Fa Vera Vee China novel coronavirus pneumonia RCT clinical trial is about to sail

Novel coronavirus pneumonia is a randomized, double-blind, controlled trial of Reed's new hope Another drug that is similar to the drug's action mechanism is the special approval of the national drug regulatory agency's drug review center (CDE), and the clinical trial is initiated On February 17, Haizheng pharmaceutical announced to the public that it had received the approval document of CDE "on the conditional approval for the listing of faveravir tablets" China's novel coronavirus pneumonia RCT clinical trial is about to start as the drug is officially approved The novel coronavirus is being planned to start a randomized, double-blind, placebo-controlled, multicenter, phase III clinical trial to assess the safety and efficacy of Fa Vera Vee in the treatment of common new-type coronavirus pneumonia At present, it is being carried out in the First Affiliated Hospital of Medical College of Zhejiang University (hereinafter referred to as the First Affiliated Hospital of Zhejiang University) Novel coronavirus Hai Zheng pharmaceutical laboratory trial scheme is a double blind control study China's clinical trial registration center, Qiu Yunqing, is also the first to launch exploratory research, which is one of the researchers to evaluate the efficacy and safety of the treatment of new coronavirus infection with the tablets of bavavavir and of the drug Another study initiated by researchers related to faveravir is familiar to the industry, that is, the intervention study of faveravir in the treatment of new coronary pneumonia carried out by Shenzhen Third People's Hospital (hereinafter referred to as Shenzhen Third Hospital) On February 14, Shenzhen Third Hospital announced that the preliminary results of 80 patients in the experimental group and the control group showed that the antiviral effect of favilavir was better than that of lopinavir / ritonavir group, and no significant adverse reactions were found, and the side effects were lower than that of lopinavir / ritonavir group The end point of China novel coronavirus PCR test novel coronavirus PCR detection rate, the detection time of new coronavirus PCR, the improvement rate of chest imaging, the incidence of liver enzyme abnormalities, and the incidence of renal damage, according to the China clinical trial registration center, were introduced by the China clinical trial registration center Compared with the previous clinical trial of radcivir, which attracted worldwide attention, the registered clinical trial of faveravir was sponsored by Haizheng pharmaceutical, an old Chinese pharmaceutical company founded in 1956 According to the drug administration law, the measures for the administration of drug registration and the procedures for special approval of drugs, the drug evaluation center shall, upon the review of the special expert group, approve the drug for clinical trials in an emergency manner Indications for novel coronavirus pneumonia According to the introduction of relevant persons, the reason why we consider launching clinical research of new drug registration is based on three points: First, the novel coronavirus was approved by Japan's Ministry of health and labour in 2014 for the treatment of new and recurrent influenza viruses that were ineffective in other influenza drugs, and accumulated a lot of safety data Two, it showed a good anti new coronavirus activity in vitro study Three, based on the clinical research results initiated by researchers from Zhejiang University and Shenzhen three hospitals, Hai Zheng pharmaceutical is confident that it will be effective A novel coronavirus pneumonia indication trial was initiated At present, Zhejiang provincial government, Taizhou Municipal government and Haizheng pharmaceutical will communicate with the Ministry of industry and information technology to donate the first batch of faveravir tablets to the front line of the epidemic for experts to use in the treatment of patients with new coronavirus infection For second novel coronavirus pneumonia RCT clinical trials conducted in China, It is commented that the drug is applied for ind by local enterprises and the production is completely localized The original drug has been listed overseas and has safety data The drug review center has a full and clear basis for review this time The clinical trial of faveravir seems to be more adequate, but the efficacy still depends on the clinical trial to confirm Japan Fushan original research exclusive patent licensing, then, how does this drug come to China? Speaking of the past and present life of favelavir, this is a new RNA dependent RNA polymerase (RdRp) inhibitor developed by Fushan chemical industry under Fujifilm group of Japan Fushan chemical found the drug through screening the chemical library of antiviral activity, and Fushan chemical carried out intracellular phosphorylation to become the active ingredient Photo source: Fukuyama chemical applied for the first compound patent of faveravir in August 1999 in the review report of Japan PMDA, with a term of 20 years In June 2016, the company and Fujifilm signed an exclusive license agreement for the compound patent of favilavir, and then signed a technical cooperation agreement with the Institute of toxicants and drugs of the Military Medical Research Institute of the people's Liberation Army of China Talking about the reason why the drug was introduced in that year, relevant people mentioned that the mechanism of the drug is special and it is a broad-spectrum antiviral drug At the same time, the pipeline of antiviral and anti infectious drugs in Haizheng pharmaceutical industry also needs to be enriched and supplemented "Fuji Chemical did not intend to list the original research drug in other countries after the listing of favelavir in Japan, only as a national strategic reserve Although I didn't expect that this drug would have such a great use today, I'm very lucky to get the patent authorization of this drug in the future " Relevant person in charge said According to GBI source, Haizheng pharmaceutical industry is the first imitated one in China Although Ruiyang Pharmaceutical Co., Ltd., Langfang gaobojingbang Pharmaceutical Co., Ltd and Zhongqi Pharmaceutical Co., Ltd of Shiyao group have applied for clinical application before, they have not been approved By 2018, Fujifilm and Haizheng pharmaceutical signed a memorandum of understanding, agreeing to provide clinical data of faveravir and develop the same active ingredients At the same time, the memorandum was signed by the China Japan Friendship Hospital, a medical institution, and the National Center for emergency pharmaceutical technology According to the memorandum, China Friendship Hospital and technology center will use the active ingredients of the drug to carry out clinical trials for patients with severe influenza from 2019 Fujifilm will cooperate in clinical trials by providing accumulated clinical data, etc In 2019, Haizheng pharmaceutical re combed the product pipeline, carried out R & D reform, cut off a number of repetitive and inefficient projects, focused on core projects, and listed potential or significant projects such as favelavir as key projects In 2019, it accelerated the promotion of pharmaceutical and clinical research, and completed the fasting be test, showing that Haizheng favelavir is equivalent to the original research A total of 4.03 million yuan has been invested in the development, and the post meal bioequivalence research is being carried out, and relevant improvements and supplements are being made according to the review comments and suggestions of CDE Faveravir is similar to radcivir in the PMDA approval process of Japan food and drug administration It is a kind of virus RNA polymerase inhibitor It is the same target, which can prevent the virus gene from replicating in the cell, so as to prevent its reproduction Its principle is: faveravir RTP (faveravir rna-5 '- triphosphate) is recognized as the matrix by RdRp and inhibits RNA polymerase activity Because the catalytic domain of RdRp is preserved in various RNA viruses, this mechanism supports the more extensive antiviral activity of faveravir In further studies, the drug has been shown to be effective against a variety of influenza virus types and subtypes, including strains resistant to existing influenza resistant drugs Coronavirus is one of RNA viruses The drug can selectively inhibit RNA polymerase of influenza virus In animal models, faveravir reduced mortality, viral load, and symptoms, even after 5 to 7 days of infection It can be used in the treatment of current antiviral treatment of drug-resistant virus infection, and has the synergistic effect with oseltamivir and palamivir Japan's Ministry of health, labor and welfare approved its listing in March 2014 The English trade name is avigan, which is mainly used to treat new and recurrent influenza The dosage form is tablet and the specification is 200mg / tablet When it is used to treat influenza, it is only used in the case that other anti influenza virus drugs are ineffective or ineffective It is administered 2 times a day, 1600mg each time; it is administered 2-5 days, twice a day, 600mg each time Medication should be given as early as possible after symptoms of influenza appear Instructions of favelavir tablets in Japan The phase I / II clinical trial conducted in the United States showed that compared with placebo, patients taking 1800mg twice on the first day and 800mg twice daily on the second to fifth days could significantly reduce influenza symptoms, but the first 2400mg, the second and the third 600mg on the first day, and the third 600mg on the second to fifth day did not significantly improve influenza symptoms Although the clinical efficacy of faveravir for a variety of influenza, the therapeutic effect depends on the specific clinical program Fujichem has selected 640 adult influenza A and B patients as research objects in the international multicenter phase III clinical trial of fujichem, and compared with oseltamivir, found that faveravir and oseltamivir showed similar antiviral efficacy and safety In addition, faveravir can also effectively inhibit the resistance of influenza virus (amantadine, oseltamivir, zanamivir) Faveravir can inhibit the synthesis of influenza virus RNA, but has no effect on human DNA and RNA Little is known that, although it is developed and approved as an anti influenza virus drug, faveravir is also used for anti Ebola virus infection The results of a preliminary clinical trial of faveravir in West Africa published in February 2015 show that it has a positive effect on reducing the mortality of people infected with Ebola virus in early stage According to the press conference of the joint defense and control mechanism of the State Council on February 15, a total of 70000 drugs were screened nationwide, 5000 potentially effective products were selected, and 100 of them were selected for in vitro test, and finally focused on three drugs, such as faveravir As early as the first time of anti epidemic, Haizheng pharmaceutical industry has urgently supported medical institutions to carry out clinical trials According to relevant people's recollection, when the outbreak occurred, Haizheng pharmaceutical R & D department held an emergency meeting Based on the research of Wuhan Institute of Virology, it was thought that it might have inhibitory effect on the new coronavirus They speculated that it might be helpful to the outbreak They submitted an urgent listing application before the Spring Festival A novel coronavirus pneumonia trial was launched in January 30th by the national infectious disease clinical medical research center and the third people's Hospital of Shenzhen According to people familiar with the matter, the favelavir used in its hospital is supplied by Haizheng pharmaceutical According to Chapter IV of the measures for the administration of drug registration, accelerated drug registration includes conditional approval procedure, priority review and approval procedure, and special approval procedure Relevant people pointed out that although it is a fast review channel, the whole review process is very rigorous and meticulous The 3 category of novel coronavirus pneumonia is the priority assessment procedure approved by the two categories of listed companies, and is subject to conditional approval When applying for new indications for new pneumonia, the special approval procedure is being adopted Novel coronavirus is now a special approval channel for the public health emergency response The "Wei Wei Wei" tablet of the Hai Zheng pharmaceutical company is a special approval for the new clinical research of new crown virus pneumonia There are strict definitions and standards for special approval procedures, which will not ignore scientific and safety considerations due to emergency The whole review process is rigorous Because the preclinical study is adequate, the drug administration has been very awesome and fast approving, but there has been no reduction in the procedures of on-site verification, technical review and sampling inspection In particular, the on-site inspectors worked overtime for 4 consecutive nights, 24 hours to communicate with the enterprise, so as to make the law