The State Food and drug administration, in accordance with the relevant provisions of the drug administration law and the special drug approval procedures, carried out emergency review and approval, and conditionally approved the application for registration of azvudine tablets of Henan Zhenzhen Biotechnology Co., Ltd. to increase the indications for treatment of novel coronavirus pneumonia.
This product is an oral small molecule novel coronavirus pneumonia treatment drug independently developed by China. On July 20, 2021, the State Food and drug administration has conditionally approved the combination of this product and other reverse transcriptase inhibitors to treat adult HIV-1 infected patients with high viral load. This is an additional indication with conditional approval for the treatment of adult patients with common novel coronavirus pneumonia (covid-19). Patients should take medicine strictly according to the instructions under the guidance of doctors.
The State Food and drug administration requires the holder of the marketing license 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.