On January 2, 2025, the official website of the National Medical Products Administration released significant news that the stem cell therapy drug Emimatosel injection has been conditionally approved for market launch through the priority review and approval process. This is the first stem cell therapy drug approved for marketing in China, and it is also the first mesenchymal stem cell drug in the country, used to treat acute graft-versus-host disease (aGVHD) in patients over 14 years old, primarily when they have failed hormone therapy with digestive tract involvement.
The National Medical Products Administration stated that graft-versus-host disease is a type of multi-organ syndrome that occurs after allogeneic hematopoietic stem cell transplantation, characterized by lymphocytes from the donor attacking the recipient's tissues. This condition manifests mainly with tissue inflammation and fibrosis affecting the skin, gastrointestinal tract, liver, lungs, and mucosal surfaces. Amimethoxel injection is a human umbilical cord-derived mesenchymal stem cell injection. The introduction of this product offers new treatment options for related patients.
