On March 10, Sino Biopharmaceutical (01177) announced that the Phase Ib/IIa clinical study results of the Group's independently developed 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. The drug is the world's first oral small molecule inhibitor with dual inhibition mechanisms of JAK and ROCK, showing good anti-inflammatory and anti-fibrosis effects.

A total of 44 subjects were included in the study, and the results showed that rovadicitinib was well tolerated, with no dose-limiting toxicity. The most common adverse event was anemia, with an incidence of 38.6%. The best overall response rate (BOR) of the study was 86.4%, 72.7% in the glucocorticoid-refractory cohort, and 90.9% in the glucocorticoid-dependent cohort. In addition, 88.6% of the treated subjects reduced their glucocorticoid doses, and 59.1% of the subjects experienced improvement in related symptoms.

The Group has submitted a marketing application for rovacitinib to the China National Medical Products Administration for the treatment of intermediate- and high-risk myelofibrosis, and plans to initiate a Phase III clinical trial in October 2024. In January 2025, the Group also obtained FDA approval to conduct a Phase II clinical trial in the United States, aiming to accelerate the global clinical development of rovacitinib and provide patients with safe and effective treatment options as soon as possible.

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