Belumosudil

Chronic graft-versus-host disease (cGVHD) is the most common long-term complication after allogeneic hematopoietic stem cell transplantation. Approximately 30% to 70% of patients will develop multi-organ involvement, and the response rate of traditional glucocorticoid therapy is less than 50%. There has been a long-term lack of targeted treatment regimens in clinical practice. Belumosudil is a ROCK2 kinase inhibitor. By targeted regulating the Rho-associated coiled-coil kinase 2 pathway and simultaneously modulating the balance of STAT3/STAT5 signaling, it reduces the secretion of pro-inflammatory factors and inhibits the process of tissue fibrosis. It is the world's first oral targeted drug approved for cGVHD, applicable to patients with chronic graft-versus-host disease aged 12 years and older who have failed at least 2 lines of prior systemic therapy, and can bring sustained improvement in organ function to this population with high clinical needs.

Belumosudil was approved for marketing by the FDA in 2021 and entered the Chinese market in 2023. Its current annual global sales have exceeded 1.2 billion US dollars, with a compound annual growth rate remaining above 45%. In the domestic market, only the original research product has been approved so far, and no generic drugs have been launched. With the annual growth rate of domestic allogeneic hematopoietic stem cell transplantation surgeries exceeding 15%, the clinical demand for this drug will continue to be released. If there is no verifiable data, please indicate it directly.

CATO can provide a full set of impurity reference standards for belumosudil API. All products of the full series meet the quality control requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. All core specifications are in stock, which can directly meet the full-process needs of pharmaceutical enterprises from generic drug declaration, process validation to routine quality testing, effectively shortening the R&D cycle and reducing compliance risks.