Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) secured U.S. FDA approval to launch a clinical trial of its JAK inhibitor, jacktinib, for severe alopecia areata, marking the second IND clearance for the drug in the U.S. The therapy targets immune-driven inflammation via JAK/STAT pathway inhibition.
Drug Profile and Mechanism
Jacktinib, a Category 1 novel drug discovered in-house, blocks Janus kinase (JAK) and signal transducer and activator of transcription (STAT) pathways to reduce immune-related inflammation. The drug is under investigation for multiple indications, including myelofibrosis (with FDA orphan drug status), idiopathic pulmonary fibrosis, and psoriasis.
Clinical Development
The FDA approval expands jacktinib’s U.S. pipeline, following prior clearance in myelofibrosis. Ongoing trials explore its efficacy in moderate-to-high-risk myelofibrosis, ruxolitinib-intolerant patients, and other immune-mediated disorders. The alopecia areata trial will assess its potential to reverse hair loss in severe cases.
Strategic Outlook
Zelgen’s global push for jacktinib underscores its ambition to address unmet needs in autoimmune diseases. With orphan drug designation in myelofibrosis and dual FDA IND approvals, the firm aims to position the JAK inhibitor as a best-in-class therapy across indications.-Fineline Info & Tech
