The Russian pharmaceutical industry has gained significant stability in the recent years thanks to manufacturers such as Medsintez Plant. This is a modern full-cycle biotechnological enterprise that develops and manufactures pharmaceutical ingredients and drugs that meet international GMP and ISO standards.
The Medsintez Plant is an active participant in the implementation of the import substitution program for drugs in the Russian Federation, and since 2020, it has been included in the list of systemic companies in Russia. One of the key advantages of the Medsintez Plant is its own research and development facilities, which allow it to develop innovative medicines and continuously improve existing products. We talked with Alexander Petrov, Chairman of the Board of Directors of Medsintez Plant LLC, about the company’s developments, which had no parallel in Russia before.
– Mr. Petrov, the Medsintez Plant is a modern, high-tech, full-cycle production facility. Tell us about your company's development strategy. What areas of medicine are strategic for you?
– At the moment, the plant has three strategic areas of work. The plant specializes in the production of drugs used to treat patients suffering from diabetes. These are genetically engineered insulin and analogue human insulin Rosinsulin, as well as hypoglycemic drugs – Liraglutide and Semaglutide, which are used in the treatment of type 2 diabetes, including in patients with obesity and overweight. Liraglutide and Semaglutide are produced in cooperation with the Promomed Group of Companies. We are planning to launch a number of drugs that have a medical auto-injector and we are currently studying innovative types of insulin that could be produced in the future. The largest share in our current production belongs, of course, to the medicines for treating diabetes.
The second strategic area of development for our company is represented by developments in the field of reproductive technologies and the production of drugs for the implementation of the full cycle of the IVF procedure. This area is still very important from the point of view of the national policy. As we know, the President of the Russian Federation declared 2024 the Year of the Family, so the development in this area is one of our priorities. We produce the finished dosage form of the first Russian recombinant follicle-stimulating hormone (FSH) and other hormonal drugs used in complex of assisted reproductive technologies, such as recombinant human chorionic gonadotropin (hCG) and human gonadotropin-releasing hormone antagonist (Cetrorelix).
The third strategically important area for us is the production of antiviral drugs, because infectious diseases are actively developing, we received confirmation of this in 2020, during the spread of the coronavirus infection. Now, many people are talking about the upcoming spread of a new virus, Disease X, so we must be prepared for such challenges.
– Medsintez is a participant in the implementation of drug import substitution programs in the Russian Federation. What medicines were commercialized within the framework of this program?
– The Medsintez Plant was founded in 2003 and even then it was conceived as an enterprise that would substitute imported drugs by domestically developed medicines. Twenty years ago, we began producing infusion solutions not just in glass bottles, but as an import-substituting product of an American company that supplied solutions in double vacuum packaging with two ports – this is a very convenient format for using them in hospitals.
The second stage was the development of insulin, because before we started producing insulin, there had been a shortage of these drugs on the market. Our plant was one of the first to bring Russian insulin to the market, having thereby substituted the imported product, whereafter the price of the imported insulin immediately fell by 30%.
The most striking example of complete import substitution is the launch of the production of Queensenta, a drug for treating type 2 diabetes, which was done jointly with the Promomed Group of Companies. In 2022, a foreign manufacturer of a similar drug stopped supplying it to Russia, and we were forced to release a substitute for this drug within six months.
I would also like to add that recombinant follicle-stimulating hormone (FSH), which is used in the IVF cycle, has never been produced in Russia before. We are the only company producing this hormone. We are currently preparing to launch production of recombinant human chorionic gonadotropin (hCG). The creation of a full line of drugs for infertility treatment will ensure drug safety in this area in Russia and allow not to depend on import supplies.
– Tell us about the plant’s innovative and promising developments. Which of them have already been registered?
– We supply the market with innovative drugs that are our own developments, and we cooperate with Russian scientists from the Ural Branch of the Russian Academy of Sciences – academicians Oleg Chupakhin, Valery Charushin, and Vladimir Rusinov. In cooperation with them we created the antiviral drug Triazavirin.
This drug has already proven to be effective and safe in the treatment of a number of respiratory viral infections, including COVID-19. Its effectiveness against COVID-19 has been proven by clinical trials, and to date it is the only antiviral drug with a direct mechanism of action approved by the Russian Ministry of Health for prevention of the coronavirus infection.
In 2024, we launched the full-cycle production of the world's first registered drug of recombinant human albumin for wide medical use. It is basically an artificial blood component that is not made from donor plasma.
These two drugs are our innovative developments. We are also actively working on creating agonist drugs similar to Semaglutide, but with two targets.
– Which significant events and projects of recent years have become especially striking in the history of the company’s development?
– One of the most important events is the registration of recombinant human albumin. This year was also marked by the expansion and modernization of the workshop for small-scale production of chemical substances and now we can produce three times more substances made by chemical synthesis.
This will also enable production of chemicals for laboratory analysis, because 2022 showed a sharp shortage of acetonitrile, which is necessary for chromatography, because it was all imported. Now we can produce it for ourselves. In general, it will allow us to be ready for new challenges, to fight viral diseases, because despite the high demand, there was a period when we did not have enough production capacity to produce the required quantities of drugs. That is what led us to the modernization of our production lines.
– I cannot help but ask your opinion about the adopted Strategy for the Development of the Pharmaceutical Industry in the Russian Federation? Does it provide for all necessary measures?
– This Strategy covers all issues in a fairly comprehensive manner; everything is taken into account in it. In turn, we will look for opportunities to implement this Strategy. I believe that the Strategy is absolutely right, because it provides a necessary basis upon which one can rely when developing a pharmaceutical enterprise. Based on this strategy, we understand the development path of the Medsintez Plant.
– Does the Medsintez Plant benefit from government support measures? Which of them are particularly valuable for the enterprise?
– We actively use the support measures provided by the Industrial Development Fund. Many of our projects were implemented thanks to the support of the Fund and the loans that we receive at a preferential rate. This is especially valuable in the current conditions, when bank loans have become unaffordable to businesses due to increased interest rates.
– Do you export your products?
– At the moment we manufacture products for the domestic market, but we have big plans for dealing with the countries of Southeast Asia too. Registration of our insulins and Triazavirin in Vietnam is currently under way, and it is worth mentioning that the registration procedure there is very complicated. So when we do complete the registration in Vietnam, the path to many countries in Southeast Asia will open up before us.
– How does the plant manage to maintain sustainable development despite the serious challenges of the present time? What are your plans for the near future?
– Medsintez is an innovative enterprise that does not just rest on its laurels, but immediately responds to the market needs. We are now aiming to complete a line of products for reproductive health. We are talking about Cetrorelix. And in order to launch its production, we have recently obtained a loan from the Industrial Development Fund. We will release it in a completely new form – in a syringe pen, and we will also launch the commercial production of recombinant human chorionic gonadotropin (hCG).
A major challenge for our company is to create our own syringe-injector, which allows easy administration of single doses of the drug to patients. This is our own project without external funding for it and we are launching it fully on our own. We are also currently awaiting registration of the children's dosage of Triazavirin.
Interviewed by Anna Dobrynina
Source: Russian Business Guide Magazine