Photo: National Immunobiological Company
NPO Microgen as part of Nacimbio holding has got a certificate of marketing authorization of a pharmaceutical product for hepatitis B. The clinical studies have shown high tolerability and safety of the drug. The drug has become Russia’s first intravenous specific immunoglobulin for hepatitis B prevention both in children and adults.
The drug called Antigen-Neo has been approved for prevention of hepatitis B in adults and children, including that transmitted from hepatitis B surface antigen-positive pregnant women.
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 has been developed using Microgen’s proprietary technology for formulation of highly purified and virally-safe immunoglobulins G. Our know-how provides high quality next generation plasma-derived medicinal products. Antigen-Neo has successfully passed all clinical study phases and is ready for commercial production. In future, the proprietary state-of-the-art process will allow to increase the output of drugs that are in high demand in various branches of medicine,” said Aleksandr Nazarov, Deputy General Director of Rostec.