Zhi Tong Cai Jing·2024-04-18 11:51Core Viewpoint - China Biopharmaceutical's innovative drug Rovadicitinib (TQ05105) for treating high-risk myelofibrosis (MF) has met its primary endpoint in key registration clinical trials, and the company is preparing to submit a marketing application to the National Medical Products Administration (NMPA) [1] Group 1 - TQ05105 is a novel JAK/ROCK inhibitor with a unique chemical structure, showing significant inhibition of JAK family kinase and ROCK kinase activities, leading to reduced phosphorylation levels of STAT3 and STAT5, thereby exerting anti-tumor activity [1] - The drug demonstrated favorable pharmacokinetics and safety in Phase I clinical trials, with a best spleen reduction rate of 63.79% and a symptom improvement rate of 87.50%, indicating its potential to provide more clinical options for MF patients [1][1] Group 2 - MF is a proliferative bone marrow disease that can progress to bone marrow failure or acute leukemia, with a significant unmet clinical need as only one product is currently approved for MF treatment in China [1] - The company is also conducting several combination studies involving TQ05105 with BET inhibitors or BCL-2 inhibitors for treating high-risk myelofibrosis, with preliminary results appearing positive [1] - The ongoing investment in innovative drug development is yielding breakthroughs, positioning the company's pipeline for a harvest period [1]