25.10.2023, 10:10
A new hepatitis B drug has been registered in Russia
Source: OREANDA-NEWS
OREANDA-NEWS The Russian anti-hepatitis B drug "Antigep-Neo" has successfully passed clinical trials, received a registration certificate from the Ministry of Health of the Russian Federation and is already ready for mass production, the Rostec state Corporation said in a statement.
"The NGO Microgen company, which is part of the holding "Natsibio" of the Rostec State Corporation, has received a certificate from the Ministry of Health of the Russian Federation on the registration of a drug against hepatitis B. Clinical studies have confirmed its good tolerability and safety," the report says.
The state corporation stressed that the drug was the first Russian intravenous specific immunoglobulin for the prevention of hepatitis B in both children and adults. It is also indicated for patients with an increased risk of hepatitis B infection before surgery, repeated hemotransfusion and hemodialysis, organ and cell transplantation.
"The drug was created on the basis of its own patented NGO "Microgen" technology for obtaining highly purified and virus-safe class G immunoglobulins. Our know-how allows us to create drugs based on blood plasma with the qualitative characteristics of the latest generation. "Antigep-Neo has successfully passed all stages of clinical trials and is ready for mass production," the words of Alexander Nazarov, Deputy General Director of Rostec, are quoted in the message.
In the last 10 years preceding the pandemic, the incidence of hepatitis B in Russia has been gradually decreasing. Meanwhile, in January 2023, Rosstat registered a sharp increase in the disease compared to the same period in 2022 - by 11%. According to experts, more than 8 million citizens are infected with hepatitis B and C viruses in Russia, Rostec recalled.
"The NGO Microgen company, which is part of the holding "Natsibio" of the Rostec State Corporation, has received a certificate from the Ministry of Health of the Russian Federation on the registration of a drug against hepatitis B. Clinical studies have confirmed its good tolerability and safety," the report says.
The state corporation stressed that the drug was the first Russian intravenous specific immunoglobulin for the prevention of hepatitis B in both children and adults. It is also indicated for patients with an increased risk of hepatitis B infection before surgery, repeated hemotransfusion and hemodialysis, organ and cell transplantation.
"The drug was created on the basis of its own patented NGO "Microgen" technology for obtaining highly purified and virus-safe class G immunoglobulins. Our know-how allows us to create drugs based on blood plasma with the qualitative characteristics of the latest generation. "Antigep-Neo has successfully passed all stages of clinical trials and is ready for mass production," the words of Alexander Nazarov, Deputy General Director of Rostec, are quoted in the message.
In the last 10 years preceding the pandemic, the incidence of hepatitis B in Russia has been gradually decreasing. Meanwhile, in January 2023, Rosstat registered a sharp increase in the disease compared to the same period in 2022 - by 11%. According to experts, more than 8 million citizens are infected with hepatitis B and C viruses in Russia, Rostec recalled.
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