智通财经网·2025-08-06 10:29Core Insights - China National Pharmaceutical Group's self-developed drug TQ05105 (Ruxolitinib) has been included in the Breakthrough Therapy Designation (BTD) program by the CDE for the treatment of chronic graft-versus-host disease (cGVHD) [1][2] - Ruxolitinib is the fastest progressing JAK/ROCK dual small molecule inhibitor globally, with a marketing application submitted to CDE for myelofibrosis (MF) treatment [1] - The drug is currently undergoing Phase III clinical trials for cGVHD in China and has received approval for Phase II trials in the United States [1] Clinical Trial Results - Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective treatment for malignant hematological diseases, with cGVHD being a major complication occurring in 30%-70% of cases [2] - Phase Ib/IIa clinical trial results published in the journal "Blood" included 44 patients with moderate to severe steroid-refractory or dependent cGVHD, showing no dose-limiting toxicities and no drug-related adverse events leading to discontinuation [2] - The best overall response rate (BOR) was 86.4%, with a 12-month failure-free survival rate (FFS) of 85.2%, and 88.6% of participants reduced their steroid dosage requirements, while 59.1% experienced improvement in cGVHD-related symptoms [2] - The company is accelerating the global clinical development of Ruxolitinib to provide better treatment options for patients worldwide [2]