China's top drug regulator said on Monday that it has granted conditional approval for a homegrown oral pill to be used to treat COVID-19 disease, adding to the growing medical arsenal against the novel coronavirus.
Azvudine, developed by the Genuine Biotech Co based in Henan province, was first conditionally approved to treat HIV-1 infected adult patients with high viral loads on July 20 last year, according to the National Medical Products Administration.
The newly issued greenlight, made possible via an emergency, accelerated approval process, clears the way for the pill to be used for adult COVID-19 patients with moderate symptoms, the administration said in a notice released on its official website.
According to the company, third and late-stage clinical trials show that the oral medication is safe, can improve clinical conditions of patients and inhibit the virus within about five days.
Chang Junbiao, vice-president of Zhengzhou University and a leading researcher of the pill, said during an interview with Henan Daily that clinical trials show that the drug is effective against all emerging variants, including Omicron.
He said that the medication's price has not been determined, but should be much lower than pharmaceutical company Pfizer's Paxlovid pill, which costs about 2,300 yuan ($340) per dose.
Paxlovid was the first easy-to-take COVID-19 oral drug approved on the mainland. It obtained conditional authorization in February. The first domestically developed COVID-19 drug on the market is an antibody medication made by researchers from Tsinghua University and Brii Biosciences and approved in December. Such a drug is usually delivered via injection.
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