New antiviral drug on the market is the first copy of the first fake favilave tablet approved in China

Pharmaceutical Network May 22 - Three months after obtaining the approval of the drug registration, Haizheng Pharmaceuticals Haifukang Favirave tablets (also known as Faviiravir, English name Favipiravir) have been officially put on the marketMedical Valley reporter was informed that this favilawe is a multi-channel comprehensive supply, the public can use prescriptions in hospitals, entityand HaizhengTmall flagship store to apply for purchase, a box of specifications of 10 x4 boardsIt is understood that Faviravir is a new type of RNA-dependent RNA polymerase (RdRp) inhibitors, belonging to the broad-spectrum anti-flu virus drugs, studies show that, in addition to influenza viruses, Faviravir also showed good inhibition effect on a variety of RNA viruses, the current new coronavirus belongs to a kind of RNA virusOriginally developed by Fujifilm Group Toyama Chemical Industry Co., Ltd., Favirawe was approved for market launch in March 2014, primarily for the treatment of new and recurrent influenza, and became Japan's national strategic reserve drugIn June 2016, Haizheng Pharmaceuticals and Toyama Chemical Industry Co., Ltdof Japan signed an exclusive licensing agreement for compound patents, allowing the development, manufacture and sale of relevant anti-flu virus drugs in China, after which Haizheng Pharmaceuticals signed a technical cooperation agreement with the Toxic medicine Research Institute of the Military Medical Research Institute of the Chinese People's Liberation Army to cooperate in the development of the Faviravir projecton February 15 this year, Favirave was approved by the National Drug Administration for the treatment of new or re-circulating influenza in adults (only for other anti-flu drugs that are ineffective or ineffective), the first copy of the drug in the countryIt is worth noting that Faviravir's approval of the market is conditional approval, i.ethe completion of the outstanding pharmaceutical and clinical pharmacological related studies after listing, after completion of the national drug review agency timely reporting of the results of the studyat the same time, because Haizheng Pharmaceutical Favirave tablets from the Spring Festival period of the registration of the official acceptance, to the final February 15 to complete the approval, only took about 10 days, but also raised the existence of a gap with the original research, whether it is a rapid priority approval of the questionthis, in this Favilawe listed media communication meeting, the relevant person in charge of the medical valley reporter son- and other reporters: The Favirawe film project has gone through a lot of twists and turns, although the project as early as 2016 with Fuji Group signed a patent licensing cooperation agreement, but until the three years before 2019, there has been no more substantial progress, in 2019 Haizheng Pharmaceutical's new management after taking up its duties Taking into account the antiviral properties of Favirawe, combined with the company's original advantages in antiviral raw materials (Haizheng Pharmaceuticals is the largest raw material supplier of the anti-flu virus drug oseltamivir), the Favirawe project was finally promoted as a priority project, and in February 2019 completed the fasting BE test, with the drug efficacy of the reference preparations, and then reported to the State Drug Administration"Generally speaking, a drug to get market approval, even in the last two years, drug approval has been greatly accelerated, it will take about 1-2 years, but by the impact of this year's outbreak of new coronary pneumonia, the relevant functional departments of the state from the drug concentration, antiviral effect, in vitro experiments and other considerations, Favilavi included in the 'three drug three programs', and carried out rapid priority approval, the approval is also the State Drug Administration on the quality of the drug strict control." "
also, for the outside world has been concerned about the results and solute after meals, the relevant person in charge revealed that the degree of dissolving related analysis has been completed, after several large-scale production has proved that the degree of dissolving is not a problem, the results are still being done at this stage 　　The pricing of favirave tablets, a potential treatment approved simultaneously for clinical trials of new coronary pneumonia, is also extremely sensitive the pricing considerations of favirave tablets, the person in charge said: "The pricing mechanism will take into account the cost of products and domestic and foreign conditions, obtain a relatively low price, different from some foreign from the pharmaceutical economics, Haizheng Pharmaceuticals as a state-controlled enterprise, more need from corporate social responsibility, coupled with the impact of the outbreak, but also to consider the payment ability and accessibility of drugs, so Haifukang Favirave film will be lower than the industry's average gross margin of the price to benefit patients "
According to a previous announcement by Haizheng Pharmaceuticals, the company has so far invested more than 40 million yuan in the Favirawe research and development project Medical Valley reporter in the interview learned that, in order to further enhance the accessibility of the Favirave tablets, Haizheng Pharmaceuticals in terms of production capacity is full of horsepower, the current daily production capacity can reach 1-2 million shares, in the sales channels, in addition to offline coverage in pharmacies and end of the academic promotion, Online, Haizheng Pharmaceuticals in March has been in Tmall Mall on the first Tmall flagship store, the next, will also be in Beijing East, Sidodo and other e-commerce platform layout, with some Internet hospital cooperation is also in negotiations, later will also consider the drug donation activities and medical insurance catalog into 　　At present, the outbreak of new coronary pneumonia is also spreading around the world, as of 6:57 beijing time on May 20, the cumulative number of confirmed cases of new coronary pneumonia exceeded 4.98 million cases, the cumulative number of deaths exceeded 324,000, "special drugs" (including vaccine development) is considered to be a powerful weapon to combat this major global public health crisis so far, a number of new coronary pneumonia drugs have been conducted in the world clinical trials, of which the most famous is Ridsywe, known as "the hope of the people", and earlier this month received an emergency FDA authorization for the treatment of serious COVID-19 patients, followed by Japan's Ministry of Health, Labour and Welfare approval However, in a randomized double-blind trial of patients with severe COVID-19, published last month in 10 hospitals in Hubei, China, there was no statistical difference in clinical improvement time (18 days vs 23 days) compared to the placebo group, no significant reduction in viral RNA load in patients, no significant reduction in patient mortality (13.9% vs 12.8%), and no difference in the incidence between the two groups (65 percent) This also means that Redsiewe did not meet the expectations of the research program design and the earliest clinical trial conducted in China was conducted in Shenzhen Third People's Hospital (hereinafter referred to as Shenzhen Three Hospitals), which is a small clinical study, the results show that the Favirawe tablet treatment group has not yet found significant adverse reactions, side effects are significantly lower than the Creech treatment group, patient compliance is good; at the same time, at the March 17 press conference of the State Council Joint Defense and Control Mechanism, Zhang Xinmin, director of the Biological Center of the Ministry of Science and Technology, further said that the Favirave tablets have completed early clinical research, showing good clinical efficacy, no obvious adverse reactions, it is recommended to be included in the diagnosis and treatment program as soon as possible it is learned that after the approval of the new coronary pneumonia clinical trial, Haizheng Pharmaceuticals immediately advanced a national multi-center randomized double-blind control clinical trial, planning to join hundreds of patients, respectively, under the existing standard treatment program to increase the Favirawe tablets or placebo treatment, medical institutions including Zhejiang, Wuhan, Shenzhen and other hospitals, at this stage, clinical trials are still in steady progress, there is no preliminary data Favilawe also registered to apply for an international multi-center clinical trial, the official said Medical Valley reporter found that as of May 19, 2020, 20 o'clock, the new coronary pneumonia clinical research registered more than 600, of which, more than 5 clinical trials about Favirawe, the first one for the Shenzhen three hospitals registered on February 6, "Favira A clinical study on the safety and efficacy of patients with new coronavirus pneumonia (COVID-19), "the most recent clinical trial program for the treatment of new coronary virus pneumonia (COVID-19) by the Favirawe tablets combined with chloroquine tablets registered on March 20 at Chaoyang Hospital in Beijing, affiliated with Capital Medical University." also worth mentioning is that after favirawe was approved for listing, based on its early clinical research data, the State Council joint prevention and control mechanism as anti-epidemic materials, and through the national unified allocation of the way to assist 26 countries, directly applied to the new coronapneumonia patients, "to Turkey, for example, the amount allocated to them is also relatively large, we get the initial application data feedback is satisfactory." The above-mentioned person in charge told the medical valley reporter.