The article is from WeChat public account: qubits (ID: QbitAI) , original title: “the first new drug approved crown pneumonia potential production to market: favipiravir significant clinical efficacy, lower side effects,” the authors: fish, sheep, Lai can

Good news!

The first potential drug for the treatment of new coronary pneumonia has been approved by the State Drug Administration.

Three potential anti-epidemic western medicines have been officially announced by the Ministry of Science and Technology before: Fapilavir, Chloroquine Phosphate, and Radixivir.

They all initially showed more obvious curative effects and lower adverse reactions in clinical trials.

Fapiravir is now the first to be approved and is being developed and put into production by Zhejiang Hisun Pharmaceutical. Although the indication approved this time is influenza, it will be able to benefit more patients with new coronary pneumonia through “sympathetic dosing” after being marketed.

Falavivir’s clinical trials for neocoronary pneumonia are also continuing.

In addition, in addition to new developments in therapeutic drugs, the good news also comes from testing. A faster antibody test kit developed by Academician Zhong Nanshan has shortened the test results to less than 15 minutes.

The dawn of the war is perhaps ahead.

What is Fapilavi?

Fapilavir, one of the three drugs focused by the scientific research group.

Favavir, also known as Favipiravir or Avigan in English, was developed by Toyama Chemical Company of Japan.

This is an experimental anti-influenza drug, a broad-spectrum anti-RNA virus drug, active against many RNA viruses. In 2014, it was approved in Japan as a stockpile for anti-flu pandemic.

Previous trials have shown that fapilavir has a certain effect on Ebola virus. Results from tests in 2015 showed that it could reduce mortality in patients with low to moderate blood levels of Ebola virus.

Fapilavir also effectively inhibits Ebola virus, yellow fever virus, Chikungunya virus, Norovirus (norovirus) . A recent study showed that in vitro cell line experiments, its EC50 against neocrown virus reached 61.88 μM.

In subsequent clinical trials of new coronary pneumonia, fapilavir gradually showed its effect.

Participating clinical trials in the Shenzhen Third Hospital concluded that fapilavir is safe and effective, has better antiviral efficacy than clizil, and side effects are significantly lower than clizil. It is recommended to expand the scale in clinical application.

On February 15, at the press conference of the joint prevention and control mechanism of the State Council, Zhang Xinmin, director of the Biological Center of the Ministry of Science and Technology, further disclosed the clinical results:

Fapilavir is an overseas marketed drug for the treatment of influenza. Currently, clinical trials are being carried out in Shenzhen. More than 70 patients have been enrolled. The control group is included here, which initially shows more obvious efficacy and lower adverse effects reaction. From 3 to 4 days after treatment, the viral nucleic acid conversion rate in the treatment group was significantly higher than that in the control group.

On the same day, Fapilavir was formally approved by the State Drug Administration for marketing, becoming the first drug approved for marketing in the country during the epidemic period with potential therapeutic effects on new coronary pneumonia.

On the morning of February 17th, Hisun Pharmaceutical announced that fapilavir tablets have obtained both drug registration approval and drug clinical trial approval.

According to the drug registration approval, this approved fapilavir is a tablet, produced by Zhejiang Hisun Pharmaceutical Co., Ltd., and is mainly used to treat new or re-influenza in adults.

Although the approved indication for fapilavir is influenza, clinical trials of this drug against the new crown virus have already begun.

The approval results of Clinical Trial Approval:

Emergency approval of this product for clinical trials, the indication is new coronavirus pneumonia.

History Pharmaceuticals previously stated in an interview with the medical media ’s Rubik’s Cube:

Fapiravir, once approved for marketing, can be used by clinical experts in small-scale sympathy to treat new coronary pneumonia. If there is more clinical evidence that fapilavir is effective in the treatment of new coronary pneumonia, it will provide more drugs to benefit patients through appropriate channels.

Simultaneous approval for marketing and clinical trials is also a manifestation of accelerating the review and filing of potential new pneumonia drugs. It only took half a month for the drug to be submitted for marketing. While clinical trials are progressing simultaneously, if the trial goes well.

Looking forward to the good news of Fapilavir’s clinical trials.

Progress in two other clinical trials

One is the previously well-known Reddivevir (“People’s Hope”) , and the other is called chloroquine phosphate.

According to Zhang Xinmin, director of the Biological Center of the Ministry of Science and Technology, as of February 16, a total of 136 studies on new coronavirus pneumonia have been put into clinical trials.

But the drugs that the scientific research group focuses on mainly include chloroquine phosphate and lendesivir (Redivevir) —— and put into production today Fapilavir.

What medicine are the first two? We started to know each one.

First, chloroquine phosphate is an antimalarial drug that has been on the market for many years.

The main anti-virus mechanisms are:

  1. Since chloroquine can change the pH of endosomes, it has a significant inhibitory effect on viral infections that invade cells through the endosome pathway, such as Borna disease virus, avian leukemia virus, and Zika virus.


  2. Chloroquine can affect viral replication by inhibiting viral gene expression. In vitro and in vivo experiments have shown that chloroquine can change the glycosylation pattern of HIV virus gp120 envelope and inhibit the replication of HIV virus in CD4 + T cells.


  3. As a good autophagy inhibitor, chloroquine can interfere with virus infection and replication by affecting autophagy response.



    Animal experiments show that the application of chloroquine can effectively inhibit autophagy in the lungs of avian influenza H5N1 mice and reduce alveolar epithelial damage. It has also been reported that chloroquine can block Zika virus-induced autophagy, thereby inhibiting virus replication; mouse experiments have also shown that chloroquine can cut off vertical infection of Zika virus from the maternal-fetal pathway.

    In addition, in 2004, in the research on SARS virus, there were reports that foreign scientists found that chloroquine could inhibit the SARS virus replication in vitro.

    Introduced by Zhang Xinming, this time, in vitro experiments showed that chloroquine phosphate has a good inhibitory effect on the new crown virus. And because it is a marketed drug, its safety is also guaranteed.

    Clinical research is currently underway in more than ten hospitals, including Beijing and Guangdong, with more than 100 patients enrolled. In the near future, Hunan Province will also start a multi-center clinical trial of chloroquine phosphate.

    Second is Redisiver, which is more known.

    Redesivir, a nucleotide analog prodrug, inhibits RNA-dependent RNA synthetase (RdRp) , by The world’s first antiviral drug research company, Gilead Scientific, has been researching and developing for nearly 10 years from the beginning of research and development.

    Redesivir is effective against both SARS and MERS coronaviruses in vitro and in animal models, so experts judge that Redesivir is also effective against neocoronaviruses.

    Reedivir was used in the treatment of the first patient diagnosed with new coronary pneumonia in the United States, and the effect was significant. Since then, Reddiveway has further high hopes.

    Currently, Redesivir is still in clinical trials. Wuhan Jinyintan Hospital, Municipal Pulmonary Hospital, Tongji Hospital, Xiehe Hospital, etc. have all launched drug trials.

    A total of 168 patients with severe illness and 17 patients with mild and ordinary patients have been enrolled.

    According to the latest news from the Yangtze River Daily, from February 5th, a 68-year-old male severely ill patient from Wuhan Jinyintan Hospital became the first trial of Redecvir, and it is progressing smoothly.

    Professor Zhong Ming, deputy director of the Department of Critical Care Medicine, Zhongshan Hospital, Fudan University, also said in a video interview:

    Including our front-line doctors, we still have great hopes for this drug. But there is no data to tell us whether this medicine is useful or not. This medicine requires a 10-day dosing cycle and is double-blind. The first batch of patients could only see real results after 10 days of unblinding.

    Professor Zhong Ming is one of the first medical staff to assist E in Shanghai and is currently treating critically ill patients at Wuhan Jinyintan Hospital.

    Peng Zhiyong, director of the intensive care unit of Central South Hospital, said that the final effect of Redecive should wait until the end of the trial.Home evaluation. There are many indicators, including virological evidence, clinical indicators, and imaging indicators for comprehensive judgment.

    The clinical trial was originally planned to end on April 27.

    Test kit developed by Zhong Nanshan: 1 drop of blood yields results in 15 minutes

    In addition to medicines and test kits, there are also new developments.

    According to CCTV, Zhong Nanshan developed a rapid test kit that takes 1 drop of blood and obtains the test results within 15 minutes.

    On February 14, the State Key Laboratory of Respiratory Diseases of Academician Zhong Nanshan revealed that the laboratory, together with the Guangzhou Institute of Biomedicine and Health of the Chinese Academy of Sciences, the Guangzhou Laboratory of Regenerative Medicine and Health, and other units recently developed a new crown Virus IgM antibody rapid detection kit, and has completed preliminary evaluation in the laboratory and clinical.

    The kit uses colloidal gold immunochromatographic technology to detect human new coronavirus IgM antibody in an indirect method. It only takes one drop of blood and it is expected to obtain the test result by visual inspection within 15 minutes, and the patient’s plasma is diluted 500 to 1000. After this time, positive bands were still detected.

    The State Key Laboratory of Respiratory Diseases revealed that this kit has been applied in a hospital in Hubei, and it has been found that some clinically confirmed positive new-type coronavirus infections (but negative for PCR nucleic acid detection) The blood samples of patients are re-examined. The kit can detect a considerable part of the (IgM) Positive, suggesting complementarity with nucleic acid detection.

    The kit is currently (for scientific research) Samples have been sent to Wuhan, Huanggang, Daye and other primary health institutions in Hubei Province in large numbers, and used in conjunction with nucleic acid detection and other technologies to detect new types of coronavirus infections Test evaluation.

    Researchers said that this method is expected to break through the limitations of existing testing methods on personnel and places, shorten the testing time, achieve rapid diagnosis of suspected patients and on-site screening in close contact with the crowd, and push forward the diagnostic screening forward. .

    So with the speeding up of testing and the good news from drugs, the day of victory in fighting the epidemic may also continue to accelerate.

    Among all things, I hope to be beautiful.

    In addition to praising the front-line medical angels, the front-line researchers who have passed the news are also admirable.

    One more thing

    Finally, after Fapilavir was first approved for production, many netizens also paid attention to the progress of traditional medicine in epidemic prevention.

    At present, there are many Chinese medicines and proprietary Chinese medicines on the website of China Clinical Trial Registration Center. Etc.) Clinical trials against neocoronavirus are also underway. The specific data and results have not been disclosed, and the specific efficacy is unknown.

    But some netizens have provided scientific evidence that traditional Chinese medicine may be effective against the new crown virus.

    It also comes from the international authoritative medical journal—NEJM (New England Journal of Medicine) , in a recent review paper, focusing on The placebo effect and the anti-placebo effect are discussed.

    The paper states that the placebo effect and anti-placebo effect are the effects of patients’ positive and negative expectations of their own health, respectively. Placebo effects lead to favorable outcomes, and anti-placebo effects lead to harmful and dangerous outcomes.

    In clinical practice, placebo and anti-placebo effects are powerful, widespread, and common. These effects can be produced by neurobiological mechanisms, treatment-related information, patient expectations, previous experience with medications or procedures, and the treatment environment.

    In clinical practice and clinical trials, strategies that promote placebo effects and avoid anti-placebo effects can improve treatment outcomes and reduce unintentional worsening of symptoms.

    A more straightforward interpretation is that in the presence of a virus attacking the immune system, having a placebo can give patients more confidence to stimulate the power of their immune system, and ultimately play a role in fighting the virus.

    Of course, for more details, we might as well move the portal:

    Chinese version address: https://nejmqianyan.cn/article/YXQYra1907805

    In addition, there are two new developments in the research of new crown virus.

    First, the new coronavirus not only totals the lungs and other respiratory systems, but may also damage the kidneys and testicles-so those who eat game have noticed that game aphrodisiac not only has no scientific basis, it may also be counterproductive.

    Second, a study from the University of South Carolina pointed out that smokers may be more susceptible to the new crown virus.

    I wish everyone good health, continue to do a good job of protection, and victory in epidemic prevention is not far away.

    Reference link:

    http://www.xjhfpc.gov.cn/info/2071/18527.htmhttps://weibo.com/tv/v/Iudni2g89?fid=1034:4472012215615539https : //www.thepaper.cn/newsDetail_forward_6019260http: //finance.sina.com.cn/roll/2020-02-17/doc-iimxyqvz3433642.shtml


    Article from WeChat public account: qubit (ID: QbitAI) author: fish, sheep, Lai can