Core Viewpoint - China National Pharmaceutical Group has received approval from the National Medical Products Administration (NMPA) for its self-developed innovative drug, Rovaxitinib tablets (brand name: Anxu), for the 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) [1] Group 1 - Rovaxitinib demonstrated excellent efficacy and safety in a Phase II clinical study compared to hydroxyurea in treating intermediate-2 and high-risk myelofibrosis patients [1] - The study results indicated that 58.33% of patients in the Rovaxitinib group achieved a spleen volume reduction of ≥35% (SVR35) at week 24, with 63.89% achieving SVR35 at any time point [1] - The average duration of SVR35 was 8.31 months, and the total symptom score improvement of ≥50% (TSS50) rate reached 77.78% [1] Group 2 - The overall tolerability of the drug was good, with an incidence rate of adverse reactions of grade ≥3 at approximately 40%, and anemia occurrence also around 40% [1] - The treatment discontinuation rate was only 6.7% [1]

Core Viewpoint - China National Pharmaceutical Group's innovative drug, Rovaxitinib (brand name: Anxu), has received approval from the National Medical Products Administration (NMPA) for the treatment of intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF) in adult patients as a first-line therapy [1] Group 1: Drug Efficacy - Rovaxitinib is a first-in-class JAK/ROCK dual-target small molecule inhibitor that provides dual effects of anti-inflammation and anti-fibrosis through the inhibition of the JAK1/2-STAT3/5 signaling pathway and ROCK1/2 [1] - In a Phase II clinical study (TQ05105-II-01) involving 107 patients, Rovaxitinib demonstrated superior efficacy compared to hydroxyurea, with 58.33% of patients achieving a spleen volume reduction of ≥35% (SVR35) at week 24 [2] - The average duration of SVR35 was reported to be 8.31 months, and the total symptom score improvement of ≥50% (TSS50) was achieved by 77.78% of patients [2] Group 2: Safety Profile - Rovaxitinib exhibited good overall tolerability, with a ≥ grade 3 adverse reaction rate of approximately 40% and an anemia occurrence rate of about 40% [2] - The treatment discontinuation rate was only 6.7%, significantly lower than that of ruxolitinib [2] Group 3: Future Development - Beyond myelofibrosis, Rovaxitinib shows promising potential in the treatment of chronic graft-versus-host disease (cGVHD), currently in Phase III clinical trials in China and has been included in the breakthrough therapy program by the NMPA [2] - In the United States, Rovaxitinib has been approved to initiate Phase II clinical research for cGVHD [2]