A new drug—recombinant human hepatocyte growth factor naked plasmid injection—for the treatment of diabetic lower-limb arterial occlusion, atherosclerotic occlusion of the lower limbs, and thrombo-obliterating endarteritis—has recently received approval from the National Medical Products Administration and has entered clinical trials.

This injection is a naked plasmid-based gene therapy drug engineered using a novel hepatocyte growth factor (HGF) and a highly efficient PCK vector. It uniquely leverages the principle of selective splicing of introns within the gene, enabling simultaneous expression of two HGF isoforms—HGF728 and HGF723—in target cells, which closely mimics the natural mechanism of action of the endogenous HGF gene. When injected into ischemic muscle tissue, the naked plasmid transfects striated muscle cells, prompting them to express and secrete HGF with angiogenic properties, thereby establishing a “molecular bridging” mechanism that promotes the formation of local collateral circulation and enhances blood supply to the ischemic area.

According to researchers from Beijing NORTHLAND Biotechnology Co., Ltd., this achievement, which boasts independent intellectual property rights, has obtained a national patent and has been approved for clinical trials in China, the United States, and South Korea. Preliminary research results indicate that this drug holds promising potential for the treatment of arterial ischemic diseases.

—– Excerpted from Page B1 of China Pharmaceutical News