SINO BIOPHARM(01177) 证券时报网·2025-01-14 09:53Core Viewpoint - The approval of TQ05105 for clinical trials by the FDA represents a significant advancement in the treatment of chronic graft-versus-host disease (cGVHD), highlighting the company's innovative capabilities and strategic international expansion [1][3]. Company Summary - The company, a leading player in the Hong Kong stock market, has received FDA approval for its JAK/ROCK inhibitor TQ05105, aimed at treating cGVHD, a common complication post-transplantation with incidence rates between 30% and 70% [1][2]. - TQ05105 is a novel JAK/ROCK inhibitor that effectively suppresses JAK family kinase activity and ROCK enzyme activity, demonstrating anti-tumor activity and a high objective response rate of 90.9% in cGVHD patients [2][3]. - The company is also advancing TQ05105 for the treatment of myelofibrosis (MF), with regulatory approval obtained in China, indicating a broader therapeutic potential for this rare myeloid tumor [3][4]. Industry Summary - Chronic graft-versus-host disease is a major complication following transplantation, often leading to severe impacts on patients' quality of life due to its diverse clinical manifestations and prolonged course [1][2]. - The approval of TQ05105 for clinical trials in the U.S. is expected to provide more treatment opportunities for patients, reflecting the industry's ongoing efforts to innovate and address unmet medical needs in hematological conditions [3]. - The company is also exploring additional clinical research avenues for TQ05105, including its use in combination with BET inhibitors or BCL-2 inhibitors for treating myelofibrosis, which is recognized in the national disease catalog in China [4].