On February 28, Rovadicitinib tablets (Anxu^®, TQ05105), a Class 1 innovative drug from CTTQ Pharma, a core enterprise of Sino Biopharmaceutical Limited (1177.HK), was approved for marketing in China for the first-line treatment of adult patients with intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythaemia vera myelofibrosis (PPV-MF), or post-essential thrombocythaemia myelofibrosis (PET-MF). 

Myelofibrosis (MF) is a rare myeloproliferative neoplasm (MPN) clinically characterized by a progressive decline in blood cells, hepatosplenomegaly, general symptoms (such as fatigue, night sweats, weight loss, pyrexia, bone pain, etc.), and a very high risk of transformation to acute myeloid leukaemia (AML)^[1]. With the aging population in China, the number of patients with myelofibrosis is on the rise, exceeding 67,000 by 2025 and projected to reach approximately 300,000 by 2030. Due to its insidious onset and complex symptoms, most patients are already in the intermediate to late stages at the time of diagnosis, with a heavy disease burden. Currently, there is no curative treatment for myelofibrosis. The clinical treatment goals are mainly focused on alleviating symptoms, delaying disease progression, and improving quality of life. 

Rovadicitinib tablets are a Class 1 new drug with a novel chemical structure and the world's first approved JAK/ROCK dual-target small-molecule inhibitor. It achieves potent anti-inflammation and improvement of fibrosis through the synergistic action of the dual JAK/ROCK pathways. A pivotal registrational clinical study of Rovadicitinib showed that the proportion of subjects achieving a spleen volume reduction of ≥35% from baseline at week 24 (SVR35), as assessed by the Independent Imaging Review Committee (IRC), was 58.33%. The proportion of subjects achieving SVR35 at any time point reached 63.89%, with an average duration of SVR35 of 8.31 months. The rate of achieving a best total symptom score improvement of ≥50% (TSS50) was as high as 77.78%. In terms of safety, the incidence of grade ≥3 adverse reactions in related studies of Rovadicitinib was approximately 40%, the incidence of anaemia was approximately 40%, and the therapy cessation rate was 6.7%. 

In addition to the myelofibrosis indication, Rovadicitinib has also shown excellent potential in the treatment of chronic graft versus host disease (cGVHD). In August 2025, this indication was included in the Breakthrough Therapy Designation program by the CDE, NMPA, and is currently in Phase III clinical studies in China. It has also received FDA approval to conduct Phase II clinical trials in the US. 

The field of haematological diseases faces numerous challenges due to the complexity of its pathological mechanisms, the heterogeneity of the patient population, and the high technological barriers to treatment methods. Sino Biopharmaceutical Limited has long focused on the unmet clinical needs in the field of blood disorders and has had more than ten products approved for marketing. These include Recombinant Human Coagulation Factor VIII for Injection (Anhengji^®), Recombinant Human Coagulation Factor VIIa N01 for Injection (Anqixin^®), Rituximab Injection (Delituo^®), Dasatinib Tablets (Yinishu^®), Imatinib Mesylate Capsules (Genike^®), Azacitidine for Injection (Weishou^®), Pomalidomide Capsules (Anyue^®), Bortezomib for Injection (Qianping^®), and the recently approved Carfilzomib for Injection (Anfeifan^®) on February 14. Together, they form a powerful product matrix covering multiple therapeutic areas such as multiple myeloma, lymphoma, leukaemia, and haemophilia. 

In addition, Sino Biopharmaceutical Limited has more than ten innovative projects in this field steadily advancing in its pipeline. Multiple products, including the BCL-2 inhibitor TQB3909, Syk inhibitor TQB3473, CD3/CD20 bispecific antibody TQB2825, and BCMA/CD3 bispecific antibody TQB2934, have all entered Phase III clinical trials, promising to bring more breakthrough treatment options to patients worldwide. In the future, Sino Biopharmaceutical Limited will continue to focus on clear clinical needs, accelerate innovative R&D and the launch of high-quality products, and continuously enhance its comprehensive strength in the field of haematological diseases. 

References:

[1] MESA R A, VERSTOVSEK S, CERVANTES F, et al.Primary myelofibrosis (PMF), post polycythemia vera myelofibrosis(post-PV MF), post essential thrombocythemia myelofibrosis(post-ET MF), blast phase PMF (PMF-BP): Consensus on ter-minology by the international working group for myelofibrosisresearch and treatment (IWG-MRT) [J].Leuk Res, 2007, 31(6): 737-740.

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