China approves homegrown oral antiviral for treating COVID-19

The Chinese company producing Azvudone claimed that 40% of COVID-19 patients administered the drug for more than a week during the third phase of the clinical trial showed improvements when it came to symptoms

August 10, 2022 by Sandipan Talukdar
Chinese Azvudone for COVID-19
(Photo: Wikimedia commons)

Azvudine is a Chinese drug used to treat HIV patients. Now, China’s drug regulating authority has granted conditional approval to use the drug, developed by Pingdingshan-based drugmaker Genuine Biotech, in the treatment of COVID-19 patients. Azvudine has become the first oral antiviral drug repurposed to treat COVID-19 patients.

In their application seeking approval for using the drug to treat COVID-19 patients in early July, the company had claimed that 40% of patients administered Azvudine for more than a week during the third phase of the clinical trial showed improvements when it came to symptoms. Besides, only 11% of the patients who were given a placebo showed clinical improvement, Genuine Biotech further claimed. However, detailed data, including whether Azvudine reduced the risk of hospitalization or even death, has not been released.

Commenting on the lack of detailed data, Jun Wang, a pharmacologist at Rutgers University, New Jersey, US, said that as Azvudine is already an approved drug in China to treat HIV infection, there should be abundant data representing the safety of the drug. According to him, this could have resulted in a fast-track application and approval of it.

Mostly, antivirals target proteins of SARS-CoV-2 that are essential for viral replication. Azvudine also stops the replication of the virus by incorporating itself into the RNA of the virus and tricks the polymerase, a protein involved in the process of viral replication.

Before the approval of Azvudine, China had approval for only one oral antiviral Paxlovid for the treatment of COVID-19 patients. Paxlovid, developed by Pfizer in New York, also shows high efficacy in reducing the risk of hospitalization and death by about 89%. However, supply of this drug is limited in China.

“The market will have room for several more drugs that may not outperform Paxlovid, but allow more people to access effective therapies,” commented Sheng Ding, a pharmaceutical chemist at Tsinghua University of Beijing, highlighting the fact that there is an enormous demand for antivirals globally, especially as COVID-19 continues.

Notably, another anti-viral made in China, VV116, is in its final stage of development and there are dozens of other such drugs in the pipeline. Reportedly, Shanghai Junshi Biosciences, which is developing VV116, is going to apply for approval soon. VV116 is the pill form of Remdesivir drug, which is applied intravenously. Remdesivir was the first drug to be approved by US Food and Drug Administration for treating COVID-19 patients. VV116, a tweaked form of Remdesivir, is already in use in Uzbekistan.

According to the developer, VV116 in its third phase clinical trials showed faster alleviation of symptoms among patients in comparison to those who received Paxlovid. However, detailed data of the trial is still not available.

According to experts, VV116 may work effectively to some extent but how much it will outperform Paxlovid still remains unclear. Moreover, without the detailed data of the clinical trials of both VV116 and Azvudine, it is difficult to say anything conclusive about the efficacy of the drugs.