Rezurock® is the commercial brand name of Belumosudil Mesylate Tablets, an orally active selective Rho-associated coiled-coil kinase 2 (ROCK2) inhibitor developed by Sanofi. It selectively inhibits ROCK2, modulates Th17/Treg immune balance, reduces pro-inflammatory cytokine release and alleviates immune-mediated tissue fibrosis and inflammatory injury.
Main Indications
Treatment of adult patients with chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy.
Clinical Research
Global multicenter phase III ROCKstar pivotal trial confirmed durable overall response rate and sustained symptom improvement for patients with second-line or later chronic graft-versus-host disease treated with belumosudil;
Long-term follow-up cohorts demonstrated persistent response maintenance and improved organ function under continuous oral administration;
Dose-finding research verified balanced anti-inflammatory and anti-fibrotic efficacy and systemic tolerability of the 200 mg once-daily standard dose;
Chinese domestic registration trials confirmed consistent therapeutic activity and manageable adverse reaction spectrum for domestic patients with chronic graft-versus-host disease.
Common Side Effects
Common mild adverse reactions: Diarrhea, nausea, fatigue, abdominal pain, vomiting and peripheral edema;
Laboratory abnormalities: Transient elevation of liver transaminases, hyperlipidemia and neutropenia;
Severe but uncommon risks: Severe gastrointestinal adverse events, opportunistic infections and liver function impairment.
Approval Status in China
Original drug Rezurock® (Belumosudil Mesylate Tablets) was officially approved for marketing in China in 2024, with the specification of 0.2 g per tablet, 30 tablets per box. It is currently a prescription targeted immunomodulatory drug included in China’s Category B medical insurance catalogue.
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