Recently, Chengdu Shengdi Medical Company Co., Ltd.., a subsidiary of Jiangsu Hengrui Pharmaceuticals Co., Ltd., received notification from the U.S. Food and Drug Administration (FDA) that the company’s Abbreviated New Drug Application (ANDA, U.S. generic drug application) for tacrolimus extended-release capsules has been approved for marketing in the U.S.. This product is suitable for use in combination with other immunosuppressants to prevent graft rejection after adult kidney transplantation. The company's tacrolimus sustained-release capsules are the first generic drug approved by the U.S. FDA for marketing, and are also the first domestic generic products. They have been approved for marketing in China in June 2022.

Tacrolimus is the core basic immunosuppressant after transplantation [1]. It is a calcineurin inhibitor (CNI). Its mechanism is to inhibit the activity of calcineurin, thereby inhibiting the production of various cytokines. Expression and/or production, such as IL-1β, IL-2, IFN-γ, TNF-α, etc., ultimately inhibit T lymphocyte activation and proliferation, thus exerting a strong immunosuppressive effect and low incidence of rejection. Now it becomes the drug for organ transplantation and autoimmune disease treatment [2].Compared with traditional tacrolimus immediate-release capsules, tacrolimus sustained-release capsules can reduce the peak concentration in the body and the fluctuation range of blood drug concentration, making the blood drug concentration more stable [3]. In addition, compared with tacrolimus immediate-release capsules, which are administered twice a day, tacrolimus sustained-release capsules only need to be administered once a day, which can significantly improve the compliance of transplant recipients and improve the patient's quality of life [ 4]. Tacrolimus is a drug with a narrow therapeutic window. Compared with ordinary oral preparations, the development of its sustained-release preparations is more difficult, and its bioequivalence standards are more stringent. The tacrolimus sustained-release capsules developed by the company have passed the BE study and it proves that it is equivalent to its originator.

Tacrolimus sustained-release capsules were launched in the European Union in 2007, and have been launched in more than 70 countries and regions around the world, including Japan, China, and the United States. The total global sales of tacrolimus in 2022 will be approximately US$3.447 billion.

The approval of Tacrolimus Sustained Release Capsules by the U.S. FDA marks that Hengrui is qualified to market the drug in the U.S., which will have a positive impact on the company's market expansion. The company will actively promote the marketing and sales of the drug.

In recent years, Hengrui has continued to steadily promote its internationalization strategy. Currently, the company's pharmaceutical products have entered more than 40 countries, and it continues to accelerate the development of global markets and focus on emerging markets. At present, the company has obtained more than 20 registration approval certificates in Europe, the United States and Japan, including injections, oral preparations and inhalational anesthetics. In the future, the company will strive to bring more Chinese pharmaceutical products to benefit patients around the world.

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