The New Drug, The New Medicine, The Old Medicine, The New Medicine, The Old Line Of Medicine, Will Be Launched In Zhejiang And Wuhan.

There is still no specific remedy.

This is the consensus of the official, academia and people since the outbreak of the new crown pneumonia in the past two and a half months. In February 18th, Zhong Nan Shan, a member of the Chinese Academy of engineering, said at a news conference of the Guangdong Provincial People's government, "facing sudden new viruses is often used before scientific research, often using similar drugs with previous mechanisms, which are used on viruses."

Under the "old medicine new use" idea, the R & D personnel all over the world are racing against the clock to "feel the stones across the river".

At the press conference of the national joint defense joint control mechanism held in February 15th, Zhang Xinmin, director of the Biotechnology Center of the Ministry of science and technology, said that the national scientific research team used computer simulation screening and in vitro enzyme activity testing and other rounds of screening. From more than 70000 drugs or compounds to five thousand candidate drugs, more than 100 drugs were launched to carry out the activity test, and finally focused on chloroquine phosphate and Len Di Nelisiwe (Switzerland). A few drugs such as De Wei Wei and France.

In February 16th, Zhejiang Hai Zheng pharmaceutical announced that it was approved to be listed for the treatment of new or re pandemic influenza in adults. Meanwhile, the clinical trial approval of new coronavirus pneumonia was obtained.

Behind the clinical trials conducted by Reed, Wei, chloroquine, and France, the clinical trials of new coronavirus registered on the China clinical trial registry platform are increasing every day. As of February 18th, the number of clinical trials was 145, and in February 4th two weeks ago, the figure was 32. There were 27 trials registered with 2019-nCoV on clinicaltrials.gov.

The "flame France" fire line was approved.

It is a RNA dependent RNA polymerase (RdRP) inhibitor, which is a broad spectrum anti influenza drug. Its original research patent belongs to a small and medium-sized pharmaceutical company in Japan, Toyama chemical company, and was bought by Fuji film Holdings Limited.

In 2014, the country was approved to be listed in Japan for the treatment of new and recurrent influenza and became Japan's national strategic reserve drug. According to a person familiar with the matter, "in other words, in Japanese pharmacies and hospitals, in fact, it can not be bought or used directly."

In 2016, Hai Zheng pharmaceutical signed the exclusive licensing agreement with the original research manufacturer, Toyama Chemical Industry Co., Ltd., and signed a technical cooperation agreement with the Institute of toxicology and pharmacology of the Chinese Academy of Military Medical Sciences. Toyama chemical also has no intention of applying for listing in China. Fuji said at the time that because the drug had high expectations against the effectiveness of RNA viruses, such as Ebora, which belong to the same category as influenza viruses, Hai Zheng pharmaceutical filed an application for Fuji patent in 2015.

Antiviral drugs in respiratory tract have always been scarce, and the original medicine of France is not a drug with broad market in Japan. The sea is listed in the announcement also said, "after querying the IMS database, we did not query the sales data of the variety in the domestic and foreign markets."

Regarding the introduction of the value of the French formula, Li Yan, President of Hai Zheng pharmaceutical company, told the economic report in twenty-first Century that "Hai Zheng has strong pipelines in the antiviral line and anti infection." The mechanism of the drug is different from the existing antiviral drugs. For Hai Zheng, the pipeline for the existing antiviral drugs is a good complement and upgrade. At that time, I did not know that there would be a so-called new crown virus, which was purely considered from the replenish of the pipeline.

According to the Hai Zheng pharmaceutical industry, the members of the virulent RNA virus family of filamentous virus, bunyavirus and gryphirivirus have good inhibitory effects in vitro and in vivo. The new type of coronavirus is also a kind of RNA virus.

But then, due to the problems of enterprise funds and personnel, the project was promoted very slowly. In 2019, Hai Zheng reorganized the product pipeline, drastically carried out R & D reform, cut down a batch of duplication of low efficiency projects, listed the potentially significant items such as the favianwei tablet as a key project, accelerated the pharmaceutical and clinical research, and completed the fasting BE test in 2019.

The "quick" listing of the Hai Zheng FA La Wei tablet also benefited from the need to cope with the rapid development of the epidemic.

Li Yan said that the reasons for the rapid approval were mainly "one is targeted at the approved influenza pandemic, there are relatively few drugs on the market." two, the results of the in vitro activity test for the new crown virus are relatively positive. Although the approval process is very fast, the State Drug Administration and provincial drug administration are very fast and efficient, including on-site verification, sampling inspection and so on.

In January 30th, the clinical trial of a new type of coronavirus pneumonia initiated by the national infectious disease clinical medical research center and the third people's Hospital of Shenzhen (Second Affiliated Hospital of Southern University of science and Technology) was carried out. In February 14th, the third people's Hospital of Shenzhen published an article on its official website: the results of 80 cases from the trial group and the control group showed that the adverse reactions were not found in the treatment group, the side effects were significantly lower than those in the group, the compliance was good, and the antiviral effect after treatment was better than that in the group.

With the official approval of the Hai Zheng FA La Wei tablet, the Hai Zheng pharmaceutical company said it will launch a registered clinical trial for the treatment of indications for new crown virus pneumonia and has been officially approved by the state. The trial was conducted in a double-blind, randomized, controlled study and was expected to end in three months. "Basically, our main PI has been fixed. The hospital is mainly a Zhejiang hospital, and there are several in Wuhan, and there are also Shenzhen." Hai Zheng pharmaceutical company president Li Yan said.

Anti malaria "old medicine" again flash

Reed West Wei, who is conducting clinical trials in Wuhan, officially updated the clinical trial of Reed West on February 17th.

There are currently two randomized controlled trials for evaluating Reed's Wei Wei, one for critically ill patients and the other for median patients. The two tests are being carried out in several hospitals in Hubei Province, and all the patients are in progress. The clinical trial was coordinated by China-Japan Friendship Hospital. The patient will receive a 10 day Reed IV injection. The primary endpoint of the two study included improvement in clinical symptoms 28 days after treatment. We expect to get the test results in April.

It is still not enough to ensure that drugs can be widely used. By comparing with the placebo group, the test will be able to determine the key issues of safety and efficacy of Reed's Wei Wei.

In the process of waiting for "blinding blindness", Reed, the first patient in the United States, has received good feedback.

Another drug that has been repeatedly mentioned recently is the "old medicine" chloroquine phosphate, which has achieved many links from R & D, clinical and production.

According to Zhang Xinmin, director of the biological center of the Ministry of science and technology, at the February 15th press conference, chloroquine phosphate was a antimalarial drug that had been on the market for many years. In vitro experiments showed that it had a good inhibitory effect on the new crown virus. In February 17th, Sun Yanrong, deputy director of the Biotechnology Center of the Ministry of science and technology, introduced the progress of chloroquine phosphate again at the National Health Committee. "Chloroquine phosphate, an old name drug, has been used in our clinic for more than 70 years. Previous studies have shown that it has not only antimalarial effect but also a broad spectrum of antiviral effects, as well as immunomodulatory effects."

But in the face of new diseases, we should not only see the external effects of drugs, but also make effective evaluation through clinical practice, so as to determine whether they can be used in a new way. "We organized more than ten hospitals in Beijing, Guangdong and Hunan to evaluate the safety and efficacy of chloroquine phosphate in the treatment of new crown pneumonia. In clinical practice, we have seen the curative effect very definitely. No matter from the rate of exacerbation, the phenomenon of antipyrexia or the improvement time of the lung, the time of negative conversion of the nucleic acid and the negative rate of the disease, and the shortening of the course of disease, we systematically and comprehensively judged that the medication group was better than the control group. For example, a patient in Beijing was admitted to the hospital at the age of 54 years after onset for fourth days. After taking the medicine for a week, the nucleic acid turned negative, and all the indicators were all good to achieve the isolation and discharge standards.

In terms of drug safety, there are no drug-related and obvious serious adverse reactions found in over 100 patients. In February 15th, a video expert meeting was held in Beijing by the major members of the Ministry of science and technology, the health and Health Committee and the pharmaceutical inspection bureau. Based on the urgent needs of current clinical treatment, the experts unanimously recommended that "chloroquine phosphate should be incorporated into the new edition as soon as possible, so as to expand the scope of clinical trial".

Academician Zhong Nanshan said, "chloroquine phosphate is not a specific drug, I think it is not yet, but a drug worth exploring."

According to Jingtai technology, the economic report said in twenty-first Century, the mechanism and molecular mechanism of chloroquine treatment of new crown pneumonia is not clear. Molecular dynamics simulation of the possible mechanism of chloroquine by Jingtai technology shows that chloroquine can form stable binding conformation with GNE protein catalyzed by sialic acid, thereby affecting the viral receptor glycosylation. At the same time, PLpro, another potential target for stabilizing chloroquine, is also found, and further affinity studies on the effective conformations of the two mechanisms are carried out.

Chloroquine phosphate has been listed for a long time without patent restrictions. Many pharmaceutical companies in China have production and marketing qualifications, which can quickly meet clinical needs, facilitate production and storage, and have higher drug accessibility, which has multiple advantages as emergency drugs.

(Intern Zhang Zhang contributed to this article)

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