Gelonghui, April 18 | China Biopharmaceutical (01177.HK) announced that the key registered clinical study of the Class 1 innovative drug Rovadicitinib (TQ05105), a class 1 innovative drug independently developed by the Group for the treatment of medium- and high-risk myelofibrosis (MF), has reached the main end. The Group has communicated with the Drug Evaluation Center (CDE) of the China National Drug Administration on the marketing application for TQ05105 tablets and obtained the CDE's approval to submit the marketing application for this product. The Group will submit a listing application for TQ05105 in the near future.
TQ05105 is a JAK/ROCK inhibitor with a novel chemical structure independently developed by the Group. Results of in vitro tests showed that TQ05105 can effectively inhibit JAK family kinase activity and ROCK kinase activity, and can significantly inhibit the phosphorylation levels of STAT3 and STAT5 in cells, thereby inhibiting the JAK/STAT signaling pathway, thereby exerting anti-tumor activity.
At the 2023 American Hematology Annual Meeting (ASH), the Group presented data from the Phase I clinical study of TQ05105 for the treatment of myeloproliferative tumors (MPN). The results showed that TQ05105 has good pharmacokinetic behavior in humans, is safe, the toxicity is tolerable, and has remarkable effects on spleen reduction (optimal spleen reduction rate of 63.79%) and improvement of patients' physical symptoms (optimal improvement rate of 87.50%). The effect lasts for a long time, and can bring more clinical choices to MF patients.
Furthermore, at the 2023 European Hematology Annual Meeting (EHA), the Group presented TQ05105 phase IB/II clinical study data in chronic graft-versus-host disease (cGVHD). The results showed that TQ05105 has good safety, has a high remission rate for all excreted organs (optimal objective remission rate of 86.7%), significantly improved clinical symptoms (40% of patients LSS score improved by ≥7 points), and 73.3% of patients reduced hormone dosage, which is expected to bring better clinical treatment options for cGVHD patients.
MF is a diffuse myelofibrillar tissue proliferative disorder. It is a type of MPN and eventually progresses to bone marrow failure or transformation into acute leukemia. In September 2023, primary myelofibrosis (PMF) was included in China's “Second Batch of Rare Diseases Catalogue”. Currently, only one domestic product has been approved for the treatment of MF patients, and there is a large unmet clinical demand.
The Group has also arranged a number of joint studies in the field of myelofibrosis, such as TQ05105 combined with BET inhibitors or BCL-2 inhibitors, clinical studies for the treatment of medium- and high-risk myelofibrosis. The initial results were positive. TQ05105 is another Class 1 innovative drug that the Group will soon declare for marketing. With the Group's continuous investment in innovative drug research and development, innovative products have made continuous breakthroughs, and the innovation pipeline has entered a harvest period.