Russia’s Health Ministry has granted Pharmasyntez-Nord, part of the Pharmasyntez Group, permission to conduct an international multicentre phase I clinical trial of PZN-107, a domestic analogue of Adcetris (brentuximab vedotin), the original drug made by Japan’s Takeda. The medicine is used as a first‑line treatment for patients with advanced stages of classical Hodgkin lymphoma who have not previously received therapy.
The trial will involve 23 medical institutions and is designed to compare the pharmacokinetics, immunogenicity, safety and efficacy of the Russian copy with those of the original Adcetris. Both drugs are supplied as 50 mg lyophilisate for infusion solution. A total of 108 patients will take part, and the trial is expected to be completed by the end of 2028.
Brentuximab vedotin is an antibody‑drug conjugate that combines a monoclonal antibody with an anti‑tumour component, GxP News notes. It is included on Russia’s list of vital and essential drugs. Clinical guidelines recommend it as a first‑line treatment for Hodgkin lymphoma in combination with chemotherapy. The incidence of this cancer type is 2.2 cases per 100,000 population.
This is not the first such trial in Russia. In autumn 2025, Russian company Biocad received approval for a similar study, which it plans to complete in 2028. In March 2023, Pharmasyntez also signed an offset contract with Moscow: the company will invest 400 million roubles to localize production of seven cancer drugs, including brentuximab vedotin, and the city will purchase them for 2.4 billion roubles. There are no patents for this compound in Russia, which makes it easier to produce copies.
The original Adcetris was registered in Russia in 2016 for the treatment of refractory and relapsed forms of Hodgkin lymphoma. The indications were later expanded: in 2019 to include previously untreated patients with stage IV CD30+ Hodgkin lymphoma (in combination with chemotherapy) and CD30+ cutaneous T‑cell lymphoma; and in 2021 to include previously untreated adults with CD30+ peripheral T‑cell lymphomas.
