JCR withdraws application for additional marketing approval of TEMCELL

TOKYO: JCR Pharmaceuticals Co., Ltd. has withdrawn its application with the Ministry of Health, Labour and Welfare of Japan for additional marketing approval of TEMCELL HS Inj., allogeneic bone marrow-derived mesenchymal stem cells, for the indication of epidermolysis bullosa (EB).

Following the filing of the application for EB in March 2019, JCR has had extensive discussions with the regulatory agency. However, in the aim to demonstrate the efficacy of TEMCELL for EB with more clarity, JCR decided to withdraw this application for the time being.

JCR will continue discussions with the regulatory agency to pursue the development of JR-031EB.

As a pioneer in cell therapy and regenerative medicine, JCR will continue to steadily pursue its R&D activities in these fields. This announcement is expected to have a minor impact on JCR’s consolidated financial results for the year ending on March 31, 2020.

Edited by Kazim Rizvi

Add a Comment

Your email address will not be published. Required fields are marked *