China's first homegrown antiviral helps relieve COVID-19 flare-ups

China's first homegrown COVID-19 antiviral, approved by the top drug regulator last month and added to the national COVID-19 treatment protocol this week, has been shipped to regions coping with virus flare-ups, according to drug developers.

The oral drug named Azvudine is priced at 270 yuan ($40) per bottle, containing 35 one-milligram tablets, said Genuine Biotech based in Pingshan, Henan province in Central China.

Henan province is battling sporadic infections; the coastal province of Hainan and Xinjiang Uygur autonomous region are also experiencing new outbreaks. These provinces are among the first to receive the pills.

Azvudine obtained emergency use authorization from China's top drug regulator on July 25 and was included in the latest COVID-19 diagnosis and treatment guideline on Aug 9.

The guideline stipulates that the drug will be used to treat adult COVID-19 patients with moderate symptoms. Each patient will take 5 mg per day and each course of treatment will last no longer than 14 days, which would cost 540 yuan at most.

The National Healthcare Security Administration also confirmed on Friday that Azvudine is temporarily added to the national reimbursement list.

"Azvudine is the first domestic anti-COVID oral pill and our pricing strategy has prioritized affordability," the company told China Daily in a written interview.

The company's production base in Pingdingshan city, spanning 32,000 square meters, passed an inspection led by drug regulators in May and officially kicked off operation earlier this month. It said that the facility's annual manufacturing capacity currently stands at 1 billion tablets and is expected to reach 3 billion tablets in the future.

"In the meantime, we have cooperated with several pharmaceutical companies, including the Beijing Union Pharmaceutical Factory, so as to meet epidemic control demands," the company said.

The recent shipment destined for virus-hit areas is arranged by Genuine Biotech and Fosun Pharma, a Shanghai-based firm. The two companies struck a deal last month to advance commercialization of Azvudine on the mainland, and possibly in foreign countries in the future.

Azvudine was first approved in July 2021 to treat HIV patients and was found to be promising in tackling the COVID-19 disease. In a late-stage clinical trial, 40.4 percent of patients put on the antiviral showed improvement in symptoms seven days after first receiving the pill, compared with nearly 10.9 percent in the control group, the company said in a release in mid July.

The drug is also safe and could clear the virus in about five days, it said.

Chang Junbiao, vice-president of Zhengzhou University in Henan province and a leading researcher behind the pill, said that the development of small, molecular, oral pills could be "the last piece of the puzzle" in the fight against the virus because such drugs hold several advantages such as high convenience, few side effects and relatively low production costs.

Li Taisheng, an infectious disease expert at the Peking Union Medical College Hospital in Beijing, said that years of research on using Azvudine as an HIV drug has helped accelerated the launch of human trials to administer it to COVID-19 patients.

"As a new oral drug, it aids virus clearance, its toxicity is low and its price is very reasonable," he said at a forum on Friday.