On March 2, China Biopharmaceutical (01177) issued an announcement stating that the group's independently developed Class 1 innovative drug...Rovaxitinib tablets (trade name: Anxu®) have been approved for marketing by the National Medical Products Administration (NMPA) of China 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).

In a multicenter, randomized, double-blind, double-dummy, positive-drug parallel-controlled phase II clinical trial, rovaxitinib demonstrated superior efficacy and good safety compared to hydroxyurea in the treatment of intermediate-2 and high-risk myelofibrosis patients.

The results showed that in the rovaxitinib group, 58.33% of subjects achieved a spleen volume reduction of ≥35% from baseline (SVR35) at week 24, 63.89% achieved SVR35 at any time point, the mean duration of SVR35 was as long as 8.31 months, and the best total symptom score improvement of ≥50% (TSS50) rate was as high as 77.78%. The drug was generally well tolerable, with an incidence of ≥ grade 3 adverse reactions of approximately 40%, anemia of approximately 40%, and a treatment discontinuation rate of only 6.7%.

https://finance.eastmoney.com/a/202603023657878663.html