Northland：NL003 received marketing approval

Saiduomingji Injection, a Category 1 new drug independently developed by Northland Biotech, is the world’s first approved plasmid-based gene therapy drug. It is indicated for the treatment of ulcers caused by severe limb ischemia (CLI) in patients who are not suitable for revascularization or have poor surgical outcomes.

CLI is an end-stage manifestation of peripheral arterial disease. Patients often suffer from refractory ulcers, rest pain, and a high risk of amputation. Conventional surgical options are applicable to a limited population, and there has long been a lack of effective pharmacological treatments in clinical practice.

Saiduomingji is administered via intramuscular injection of plasmid DNA. Upon transfection of striated muscle cells, it continuously secretes bioactive HGF isoforms, activating the HGF/C-MET pathway. This promotes the establishment of microcirculation and collateral circulation, restores blood flow to the ischemic region, and reduces the immunogenicity risks associated with gene therapy.

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