The first domestic new crown oral medicine Azf is incorporated into the medical insurance: the price advantage is obvious, and the characteristics of treating the standards are both
Author:21st Century Economic report Time:2022.08.12
21st Century Business Herald reporter Ji Yuanyuan Shanghai report
On August 12, according to the State Medical Insurance Bureau, in accordance with the relevant provisions of basic medical insurance, in order to better guarantee the needs of diagnosis and treatment, all medicines included in the new coronary pneumonia diagnosis and treatment plan can be temporarily included in the scope of medical insurance payment. On August 9, the National Health and Health Commission has issued a notice to include Azf's fixed slices into the new type of coronary virus pneumonia diagnosis and treatment plan. Therefore, the medical insurance fund can be paid in accordance with regulations when using the drug.
At the same time, according to the 21st Century Business Herald, reporters learned from Fosun Pharmaceutical that at present, the commercialization of Azfdin has also accelerated, and has been shipped to Henan, Hainan, Xinjiang and other places. According to the price of medical insurance networks in various places, Azf's fixed price is priced at 270 yuan per bottle. Compared with the new crown therapeutic drugs currently on the market, the price of Azf's fixed tablet has a great advantage. According to public information, the price is 2300 yuan/box.
In terms of price, Azf will only be about one -tenth of the new crown oral drugs that have been launched on the market, and at the same time, its effectiveness and safety have attracted much attention.
At the "Seventeenth National Academic Conference and 3rd International Infection Summit Forum" hosted by the Chinese Medical Association and the Chinese Medical Association Infectious Disease Branch, Jiang Jiandong, an academician of the Chinese Academy of Engineering, accepted the 21st Century Business Herald In an interview with the reporter, the specimen said that both the specimen is an important treatment principle that my country's medicine follows. It not only emphasizes the treatment of disease symptoms and the cause of the disease. Azif to treat the symptoms of antiviral drugs will have the characteristics of cure and the inscriptions. Thymus protection is equivalent to Gu "Ben". Azf's anti -crown conforms to the two pharmacological modes. The first item is antiviral to inhibit the new coronal virus RDRP function. Its antiviral effect is mainly concentrated in the thymus; thymus is actually a amplifier. As long as T cells can produce sufficient function You can enter the second item, that is, to eliminate the virus through the immune system. The dosage of Azfdin only needs to take 5mg once, far lower than the dosage of imported drugs.
Regarding the public's high concern to the price, "the pricing of the new crown oral medication is a normal phenomenon. Domestic drugs need to be in line with China's national conditions and can benefit the general public." Academician Jiang Jiandong said that in addition to the price, the current crown virus variants are currently targeted at the new crown virus variants. The situation also needs to be further strengthened. Azfdin was originally used for HIV patients and was recently approved for treatment of new crown pneumonia, which is also another example of "old medicine and new use".
At present, the global new coronary pneumonia epidemic is raging, and the domestic epidemic prevention and control situation is still severe and complicated. In order to better control the epidemic, the first domestic anti -new crown oral medication was included in the "New Coronary Virus Pneumonia diagnosis and treatment plan (ninth "Edition) (hereinafter referred to as" Diagnosis Plan "). According to the "diagnosis and treatment plan", Azf's fixed tablet is used to treat adult patients with COVID-19). The usage is swallowed in an empty stomach, 5mg each time, once a day, the course of treatment is not more than 14 days.
Professor Wang Guiqiang, director of the Department of Infection of the First Hospital of Peking University, also emphasized in an interview with the 21st Century Business Herald reporter that under the current epidemic situation, the domestic drug is urgently needed to take effective small molecular antiviral oral drugs to meet the clinical needs of first -line resistance. At present, Azf is mainly suitable for the treatment of ordinary adult patients. In terms of the applicability of elderly people, patients with basic diseases, and low immune function, their effectiveness and safety still need to be further practiced in clinical verification. "For the elderly, vaccines and small molecular drugs are important prevention and treatment methods. Small molecular drugs will also become an effective measure to reduce the risk of intensive illness. In addition to the treatment of oral administration of vaccines and small molecules, subsequent clinical drug development will also pay attention to follow Prevention after exposure is also a strong support for the prevention and control of the epidemic. "Wang Guiqiang said.
Azfdin "old medicine new use"
Before being treated with new crown pneumonia, Azf was used to be used for HIV patients. 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.
Professor Cai Weiping, chief physician of the Infectious Department of the 8th People's Hospital of Guangzhou City, introduced in the above forum that Azf's mechanism of Azf's fixed resistance to HIV is mainly due to its dual target and strongly block the life cycle of HIV. Its dual target refers to the simultaneous inhibitory nucleoside reversal recording enzyme and VIF targets. As a nucleoside reverse transcriptionase inhibitor (NRTI), it can inhibit the extension of the reverse transcription enzyme and the virus nucleic acid chain to prevent the virus from copying, as a time as a virus. VIF inhibitors can increase the level of host antiviral factor A3G, reduce the infection of newly generated virus particles, and then achieve the effect of strongly suppressing HIV replication.
The arrival of the new crown epidemic is urgently needed to develop new antiviral drugs, and the development of new drugs is a process that takes time, a large consumption and a low success rate. Special effects of pneumonia. Azf has the effect of broad -spectrum inhibitory RNA virus replication. Although the new coronal virus is different from AIDS virus, it belongs to RNA viruses as genetic materials. Since then, the two -year -old Azf fixed anti -new coronal virus research and development process.
In January 2020, Chang Junbiao, deputy secretary of the Party Committee of Zhengzhou University, and the inventor of Azf, determined that Azf's new coronary virus project was established. The provincial new coronary virus prevention and control emergency research project "drug screening of anti -new coronary virus" was approved by the Henan Provincial Department of Science and Technology, and then in April of the same year, it was obtained by the National Drug Administration for treatment of the new Coronatte Poor Phase III clinical approval, and carried out the domestic phase III clinical clinical clinical. Tests, the following year, obtained the clinical approval of Phase III in the treatment of new coronary virus pneumonia abroad, and conducted phase III clinical trials in Russia and Brazil. In April 2022, Azf completed the phase III clinical trials at home and abroad and officially unveiled. On July 25, 2022, Azf was formally approved for listing as the first anti -new crown pneumonia small molecule oral medication. According to Chang Junbiao, Azf must be a nucleoside drug, and nucleoside drugs are a very important antiviral drug. Nearly 60%of the antiviral drugs currently used are nucleoside drugs, nucleosides (acid) are the most basic drugs for RNA and DNA synthesis. About 55 registered nucleoside drugs worldwide are used for clinical clinic; There are 46 clinical drugs, which have been used for clinical and clinical nucleoside drugs that are metabolized for their triple phosphate.
"Azov antiviral drugs are definitely a oral small molecular drug. The advantage of the small molecule oral drugs is that the target is conservative and still valid for the mutant virus; Good, high safety, and small side effects; easy to produce, store and transport, can achieve global distribution; production cost and price are far lower than antibody drugs. "Chang Junbiao said to the 21st Century Business Herald reporter that reviewing the history of century -old influenza is truly free The means of influenza influenza is the "prevention+treatment" combination of "vaccine+oral drugs", especially the emergence of oral anti -influenza drugs, so that influenza virus is no longer terrible, and small molecules oral drugs are expected to become the last of the new crown epidemic prevention and control. Puzzle.
As for whether the drug is effective for the mutant strain, Chang Junbiao believes that theoretically, Azfdin is effective for new mutant strains, but it also needs to see the actual use of the drug in clinical practice. In addition, Ren Zhigang, deputy chief physician of the Department of Infectious Diseases, the First Affiliated Hospital of Zhengzhou University, also emphasized in an interview with the 21st Century Business Herald reporter that in the applicable population of drugs, the drug is currently applied to the adult patients of new crown pneumonia, but the specific medication is used for the specific medication. The situation needs to be judged by the doctor according to the patient's condition. As an antiviral drug, the early reduction of the virus load is very meaningful. The specific medication situation must be complied with the doctor's order.
How big is the market space?
Anti -virus drugs should be used for early intervention of peak intervention released after the virus enters the human body after entering the human body. According to real biological aspects, Azf's semi -might of more than 120 hours in a target cell is a long -acting drug. At the request of the state, Azf will undermine clinical trials to prevent the field of new crown pneumonia, which is expected to become the first choice for preventing new crown pneumonia in the future.
In this situation, how much is the market space of this medicine? In the case of many pharmaceutical companies that laid out new crowns and prevent the market, what are the market directions that need to pay attention to in the future.
In this regard, the new crown therapy drug introduced in an interview with the 21st Century Business Herald. It is not the most important factor. The most important thing is the safety and effectiveness of the drug. Whether it can clearly bring clinical value to the patient. "The executive introduced that the clinical expert now has a consensus: on the one hand, asymptomatic infection infection Those who do not intervene. This is also because the new crown pneumonia itself is a self -limited disease. The risk benefit after taking the medicine cannot be used as the basis for taking medicine. On the other hand, a drug development must meet the clinical needs of existing people. Judging from the current situation of virus infection, it may be necessary to use different mechanisms for different effects mechanisms for people with low immunity or severe symptoms. In the treatment of other viral infections, this is a better strategy that can quickly suppress the virus that produces resistance. Therefore, at this point, different development paths, drugs of different mechanisms, and space for combined use, and these have to be proven more clinical trials.
In fact, in order to accelerate the market layout to the greatest extent, in addition to the real creature, Azf is scheduled to be approved, at present, there are already several new crown oral medicines in China to enter the clinical trial stage: the VV116 of the Junshi creatures and the pioneering pharmaceutical industry Pukruamine has entered the third phase of the clinic; the FB2001 of the cutting -edge creatures has been approved to conduct the second and third international multi -center clinical trials; Entering the first phase of clinical trials, the Shen26 developed by Kochi Pharmaceutical and Shenzhen Antawei Biomedicine has been approved for the first phase of clinical trials; the clinical trials of Zezhe Pharmaceutical for the treatment of heavy new crown patients have also been approved.
On the whole, the drug action mechanism of global anti -new coronal virus infection can be summarized into two categories. One is to prevent the combination of virus and host cells, such as S protein and ACE2, which is also the target of single cloning antibody drugs; It is to prevent the new virus from being produced in the host cells, and there are more targets that can act, such as 3CL, RDRP, etc. Chang Junbiao said that because the target entry point is different, the drugs of the Azfdin RDRP mechanism are different from the 3CL in the blocking mechanism. As for the future market application prospects of the two mechanisms, comprehensive security and effectiveness are required for comprehensive assessment. In addition, it is important to emphasize that the research and development of new crown pneumonia should not be rushed to achieve success, and it needs to be treated with caution. Therefore, after the listing, Azf will also need to stand the test of various tests to obtain widespread recognition of society.
"Right now, from the perspective of the entire domestic market, the imported drugs have been approved to be listed. Among the domestic drugs, Azf will be the first small molecular drug to be approved to be listed. At present, it has arrived in Henan, Hainan, Xinjiang and other places, and we also look forward to the further clinical results of the drug. "Ren Zhigang said.
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