"New Crown Oral Medicine" is here!Virus, retreat!retreat!retreat!

Author:Youth Hubei Time:2022.07.27

According to the website of the State Drug Administration, on July 25, in accordance with the relevant provisions of the Drug Management Law, the State Drug Administration shall conduct emergency review and approval in accordance with the special approval procedures for the drug, and approve the conditions of Henan Real Biotechnology Co., Ltd. Azf Increase application for the treatment of new coronary virus pneumonia adaptation.

Azf's fixed film is the treatment of oral small molecular virus pneumonia therapy drugs independently developed by my country. On July 20, 2021, the State Drug Administration has attached conditions to approve this product and other reverse-translitease inhibitors to treat adult HIV-1 infection patients with high virus load. This is an attachment to approve new indications for the treatment of adult patients with COVID-19) for the treatment of ordinary new type of coronary virus pneumonia. Patients should be used strictly under the guidance of the doctor.

Conditional approval

According to the Drug Management Law of the People's Republic of China, diseases that have severe life and have no effective treatment and drugs that are urgently needed in public health in the People's Republic of China. If the drug clinical trial existing data shows the efficacy and can predict its clinical value, it can be approved for conditions. Related matters in the pharmaceutical registration certificate.

For drugs approved, the holders of the drug listing permit shall take corresponding risk management measures and complete the relevant research within the request within the prescribed period; if the research is not completed in accordance with the requirements or proves that the benefits of their benefits are greater than the risk, the Drug Supervision of the State Council is supervised by the State Council's drug supervision. Management departments shall handle it in accordance with the law until the cancellation of the drug registration certificate.

In the previous application for listing to the State Drug Administration, the real creature attached the result of the results of the phase III registered clinical trial, pointing out that Azf will significantly improve the clinical symptoms, that is, "can significantly shorten the moderate new coronary virus infection pneumonia patient Symptoms improve time, increase the proportion of patients with improvement of clinical symptoms, and achieve clinical excellent effects. "

In addition, Azfdin also "has the activity of inhibiting the new coronary virus, and the virus clearance time is about 5 days." In terms of security, "Azf's final tolerance is good" and "no risk of subjects."

The State Drug Administration requires listing permit holders to continue to carry out relevant research work, complete the requirements for qualified conditions within a time limit, and submit subsequent research results in a timely manner.

At present, Azf has the basic conditions for the entire industrial chain from R & D, raw medicine, preparation to produce, preparation production, and sales headquarters.

The new crown oral medication is an important part of controlling the new crown epidemic. It also adds new members to our weapon library after vaccine and antibody drugs. With the efforts of the new drug R & D personnel, we look forward to that we can make the epidemic no longer terrible.

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