Is Belumosudil tablets currently on the market? What is the sales situation?

Belumosudil mesylate tablets (Belumosudil) has been an important new drug in the field of treatment of chronic graft-versus-host disease in recent years, and its marketing progress and global accessibility have always attracted much attention. Judging from current public information, Besudil has completed marketing approval in multiple key markets, but there are still significant differences in availability in different countries and regions.

In the United States, Besudil was approved by the U.S. Food and Drug Administration in July 2021 under the trade name REZUROCK for the treatment of chronic GVHD patients 12 years old and above who have an inadequate response to glucocorticoids or other systemic treatments. Being the first to be approved in the U.S. market, it entered clinical practice earlier and accumulated rich real-world drug experience, providing an important reference for approval in other regions around the world. Within the EU, Besudil has not yet officially received centralized approval for marketing authorization.

In the Chinese market, Besudil was officially approved for marketing on August 1, 2023, with the trade name REZUROCK, becoming one of the few targeted oral drugs in the domestic chronic GVHD treatment field. This approval is of great significance to the patient group who have long-term dependence on hormones and traditional immunosuppressants. It also marks the gradual integration of domestic treatment of post-transplantation complications with international progress.

From the perspective of sales and application, since chronicGVHD is a relatively niche disease with a long treatment cycle, Besudil is not an "explosion" medication, but is mainly used in specialized disciplines. In overseas markets, it is mainly used through transplant centers and hematology channels, emphasizing doctor experience and patient screening. In the early stages of its launch in China, it is more in the stage of clinical understanding and real-world accumulation. In the future, as the guidelines are updated and doctors’ familiarity increases, its application population is expected to gradually expand.

Reference: https://www.drugs.com/pro/rezurock.html