Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has filed a New Drug Application (NDA) with the National Medical Products Administration (NMPA) for its JAK inhibitor, jacktinib, to treat medium to high risk myelofibrosis (MF). This includes primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (Post PV MF), and post-essential thrombocytosis myelofibrosis (Post ET MF). This marks the first market filing for jacktinib in China.
Mechanism and Clinical Development
Jacktinib works by blocking the signal transducer and activator of transcription (STAT) and JAK signaling pathways, thereby improving immune-related inflammatory effects. Classified as a Category 1 drug, jacktinib is currently undergoing multiple clinical studies in various indications, including moderate- to high-risk myelofibrosis, myelofibrosis intolerant to ruxolitinib, severe alopecia areata, idiopathic pulmonary fibrosis, ankylosing spondylitis, moderate to severe plaque psoriasis, and moderate to severe atopic dermatitis. The drug has also obtained Orphan Drug Designation status for myelofibrosis from the US FDA.
Future Outlook
The filing of the NDA for jacktinib represents a significant step forward in Zelgen’s efforts to bring this innovative JAK inhibitor to patients in need. With its broad clinical development program and regulatory recognition, jacktinib is poised to address significant unmet medical needs across multiple inflammatory and fibrotic diseases.-Fineline Info & Tech
