The Chinese National Medical Products Administration (NMPA) said on Monday that it had granted conditional approval to a domestically developed oral drug for COVID-19 treatment. The announcement was made on the same day that NMPA officials vowed to accelerate the development and approval of COVID-19 therapies.
Azvudine, produced by Genuine Biotech Limited, based in Central China Henan, has been approved to treat adults who show normal symptoms after a COVID-19 infection, according to the announcement by the NMPA.
The administration required the developer to continue further studies on the pill's efficiency against the novel coronavirus and finish and submit results in a limited period.
In July 2021, the pill was approved for AIDS treatment, showing efficacy in treating AIDS and good safety performance during the 48 weeks of oral treatment, according to the company.
Limited information on the clinical trials on the efficacy of Azvudine in treating COVID-19 can be found online. According to a study published in December 2021 on the Signal Transduction and Targeted Therapy, an open access online-only journal, a randomized, single-arm clinical trial of Azvudine on compassionate use showed that an oral dose of 5 mg cured all 31 COVID-19 patients, with 100 percent viral ribonucleic acid negative conversion in 3.29 ± 2.22 days and 100 percent hospital discharge rate in 9.00 ± 4.93 days.
The side effect of Azvudine is minor and causes transient dizziness and nausea in 16 percent of patients. The drug might cure COVID-19 through its anti-SARS-CoV-2 activity concentrated in the thymus, followed by promoted immunity, read the paper.
China approved Pfizer's COVID-19 pill Paxlovid and the domestic neutralizing antibody therapy BRII-196/BRII-198 for COVID-19 treatment. Paxlvoid is sold at about 2,400 yuan ($355) per course and the BRII-196/BRII-198 therapy costs 10,000 yuan ($1,482) for one course of treatment.
The high prices of the two drugs have caused controversy on Chinese social media with some netizens worrying they are too expensive for many families to afford.
Considering this, the approval of Azvudine, sold at less than 1,000 yuan ($148) per course, will ensure more Chinese families can access to COVID-19 treatment, observers said.
According to media reports, Genuine Biotech is able to produce 6.8 billion pills of Azvudine a year, which is enough to treat 200 million people.
On the same day of the announcement of the conditional approval of Azvudine, the NMPA held a nationwide video meeting where officials vowed to accelerate the development and approval of COVID-19 therapies, enhance supervision on the quality of COVID-19 vaccines and guarantee the safety and efficiency of COVID-19 nucleic acid testing kits, according to an announcement by the NMPA.
As China is facing epidemic flare-ups caused by Omicron subvariants, the public have been eagerly calling for more treatment options as Chinese experts noted that China will triumph over the virus when the right conditions are set, which include high vaccination coverage, especially for the elderly and other vulnerable groups, medical resources such as isolation beds, effective medicines and abundant emergency protocols.