Sino Biopharm's self-developed Class 1 innovative drug, Rivoceranib Tablets, has been approved for marketing.

SINO BIOPHARM (01177) announced that the group's independently developed national class 1 innovative drug, Lofexidine Tefinostat tablets (trade name: Anxu), has obtained approval from the National Medical Products Administration (NMPA) of China for first-line treatment of adult patients with intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF). Lofexidine Tefinostat is a globally innovative JAK/ROCK dual-target small molecule inhibitor that achieves dual anti-inflammatory and anti-fibrotic effects through synergistic action on the JAK/ROCK dual pathways. On one hand, it reduces the production of high levels of inflammatory cytokines by inhibiting the JAK1/2-STAT3/5 signaling pathway, demonstrating an anti-inflammatory effect and improving splenomegaly and systemic symptoms. On the other hand, by inhibiting ROCK1/2, it decreases the polarization level of helper T cells and inflammatory cell cytokine load in patients with myelofibrosis, further enhancing the anti-inflammatory effect and providing support for long-term disease control. In a multicenter, randomized, double-blind, double-simulation, positive drug parallel-controlled Phase II clinical study (TQ05105-II-01), Lofexidine Tefinostat demonstrated excellent efficacy and safety in comparison to hydroxyurea in the treatment of intermediate-2, high-risk myelofibrosis patients. A total of 107 patients were recruited in the study and were randomly assigned to receive either Lofexidine Tefinostat 15mg or hydroxyurea 0.5g, administered orally twice daily. In terms of efficacy, the proportion of subjects in the Lofexidine Tefinostat group with a 35% reduction in spleen volume from baseline (SVR35) as assessed by an independent imaging review committee (IRC) at week 24 was 58.33%, reaching 63.89% at any time point, with an average duration of SVR35 of 8.31 months, and a high rate of improvement in total symptom score of 50% (TSS50) at 77.78%. In terms of safety, Lofexidine Tefinostat showed good overall tolerability, with an occurrence rate of adverse reactions grade 3 of approximately 40%, anemia occurrence rate of approximately 40%, and a treatment discontinuation rate of only 6.7%, all much lower than ruxolitinib. In addition to myelofibrosis, Lofexidine Tefinostat also shows breakthrough potential in the treatment of chronic graft-versus-host disease (cGVHD). Currently, the development of this product for cGVHD is progressing smoothly: it has entered Phase III clinical trials in China and was included in the breakthrough therapy program by the Center for Drug Evaluation of the NMPA in August 2025; it has also received approval to conduct Phase II clinical studies in the United States.