The board of directors of Sino Biopharmaceutical Limited announced that the key clinical research for registration of ?Rovadicitinib (TQ05105)?, a Category 1 innovative drug independently researched and developed by the Group for the treatment of moderate and high-risk myelofibrosis (MF), has met the primary endpoint. The Group has communicated with the Center for Drug Evaluation (CDE) of the National Medical Products Administration of the PRC regarding the marketing application of TQ05105 tablets and obtained the CDE's consent to submit the application for marketing of this product. The Group will recently submit the application for marketing of TQ05105 tablets.

TQ05105 is a JAK/ROCK inhibitor with new chemical structure independently researched and developed by the Group. The results of in vitro test showed that TQ05105 could effectively inhibit the activity of JAK family kinases and ROCK kinase, and significantly inhibit the phosphorylation levels of STAT3 and STAT5 in cells, thereby inhibiting the conduction of JAK/STAT signaling pathway, and in turn exerting anti-tumor activity. The Group announced the findings of the Phase I clinical research of TQ05105 for the treatment of myeloproliferative neoplasms (MPN) at the Annual Meeting 2023 of American Society of Hematology (ASH).

The results showed that TQ05105 had good human pharmacokinetic behavior, good safety and tolerable toxicity, and the efficacy on spleen shrinkage (with the best spleen shrinkage rate of 63.79%) and the improvement of patients' physical symptoms (with the best improvement rate of 87.50%) was significant, and the duration of effectiveness was long, which could bring more clinical options to MF patients. In addition, the Group presented the findings from the Phase Ib/II clinical research of TQ05105 in chronic graft-versus-host disease (cGVHD) at the Annual Meeting 2023 of European Hematology Association (EHA). The results showed that TQ05105 had a good safety profile and a high remission rate for each rejection organ site (with the best objective response rate of 86.7%), and significantly improved clinical symptoms (40% of patients improved LSS score by 7 points), with 73.3% of patients reduced the dose of corticosteroids, which is expected to bring better clinical treatment options for patients with cGVHD.

MF is a diffuse bone marrow fibrous tissue proliferative disorder that belongs to the category of MPN and eventually progresses to the bone marrow failure or transforms into acute leukemia. In September 2023, primary myelofibrosis (PMF) was included in China's Second Batch of Rare Disease List. Only one product has currently been approved for the treatment of MF patients in China, and there is a large unmet clinical demand.