China Biopharmaceuticals (01177)'s independently developed Class 1 innovative drug, Rovaxtinib Tablets, approved for market launch

CNBC Finance APP News: China Bio-Pharmaceuticals (01177) announced that the group’s independently developed Class 1 innovative drug, Rovaxtinib tablets (brand name: Anxu®), has received approval from the National Medical Products Administration (NMPA) of China for market launch. It is indicated as a first-line treatment for adult patients with intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF).

Rovaxtinib is a globally first-in-class small molecule inhibitor targeting both JAK and ROCK pathways. By synergistically acting on these dual pathways, it achieves dual effects of anti-inflammation and anti-fibrosis. The drug works by inhibiting the JAK1/2–STAT3/5 signaling pathway, reducing high levels of inflammatory cytokines produced by myeloid cells, thereby exerting anti-inflammatory effects and improving spleen enlargement and systemic symptoms. Additionally, by inhibiting ROCK1/2, it decreases the polarization of helper T cells and inflammatory cytokine load in the bone marrow of fibrotic patients, further enhancing anti-inflammatory effects and supporting long-term disease control.

In a multicenter, randomized, double-blind, double-dummy, positive-controlled Phase II clinical trial (TQ05105-II-01), Rovaxtinib demonstrated excellent efficacy and good safety compared to hydroxyurea in treating intermediate-2 and high-risk myelofibrosis patients. The study enrolled 107 patients, randomized in a 2:1 ratio to receive Rovaxtinib 15 mg or hydroxyurea 0.5 g, administered orally twice daily.

In terms of efficacy, 58.33% of patients in the Rovaxtinib group achieved a spleen volume reduction of ≥35% (SVR35) at week 24 as assessed by an independent imaging review committee (IRC). The proportion of patients reaching SVR35 at any time point was 63.89%. The average duration of SVR35 was 8.31 months. The rate of improvement in total symptom score (TSS50) was as high as 77.78%. Regarding safety, Rovaxtinib was generally well tolerated. The incidence of grade 3 or higher adverse events was about 40%, with anemia occurring in about 40% of patients. The treatment discontinuation rate was only 6.7%, significantly lower than that of ruxolitinib.

Beyond MF, Rovaxtinib has also shown breakthrough potential in the treatment of chronic graft-versus-host disease (cGVHD). Currently, the product’s development for cGVHD is progressing smoothly: it has entered Phase III clinical trials in China and was included in the Breakthrough Therapy Designation by the China Center for Drug Evaluation (CDE) in August 2025; in the United States, it has received approval to conduct Phase II clinical studies.