Beijing Northland Biotechnology’s gene therapy drug NL003 gets approval for market
On May 28, the NMPA website shows that Beijing Northland Biotechnology’s Class 1 new drug **NL003** is approved for market in China for the treatment of ulcers caused by critical limb ischemia (CLI).
NL003 injection is a novel plasmid-based gene therapy drug with a new target and mechanism of action. The drug is administered by local intramuscular injection of naked plasmid DNA. After transfection of striated muscle cells, it continuously secretes active HGF isoforms, specifically activating the HGF/C-MET signaling pathway. This promotes microcirculation formation, improves the microcirculatory environment, develops collateral circulation, and restores blood flow to ischemic areas, thereby achieving therapeutic effects while minimizing/avoiding adverse reactions and potential risks of gene therapy.
NL003 injection provides a new treatment option beyond traditional revascularization surgery, filling the gap in current CLI clinical care where therapeutic drugs are lacking. In particular, it offers a new treatment solution for patients who respond poorly to surgery, are not candidates for surgery, have poor expected outcomes after surgery, or have thromboangiitis obliterans.
Critical limb ischemia (CLI) is one of the vascular surgery emergencies. Approximately 20% of patients without surgical options can only receive conservative treatment and face a high risk of amputation, representing a significant unmet clinical need.
In China, following this approval, NL003 becomes the first and only new drug for the treatment of CLI. In addition, Humanwell Healthcare submitted a similar drug, pUDK HGF (acceptance number: CXSS2400137), in 2024, but received a notice from NMPA in December 2025 and was not approved.
From a competitive landscape perspective, NL003 is expected to maintain a leading market position for a considerable period. According to Insight Database statistics, apart from NL003, there are currently only five active clinical research projects for CLI in China, with the highest phase being Phase II.
