Recently, a clinical study initiated by Professor Changwei Liu’s team from the Department of Vascular Surgery at Peking Union Medical College Hospital—titled “Evaluation of the Impact of Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection (hereinafter referred to as NL003) on Blood Flow in Ischemic Limb Areas Using PET/CT Imaging”—has been reviewed and approved by the hospital’s ethics committee.

NL003 is Our company has developed a Class 1 innovative drug—a gene therapy product—intended for the treatment of lower-limb ischemic diseases. Following Phase I and Phase II clinical trials, the safety and efficacy of NL003 have been preliminarily confirmed. Currently, two separate clinical study protocols are underway, with the primary endpoints of Phase III clinical trials being rest pain and ulcers. At present, there is no established quantitative method for assessing lower-limb blood flow in clinical practice. This research project aims to develop a novel, intuitive, and quantitative method for measuring lower-limb blood flow using imaging techniques such as PET-CT. This study represents a global first and holds broad potential for application in clinical diagnosis and evaluation of the efficacy of treatments for lower-limb ischemic diseases.

        This project has completed preclinical animal studies and has initially explored its feasibility. The company will actively support the research team in conducting this exploratory clinical trial, ensuring it stays synchronized with the Phase III clinical study of the NL003 program. We look forward to leveraging objective imaging data to further elucidate the mechanism by which NL003 promotes angiogenesis in the lower limbs, thereby providing more objective, comprehensive, and scientifically sound evidence for new drug review and approval.