CSPC PHARMA (01093) announced that its self-developed Tacrolimus Extended-Release Capsules (0.5mg, 1mg) have received drug registration approval from the National Medical Products Administration of the People's Republic of China, and are deemed to have passed the generic drug quality and efficacy consistency evaluation.

Tacrolimus is a macrocyclic lactone immunosuppressant belonging to the calcineurin inhibitor class. Both in vivo and in vitro studies have confirmed that tacrolimus possesses potent immunosuppressive effects, capable of inhibiting the formation of cytotoxic lymphocytes that cause transplant rejection. Its mechanism of action primarily includes suppressing T-cell activation and T-helper cell-dependent B-cell proliferation, while inhibiting the formation of lymphokines (such as interleukin-2, interleukin-3, and interferon-γ) and the expression of interleukin-2 receptors.

The product is indicated for preventing transplant rejection following kidney transplantation, preventing transplant rejection during the maintenance phase after liver transplantation, and treating transplant rejection following kidney or liver transplantation that cannot be controlled by other immunosuppressive drugs.

The approval of this product will further enrich the Group's product portfolio in the field of immunosuppressive therapy for transplant rejection treatment.