Russian Medical Development: News

WHO confirms the quality of the Russian influenza vaccine "Flu-M", 02.27.2023.

The FMBA reported that WHO confirmed the quality of the Russian influenza vaccine "Flu-M".

MOSCOW, February 27 - RIA Novosti. The World Health Organization has confirmed the quality of the Russian influenza vaccine Flu-M, developed by specialists from the Federal Medical and Biological Agency, the press service of the Federal Medical and Biological Agency of Russia reported.

"As part of the prequalification procedure, two independent laboratories of the World Health Organization ( WHO ) confirmed the high quality of the Flu-M flu vaccine developed by the St. in the message.

The evaluation was carried out according to the WHO requirements for influenza vaccine. The test results confirmed the acceptability of the seasonal flu vaccine, the press service said.

"Own technology for the production of vaccines from a strain to a finished product makes it possible to achieve high-quality purification of antigens, in which the content of ovalbumin (the main allergen of a chicken egg) is in the range of 1-2 ng at a dose, which is a thousand times less than the permissible norms," said the head of the FMBA of Russia Veronika Skvortsova , whose words are given in the message.

https://ria.ru/20230227/vaktsina-1854720098.html

An enterprise for the production of insulin was built in Serpukhov, 04.06.2023.

A production and warehouse complex for the assembly of syringe pens with cartridges for insulin preparations (Rinsulin R, Rinsulin NPH) was built in the urban district of Serpukhov, near the existing warehouse for finished insulin products - in the village of Obolensk.

The area of ​​the enterprise for the production of insulin was 2.2 thousand square meters. The plant will produce 21 million syringe pens per year. Therefore, the production of the substance will double. 17 people can find a job there.

In Serpukhov, the domestic biotechnology company Geropharm launched a full-cycle plant for the production of genetically engineered human insulin back in 2013. To expand production, the enterprise attracted a loan from the Russian Agricultural Bank in the amount of 1.8 billion rubles. The investment transaction made it possible to modernize the production of the insulin substance in Pushkin in St. Petersburg and create a new packaging and bottling site for medicines in the village of Obolensk, Serpukhov city district.

The construction of a complex for the production of import-substituting insulin began in June 2021. A few days ago, a final inspection took place at the facility. The Glavgosstroynadzor of the Moscow Region issued a conclusion to the developer LLC "Geropharm" on compliance with the requirements of the project documentation.

https://sdelanounas.ru/blogs/150822/

Golikova announced the production in Russia of 62% of drugs consumed, 06.19.2023.

Golikova: more than 62% of pharmaceuticals consumed in the country are produced in Russia.

Medicines are produced in Russia "in almost all segments of the pharmaceutical market," Deputy Prime Minister Tatyana Golikova said at an operational meeting with Prime Minister Mikhail Mishustin, the government's press service reports.


According to her, “due to the development of domestic production, 62% of all drugs consumed in the country are produced in the territory of the Russian Federation.” Golikova noted that, according to Rosstat, at the end of 2022, the volume of drug production amounted to 608 billion, which is an increase of 11% compared to 2021.

At the same time, Golikova noted that as part of the list of essential and essential medicines for medical use, a technological opportunity was created to produce according to 667 international generic names out of 815.

On June 19, the government approved a strategy for the development of the pharmaceutical industry until 2030. The main tasks, in particular, include supporting the organization of the production of medicines and their export, the elimination of administrative barriers, the accelerated introduction of new technologies and the training of scientific and industrial personnel for the industry.

In the next eight years, the share of Russian production of full-cycle drugs on the market “under the current conditions of current challenges” should be increased to almost 70%, Mishustin said.

After the start of the military operation in Ukraine, Western countries imposed sanctions against Russia. After that, the German company Bayer, the American MSD and Pfizer, as well as the Swiss Novartis reported about the restriction of activities in the country. They have suspended their investments in the country. Eli Lilly from the USA, which produces Cialis for the treatment of erectile dysfunction and the neuroleptic Zyprexa, has stopped supplying non-essential drugs to Russia.

https://www.rbc.ru/rbcfreenews/6490b35c9a79471957b648fa

Sobyanin and Manturov opened a new drug production plant in Zelenograd, by Lyubov Protsenko for Rossiyskaya Gazeta. 08.21.2023.

The new pharmaceutical plant, which was launched in Zelenograd by Deputy Prime Minister of the Russian Federation, Minister of Industry and Trade Denis Manturov and Moscow Mayor Sergei Sobyanin, will produce 26 vital drugs, many of which have not been produced in our country before. Anticancer and drugs for the treatment of cardiovascular, autoimmune diseases, for the treatment of HIV infection and many others. An enterprise was built on the site "Alabushevo" of the special economic zone "Technopolis" Moscow".

“Together with the Ministry of Industry, five years ago we set the task of localizing the production of imported drugs in Russia as much as possible, avoiding their import from abroad. This is especially true of vital drugs in the field of oncology,” said Sergei Sobyanin. “During this time, 8 plants, in the coming years we will build seven more.The results are as follows: this year the volume of their production in Moscow increased by 67.5%, more than two-thirds." So step by step, according to the head of the city, our country is becoming more and more independent in providing Russians with medicines.

Noting how important it is when a subject of the Federation takes on such a task, Denis Manturov thanked the Moscow government for supporting the development of industry: “This is such a joint collaboration of the state represented by the federal government, of course, with your support and with the benefits that are provided to the investor, and directly the investments themselves are already from the company. I believe that this is the most effective way to reduce the risks and costs of entrepreneurs."

Moscow, which is interested in creating a new plant, signed an offset contract with the R-Pharm group of companies in 2018. In accordance with it, the company undertook to build a production complex with an area of ​​more than 30.5 thousand square meters in Alabushev. To organize the production of 26 international non-proprietary names of medicines in the built workshops, and the government of the capital guaranteed their purchase for seven years. The Industry Development Fund issued a loan of 2 billion rubles. The total investment amounted to 6.99 billion rubles. And this summer, construction was completed.

We are walking along one of the ultra-modern lines of the new plant. Chief engineer Oleg Dyashkin says: "Highly active preparations are produced here. The whole process is concentrated - from washing of vials, sterilization, bottling, capping, final washing, visual quality control and lyophilization." The visible part of the production is located on the first floor of the building, and there is also a second floor, from where the line is supplied with water, air and other components. There are also biofilters that protect the environment from emissions of harmful substances. The line is served by only four operators, despite the fact that its capacity is 200 ready-made bottles of medicine per minute.

Nearby is another site - for the packaging of drugs in capsules. "It produces drugs in a non-contact way - 9,000 blisters per hour," chief mechanic Anton Pankratovsky demonstrates the operation of the new equipment.

Denis Manturov recalled that in 2022 the plant refused foreign suppliers of components for managing engineering systems. And today, controllers and components from a Russian manufacturer are successfully used here to automate engineering systems. The situation is the same with the system for monitoring climatic parameters; at R-Opra it is made on a hardware and software system from a domestic company.

"The capacity of the enterprise will allow to produce 270 million packages of drugs per year. I am sure that soon doctors and patients will appreciate the quality and availability of domestic drugs - antitumor drugs produced at this plant will go into circulation in 2024," Denis Manturov concluded.


Vasily Ignatiev, General Director of R-Pharm, noted that the launch of the first offset plant in the capital is a significant event for the company: “We took advantage of a wide range of support measures from both the Moscow Government and the Ministry of of the Industrial Development Fund. And of course, the offset itself is still the main thing, it is the backbone, the backbone of the entire project."

The new enterprise has the status of a resident of the Technopolis Moscow special economic zone, which gives it access to significant benefits. Among them - a zero rate on taxes on property, land and transport tax, a 10-fold reduction in income tax, the possibility of buying land at a reduced price. The company also receives financial support from the Moscow Industry and Entrepreneurship Support Fund in the form of compensation for part of the interest rate on a preferential investment loan.

Let me remind you that in recent years Moscow has become one of the largest manufacturers of medicines and medical devices in Russia. There are 95 enterprises operating in the city, which employ over 15 thousand people. The most important part of this branch of the capital has become a cluster of enterprises operating at the sites of Technopolis Moscow in Zelenograd and Pechatniki. Its investment program of 41.4 billion rubles provides for the development of the production of 128 generic drugs, of which 98 have never been produced in Russia. This will provide more than 80% of the need for domestic oncological drugs.

https://rg.ru/2023/08/21/reg-cfo/sobianin-i-manturov-otkryli-novyj-zavod-po-proizvodstvu-lekarstv-v-zelenograde.html

"Promomed" will replenish the drug market with Russian drugs against diabetes, 09.19.2023.

Promomed will replenish the market with Russian drugs for the treatment of diabetes mellitus.

MOSCOW, September 19 – RIA Novosti. The pharmaceutical company Promomed is introducing import-substituting drugs for the treatment of diabetes to the Russian market, the manufacturer told RIA Novosti.

"The Promomed group of companies <...> announces the launch on the market of the first domestic drug of the group of "glutides" (agonists of glucagon-like peptide receptors) for the treatment of patients with type 2 diabetes mellitus, overweight and obesity, as well as for the prevention of the development of heart disease. -vascular complications associated with these diseases,” the statement says.

It is clarified that the new line includes the drugs "Enligria", "Quinliro" (international nonproprietary name - liraglutide) and "Quincenta" (international nonproprietary name - semaglutide).
Liraglutide is one of the most powerful stimulants of insulin production, allowing you to achieve stable control of blood sugar levels. The drug also slows digestion, helping to avoid sudden spikes in sugar after meals. Used as an independent medicine or in combination with others.

Thus, a drug under the trade name "Enligria" is liraglutide, which is available in the form of a pre-filled pen syringe. This drug received a registration certificate on September 18 and will be available in pharmacies in the second ten days of October. "Quinliro" and "Quincenta" are at the stage of state registration.

As the pharmaceutical company emphasized, these drugs will make it possible to close the shortage of similar drugs that arose last year due to the cessation of supplies from the only manufacturer.

It is noted that Promomed produces these drugs in partnership with another pharmaceutical company, the Medsintez plant.

Promomed Group of Companies is a Russian pharmaceutical company that produces five main groups of drugs: antitumor, antiviral, endocrinological, neurological and antibiotics. We are talking about more than 300 types of medicines, 80 percent of which are on the list of vital and essential medicines (VED).

https://ria.ru/20230919/rynok-1897243990.html

Clinical trials of the diabetes drug Semavik have been completed in Russia, 09.19.2023.

Clinical trials of the diabetes drug Semavik have been completed in Russia.

MOSCOW, September 19 – RIA Novosti. The Russian pharmaceutical company Geropharm has completed clinical trials of the diabetes drug Semavik, a domestic analogue of the Danish Ozempic, the organization told RIA Novosti.

“Several companies are preparing to introduce analogues of Ozempic to the Russian market. Geropharm has successfully completed clinical studies, during which the comparability of the analogue and the reference drug in terms of biological comparability was proven <...> It is expected that the drug Semavik , which is already being registered, will become the first analogue of Ozempic <...> All necessary documents have already been submitted to the regulators,” the statement says.

At the end of March, Roszdravnadzor reported that in November last year it received a notification from Novo Nordisk, the manufacturer of Ozempic (the active ingredient semaglutide), about the planned cessation of supplies to Russia. At the same time, the drug will be available to patients at least until December of this year. At the end of June, Geropharm received permission for clinical trials of an analogue of Ozempic.

It is clarified that Novo Nordisk has a valid patent for the molecule until 2035, so analogues of the drug can be registered through the compulsory licensing procedure.

As noted by Geropharm, the new drug will be included in the list of vital and essential drugs (VED), and its cost will be fixed by the state and will be about six thousand rubles. Now the price for one package of injectable semaglutide when purchased on the gray market ranges from 15 to 30 thousand rubles.

According to the general director of the company, Peter Rodionov, the availability of a drug based on semaglutide in Russia is a guarantee of patient safety. He emphasized that this is a vital medicine that is used in a course, so it is important to ensure its availability in the usual form of release.

The production capabilities of Geropharm allow us to begin production of the drug at our own plant now and fully satisfy the needs of the domestic market, Rodionov added.

https://ria.ru/20230919/diabet-1897345937.html

Expert: The effectiveness of the Russian cancer drug can reach 100%, 09.29.2023.

Pogrebnyakov: the effectiveness of the new Russian cancer drug reaches 100%.

MOSCOW, September 29 – RIA Novosti. The effectiveness of a new domestic drug for the treatment of cancer with the help of light in some cases can reach 90-100 percent, the head of the department - a doctor for x-ray endovascular diagnostics and treatment of the department of x-ray surgical methods of diagnosis and treatment of the department of interventional radiology of the Research Institute of Clinical and Experimental Radiology of the Federal State Budgetary Institution "National Medical Research Center of Oncology" told RIA Novosti named after N. N. Blokhin" of the Russian Ministry of Health, Candidate of Medical Sciences Igor Pogrebnyakov.

“The drug can be used in the treatment of patients with various types of tumors of the gastrointestinal tract, bile ducts, genitourinary system, upper respiratory tract and skin. At certain stages of the disease, if all indications for use are followed, the effectiveness can reach 90-100 percent,” he said.

According to the specialist, the product has several domestic analogues, the experience of using which was taken into account during production. This type of drug is well tolerated by patients and has no serious side effects, the doctor said.

The only absolute contraindication to its use is porphyrin disease, which is rare in Russia, Pogrebnyakov clarified.
The day before, Moscow Mayor Sergei Sobyanin announced that a drug for the treatment of cancer with the help of light began to be produced in the capital, the company plans to produce up to 40 thousand bottles per year.

As the head of the city noted, in the early stages of the disease, this method of treatment can replace surgical intervention. The drug is administered to the patient, it accumulates in the tumor cells, then is activated by laser or LED radiation. After this, the neoplasm is almost completely destroyed.

https://ria.ru/20230929/preparat-1899547258.html

A “smart” blood pressure monitor has been developed in Russia, 09.30.2023.

NTI: Russia has developed a tonometer watch that sends a person’s indicators to the doctor.

MOSCOW, September 30 – RIA Novosti. In Russia, they have developed a “smart” tonometer watch that measures a person’s pulse, blood pressure and ECG and, if necessary, sends information to the doctor, the press service of the National Technological Initiative (NTI) told RIA Novosti.

“A team of developers from Kazan came up with a tonometer in the format of a smart watch with data analysis by artificial intelligence. Such a device is planned to be introduced into a unified ecosystem of remote health monitoring according to the “Clinic at Home” model. The project went through an acceleration program at the design and educational intensive “Archipelago 2023” , - NTI reported.

In general, as the developers noted, the gadget is configured personally for a person’s tasks through a mobile application associated with the device and takes measurements throughout the day - ECG, pulse, blood pressure, as well as reading the user’s activity. Next, the received data is analyzed by AI and, if necessary, push notifications are sent, and monitoring information is sent to the doctor to adjust therapy.

“The uniqueness of the project lies in the fact that the device is part of a medical ecosystem that is built around the user. For example, there are Korean watches that also perform an ECG, but their data is not analyzed and does not become part of the user’s medical history,” said project leader Linar Garifullin.

He noted that the gadget will become ahead of imports, and all data generated during monitoring will be stored in Russia with access for doctors.

“We are planning to obtain a registration product from Roszdravnadzor for our device, so it will combine a medical device and the functions of a familiar smartwatch,” added Garifullin.

As he also emphasized, the main difference between a blood pressure monitor and a smart watch is that the data from the latter cannot be used for medical purposes, so it is impossible to integrate them into the medical ecosystem.

The project is currently at the prototype stage; the developers plan to release the first batch of devices in 2024.

https://ria.ru/20230930/tonometr-1899609844.html

Prepare for future exports at a low cost to compete with the Danish stuff Ozempic worldwide.

An analogue of the Danish diabetes drug Ozempic has been registered in Russia., 10.06.2023.

"Geropharm": domestic diabetes drug "Semavik" registered in the Russian Federation.

MOSCOW, October 6 – RIA Novosti. The Geropharm company has registered a domestic analogue of Ozempic, a Danish drug for the treatment of diabetes, and production will be launched in the Moscow region, the pharmaceutical company told RIA Novosti.

“The drug Semavik from the Geropharm company has been registered in Russia, which will replace Ozempic, which left the country,” the press service said.

They noted that the manufacturer of the Danish drug, Novo Nordisk, completely stopped supplying it to Russia this year, despite the inclusion of segmalutide in the list of vital drugs (VED).

“The production of the drug “Geropharm” will be carried out at its own plant in the Moscow region, which allows the production of lyophilized forms, solutions and suspensions in vials, cartridges and syringe pens,” the company added.

In September, Geropharm told RIA Novosti that the cost of the Russian analogue would be about six thousand rubles.

Preparations containing segmalutide are used primarily for type II diabetes mellitus. As prescribed by a doctor, their use is also permissible for overweight or obesity.

https://ria.ru/20231006/semavik-1901018355.html