AnGes, Inc. announced that they have obtained conditional approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for HGF plasmid to treat patients with critical limb ischemia (CLI). HGF plasmid is the first gene therapy product to be approved in Japan, for the improvement of ulcers in patients suffering from chronic arterial occlusion (arteriosclerosis obliterans and Buerger's disease) who have had an inadequate response to standard pharmacotherapy and who experience difficulty in undergoing revascularization. AnGes applied for marketing approval to the MHLW in January 2018 based on positive results from the randomized, placebo-controlled phase three trial and investigator-led clinical study conducted in Japan.

HGF plasmid is one of the first gene therapy products to be approved for a non-genetic disease with chronic and progressive symptoms. In accord with the conditions of the approval, AnGes will conduct a confirmatory study for all patients who receive treatment with HGF plasmid under the conditional approval and will submit an application to lift the conditions within five years. AnGes has granted to Mitsubishi Tanabe Pharma Corporation the marketing rights to HGF plasmid in Japan and the U.S.A. for treating peripheral arterial diseases including CLI. Mitsubishi Tanabe is responsible for sales and marketing of the product.