just!"Azf Fixed Side" was approved by the Emergency Conditions of the Pharmaceutical Supervision Bureau

just! "Azf Fixed Side" was approved by the Emergency Conditions of the Pharmaceutical Supervision Bureau

Source: National Drug Administration, Enterprise Announcement

Just now, in accordance with the relevant provisions of the Drug Management Law, the State Drug Administration conducts emergency review and approval in accordance with the special approval procedures of the drug, and approves Henan True Biotechnology Co., Ltd. Azf Fixed Pixel to increase the treatment of new coronary virus pneumonia. Application.

This product is the treatment of oral small molecular virus pneumonia for oral small molecular virus pneumonia in 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.

It is worth mentioning that on July 15th, the real creature has just announced the results of Azf's fixed tablet to treat the new type of coronary virus pneumonia.

According to the real biological enterprise announcement, the key III registered clinical trials that support the listing of this product are the clinical trial design of multi -center, random, double -blindness, and placebo control. The clinical trial results show:

(1) Significant improvement of clinical symptoms: Azf's fixed tablet can significantly shorten the moderate new type of coronary virus infection with pneumonia patients, improve the proportion of patients with improvement of clinical symptoms, and achieve clinical excellent results. On the first 7th day of the administration, the proportion of the subjects of the clinical symptoms improved 40.43%, and the placebo group was 10.87%(P value <0.001). There are very significant statistical differences with the placebo group (P value <0.001). (PPS set)

(2) Inhibit the role of new coronal virus: Azf will definitely have the activity of inhibiting the new coronary virus, and the virus clearance time is about 5 days.

(3) In terms of safety: The overall tolerance of Azf's fixed decision is good, and the incidence of adverse events has no statistical differences with the placebo group, and the risk of the subject does not increase.

Dr. Du Jinfa, chief scientist of real biological biological biology, said: "We are very happy to usher in this important moment. I look forward to Azf's fixed film approval as soon as possible and contribute to the prevention and control of domestic and global epidemic conditions."

Azf's drug inventor, former president of Henan Normal University, Deputy Secretary of Zhengzhou University, and Vice President Chang Junbiao said: "Azfding is a nucleoside of a virus RNA dependent RNA polymerase (RDRP) Things, the specificity can act on the new coronary virus RDRP, thereby inhibiting virus replication, and its drug is targeted. "

Academician Jiang Jiandong of the Academy of Pharmaceuticals of the Chinese Academy of Medical Sciences said: "Azf will have obvious anti -new coronary virus effects and is effective for patients with clinical severe illnesses. Different biological characteristics. "

Now just 10 days, defeating Jun Shi, successfully became my country's first oral anti -new crown drug with a complete self -intellectual property rights!

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