Recently, Chiatai Tianqing Pharmaceutical Group has reached the primary endpoint in the pivotal registration clinical study of Rovadicitinib (TQ05105), a Class 1 innovative drug independently developed by Chiatai Tianqing Pharmaceutical Group, for the treatment of intermediate- to high-risk myelofibrosis (MF). The Company has communicated with the Center for Drug Evaluation (CDE) of the State Drug Administration regarding the marketing application for TQ05105 tablets and has obtained the CDE's consent to submit a marketing application for this product, which will be submitted in the near future.

TQ05105 is a JAK/ROCK inhibitor with a new chemical structure developed by the company. In vitro test results show that TQ05105 can effectively inhibit JAK family kinase activity and ROCK kinase activity, and can significantly inhibit the phosphorylation level of STAT3 and STAT5 in cells, thus inhibiting the JAK/STAT signaling pathway conduction and thus exerting anti-tumor activity.

The Company announced data from a Phase I clinical study of TQ05105 for the treatment of myeloproliferative neoplasms (MPN) at the American Society of Hematology Annual Meeting (ASH) 2023. The results showed that TQ05105 has good pharmacokinetic behavior in humans, with tolerable toxicity, an optimal spleen reduction rate of 63.79%, and an optimal improvement rate of 87.50% in somatic symptoms, which is expected to bring more clinical options for MF patients.

In addition, the Company announced data from a Phase Ib/II clinical study of TQ05105 in chronic graft-versus-host disease (cGVHD) at the European Hematology Annual Meeting (EHA) 2023. The results showed that TQ05105 in cGVHD patients showed tolerable toxicity, 86.7% best objective remission rate for each draining organ site, 40% improvement in LSS score of ≥7 in patients, and 73.3% reduction in the dose of hormone use, which is expected to bring more clinical treatment options for cGVHD patients.

MF is a diffuse myelofibrous tissue proliferative disease, a type of MPN, which eventually progresses to bone marrow failure or transforms into acute leukemia.2023 In September 2023, primary myelofibrosis (PMF) was included in China's "Second Rare Disease Catalogue". Currently, only rucotinib is approved for the treatment of MF patients in China, leaving a large unmet clinical need.

Chiatai Tianqing has also laid out a number of combination studies in the field of myelofibrosis, such as TQ05105 combined with BET inhibitors or BCL-2 inhibitors for the treatment of intermediate- and high-risk myelofibrosis in the clinical study, the preliminary results of which are relatively positive.TQ05105 is another Class 1 innovative drug that the Company will soon declare for marketing. With the company's continuous investment in innovative drug development, the innovation pipeline has entered the harvest period.

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