The NL003 project has received clinical study approval from the SFDA.

Category:

2008-06-30


The NORTHLAND NL003 project has been reviewed and approved by the National Medical Products Administration on June 3, 2008, and has officially entered Phase I clinical trials.


This product is a naked plasmid-based gene therapy drug constructed using a novel hepatocyte growth factor gene and a highly efficient gene delivery vector. Preclinical studies have shown that when this product is injected into the muscle tissue at ischemic sites, it can transfect muscle cells, effectively express and secrete hepatocyte growth factor, which promotes angiogenesis. This local action facilitates the formation of collateral circulation, enhances and restores blood supply to ischemic areas, and demonstrates significant therapeutic efficacy in treating arterial ischemic diseases without any obvious toxic effects. Clinically, it can be used for conditions such as lower-limb arteriosclerotic occlusion, diabetic lower-limb arterial occlusion, thrombo-obliterating endarteritis, and coronary artery disease.


With strong support from the national “Science and Technology Innovation” Fund and governments at all levels in Beijing, after more than four years of intensive scientific and technological research, the company has systematically completed all preclinical studies and now possesses independent intellectual property rights to this product. The company will promptly select clinical research hospitals and, in accordance with GCP standards, conduct scientific clinical trials and safety evaluations, so as to bring a safe and effective new drug to clinical disease treatment at an early date.

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