The Russian company Pharmasyntez is preparing to register and launch Vamotinib (vamotinib), which is in phase III clinical trials. The drug was fully developed and manufactured in Russia, according to the company. This is the first original third-generation tyrosine kinase (TKI) inhibitor for the treatment of patients with chronic myeloid leukemia (CML) resistant and/or intolerant to prior therapy.
«The data from the interim analysis confirm the high efficacy and favorable safety profile»,— Pharmasyntez said, adding that the drug took about 7 years to develop. The company expects that the Russian drug has a promising future in the global market.
Chronic myeloid leukemia (CML) is a type of leukemia marked by the malignant transformation of hematopoietic stem cells, leading to the accelerated and uncontrolled proliferation of predominantly myeloid cells in the bone marrow, which then accumulate in the bloodstream. About a thousand new patients with CML are identified annually In Russia, with the disease accounting for about 15% of all adult leukemias. Before the first drugs appeared in 2001 (the first generation of tyrosine kinase inhibitors), the disease was considered incurable and fatal.
Pharmasyntez Group has published its financial results for 2024. The company’s consolidated revenue under RAS in 2024 went up by 35% compared to 2023, reaching 50.1 billion rubles. Earnings before interest, taxes, depreciation, and amortization (EBITDA) in 2024 amounted to 8,7 billion rubles. The company registered and marketed 25 new drugs last year.
