Russian pharmaceutical manufacturers have launched new drug production to combat COVID-19

Promomed 15 March 2022

Russian healthcare received a new effective medicine to combat the coronavirus pandemic in accordance with the international protocol.

In Saransk, the production of a fully domestic drug based on molnupiravir has begun: its use in outpatient practice reduces the recovery process to five days, and the number of hospitalizations by three times. Russian developers managed to create the new product and launch it into production almost simultaneously with leading pharmaceutical companies of Western countries.

Doctors and patients now have a choice

The world started talking about a modern effective medicine for coronavirus with the active substance molnupiravir at the end of last year, when the innovation was adopted by the EU countries. At the end of December, foreign companies delivered the first limited batches of the drug to Russia. And as soon as in the beginning of February 2022, a domestic, much more affordable product based on an internationally recognized molecule was successfully approved.

«This is a new advance and a new quality in the treatment of COVID-19 and a new hope that even more human lives will be saved,» said Petr Bely, Chairman of the Board of Directors of Promomed Group. «We were among the first Russian pharmaceutical companies to enter the battle against the pandemic by offering the first antiviral drug as early as mid-2020. And now we are launching another drug with different characteristics and benefits.»

Earlier in Russia, medicines based on favipiravir as active substance have been launched to treat patients with COVID-19. What these substances have in common is that they block further spread and contribute to the complete elimination of the virus from the body. But they do it in different ways, attacking different targets of the virus. It is important that both drugs remain effective against the Omicron strain and can complement each other.

According to experts, today, for the first time in a pandemic, doctors finally have a choice: a medicine for etiotropic therapy can be selected personnally for a patient, taking into account concomitant diseases.

«Russian developers managed to create the new product and launch it into production almost simultaneously with leading pharmaceutical companies of Western countries»

«The peculiarity of the new coronavirus infection is its fast progression. The virus leaves doctors almost no room for error,» said Sergey Avdeev, Chief pulmonologist of the Ministry of Health of Russia, Corresponding Member of the Russian Academy of Sciences. «The merit of Russian scientists and developers is that they made a whole line of anti-COVID drugs available for the national healthcare system.»

According to the expert, despite the fact that the new drug has just recently became available in the country, drugs based on this molecule are already well studied. Doctors can rely on the results of about ten clinical trials conducted in different countries, including Russia.

For example, studies conducted since December in 16 medical institutions across the country, including Moscow, Saransk, Yaroslavl, Smolensk, Ryazan, Kirov, St. Petersburg, Ivanovo, Voronezh and other cities, have convincingly proved the advantages of the new medicine.

Already on the fifth day of treatment, more than 80 percent of patients had complete elimination of the virus, and over 40 percent of patients, including patients with risk factors for the development of complicated COVID-19, recovered completely.

Lessen the load on hospitals

The results of international clinical trials that in total enrolled more than 3,000 patients have been discussed at an expert council held in February with the participation of six academicians of the Russian Academy of Sciences, well-known medical scientists and clinicians. It was noted at the meeting that COVID-19 continues to pose a serious threat to human health and life. This means that the toolbox for treatment needs to be replenished with highly effective means that have a universal effect on RNA viruses, regardless of the variability of strains. At the same time, the early start of targeted antiviral therapy is the key to successful prevention of the disease progression to severe course.

Larisa Balykova, professor, corresponding member of the Russian Academy of Sciences, director of the Medical Institute of the OgarevMordovia State University said that the new drug has a very favorable safety profile – it is a short five-day treatment. Therefore, the most correct tactic would be to prescribe it at an early date, especially in patients from risk groups.

This will help to make a real revolution in the treatment of patients with coronavirus: the new development can significantly reduce the burden on healthcare by reducing the number of hospitalizations and severe cases. For example, the results of studies suggest that due to the use of new drug, the percentage of patients who need inpatient treatment can be reduced by more than three times. This means that doctors and beds will became available for the treatment of other categories of patients.

«The launch of our domestic drug based on molnupiravir is an opportunity to provide the majority of citizens of our country with decent effective treatment,» commented Vladimir Chulanov, the lead infectious diseases specialist of the Russian Health Ministry, Deputy Director of the National Medical Research Center for Phthisiopulmonology and Infectious Diseases.

From molecule to tablet

Experts pin great hopes on the new drug. A few days after approval, it was put into production. It is produced at the Biokhimik plant in Saransk using full-cycle technology, from the active pharmaceutical substance to the finished dosage form. The first batch was sent to the healthcare system, including distributors and pharmacy chains, in the first hours after the end of post-approval procedures.

«We consider it critically important to make the world's most advanced coronavirus therapy available to our compatriots as quickly as possible,» said Maxim Smagin, CEO of the developer company. «The first anti-COVID drug based on the internationally recognized molnupiravir molecule was approved abroad in December, and already in February, a domestic drug, which we developed based on this molecule using the original technology, was made available for the healthcare system. Our plant in Saransk is working at full capacity to meet the needs of all regions.

Today, we can say with confidence that the Russian pharmaceutical industry has withstood the test of the pandemic: during this difficult period, the industry managed to mobilize and develop the necessary vaccines and drugs in a short time, multiplying the production of medicines. The creation of this new drug is another example of qualitative changes in the industry.

«Thanks to the efforts of our team, the drug was launched in Russia almost simultaneously with the launches of molnupiravir-based drugs in the United States, Great Britain, other European countries, and Japan,» said Petr Bely. «Now our doctors can use one of the most modern achievements of the world pharmacy. We are pleased that we have contributed to the world's collection of data on its efficacy and safety.»

The expert recalled that in order to avoid severe consequences of the coronavirus, treatment should be started as early as possible. This will prevent a cascade of pathological reactions from starting. After all, the consequences of the so-called post- COVID syndrome are experienced even by those who have suffered a mild disease. Often such people neglect treatment, and complete elimination of the virus does not occur, it remains in the body for a long time, even in a latent form. Experts associate most of the negative manifestations that last for weeks and months: asthenia, hypomnesia, mental performance, cardiovascular disorders.

«The first thing to do at the slightest sign of illness is to seek medical help. It can be local doctor, telemedicine service, hotline. After that, a person usually receives a free package of a highly effective antiviral drug from a doctor. In this case, the patient will have a very high chance of a quick recovery and the elimination of the risk of complications,» Peter Bely assured. «This is a drug with a universal effect against the replication of RNA-containing viruses. By bringing such products to the market, we create a reserve for the future. After all, after the end of the pandemic, the coronavirus will not disappear. Even if it mixes with the usual ARVI, people with risk factors will still be at risk of complications, so they will need effective therapy.»