Russia (bbabo.net), - The most demanded task today is the formation of a strong and reliable protection against new infections. Vladimir Putin spoke about this during a meeting of the Council for Science and Education under the President of the Russian Federation.
Putin noted that in the context of the epidemic, along with operational decisions, the government took a whole range of strategic measures to create new drugs, a system for monitoring and preventing biological risks and threats. However, we need to bring this work to an even higher, even higher quality level.
"To do this, we must have our own, domestic equipment, components, raw materials, advanced and even unique competencies in the development and use of pharmaceuticals, including new generation medicines, including for the treatment of antibiotic-resistant infections," the President stressed.
It is worth saying that before the pandemic, Russian pharmaceutical companies were practically not mentioned among the leaders in their own original developments. However, the situation is changing, and Russian pharmaceutical manufacturers are now paying great attention to the creation of domestic innovative drugs. The impetus was given by the pandemic of a new coronavirus infection, against which the pharmaceutical market began to grow, and business turned to science for help.
So, in 2020, clinical trials (CTs) of three experimental drugs for the treatment of COVID-19 started in our country. As the media wrote then, the permits were issued by the Ministry of Health of the Russian Federation, which approved the testing of drug molecules APN01, DFV890 and XC221. It is noteworthy that the latter was developed for the treatment of influenza and SARS, so its first clinical trials took place in Russia even before the pandemic.
In 2017, they were organized by the developer - Pharminterprices, a resident of the Skolkovo Center, specializing in the creation of innovative medicines. The studies were carried out by the Russian company IPHARMA, which received permission from the Ministry of Health of the Russian Federation. The tests were successful, and the molecule was recommended for further research.
Interest in the drug arose with renewed vigor in 2020, when Russia and the world urgently began to look for remedies against COVID-19. As the media wrote with reference to the data of the State Register of Medicines (GRLS), the development of such a drug was started by the Valenta Pharm company, which in 2021 became one of the leaders in the number of approved studies of molecules of its own design. By the way, Valenta Pharm is a Russian innovative pharmaceutical company that "actively invests in research and development and product portfolio development, as well as in medical projects and health innovations."
In 2020, a clinical study of the molecule was conducted in 118 patients hospitalized with coronavirus infection. The results obtained revealed the positive effects of XC221 in relation to the normalization of temperature, heart rate and the need for oxygen support, which served as the basis for further research.
In 2021, another clinical study of the drug was conducted in outpatients who received positive laboratory tests for the presence of SARS-CoV-2. Based on data obtained in the evaluation of treatment outcomes in 139 patients, it was concluded that XC221 may reduce the proportion of patients who develop deterioration. Already by such indicators it is possible to judge the effectiveness of the drug, and a high safety profile was demonstrated.
Typically, such trials are one of the final steps in preparing a drug for registration and release, and since we are talking about the treatment of COVID-19, this will be a breakthrough to some extent. In total, this molecule, according to the registry of international clinical trials, was studied in six clinical studies involving more than 500 people. According to media reports, in the fall of 2021, Valenta Pharm submitted the drug for registration.
In the past two years, the number of studies sponsored by domestic pharmaceutical companies has been growing. This is evidenced by the results of a recently published analysis of data obtained through an open clinical research reference portal published in the media. Thus, it is reported that the share of original Russian drug molecules in 2021 reached 11% in the total amount of research.
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