Sino Biopharmaceutical Limited (1177) disclosed that its self-developed rovadicitinib tablet (trade name: Anxu (安煦®)) received marketing approval from the National Medical Products Administration of China. The product is indicated 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).

Rovadicitinib is described as a global first-in-class small-molecule inhibitor targeting both JAK/ROCK pathways, offering dual anti-inflammatory and anti-fibrotic effects. In a multicenter Phase II trial involving 107 patients, 58.33% of those treated with rovadicitinib achieved at least a 35% reduction in spleen volume at Week 24, with a best total symptom score reduction of 50% or more in 77.78% of patients. The incidence of Grade≥3 adverse events was about 40%, and the treatment discontinuation rate was 6.70%.

According to the announcement, myelofibrosis is a rare myeloproliferative neoplasm with an increasing incidence in China. By 2025, the patient population had exceeded 0.07 million, and it is projected to reach around 0.30 million by 2030. Rovadicitinib, which combines anti-inflammatory and anti-fibrotic effects, is anticipated to address significant unmet clinical needs. Beyond myelofibrosis, it also shows potential for chronic graft-versus-host disease, with Phase III clinical trials underway in China and Phase II studies approved in the United States.