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]

Core Viewpoint - China Biologic Products (01177.HK) announced that its self-developed drug TQ05105 (a JAK/ROCK inhibitor) has been included in the Breakthrough Therapy Designation (BTD) program by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China for the treatment of chronic graft-versus-host disease (cGVHD) [1] Group 1 - TQ05105 is the fastest developing dual small molecule inhibitor of JAK/ROCK globally [1] - The company submitted a marketing application for TQ05105 to the CDE in July 2024, which has been accepted for the treatment of intermediate to high-risk myelofibrosis (MF) [1] - Currently, TQ05105 is undergoing a Phase III clinical trial for cGVHD in China, and has been approved to conduct a Phase II clinical trial in the United States [1] Group 2 - The Phase III clinical trial for TQ05105 in treating moderate to severe cGVHD is currently in the subject recruitment phase [1] - The company aims to accelerate the global clinical development of TQ05105 to provide better treatment options for patients worldwide as soon as possible [1]