Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that its Phase III clinical study (ZGJAK016) for jakitinib, an in-house Janus kinase (JAK) inhibitor, has achieved primary endpoints. The trial focused on medium- to high-risk myelofibrosis, with the company planning to file for a pre-IND meeting with the Center for Drug Evaluation (CDE).
Clinical Trial Details
The study was conducted across 37 hospitals in China, led by the First Affiliated Hospital of Zhejiang University. A total of 105 eligible subjects were randomly assigned to either the jakitinib 100 mg bid group or the hydroxyurea 0.5 g bid group in a 2:1 ratio. The primary efficacy endpoint was the proportion of patients achieving a ≥35% reduction in spleen volume from baseline, as assessed by central imaging at 24 weeks. An interim analysis by the Independent Data Monitoring Committee (IDMC) confirmed that the results met the predefined primary efficacy endpoint.
Mechanism and Applications
Jakinib works by blocking the STAT and JAK signaling pathways, thereby improving immune-related inflammatory effects. The drug is being studied in multiple clinical trials, including for myelofibrosis intolerant to ruxolitinib, severe alopecia areata, idiopathic pulmonary fibrosis, ankylosing spondylitis, and various dermatological conditions. It has received orphan drug designation for myelofibrosis from the US FDA and gained approval for a Phase II clinical study in severe COVID-19 in China.-Fineline Info & Tech
