Sechenov University and Petrovax Pharm join forces to increase the availability of innovative domestic drugs

The First Moscow State Medical University named after I.M. Sechenov and the biopharmaceutical company Petrovax Pharm have signed a cooperation agreement. The goal of the partnership is to develop joint effective solutions to accelerate import substitution in the pharmaceutical industry and increase the availability of innovative drugs for Russian patients.

To this end, the partners are launching a series of scientific studies that will show in practice that Russian developments can be not just an alternative to foreign ones, but leaders in their field — high-quality, safe and effective. Among the partners' joint projects are studies of biotechnological drugs in the field of orphan and oncological diseases, as well as vaccines against the most dangerous infections. The first of the projects will be an assessment of the experience of treating an orphan (rare) disease — Fabry disease in Russian clinical practice and the determination of optimal approaches to treating patients. The partnership agreement was signed on June 19 at the XXVIII St. Petersburg International Economic Forum by the rector of Sechenov University, academician of the Russian Academy of Sciences Petr Glybochko and the president of Petrovax Pharm Mikhail Tsyferov.

The partnership agreement is about combining the scientific, technological and expert potential of the parties to develop, implement and use domestic innovative medicines, as well as improve diagnostics and therapy of oncological, orphan and infectious diseases. The agreement also provides for the development of a domestic medical center for import substitution, for which the partners will implement joint R&D projects, information programs and scientific and practical events.

"Sechenov University is one of the top five in terms of the number of clinical trials and testing of new drugs and medical devices in Russia. Our Clinical Center for Health Sciences has more than 200 permits for clinical trials of new drugs and cooperates with all leading pharmaceutical manufacturers. It was here that the first Russian vaccine against COVID-19, Sputnik V, was tested, as well as a number of foreign anti-COVID vaccines. Today, we have all the competencies, both medical, scientific and clinical, to conduct clinical trials of both bioanalogues and innovative domestic drugs. The cooperation agreement with Petrovax Pharm will help accelerate import substitution in the pharmaceutical industry and increase the availability of innovative drugs for Russian patients. Especially in such an important area as the treatment of patients with orphan diseases," said Pyotr Glybochko, Rector of Sechenov University and Academician of the Russian Academy of Sciences, commenting on the agreement.

One of the projects of Sechenov University and Petrovax Pharm will be a study in which specialists will evaluate the experience of treating Fabry disease in Russian clinical practice to identify optimal approaches to patient management. In this rare genetic pathology, a mutation of the GLA gene leads to a disruption in the production of the α-galactosidase enzyme, which is necessary for the breakdown of complex fats. As a result, fats accumulate in the lysosomes of cells, triggering a cascade of disorders that lead to damage to various organs and systems.

The study, which will start this year, 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 drugs is a promising approach that will help increase the confidence of doctors and patients in domestic medicinal products manufactured on modern equipment and undergoing strict quality control.

"The powerful research base of Sechenov University, combined with the expertise of our specialists in the field of orphan diseases, is a solid platform for developing advanced approaches to modern medical care," said Mikhail Tsyferov, President of Petrovax Pharm. "Early diagnosis and timely initiation of therapy for Fabry disease are critical for maintaining the quality and duration of life of patients. We are confident that the joint project will not only improve medical care, but also make innovative drugs more accessible to everyone who needs them."

In 2024, Petrovax Pharm completed an advanced project to transfer technologies for the production of agalsidase beta for the treatment of Fabry disease, including the synthesis of the substance from a cell line. This was an important step in ensuring uninterrupted availability of life-saving therapy for Russian patients. The quality of the drug was noted by leading Russian and world experts at the XI Congress of the Russian Society of Medical Geneticists in St. Petersburg. In particular, American geneticist Robert J. Desnik, the founder of modern enzyme replacement therapy, called this drug the "gold standard" of Fabry disease therapy.

The cooperation between Sechenov University and Petrovax Pharm will become the basis for a sustainable strategic partnership aimed at ensuring Russia’s sovereignty in the field of drug provision.