Recently, 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 conditionally approved Henan True Biotechnology Co., Ltd. Azvudine Tablets to increase the treatment of new coronavirus pneumonia. Disease registration application.
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 a new 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.
No.1
Azvudine has a wide range of The role of spectrum inhibiting RNA virus replication
According to Henan Daily, the State Drug Administration officially approved the application of Henan True Biotechnology Co., Ltd. The application of Fuding Tablets for the treatment of new coronavirus pneumonia has been increased, which means that the first small molecule oral innovative drug for the treatment of new coronavirus pneumonia in China has been officially approved.
Azvudine is the world’s first dual-target anti-AIDS innovative drug, which has been patented and obtained in China, the United States and other countries authorized. As an oral antiviral small molecule drug, Azvudine has a broad-spectrum inhibitory effect on RNA virus replication, and the new coronavirus belongs to the virus with RNA as the genetic material, so the drug has an inhibitory effect on the new coronavirus.
Since April 2020, Azvudine has been approved for Phase III clinical trials at home and abroad. The results of the clinical trial showed:
(1) Significantly improve clinical symptoms: Azvudine tablets can significantly shorten the symptom improvement in patients with moderate novel coronavirus infection pneumonia time, increase the proportion of patients with improved clinical symptoms, and achieve clinically superior results.
The proportion of subjects whose clinical symptoms improved on the 7th day after the first administration was 40.43% in the azvudine group and 10.87% in the placebo group (P value<0.001). The median time to clinical improvement of the subjects in the azvudine group was significantly different from that in the placebo group (P < 0.001).
(2) Inhibition of the new coronavirus: Azvudine has the activity of inhibiting the new coronavirus, and the virus clearance time is about 5 days.
(3) In terms of safety: Azvudine tablets were generally well tolerated, and there was no significant difference in the incidence of adverse events between the Azvudine group and the placebo group. No increased subject risk.
Jiang Jiandong, Academician of the Chinese Academy of Engineering and Dean of the Institute of Pharmacy, Chinese Academy of Medical Sciences and Peking Union Medical College, said: “Azvudine has obvious anti-coronavirus effects, and it is suitable for clinical mild and severe cases. All patients are effective, and Azvudine treats the new crown through a molecular mechanism that treats both the symptoms and the symptoms, which is its unique biological feature.”
However, no investigation has been conducted so far. Research paper published in Phase III clinical trial of Azvudine. The State Food and Drug Administration also stated in the notice that it requires marketing license holders to continue to carry out relevant research work, complete the conditional requirements within a time limit, and submit follow-up research results in a timely manner.
No.2
What is Conditional Approval?
According to the Drug Administration Law of the People’s Republic of China, clinical trials of drugs and drugs for the treatment of serious life-threatening diseases for which there is no effective treatment and urgently needed public health Existing data showing efficacy and predicting its clinical value may be subject to conditional approval, and relevant matters should be stated in the drug registration certificate.
For the conditionally approved drugs, the drug marketing authorization holder shall take corresponding risk management measures, and complete the relevant research as required within the specified time limit; If the research is not completed as required or it cannot be proved that the benefits outweigh the risks, the drug regulatory department of the State Council shall deal with it in accordance with the law, until the drug registration certificate is cancelled.
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