Sino Biopharm's TDI01 receives breakthrough therapy designation

Sino Biopharmaceutical Limited (HKEX:1177) announced that its self-developed Class 1 innovative drug, TDI01 suspension, a ROCK2 inhibitor, has been included in the Breakthrough Therapy Designation (BTD) process by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China. TDI01 is intended for the treatment of moderate to severe cGVHD in patients who have received at least one and no more than five prior lines of systemic therapy. Phase Ib/II clinical study results demonstrated significant efficacy and good safety for TDI01 in treating moderate to severe cGVHD, and were presented at the 51st Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT). cGVHD is a major complication following allogeneic hematopoietic stem cell transplantation, with an incidence ranging from 30% to 70%. TDI01 has also been approved for clinical trials in China for idiopathic pulmonary fibrosis, pneumoconiosis, and liver fibrosis.