中国生物制药:集团自主研发的1类创新药罗伐昔替尼上市获得药监局上市批准
Cai Jing Wang·2026-03-02 10:20

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]

SINO BIOPHARM-中国生物制药:集团自主研发的1类创新药罗伐昔替尼上市获得药监局上市批准 - Reportify