Rus Biopharm Group of Companies has announced the registration of a domestic drug product, Raltiko, containing the active ingredient raltegravir, for the treatment of human immunodeficiency virus (HIV) in children aged 2 to 12.
Raltiko is a film-coated tablet registered in 25 mg and 100 mg dosage strengths. The product is intended for pediatric patients aged 2 to 12 years. It is the fifth HIV medicine in the portfolio of PSK Pharma (part of Rus Biopharm Group). The company’s existing HIV portfolio already includes Raltegravir PSK - film-coated tablets for adult patients at a dosage of 400 mg - as well as products based on such active ingredients as etravirine, lopinavir, and ritonavir.
Evgenia Shapiro, General Director of PSK Pharma, commented:
“A clinical study completed in 2024 confirmed the equivalence of our product Raltiko to the reference product - Isentress chewable tablets at dosages of 25 mg and 100 mg. Going forward, we will continue to expand our HIV portfolio with high-quality and effective medicines.
The registration dossier for the new product Raltiko also includes the active pharmaceutical ingredient (API), the synthesis of which was developed in the company’s own laboratory, while production is carried out at the manufacturing facility located in the Dubna Special Economic Zone. API localization remains one of the company’s key strategic priorities.”
According to data from the Republican Clinical Infectious Diseases Hospital in Saint Petersburg, by the end of 2024 more than 10,000 children and adolescents living with HIV were registered in Russia.[1] In 90% of cases, pediatric HIV infection results from mother-to-child transmission. To reduce the number of vertical transmission cases, the state offers preventive measures, free testing, and access to antiretroviral medicines.