Pharmasyntez Group, a leading Russian pharmaceutical company, has announced plans to introduce three innovative domestic drugs to the market in 2025-2026, all with blockbuster potential in their respective therapeutic areas. The announcement was made by Vikram Punia, the company's president and owner, during the 32nd N.A. Semashko Russian Pharmaceutical Forum.
"This year and possibly in the first half of 2026, we will launch three new innovative drugs onto the market. In fact, all three have the potential to become blockbusters in their fields," Punia stated.
Vamotinib: A Breakthrough for Chronic Myeloid Leukemia
The most advanced of these products is Vamotinib (vamotinib), Russia's first original third-generation tyrosine kinase inhibitor (TKI) for treating patients with chronic myeloid leukemia (CML) who are resistant or intolerant to prior therapies. The drug, which took approximately seven years to develop, has already completed Phase III clinical trials.
"The data from the interim analysis confirm the high efficacy and favorable safety profile," according to company statements. Pharmasyntez has already submitted registration documents to the national regulatory authority and believes the drug has significant global market potential.
Chronic myeloid leukemia is characterized by malignant transformation of hematopoietic stem cells, leading to accelerated proliferation of myeloid cells. In Russia, approximately 1,000 new CML cases are diagnosed annually, accounting for about 15% of all adult leukemias. Before the introduction of first-generation tyrosine kinase inhibitors in 2001, CML was considered incurable.
Punia expressed high confidence in the drug's commercial prospects: "I can virtually guarantee that this drug will generate foreign currency revenue exceeding one billion euros."
Serogard: Addressing Adhesive Disease
The second innovative product in Pharmasyntez's pipeline is Serogard (adesmapimod vimdemer), which the company describes as the world's first innovative drug for preventing adhesive disease. This condition causes numerous complications annually, including life-threatening ones, and often necessitates repeat surgical interventions.
Adhesive disease, characterized by abnormal tissue adhesions following surgery or inflammation, represents a significant unmet medical need. Serogard's development could potentially reduce the need for repeat surgeries and improve patient outcomes.
Saterax: A Domestic Solution for Type 2 Diabetes
The third product scheduled for release is Saterax, Russia's first original dipeptidyl peptidase-4 (DPP-4) inhibitor for treating type 2 diabetes. According to Punia, this medication addresses the critical need for modern, safe treatment options as part of the country's import substitution efforts.
DPP-4 inhibitors are an established class of oral antidiabetic medications that work by increasing incretin levels, which inhibit glucagon release and stimulate insulin secretion, thereby improving glycemic control in patients with type 2 diabetes.
Strong Financial Performance
The announcement comes on the heels of strong financial results for Pharmasyntez. The company reported that its consolidated revenue under Russian Accounting Standards (RAS) in 2024 increased by 35% compared to 2023, reaching 50.1 billion rubles (approximately $550 million). Earnings before interest, taxes, depreciation, and amortization (EBITDA) in 2024 amounted to 8.7 billion rubles (approximately $95 million).
The company also registered and marketed 25 new drugs last year, demonstrating its commitment to expanding its product portfolio and addressing various therapeutic needs in the Russian market.
Pharmasyntez's focus on developing innovative domestic pharmaceuticals aligns with Russia's broader strategy to reduce dependence on imported medications while building domestic pharmaceutical research and manufacturing capabilities.
