Core Viewpoint - 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] Group 1: Drug Development and Approval - Ruxolitinib is the fastest progressing JAK/ROCK dual small molecule inhibitor globally [1] - The company submitted a marketing application for Ruxolitinib to the CDE in July 2024, which has been accepted for the treatment of intermediate to high-risk myelofibrosis (MF) [1] - Currently, Ruxolitinib is undergoing a Phase III clinical trial for cGVHD in China and has been approved for a Phase II clinical trial in the United States [1] Group 2: Clinical Trial Results - The Phase Ib/IIa clinical results for Ruxolitinib were published in the top journal "Blood," involving 44 patients with moderate to severe steroid-refractory or dependent cGVHD [2] - No dose-limiting toxicities were observed, and there were no adverse events leading to discontinuation related to Ruxolitinib [2] - The best overall response rate (BOR) was 86.4%, with a 12-month failure-free survival rate (FFS) of 85.2% [2] - 88.6% of participants reduced their steroid dosage requirements, and 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]