Sechenov University and Petrovax Pharm team up to increase access to innovative domestic medicines

Moscow, June 19, 2025 — I.M. Sechenov First MSMU and Petrovax Pharm signed a cooperation agreement. The idea behind this partnership is to develop efficient cooperative solutions to accelerate import substitution in the pharmaceutical industry and create more opportunities for Russian patients to access innovative medications. To accomplish this, the partners are starting a series of scientific studies that will demonstrate in practice that Russian developments may be not just alternatives to international ones, but rather high-quality, safe and efficient leaders, each in its practical area.

The joint projects that the partners are willing to undertake include research on biotech medicines used to treat orphan and oncological diseases, as well as vaccines against the most dangerous infections. A starting project will assess the experience of treating orphan (rare) Fabry disease in Russian clinical practice and find the best approaches to patient treatment. The partnership agreement was signed on June 19 at the 28 St. Petersburg International Economic Forum by Vadim Tarasov, Vice Rector for Scientific and Technological Development at Sechenov University, and Mikhail Tsyferov, President of Petrovax Pharm.

This agreement aims to combine the scientific, technological and expert potentials that partners possess for the creation, implementation and use of domestic novel medicines, as well as improving the diagnosis and treatment of oncological, orphan and infectious diseases. The agreement also contains provisions that expand the operations of a domestic import substitution medical center. This task the partners aim to solve by implementing joint R&D projects, information programs and scientific and practical events.

An example of such projects by Sechenov University and Petrovax Pharm will be a study where specialists will be tasked to evaluate the experience of Fabry disease therapy in Russian clinical practice in order to identify optimal approaches to patient management. This rare genetic condition presents with a mutation in the GLA gene disrupting the production of the enzyme α-galactosidase, which is needed to break down complex fats. This results in fat accumulation in the lysosomes of cells, triggering a cascade of disorders that eventually damage various organs and systems.

Beginning later this year, the study will involve patients with Fabry disease from all over the country. In particular, specialists will evaluate the use of the domestic orphan drug agalsidase beta in the treatment of patients. Studying and presenting practical experience in the use of high-quality local products is a promising approach that will help increase the confidence of physicians and patients in domestic medicinal products manufactured on modern equipment with strict quality control in place.

In 2024, Petrovax Pharm completed an advanced production technology transfer project for agalsidase beta, which is used in Fabry disease therapy, including the cell line-based substance synthesis. This was a key step in ensuring continued access for Russian patients to life-saving therapy. Leading Russian and international experts highly appreciated the quality of the drug at the 11th Congress of the Russian Society of Medical Geneticists in St. Petersburg. In particular, American geneticist Robert J. Desnick, the inventor of modern enzyme replacement therapy, called this product the «gold standard» for the treatment of Fabry disease.

Sechenov University and Petrovax Pharm have set up a task to establish a long-term partnership that is focused on ensuring Russia's sovereignty in pharmaceutical supplies.

Reference information

The orphan drug Fabagal^® (agalsidase beta) was authorized in Russia in 2023^[1]. In 2024, Petrovax Pharm and N.F. Gamaleya NRCEM have established its full cycle production, including the cell line-based substance synthesis. The drug is used in adults and children over 8 years of age as enzyme replacement therapy for Fabry disease, the orphan genetic disorder that causes kidney damage, neuropathic pain in the extremities, congestive heart failure, heart attack and stroke. Without an early diagnosis and properly selected therapy, the disease results in permanent disability and death. Enzyme replacement therapy can reduce the severity of disability and increase the economically active life expectancy of patients by 5.7 years^[2]. The drug has been used in South Korea since 2014.