Chia Tai Tianqing, a renowned pharmaceutical company based in China, has declared that it has successfully met the primary endpoint in a pivotal study for its Category 1 drug, rovadicitinib, for the treatment of medium-to-high-risk myelofibrosis (MF). The company is advancing towards filing for market approval in China, following consultations with the Center for Drug Evaluation (CDE).
Rovadicitinib, also known as TQ05105, is an innovative JAK/ROCK inhibitor with a novel chemical structure developed in-house. In vitro studies have demonstrated that TQ05105 can effectively suppress JAK family kinase and ROCK kinase activities, significantly reducing STAT3 and STAT5 phosphorylation levels in cells. This mechanism inhibits the JAK/STAT signaling pathway, which is crucial for its anti-tumor effects.
Phase Ib/II clinical trial data on TQ05105, presented at the 28th annual European Hematology Association (EHA) congress, showed that the drug has a tolerable safety profile in patients with chronic graft-versus-host disease (cGVHD). The trial indicated an optimal objective response rate of 86.7% across various organ sites. Additionally, it was noted that 40% of the patients experienced an improvement in their LSS score by 7 points or more, and 73.3% of the patients had a reduction in their steroid dosage.-Fineline Info & Tech
