NPO Microgen as part of Nacimbio Holding got a Registration Certificate by the Ministry of Health of the Russian Federation of a medicinal product against hepatitis B. The clinical studies have shown high tolerability and safety of the drug. The drug has become Russia’s first intravenous specific immunoglobulin created to prevent hepatitis B in both children and adults.
The drug called Antigen-Neo has been approved for prevention of hepatitis B in adults and children, including including the disease inherited from mothers who are deemed to be carriers of the hepatitis B surface antigen. The drug is also indicated in patients at increased risk of hepatitis B infection before surgery, repeated hemotransfusion and hemodialysis, organ and cell transplantation.
Antigen-Neo manufacturing process involves several additional purification stages to ensure high viral safety of the drug and minimize the risk of adverse reactions in patients. Unlike the previous-generation immunoglobulin drug, Antigen-Neo is given intravenously to ensure high therapeutic efficacy.
“The drug was created based on NPO Microgen’s patented technology for producing highly purified and virus-safe class G immunoglobulins. Our know-how allows us to create blood-plasma-based products with the next-gen qualitative characteristics. Antigen-Neo has successfully passed all clinical trials phases and is ready for mass production. Modern domestic technology will boost Russian-based production of pharmaceuticals that are highly sought in a variety of medical branches,” said Alexander Nazarov, Deputy Director General of the Rostec State Corporation.
According to WHO, hepatitis B is one of the most significant medical and social health problem worldwide. The infection can progress to a chronic form with a high risk of fatal cirrhosis and liver cancer. WHO estimates the global mortality from this infection, mainly due to cirrhosis and hepatocellular carcinoma (primary liver cancer), at 820,000 people per year. Meanwhile, the total number of people living with chronic hepatitis B has reached 296 million (according to data for 2019).
Over the past 10 years preceding the pandemic, the incidence of hepatitis B in Russia has been gradually declining. Meanwhile, in January 2023, the Russian Federal State Statistics Service (Rosstat) registered a sharp increase in the disease by 11% compared to the same period in 2022. According to experts, more than 8 million citizens are infected with hepatitis B and C viruses in Russia.
