Mesoblast cell therapy submitted in Japan

Regenerative medicine company Mesoblast Ltd. (ASX:MSB; Pink:MBLTY) said partner JCR Pharmaceuticals Co. Ltd. (Tokyo:4552) is seeking Japanese approval of JR-031 to treat graft-versus-host disease (GvHD) in children and adults. JR-031, which consists of allogeneic adult mesenchymal precursor cells (MPCs) used to expand cord blood by up to 40-fold, has Orphan Drug status in Japan and will undergo Priority Review. If JR-031 is approved, Mesoblast said it would be the first allogeneic cell-based product available in Japan. The Australian company is eligible for regulatory and sales milestones as well as royalties on sales. Mesoblast has worldwide rights to develop JR-031 in all indications except for hematologic indications in Japan. ...