Hangzhou Biosunpharma Co., Ltd. has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its investigational compound OB756. The company is seeking regulatory approval for the treatment of patients with medium to high-risk myelofibrosis (MF).
OB756 is a novel JAK2 inhibitor with a distinct chemical structure. It is designed to inhibit JAK2 V617 kinase activity in bone marrow proliferative tumors, interrupt the JAK-STAT signaling pathway, and impede various cytokine signaling pathways associated with these conditions. OB756 is intended for clinical use in the treatment of diseases such as myelofibrosis, polycythemia vera, and primary thrombocythemia.
The NDA submission follows the successful completion of a Phase II/III study in China, which met its primary endpoint in December of the previous year. The study demonstrated that patients treated with OB756 experienced significantly greater improvements in spleen contraction efficiency, physical symptoms, and overall quality of life compared to the control group. Throughout the trial, OB756 exhibited satisfactory overall safety and tolerability profiles.- Flcube.com
