JCR pulls Japanese Temcell filing; gains approval for Darbepoetin Alfa

Japanese drugmaker JCR Pharmaceuticals (TYO: 4552) has withdrawn its application with the Ministry of Health, Labor and Welfare of Japan (MHLW) for additional marketing approval of Temcell HS Inj, allogeneic bone marrow-derived mesenchymal stem cells, for the indication of epidermolysis bullosa (EB) (development code: JR-031EB). 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. The disappointing news comes just ahead of  EB Awareness Week, which takes place in the last week of October.

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.