Belumosudil Mesylate Tablets

Besudiol Mesylate Tablets are the world’s first, Asia’s first and only ROCK2 inhibitor approved by the US FDA for the treatment of cGVHD. 1 The drug was previously granted breakthrough therapy and priority review qualifications by the FDA. 2 The product was developed by Kadmon Pharmaceuticals and was first approved for marketing in the United States in July 2021. In 2019, Yehui Pharmaceuticals obtained Kadmon’s exclusive clinical and commercial authorization for Besudiol Mesylate Tablets in China, completed clinical development and new drug application, and officially obtained approval for marketing from the China National Medical Products Administration (NMPA) on August 1 this year.
At the same time, China-Sanofi announced that the first ROCK2 inhibitor Besudiol Mesylate Tablets will be officially commercially launched by Sanofi China for the treatment of chronic graft-versus-host disease (cGVHD) patients aged 12 years and above who have inadequate response to glucocorticoids or other systemic treatments. The main pathophysiological process of cGVHD is immune inflammatory response, and the common and characteristic pathological changes are fibrosis. Besudiol mesylate is a selective Rho-associated coiled-coil kinase (ROCK2) inhibitor that simultaneously targets the inflammatory and fibrotic processes of cGVHD and can reduce fibrosis while restoring immune homeostasis.