BEIJING, Dec. 30, 2022 /PRNewswire/ -- Grand Pharmaceutical Group Limited (Grand Pharma, stock code: 0512.HK) announced that GS221, an innovative oral small molecule 3CL protease (3-chymotrypsin-like protease, 3CLpro) inhibitor against SARS-CoV-2 that independently developed by the Company, has conducted three clinical trials. The results of clinical trials that have been completed so far showed favorable safety and tolerance in the subjects, and no adverse events that were serious or led to discontinuation were observed.
Preclinical studies have shown that GS221 exhibits the effective inhibitory effect on SARS-CoV-2 and its various mutant strains; animal studies and Phase I clinical trial showed favorable product safety; and GS221 showed better metabolic stability and bioavailability compared with other similar oral anti-SARS-CoV-2 products.
The ongoing effectiveness study for evaluating GS221 in treating mild to moderate COVID-19 is also progressing smoothly. The study is divided into two stages, the first stage trial plans to enroll 70 asymptomatic/mild/common patients with positive COVID-19 nucleic acid test; the second stage trial plans to enroll 312 mild/common patients with positive COVID-19 nucleic acid tests, to research the time needed for negative nucleic acid test.
At present, the first stage trial has completed enrollment and follow-up of all patients with favorable safety, and no adverse events that were serious or led to discontinuation were observed. After administration, the patients showed trends of improvement of clinical symptoms, shortening time for negative nucleic acid test, and rapid decline of viral load, indicating that GS221 has potential clinical benefits for the patients; the second stage trial has initiated and commenced enrollment of subjects.
GS221 is an oral small molecule 3CLpro inhibitor against COVID-19 developed by Grand Pharma with independent intellectual property rights. Grand Pharma has completed 31 patent strategic plan (including 4 overseas patent applications). Among them, 6 patents have been officially authorized by China National Intellectual Property Administration. At the same time, Grand Pharma is continuously to develop the second generation of small molecule 3CLpro inhibitors to achieve product iteration.
The company said that it will continue to make all its efforts to promote relevant research and communicate with the National Medical Products Administration of the People's Republic of China (NMPA), striving for the product to be approved for commercialization as soon as possible. It has achieved pilot scale-up of GS221 and has established corresponding production lines, and the annual production capacity is capable of serving 40 million people to meet treatment demands.
According to the announcement, giving the current positive clinical trial results, after GS221 being successfully approved for commercialization, it is expected to become a broad-spectrum oral drug anti-SARS-CoV-2 that is economical and with excellent therapeutic effect, good safety, and is expected to significantly improve drugs accessibility and reduce the economic pressure of the public to purchase drugs.
It is noteworthy that Grand Pharma's another innovative drug STC3141 has completed the Phase IIa clinical trial for severe pneumonia caused by COVID-19 in Europe and successfully achieved the primary clinical study endpoint, and its clinical trial in China is also conducting smoothly. These two products are expected to achieve coverage of treatment of mild, moderate and severe COVID-19 patients, providing more treatment services to the patients for unmet clinical needs.