The R-Pharm Group, which develops advanced medicines in Pushchino near Moscow, is introducing its proprietary rheumatoid arthritis therapy to the pharmaceutical market of the Socialist Republic of Vietnam. As reported by the press service of the Moscow Region Government, the monoclonal antibody under the international nonproprietary name olokizumab (trade name Artlegia) has successfully received a registration certificate from the country’s health regulator.
Unique Mechanism of Action and Large-Scale Studies
From a medical perspective, the Moscow region’s development is a breakthrough: olokizumab is the world’s first registered monoclonal antibody with a unique mechanism of action. Its main feature is the direct blockade of IL‑6. This inflammatory cytokine plays a key role in the pathogenesis and development of rheumatoid arthritis, and its neutralization effectively combats the disease.
The decision of the Vietnamese medical regulator was based on a strong evidence base. The registration was supported by real-world clinical practice data, as well as the results of the global international program of multicenter clinical trials CREDO. As part of this large-scale scientific project, the efficacy and safety of the drug were confirmed in a sample of over 2,400 patients living in 19 countries around the world.
Mikhail Samsonov, Chief Medical Officer at R-Pharm Group, highly evaluated the scientific significance of this event:
“Obtaining a registration certificate in Vietnam is the result of extensive scientific and research work. Olokizumab has a compelling evidence base… We are glad that Vietnamese rheumatologists will now be able to use this drug in their daily practice, relying on accumulated international experience.”
Global Expansion Strategy
Entering the Vietnamese market is part of the company’s consistent strategy for the international promotion of domestic innovations.
“The registration of olokizumab in Vietnam is an important step in implementing our strategy to expand the geographical presence of our proprietary innovative drugs. Vietnam is one of the most promising pharmaceutical markets in Asia with high demand for modern treatment methods. We see great potential for developing our portfolio in the region and are glad that our innovative development will now be available to Vietnamese partners and patients, strengthening our positions in the international arena.”
— Adnan Chaudhry, Director of the Export Operations Department at R-Pharm
In the near future, olokizumab will become physically available to Vietnamese patients. According to plans, the drug will be actively used in a wide range of medical institutions across the country: in public, military, and private hospitals.
It is worth noting that Vietnam is not the first foreign jurisdiction for this drug. To date, the drug has already been successfully registered in Russia, Belarus, Kazakhstan, Kyrgyzstan, and Azerbaijan. For the purpose of further export promotion under a national brand, olokizumab was officially awarded the “Made in Russia” certificate, a program implemented by the Russian Export Center.
