
The Russian biotech company Biocad plans to register ANB-002 (arvenacogene sanparvovec), the first domestic original drug for hemophilia B gene therapy, early in 2026, Valentin Dodonov, the company’s vice president, said that at the forum of scientific communicators SciComm 2025 Neva at St. Petersburg State University. His words were quoted by TASS.
“We are venturing into a new niche — genetic drugs. We currently have more than six drugs in development, and Russia’s first genetic drug for the treatment of hemophilia B will be registered early next year,” Dodonov said.
According to him, a single injection of the drug will enable regulation of clotting factor production, potentially leading to prolonged remission.
In mid-April, Biocad announced that the company had submitted documentation to the Russian Ministry of Health seeking approval to register the country’s first original gene therapy for hemophilia B. The drug received the international nonproprietary name (INN) arvenacogene dezaparvovec. It was reported that investments in its creation and research will exceed 3 billion rubles.
The development of the drug began more than seven years ago with the creation of the Genext platform technology, which allows the production of recombinant AAV vectors. Work on the platform was launched in 2016, and in 2018, Biocad began developing gene therapy for hemophilia B. In 2024, the Ministry of Health of the Russian Federation authorized Biocad to initiate a Phase III clinical trial.
Hemophilia B, also known as Christmas disease, is a rare, inherited bleeding disorder caused by a deficiency in Factor IX (FIX), a protein crucial for blood clotting. This deficiency leads to prolonged or excessive bleeding, which can occur spontaneously or be triggered by injury or surgery. As of 2023, 1,354 patients in Russia have been registered with this diagnosis.