Recently, Beijing Northland Biotechnology Co., Ltd. received the "Drug Clinical Trial Approval" (Approval No.: 2017L04713) approved and issued by the National Medical Products Administration, authorizing the Phase III clinical trial of recombinant human hepatocyte growth factor naked plasmid injection for the indication of lower limb arterial ischemic disease.

The recombinant human hepatocyte growth factor naked plasmid injection is a naked plasmid gene therapy drug independently developed by NORTHLAND. It can be used for the treatment of indications such as lower limb arterial ischemic disease, coronary heart disease, and diabetic peripheral neuropathy. Currently, no similar product has been launched worldwide. Clinical trials are being conducted simultaneously in China, South Korea, the United States, and other countries, and this product has the potential to become the first naked plasmid gene therapy drug to be approved and marketed in China—and possibly globally.

Currently, NORTHLAND is developing an indication for lower-limb arterial ischemic disease. In China, there are at least 30 million patients suffering from lower-limb arterial ischemia, and currently, there is still no effective treatment available in clinical practice. This drug is administered via local, precise injection into the muscles at the site of ischemia, where it transfects striated muscle cells to express and secrete hepatocyte growth factor (HGF), a substance with angiogenic properties. As a result, new blood vessels are promoted, collateral circulation is established locally, and a “molecular bypass” mechanism is created, thereby increasing blood supply to the ischemic area and achieving the goal of treating arterial ischemic disease. In previous clinical trials, the safety of this drug has been demonstrated, and it has shown promising efficacy in effectively relieving pain and promoting the healing and improvement of ulcers or gangrene. If this drug is successfully brought into production, it will generate significant economic and social benefits.

NORTHLAND has meticulously prepared for the Phase III clinical trial of this new drug and has organized experts to thoroughly validate the protocol. We will, in strict accordance with GCP standards and with a scientific and rigorous attitude, carefully conduct the Phase III clinical trial of this project to ensure its smooth implementation.