News about the progress of Chinese small-molecule oral antiviral drug for COVID-19 has been disclosed in recent days and the related R&D ushers in a critical point.
On the evening of April 17, Junshi Biosciences released the latest research results of VV116, an oral antiviral drug for COVID-19. The antiviral effect of VV116 is a lot better than that of ribavirin in a mouse model, and it could alleviate the pathological damage to lung tissues.
On April 6, Kintor Pharmaceuticals announced key data results from Phase III global multicenter clinical trials of proxalutamide for the treatment of outpatients infected with mild and moderate COVID-19. The research showed that proxalutamide was effective in reducing hospitalization/mortality rates in patients infected with mild and moderate COVID-19. Especially, it has a protection rate of 100% for all patients taking the drugs for more than 7 days.
On April 2, the official website of the Center for Drug Evaluation revealed that the status of the application for a Class III exchanging meeting submitted by Genuine Biotech had been changed from "in process" to "feedback received". In the market, it was interpreted as the indication of the clinical unblinding of Azvudine Phase III and the imminent declaration of marketing.
The first Chinese small-molecule oral antiviral drug for COVID-19 will be launched soon, and it will probably come from the above three drugs. What are the stories of these three drugs? What new opportunities will the development of oral antiviral drugs for COVID-19 bring to the companies in the related industry chain in China?
Junshi Biosciences: VV116
VV116 is a new nucleoside oral antiviral drug against SARS-CoV-2, which can inhibit the self-replication of viruses. In September last year, DreamTop Biotech, a holding subsidiary of Junshi Biosciences, entered into a co-development contract with Vigonvita to jointly undertake the clinical development and industrialization of VV116 in the cooperation zone.
The preclinical research has shown that VV116 has significant effects against SARS-CoV-2 both in vitro and in vivo, exhibiting antiviral activity against both the original and known significant variants (Alpha, Beta, Delta, and Omicron) of SARS-CoV-2. There are also high oral bioavailability and good chemical stability. VV116 is now approved in Uzbekistan for the treatment of patients infected with mild and moderate COVID-19. Results of the clinical research conducted in Uzbekistan in 2021 revealed that: in the VV116 group, compared with the control group, the patients' clinical symptoms can be improved, shortening the time to change from positive to negative results of nucleic acid tests for COVID-19, and significantly reducing the risk of developing into severe ones and even death.
Kintor Pharmaceuticals: Proxalutamide
Kintor Pharmaceuticals' proxalutamide is an ACE2 and TMPRSS2 degradation agent that has shown promising efficacy throughout the period (including early and mid-late stage) of infection with COVID-19.
On April 6, Kintor Pharmaceuticals announced the final analysis results of a global multicenter Phase III clinical trial (NCT04870606) of its self-developed oral antiviral drug for COVID-19, proxalutamide, for the treatment of patients infected with mild and moderate COVID-19.
According to data, proxalutamide is effective in reducing hospitalization/mortality rate in patients infected with COVID-19 (mainly infected by Delta and Omicron mutant strains). Especially, for all patients taking drugs for more than 7 days, and middle and high age patients suffering from COVID-19 with high-risk factors, there is a protection rate of 100%, which is statistically significant. Moreover, proxalutamide can significantly reduce the viral load of SARS-CoV-2 and improve the symptoms. The safety of proxalutamide administration was further validated (for adult men and women aged over 18).
When the data were released, the share price of Kintor Pharmaceuticals jumped nearly 2 times in one day.
Genuine Biotech: Azvudine
Azvudine is one of the new oral antiviral drugs for COVID-19 that has received the most public attention recently. It was initially an anti-HIV drug. In Febru...
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