Amimestrocel Injection Approved with Conditions for Marketing by China NMPA
Recently, the Amimestrocel Injection (trade name: 睿铂生) of Platinumlife Biotechnology (Beijing) Co., Ltd. is approved with conditions through the priority review and approval procedure by China NMPA. Indication: This product is indicated for the treatment of steroid-refractory acute graft-versus-host disease with predominant gastrointestinal involvement in patients aged 14 years and older.
Graft-versus-host disease is a multi-organ syndrome that occurs after allogeneic hematopoietic stem cell transplantation, in which lymphocytes from the donor attack the tissues of the recipient, manifesting as tissue inflammation, fibrosis, etc., mainly involving the skin, gastrointestinal tract, liver, lungs, and mucosal surfaces. Amimestrocel Injection is an injection of human umbilical cord-derived mesenchymal stem cells. The marketing of this drug provides a new treatment option for relevant patients.