Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic version of Tepadina (thiotepa), originally developed by Switzerland-based Adienne S.r.l. The infusion is indicated as a conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in children with severe β-Mediterranean anemia, marking it as the first of its kind approved for use in transplantation conditioning in China.
β-Mediterranean anemia is a prevalent hemolytic disease, with China currently housing 300,000 patients suffering from severe and intermediate thalassemia-β. Current treatment measures primarily consist of blood transfusion therapy, iron removal therapy, and hematopoietic stem cell transplantation, the latter of which can increase patient survival rates to 90%. In recent years, an increasing number of thalassemia-β patients have achieved a higher quality of survival through transplantation. Preprocessing is a crucial component of the transplantation technology system, and an ideal pre-treatment drug must balance effective therapeutic outcomes with minimal toxic side effects. Tepadina is a broad-spectrum anti-tumor drug used for pre-treatment of bone marrow before transplantation, known for its strong cytotoxic effects. The pre-treatment regimen containing tepadina offers the core advantages of comprehensive myeloablative therapy, promotion of hematopoietic stem cell implantation, and safety and controllability. It can improve the success rate of transplantation and reduce the recurrence rate of diseases post-transplantation.
The originator drug Tepadina received approval in Europe and the US in March 2010 and January 2017, respectively, and has not yet been commercially available in China.- Flcube.com
