Mesoblast Allogeneic Cell Therapy Products Are Designated 'U.S. Country of Origin' and Not Subject to U.S. Tariffs

Core Viewpoint - Mesoblast, a leader in allogeneic cellular medicines for inflammatory diseases, announced that its products, including Ryoncil® and Revascor®, are not expected to be affected by the U.S. Government's tariffs on imported products [1]. Company Overview - Mesoblast specializes in developing allogeneic products using proprietary remestemcel-L and rexlemestrocel-L mesenchymal lineage stromal and precursor cell platform technologies [2]. - The company is recognized for its allogeneic cellular products manufactured from U.S. donors, which are classified as U.S. origin products [2]. Product Information - Ryoncil® (remestemcel-L) is the only FDA-approved allogeneic mesenchymal stromal cell therapy for any indication, specifically for pediatric patients aged 2 months and older with steroid-refractory acute graft versus host disease (SR-aGvHD) [3][5]. - Ryoncil® is designated as a 'U.S. Country of Origin' product, complying with FDA and Customs regulatory guidance [3]. Therapeutic Focus - Mesoblast is committed to developing additional cell therapies for various indications, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease, as well as heart failure and chronic low back pain [6]. - The company has established commercial partnerships in Japan, Europe, and China to expand its market reach [6]. Intellectual Property - Mesoblast holds a robust global intellectual property portfolio with over 1,000 granted patents or patent applications, providing commercial protection expected to last until at least 2041 in major markets [7]. Manufacturing Capabilities - The company utilizes proprietary manufacturing processes to produce industrial-scale, cryopreserved, off-the-shelf cellular medicines, ensuring availability to patients worldwide [8].