The board of directors of Sino Biopharmaceutical Limited announced that the rovadicitinib tablet It is indicated for the first-line treatment of adult patients with intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF). Rovadicitinib is a global first-in-class small-molecule inhibitor that targets both JAK/ROCK. By leveraging the synergistic effects of the dual JAK/ROCK pathways, it achieves dual therapeutic effects of anti-inflammation and anti-fibrosis.
Rovadicitinib, on one hand, inhibits the JAK1/2-STAT3/5 signaling pathway to minimize high-level inflammatory cytokines produced by myeloid cells, thereby exerting anti-inflammatory effects that alleviate splenomegaly and systemic symptoms. On the other hand, by inhibiting ROCK1/2, it lowers the polarization level of helper T cells and the pro-inflammatory cytokine load in patients with myelofibrosis, which further enhances the anti-inflammatory effect while supporting the long-term disease control. In a multicenter, randomized, double-blind, double-simulation, positive drug-parallel controlled Phase II clinical study (TQ05105-II-01), rovadicitinib demonstrated superior efficacy and showed a favorable safety profile compared to hydroxyurea in treating patients with intermediate-2 or low-risk myelofibrosis. A total of 107 patients were enrolled in the study and randomized in a 2:1 ratio to receive either 15 mg of rovadicitinib or 0.5 g of hydroxyurea orally twice daily.
In terms of efficacy, in the rovadicitinIB group, 58.33% of patients achieved a 35% reduction in spleen volume (SVR35) at Week 24 compared with baseline as assessed by the independent radiology review committee (IRC), 63.89% of patients achieved SVR35 at any time point, with an average SVR35 duration of 8.31 months. The best 50% reduction in total symptom score (TSS50) rate was 77.78% in the rovadicit in the rovadicit Inib group. In terms of safety, rovadicitinib was generally well-tolerated.
In relevant studies, the incidence of Grade3 adverse events was approximately 40%, with the incidence of anemia being approximately 40%, and the treatment discontinuation rate being merely 6.7%, all of which were significantly lower than those observed with ruxolitinib. In 2025, there were more than 67,000 patients and the number of patients is projected to reach approximately 300,000 by 2030. Due to the features such as insidious onset and complex symptoms, most patients are already at an intermediate or advanced stage when being diagnosed, resulting in a significant disease burden.
Currently, there is no curative treatment for MF, and the clinical therapy primarily focuses on relieving symptoms, delaying disease progression, and improving the quality of life. With its dual therapeutic effects of anti- inflammation and anti-fibrosis, rovadicitinIB is expected to act as a breakthrough treatment option for patients with MF, thereby reshaping the clinical treatment landscape. Beyond MF, rovadicitinab has also demonstrated breakthrough potential in the treatment of chronic graft-versus-host disease (cGVHD).
Currently, the development of rovadicitinIB for cGVHD is progressing smoothly: in China, it has advanced to the Phase III clinical trial stage and was included in the Breakthrough Therapy Designation (BTD) process by the Center for Drug Evaluation (CDE) of the NMPA in August 2025; in the United States, it has been approved to conduct Phase II clinical studies.
