Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its sustained-released generic version of Astagraf XL (tacrolimus), originally developed by Japan-based Astellas. With this approval, Hengrui secures its position as the first company to offer a generic version of the drug in the US market.
Tacrolimus is a potent immunosuppressive agent capable of inhibiting the generation of cytotoxic lymphocytes, T cell activation, T helper cell dependent B cell proliferation, and the production of lymphokines such as interleukin-2, interleukin-3, and γ interferon. It also suppresses the expression of interleukin-2 receptor, thereby preventing graft rejection. Clinically, the drug is used to prevent rejection in patients who have undergone kidney or liver transplantation.
Hengrui’s sustained-released tacrolimus, which was the first generic version to gain marketing approval in China in 2022, offers improved patient compliance through once-daily administration. The originator drug was approved for marketing in Denmark, Lativa, Holland, and the Czech Republic in 2007, and subsequently in Japan and the US in 2008 and 2013, respectively.- Flcube.com
