CSPC PHARMA(01093): Tacrolimus sustained-release capsules obtained drug registration approval document.

CSPC PHARMA (01093) announced that the Tacrolimus sustained-release capsules (0.5mg, 1mg) developed by the group have obtained a drug registration certificate issued by the National Medical Products Administration of the People's Republic of China, and are considered to have passed the generic drug quality and efficacy consistency evaluation. Tacrolimus is a macrolide immunosuppressant that belongs to the class of calcineurin inhibitors. Studies both in vivo and in vitro have confirmed that Tacrolimus has strong immunosuppressive effects, can inhibit the formation of cytotoxic lymphocytes that cause transplant rejection reactions, and its mechanism of action mainly includes inhibiting the activation of T cells and the proliferation of T helper cell-dependent B cells, as well as inhibiting the formation of lymphokines (such as interleukin-2, interleukin-3, and -interferon) and the expression of interleukin-2 receptors. This product is indicated for preventing transplant rejection reactions after kidney transplantation, preventing transplant rejection reactions during the maintenance period after liver transplantation, and treating transplant rejection reactions that cannot be controlled by other immunosuppressive drugs after kidney or liver transplantation. The approval of this product will further enrich the group's product line in the field of immunosuppressive therapy for transplant rejection.