Sino Biopharmaceutical Ltd (HKG: 1177) has announced that the Center for Drug Evaluation (CDE) in China has accepted for review its market approval filing for the investigational Category 1 drug rovadicitinib (TQ05105). The drug is being developed for the treatment of moderate- to high-risk myelofibrosis (MF), a serious bone marrow disorder that can progress to bone marrow failure or transform into acute leukemia.
Myelofibrosis is a myeloproliferative tumor that includes primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV-MF), and post thrombocytopenia myelofibrosis (PETMF). PMF was recognized as a rare disease by China’s health authorities in September 2023, highlighting the urgency of developing effective treatments for this patient population.
Rovadicitinib is a novel JAK/ROCK inhibitor with a unique chemical structure that has shown promise in in vitro studies. The drug has been found to inhibit the activity of JAK family kinases and ROCK kinases, as well as suppress the phosphorylation levels of STAT3 and STAT5 in cells. By inhibiting the JAK/STAT signaling pathway, rovadicitinib exerts anti-tumor activity and may offer a new treatment option for patients with MF.
The acceptance of the market approval filing by the CDE is a significant step forward for Sino Biopharmaceutical as it seeks to bring this potential new treatment to patients in China. If approved, rovadicitinib would provide an additional therapeutic option for the treatment of MF, addressing a significant unmet medical need.
This development underscores Sino Biopharmaceutical’s commitment to advancing innovative therapies for oncology and rare diseases. As the company progresses through the regulatory process, it aims to demonstrate the safety and efficacy of rovadicitinib, potentially offering hope to patients with myelofibrosis and other related conditions.- Flcube.com
