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20.09.28 [JW Pharmaceutical] Final Approval on Japanese New Drug Application Granted to JTZ-951, Renal Anemia Therapy

- Approval for manufacturing and marketing acquired in Japan based on successful phase-3 clinical trials of JTZ-951

- Oral administration allowed, unlike existing injections or erythropoiesis stimulating agent … Expectation for new therapeutic option

- Phase-3 clinical study in progress in Korea, improvement for quality of life anticipated for patients with renal anemia

September, 2020

A new therapeutic agent for renal anemia, of which distribution right in Korea is owned by JW Pharmaceutical, acquired final approval for manufacturing and marketing in Japan.

JW Pharmaceutical announced on the 28th that Japan Tobacco Inc. (“JT” hereafter) acquired approval on new drug application (NDA) for 2mg and 4mg tablet products of ‘JTZ-951,’ therapeutic agent for renal anemia, from the Ministry of Health, Labour and Welfare (MHLW) in Japan.

JTZ-951 is a new drug based on novel mechanism designed to promote erythropoiesis by activating the internal generation of erythropoietin (EPO), hormone promoting erythropoiesis, and controlling the expression of molecules responsible for iron metabolism. Unlike conventional injections, this drug is developed for oral administration to offer new options for treatments.

During the phase-3 clinical trials conducted in Japan, JT verified the efficacy and safety of JTZ-951 up to 52 weeks from the study subjects of patients with renal anemia at the stage prior to dialysis and undergoing dialysis.

JW Pharmaceutical signed a license agreement with JT on development and commercialization of JTZ-951 in Korea and has been engaging in the phase-3 clinical study at 20 general hospitals in Korea since last January.

“Patients with anemia caused by chronic kidney disease mostly complain the lack of energy due to insufficient internal oxygenation,” an official at JW Pharmaceutical said. “We are determined to contribute to improving the quality of life for patients by completing clinical study as quickly as possible in Korea on JTZ-951 which expected to offer a new option for treatment of renal anemia,” the official stressed.

Renal anemia is a kidney-caused anemia, and it is one of serious complications to patients with chronic kidney disease (CKD). The disease of kidney dysfunction deteriorates a capability to generate erythropoietin, hematogenous hormone, at the kidney. As of today, the volume of domestic market for renal anemia therapy is estimated at approximately \80 billion KRW.

Based on independent technologies of its own, JW Pharmaceutical not only expands the development of First-in-Class drugs but also introduces First-in-Class candidates currently under clinical study in overseas, in order to expand superb original pipelines through distinct strategies to procure permits and licenses in Korea.