JW Jungwo Pharmaceutical, New Anemia Treatment Drug Approved as New Drug in Japan

[Asia Economy Reporter Cho Hyun-ui] JW Pharmaceutical has obtained marketing approval in Japan for an anemia treatment for chronic kidney disease patients, for which it holds the domestic development and sales rights.

On the 28th, JW Pharmaceutical announced that Japan Tobacco (hereinafter JT) received manufacturing and sales approval for 'JTZ-951' from the Japanese Ministry of Health, Labour and Welfare (MHLW).

This drug is a new mechanism medication that activates the internal production of erythropoietin (EPO), a hormone that promotes red blood cell production, and controls the expression of molecules responsible for iron metabolism to stimulate red blood cell generation. It is used for 'renal anemia' in chronic kidney disease patients whose production of hematopoietic hormones in the kidneys decreases due to renal dysfunction. Unlike existing injectable drugs, it has been developed in an oral form.

JT confirmed the safety and efficacy of JTZ-951 for up to 52 weeks in a Phase 3 clinical trial conducted in Japan targeting renal anemia patients before and after dialysis. The product name of JTZ-951 is 'Enaroi,' and it will be launched in two tablet dosages: 2 mg and 4 mg.

JW Pharmaceutical signed a domestic clinical and sales license agreement with Japan Tobacco for JTZ-951 in 2016, holding the rights. Since January last year, a Phase 3 clinical trial has been underway at 20 general hospitals in Korea.

A JW Pharmaceutical official stated, "We will promptly complete the domestic clinical trials of JTZ-951, which is expected to become a new option for treating renal anemia, and contribute to improving patients' quality of life."