Recently, Hengrui Pharmaceuticals' subsidiary Chengdu Shengdi Pharmaceuticals Co., Ltd. has received notification from the U.S. Food and Drug Administration (FDA) that the company's abbreviated new drug application (ANDA, i.e., U.S. generic application) for the filing of tacrolimus extended-release capsule has been approved for production and marketing in the U.S. market. The product is indicated for use in combination with other immunosuppressive agents for the prevention of graft rejection following kidney transplantation in adults. The Company's tacrolimus extended-release capsule is the first generic of this product approved for marketing by the U.S. FDA, and is also the first generic product approved for marketing in China.

Tacrolimus is the core basic immunosuppressant after transplantation, which belongs to calmodulin neural phosphatase inhibitor (CNI), and its mechanism of action is to inhibit the expression and/or production of various cytokines, such as IL-1β, IL-2, IFN-γ, TNF-α, etc., by inhibiting the activity of calmodulin phosphatase, and ultimately inhibit the activation and proliferation of T-lymphocytes, so as to exert a stronger immune-suppressant effect, and the incidence of rejection is low. With a low incidence of rejection, it has become the drug of choice for organ transplantation and autoimmune disease treatment.

Compared with the traditional tacrolimus immediate-release capsules, tacrolimus extended-release capsules can reduce the peak concentration and fluctuation of blood concentration in the body, so that the blood concentration is more stable. In addition, compared with tacrolimus immediate-release capsules administered twice daily, tacrolimus extended-release capsules need to be administered only once daily, which can significantly improve the adherence of transplant recipients and improve the quality of life of patients. Tacrolimus is a narrow therapeutic window drug, compared with ordinary oral preparations, the development of its extended-release preparations is more difficult, and its bioequivalence standards are more stringent, the company developed tacrolimus extended-release capsules have passed bioequivalence tests to prove that they are equivalent to the originally developed agent.

Tacrolimus extended-release capsules were launched in the European Union in 2007, and have since been marketed in more than 70 countries and regions around the world, including Japan, China, and the U.S. Tacrolimus global sales in 2022 will total about $3.447 billion.

The approval of tacrolimus extended-release capsules by the FDA signifies that Hengrui Pharmaceuticals is qualified to sell the drug in the U.S. market, which will have a positive impact on the company's expansion of the market, and the company will actively promote the marketing of the drug.

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