Nipro’s regenerative medicine product for spinal cord injury, Stemirac Injection, is expected to move to full approval following conditional approval, with the company aiming to become profitable by around 2029. The product was jointly developed with Sapporo Medical University.
Nipro’s regenerative medicine product for spinal cord injury, Stemirac Injection, is expected to move from conditional and time-limited approval to full approval. This would give the product formal approval and is expected to establish the framework for its commercial supply.
Stemirac was jointly developed with Sapporo Medical University. In 2018, it became the world’s first regenerative medicine product for spinal cord injury, and provisional sales were authorized after its safety had been confirmed and its efficacy could be inferred.
Sales had continued under provisional approval, while the product remained in the red, but full approval could stabilize its sales operations. Formal approval is expected to improve the company’s financial condition.
According to Nikkei reports, the company has indicated that it aims to become profitable by around 2029, against the backdrop of full approval for Stemirac Injection. It is looking ahead to business expansion and improved earnings after approval.