The coronavirus pandemic has become a serious test for thousands of Russian enterprises. Some of them failed to adapt to the new reality and dropped out of the game. Others have become the vanguard in the fight against COVID-19 and its consequences. Medsintez, a pharmaceutical plant, is in their number. In 2020, it assumed an extra responsibility for the quality and duration of life of Russia citizens.

 

 

The Medsintez plant is the largest manufacturer of pharmaceutical products in the Middle Urals. It was designed and built from scratch in Novouralsk in 2003. Today, the enterprise employs more than 300 highly skilled specialists. The plant is able to ensure all stages of drug creation, from development to shipment to pharmacy chains.

 

Medsintez is one of Sverdlovsk region's core healthcare enterprises. In June 2020, it was enrolled as a systemic enterprise of Russia. The production efficiency and effectiveness are achieved due to continuous quality control and high labour organization.

 

 

 

“Federal executive bodies pay much attention to drug production. The Ministry of Industry and Trade, Roszdravnadzor and FMBA carry out inspections on a regular basis. In 2018 and 2019, the plant successfully passed the inspections, which included a thorough analysis of all product production stages. Also, experts and auditors from independent domestic and foreign certification bodies are invited annually. This ensures the continuous production growth and finding out a way to improve,” said Alexander Petrov, Chairman of Medsintez Board of Directors.

 

In 2019, the first open tour around the plant premises was arranged for the Sverdlovsk Region's Ministry of Health and the Ministry of Industry and Science. Representatives of the Ministry of Health and the Ministry of Industry and Science visited the plant's workshops and research labs, as well as got acquainted with the technological process of manufacturing the main products. They noted the Medsintez's commercial scale and innovation potential as well as expressed their confidence in a promising and fruitful cooperation.

 

Alexey Orlov, First Deputy Governor of the Sverdlovsk Region:

 

"Medsintez is the biggest enterprise of our Ural biomedical cluster. And, of course, it has a very serious human, scientific and production potential. And also the potential to increase its product line. Over these years, we have had active cooperation. And the events currently taking place in the world are a new challenge for Medsintez. The tasks that the governor set for our industrial enterprises and pharmaceutics are manifested quite clearly here”.

 

 

The coronavirus pandemic has created new demands in society; the main one is the demand for safety. According to the WHO, masks are one of the best protection methods when it comes to COVID-19. Medical masks partially protect the user from the pathogen entering their respiratory tract. This is a good barrier between a virus carrier and other people.

 

The Medsintez plant was one of the first companies to join the anti-epidemic fight. In May 2020, the enterprise launched an automatic technological line to produce three-layer protective masks with a high-filtration layer. Medsintez specialists launched the production within a very short period. Since then, the plant has been producing 2.5 million items monthly. This amount is enough to meet the increased demand for protective equipment in hospitals and pharmacies of the Sverdlovsk region. A drop in mask prices was an indirect effect of sales by Medsintez.

 

“It should be noted that specialists and managers of the Medsintez plant launched the line within just a few hours. Even though they had no manual or explanations, only a video tutorial. We should be happy about the fact that Novouralsk and the Medsintez plant have such engineers, who are able to launch a line very quickly and deliver high-quality products. Now, the machine works and produces very high quality, which is checked in Medsintez test labs," - says Alexander Petrov, Chairman of Medsintez Board of Directors.

 

Today, Medsintez is the region's only enterprise that performs post-production lab diagnostics of masks. Experts test the masks for permeability - how many particles get through the tissue. This is a very important factor, which shows how efficiently the product protects against infections.

 

 

The new coronavirus infection has killed more than 250 thousand people all over the world. Hundreds of labs began to work on a drug that could help stop the wave of the disease. Triazavirin can be one of these drugs. Its production was established at the Medsintez plant.

 

The enterprise has been producing Triazavirin since 2014. This is a direct-action antiviral drug effective against 15 types of influenza, including A/H1N1 (swine flu) and H5N1 (avian influenza) viruses, as well as parainfluenza, rubella, tick-borne encephalitis and dengue fever. Virologists suggest that Triazavirin is able to cope with the coronavirus because the latter belongs to RNA viruses, which the drug is effective for.

 

"There are two types of viruses: DNA- and RNA-dependent. For example, influenza, SARS and Ebola viruses are RNA-dependent molecules. The new drug copes with them successfully. Since the new coronavirus is RNA-dependent too, it is very likely that the drug can suppress its development in the body,” says Vladimir Rusinov, chemist, Corresponding Member of the Russian Academy of Sciences and a co-creator of the drug.

 

In Russia, other drugs for coronavirus are being tested as well, yet Triazavirin features a different mechanism of treating RNA viruses. Typically, a drug either stimulates the immune system to fight a disease or just eliminates symptoms. Triazavirin kills a pathogen, so symptoms pass. Many famous Russian scientists and clinicians leave positive reviews about Triazavirin.

 

Oleg Chupakhin, Academician of the Russian Academy of Sciences, Head of the Institute of Organic Synthesis, the Ural Branch of the Russian Academy of Sciences:

 

“The main advantage of the drug is its mechanism of action, namely inhibiting the synthesis of viral RNAs, which disrupts the viral reproduction process in cells. Simply put, the drug eliminates disease symptoms caused by RNA-dependent viruses by killing their pathogens. Therefore, it is classified as a direct-action antiviral drug, which is its main advantage."

 

Valery Charushin, Chairman of the Ural Branch of the Russian Academy of Sciences, Director of the Institute of Organic Synthesis of the Ural Branch of the Russian Academy of Sciences, Academician of the Russian Academy of Sciences:

 

“From the very beginning of the new coronavirus infection spreading around the world, we believed that Triazavirin is worth trying out. It affects fragments of viral proteins, which are considered conservative because they do not change during mutation and are found in many RNA virus strains. This drug has a wide spectrum of action and affects not only flu virus strains but even the tick-borne encephalitis virus. This is the reason to suggest that it can be effective with the new coronavirus too.”

 

Mikhail Shchelkanov, Professor of the Far Eastern Federal University, who researched coronaviruses for multiple years, told about the drug's potential:

 

“The new coronavirus that the world is facing now belongs to the same group of RNA viruses as other SARS and influenza. This is just another mutation of the virus, yet it retains all characteristics of RNA viruses. The way the formula of Ural Triazavirin acts allows to suggest that it can be effective with COVID-19. We have to use it in treatment and continue to monitor the results."

 

Alexander Sergeev, President of the Academy of Sciences of Russia:

 

"The drug has already worked well in some hot spots, particularly when fighting against infections worldwide."

 

It's worth noting that there is no direct evidence of Triazavirin's efficacy with coronavirus yet. Still, no drug can boast of proven efficacy with COVID-19 by now.

 

Nevertheless, the coronavirus statistics in the Sverdlovsk region speaks in favour of Triazavirin. In accordance with the recommendations of the Academic Council of the Ural State Medical University, the drug is used here to treat adult COVID-19 patients as well as for post-exposure prophylaxis of medical specialists and on COVID-19 sites (family, custodial institutions). As of June 24, there are 11,492 confirmed cases of the new coronavirus type in the region. Of these, 6,250 patients have already recovered, while 79 died.

 

At the end of April 2020, dozens of thousands of Triazavirin packages were purchased for hospitals by order of the Sverdlovsk Region's Governor. The Ministry of Health of Moscow bought the drug too with view of the dangerous situation in the capital.

 

Also, Triazavirin has been recognized abroad. A large batch of the drug, several thousand packages, was shipped to China, where its efficacy for coronavirus is currently tested.

 

Today, the Medsintez plant is able to manufacture up to 21 thousand packages per day to fully cover the demand for Triazavirin during the pandemic.

 

“We had to triple the output. But if the pandemic grows, we will be able to triple again. Currently, we are preparing to prove that Triazavirin is effective against coronavirus. A decision of the medical commission of the independent ethical committee is required in order that the drug can undergo scientific research according to the decree No. 441 of the Government of the Russian Federation. By now, there are two drugs that are used to treat coronavirus on an off-label basis. So, this kind of practice exists. And we are preparing Triazavirin for official tests of its efficacy against COVID-19,” says Alexander Petrov, Chairman of Medsintez Board of Directors

 

 

Even during the pandemic, when a part of the plant's premises is involved in manufacturing products for coronavirus, Medsintez keeps creating the recombinant follicle-stimulating hormone, which is so important for citizens of Russia.

The follicle-stimulating hormone (FSH, follitropin alpha) is a pituitary hormone that regulates the development of ovarian follicles in the female body and sperm maturation in the male one. Normal FSH levels in the body are essential for the proper functioning of the reproductive system.

 

Since 2019, the Medsintez plant has been producing the substance and the finished dosage form of Primapur, the first Russian drug for infertility, . This is a recombinant (i.e. genetically engineered) follicle-stimulating hormone used during in vitro fertilization (IVF). It helps the human body to produce the required number of mature eggs ready for fertilization.

 

"As soon as the drug was released, and the first test batches were made, they were immediately purchased and used in clinics of Moscow. Primapur has actually been a long-expected product, and an affordable one by the way. Nevertheless, its efficacy is not inferior to that of its international analogue," says Alexander Petrov, Chairman of Medsintez Board of Directors

Primapur is unique with its way of administration. It uses a disposable syringe pen.