CSPC PHARMA: Tacrolimus sustained-release capsules have received drug registration approval
CSPC PHARMA announced that its developed tacrolimus sustained-release capsules (0.5mg, 1mg) have obtained the drug registration approval from the National Medical Products Administration of China and have passed the consistency evaluation of quality and efficacy for generic drugs. This medication is an immunosuppressant suitable for the prevention and treatment of rejection reactions after kidney and liver transplantation, and its approval will enrich the group's product line in the field of immune rejection treatment
According to the announcement from CSPC PHARMA (01093), the tacrolimus sustained-release capsules (0.5mg, 1mg) developed by the group have received the drug registration approval issued by the National Medical Products Administration of the People's Republic of China, and are considered to have passed the consistency evaluation of quality and efficacy for generic drugs.
Tacrolimus is a macrolide immunosuppressant that belongs to the class of calcineurin inhibitors. Both in vitro and in vivo studies have confirmed that tacrolimus has a potent immunosuppressive effect, capable of inhibiting the formation of cytotoxic lymphocytes that cause graft rejection. Its mechanism of action mainly includes the inhibition of T cell activation and the proliferation of T helper cell-dependent B cells, as well as the suppression of lymphokine production (such as interleukin-2, interleukin-3, and γ-interferon) and the expression of interleukin-2 receptors. This product is suitable for preventing graft rejection after kidney transplantation, preventing graft rejection during the maintenance phase after liver transplantation, and treating graft rejection 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 immunological rejection treatment
