The first domestic anti -new crown oral medication preliminary pricing per bottle is not over 300 yuan

On August 7, the reporter learned from Henan Real Biotechnology Co., Ltd. that at present, the price of Azf's fixed tablet for the treatment of new crown pneumonia is initially set, with less than 300 yuan per bottle, 35 tablets per bottle, and 1 mg per piece.

On July 25, the State Drug Administration conducted emergency review and approval in accordance with the relevant provisions of the Drug Management Law in accordance with the relevant provisions of the Drug Management Law. Application for registration.

This means that Azf's fixed film has become the first newly -developed oral small crown therapy drug in China.

Azf's fixed film is officially put into production in Pingdingshan

On August 2nd, the first domestic anti -new crown oral medication -Henan Real Biotechnology Co., Ltd. Azf's fixed film was put into production in Pingdingshan, and the annual output of the preparation in the future can reach 3 billion pieces.

According to reports, Azf's fixed film was approved for listing as a treatment of AIDS drugs in July last year, and was commissioned by real biological commissioned Beijing Union Pharmaceutical Factory Co., Ltd. In May of this year, the real biological Pingdingshan production base successfully passed the medical production quality management specifications organized by the Henan Provincial Pharmaceutical Supervision Bureau in accordance with the compliance inspection, marking that the company's own production bases can comply with the production and operation of drugs. On July 25, after the conditions of the State Drug Administration approved the application of Azf's fixed tablet to increase the application for the registration of the new coronary virus pneumonia, in order to meet the needs of large -scale production, real creatures officially launched the production of preparations.

Why can an innovative medicine that treats AIDS can resist the new crown?

As the first anti -new crown oral medicine in my country, how does Azf's fixed film performance? Why can an innovative medicine that treats AIDS can resist the new crown?

Azf's fixed medicine inventor, former president of Henan Normal University, Professor Chang Junbiao, deputy secretary and vice president of Zhengzhou University, said that Azf is the first in my country to have independent intellectual property rights to have independent intellectual property rights. It ended the history of domestic AIDS patients that rely on foreign imported drug treatment. In July 2021, Azf's fixed table was as a type 1 innovative medicine and was approved to be listed on the conditions, providing new treatment options for HIV infected.

Studies have found that Azf will have a broad -spectrum to inhibit RNA virus replication. Although the new coronal virus is different from AIDS virus, it belongs to the RNA virus as a genetic material.

Azfdin, as a nucleoside analog of inhibitory RNA -dependent RNA polymerase (RDRP), can specific effects on the new coronary virus RDRP, thereby inhibiting virus replication, and its drug is targeted and long -term. Azf must be oral drugs for small molecules, which has the advantages of convenient administration, conservative targets, good efficacy, and easy production and storage. Clinical trials show that Azf will significantly increase the nucleic acid ride yin rate, significantly shorten the rotation time, and shorten the patient's hospitalization time, no obvious adverse events, and good safety. Compared with other similar drugs, Azf has the following characteristics -one is that the dose of medication is small, and Azfdin is only 5mg per day.

The second is the low price of drugs. Pfizer's approval of imported new crown oral medication pricing is currently 2300 yuan per box. Azf is designated as my country's first anti -new crown oral medication with independent intellectual property rights. Its price is relatively low.

Azf will definitely treat both the name

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. "

Why do Azfsfu and both cure? Professor Chang Junbiao mentioned that we broke through traditional ideas, developed new strategies for nucleoside drug design, and innovatively used the characteristics of micro -environment RNA polymerase in the process of virus replication, so that drugs "lived" in the target cells activated and lived up and and made the drug. Original role. Through the trials of animal and healthy people, Azfdin entered the body and stayed in the peripheral blood short time. It would soon enter the human body's immune system and enrich the lymphatic system.

Under normal immune situation, the human body is in a controllable state and does not hurt the human body itself. Within a few days after the human body was infected with the new coronary virus, the virus was copied in large quantities. In order to fight against the virus, the immune system would respond. Once a "immune storm" occurred, it harmed the human body very much. Azf will quickly complete three phosphates in immune cells, and the role of specific cells will be used to block virus replication and remove the virus in the immune system. It has no side effects on non -specific cells. It also produces the role of antiviral.

Inhibiting virus replication is a "standard", and the protection of the immune system is equivalent to "books", so Azf's fixed symptoms and cure. In addition, studies have proved that the half -life of Azf in CD4T cells is greater than 120 hours, which shows that the drug is targeted and long -term.

Azf also has a good treatment effect on the new crown virus mutant strain

At present, global scientists are stepping up the development of anti -new coronal virus drugs, but the mutation of the new coronal virus is also continuing.

Especially since November last year, the new crown virus variants Omi Coco has attracted widespread attention. Is Azf the new crown virus variants effective? Professor Chang Junbiao introduced that in the process of anti -new coronal virus drug research and development, my country has deployed three technical routes: inhibiting virus replication, blocking viruses into cells, and regulating human immune systems. The three routes have their own characteristics. Different strategies are adopted to implement "blocking" in different physiological links in the new coronal virus infection. Azf settled the first route, that is, by inhibiting the key enzymes of virus replication to block the replication of the new coronary virus in the human body. Popularly speaking, by creating a "inferior" nucleotide "deception" virus, it uses this "inferior material" when copying itself to achieve the goal of blocking copying and making the virus itself the "rotten project". With a small structure and chemistry composition, it can easily penetrate the cell membrane and then inhibit virus replication.

In addition, Azf must be a unique nucleoside small molecular drug design. Its structure is very similar to the nucleotide substrate required during the virus replication process, and the target target is relatively conservative, so it is still effective for virus variants. Clinical trials have proved that it has good therapeutic effects on the new crown virus variable strains, including Alpha, Beta, Delta, and Omikon.

The annual output of Azfdin's future preparation can reach 3 billion tablets

In May of this year, the real creature Pingdingshan production base has successfully passed the quality management specifications organized by the Provincial Pharmaceutical Supervision Bureau. 32,000 square meters, the annual output of the future preparation can reach 3 billion pieces.

After August 2nd, the production line in the solid agent workshop began to operate after the Azf's fixed production ceremony was completed. "After disinfection of the raw and auxiliary materials, enter the clean area after disinfection, first make a wet granules, then process it into uniformly dry particles, and finally add lubricants to mix. After passing the inspection The specifications are 1 mg. "Zhu Guoshan, Minister of Real Biological Production Department. After the application for the application for an indication certificate was approved, the real biological biology had made a lot of preparations for production, including the printing of drug labels, instructions, equipment debugging, personnel configuration and training. The company's new quality inspection center has completed the relevant verification, which can complete the inspection and testing of raw auxiliary materials, preparations, and packaging materials.

This article comprehensive Henan Daily, etc.

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