinical Trial of QLS1128 for Mild-to-Moderate COVID-19

On March 7, Qilu Pharmaceutical registered a Phase III clinical trial on clinicaltrials.gov to evaluate the efficacy and safety of QLS1128 in treating patients with mild to moderate COVID-19.

This is a multi-center, randomized, double-blind, placebo-controlled clinical trial, expected to enroll 1,220 patients with mild to moderate coronavirus infection. It was launched on March 7, 2023, with a completion date of June 30, 2023.

The primary endpoint is the time to sustained recovery from COVID-19 symptoms (defined as the time from the start of treatment until 11 COVID-19 symptoms score 0 for 3 consecutive days) after taking QLS1128. Secondary endpoints include the time to sustained alleviation of 11 COVID-19 symptoms for 2 consecutive days, viral load, time to first negative nucleic acid test, proportion of patients with negative nucleic acid tests, etc.

As of March 8, 2023, three COVID-19 drugs have been approved for marketing in China: Simcere Pharmaceutical's 3CL inhibitor SIM0417, Genuine Biotech's RdRp inhibitor Azvudine, and Junshi Biosciences' RdRp inhibitor VV116.

Overview of the Research Progress of China-Produced COVID-19 Drugs

Source: Nextpharma database of PharmaCube; Note: TMC310911 was introduced by Ascletis Pharma from Johnson & Johnson, and LGN-20 was introduced by China Resources Double-Crane from Ligand Pharmaceuticals, thus they are not included in the statistics.

Currently, Qilu Pharmaceutical's QLS1128 has not disclosed the specific target.

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