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According to the latest announcement by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China, AstraZeneca's application for clinical trial of anifrolumab injection submitted by AstraZeneca according to category 1 of therapeutic biological products has obtained implied permission, and it is planned to be developed for moderate to severe Active systemic lupus erythematosus.
Screenshot source: CDE official website
Anifrolumab can bind to subunit 1 of type I interferon receptor, thereby antagonizing all activities related to type I interferon (IFN-α, IFN-β and IFN-ω).
Previously, anifrolumab has achieved positive results such as significantly reducing disease activity in a pivotal phase 3 trial called TULIP 2.
The improvement of BICLA means that the disease activity of all organs of the patient has improved, and there is no new disease outbreak.
Systemic lupus erythematosus is a complex chronic autoimmune disease caused by the body's immune system attacking its own tissues.
Congratulations to AstraZeneca anifrolumab for its clinical approval in China, and hope that the product will progress smoothly in clinical research and bring innovative therapies to SLE patients as soon as possible.
