On July 25, the State Food and Drug Administration, in accordance with the relevant provisions of the “Drug Administration Law” and in accordance with the special drug approval procedures, conducted emergency review and approval, and approved Henan True Biotechnology Co., Ltd. Azvudine Tablets to increase the treatment of new crowns with conditions. Application for registration of viral pneumonia indications.
This product is an oral small molecule novel coronavirus pneumonia treatment drug independently developed by my country. On July 20, 2021, the State Food and Drug Administration has conditionally approved this product in combination with other reverse transcriptase inhibitors for the treatment of adult HIV-1 infected patients with high viral load. This is a conditional approval of an additional indication for the treatment of adult patients with common novel coronavirus pneumonia (COVID-19). Patients should strictly follow the instructions for medication under the guidance of a physician.
The State Food and Drug Administration requires the marketing authorization holder to continue to carry out relevant research work, complete the conditional requirements within a time limit, and submit the follow-up research results in a timely manner.
Source: State Food and Drug Administration website