SINO BIOPHARM(01177): The global first-in-class JAK/ROCK inhibitor "Rovadicitinib" IB/IIA phase clinical study results published in "Blood"

SINO BIOPHARM (01177) announced that the Phase Ib/IIa clinical trial results of its independently developed national class 1 innovative drug, Rovadicitinib, for the treatment of chronic graft-versus-host disease (cGVHD) have been published in the top international hematology journal "Blood" (IF: 21.0). Rovadicitinib is the world's first oral small molecule inhibitor with dual JAK and ROCK inhibition mechanism, targeting JAK1/2 and ROCK1/2, with dual anti-inflammatory and anti-fibrotic effects. The drug has shown therapeutic potential in treating cGVHD, bone marrow fibrosis, and myelodysplastic syndromes. The study included 44 subjects, with 29 in the 10mg twice daily (bid) group and 15 in the 15mg bid group. The results showed that Rovadicitinib had good tolerability, with no dose-limiting toxicities in either dose group, and no adverse events leading to discontinuation of the drug. The most common hematologic adverse event was anemia (incidence rate of 38.6%, with a grade 3 incidence rate of 4.6%). The best overall response rate (BOR) in the overall study population was 86.4% (95% confidence interval (CI) 72.6-94.8), with no difference between the two dose groups. Additionally, in the corticosteroid-refractory cohort, the BOR was 72.7% (8/11), and in the corticosteroid-dependent cohort, it was 90.9% (30/33). Regardless of previous treatment, all affected organs showed signs of improvement. The 12-month failure-free survival rate (FFS) was 85.2% (95% CI, 64.5-94.3). 88.6% of subjects who received Rovadicitinib treatment had a reduction in corticosteroid dose. 59.1% of subjects showed improvement in cGVHD-related symptoms. Rovadicitinib has shown excellent clinical response rates and good tolerability in the cGVHD population, while also improving the quality of life for corticosteroid-refractory or dependent cGVHD patients and reducing the need for corticosteroid dose. It is reported that JAK and ROCK are two key signaling pathways that regulate immune response and fibrosis process. Rovadicitinib, through its globally pioneering dual inhibition mechanism, simultaneously blocks abnormal immune activation and fibrosis processes, demonstrating excellent disease control rates in cGVHD patients and providing them with a safe and effective treatment option. This study has been certified by the authoritative journal "Blood", not only confirming the scientific value of the drug, but also providing a new treatment option for cGVHD patients. The group submitted an application for the marketing of Rovadicitinib for the treatment of moderate to high-risk bone marrow fibrosis to the China National Medical Products Administration Drug Evaluation Center (CDE) in July 2024, and initiated Phase III clinical trials for the treatment of moderate to severe cGVHD in October 2024. In addition, the group received approval from the United States Food and Drug Administration (FDA) in January 2025 to conduct Phase II clinical trials of Rovadicitinib for the treatment of cGVHD in the United States. The group will accelerate the global clinical development of Rovadicitinib, promote the product to market as soon as possible, fill the clinical gap, and benefit a large number of patients.