Zelgen’s Jaktinib Receives NMPA Approval for Myelofibrosis Treatment

Zelgen's Jaktinib Receives NMPA Approval for Myelofibrosis Treatment

Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its self-developed jaktinib. The Category 1 drug is indicated for the treatment of adult patients with intermediate- or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), and post-essential thrombocythemia myelofibrosis (PET-MF), targeting disease-related splenomegaly or disease-related symptoms.

Jaktinib: A Novel JAK Inhibitor
Jaktinib is a novel Janus kinase (JAK) inhibitor that demonstrates significant inhibitory effects on all four JAK kinase subtypes—JAK1, JAK2, JAK3, and TYK2. Additionally, it inhibits activin receptor 1 (ACVR1), which helps improve iron metabolism disorders and anemia. Phase III clinical trials confirmed that jaktinib achieved a spleen volume reduction of ≥35% from baseline (SVR35) in 72.3% of subjects at 24 weeks. Other efficacy endpoints, including anemia response and hemoglobin levels, also showed significant clinical benefits.

Expanding Therapeutic Potential
Currently, jaktinib is also being tested in other indications, such as severe alopecia areata, atopic dermatitis, and ankylosing spondylitis. This approval marks a significant milestone for Zelgen Biopharmaceuticals, highlighting its commitment to developing innovative treatments for patients with unmet medical needs.-Fineline Info & Tech