The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has recently announced that Hengrui Medicine (SHA: 600276)’s Class 2.2 improved drug, HR19042 capsule, is planned to be included in the breakthrough therapy category, targeting active autoimmune hepatitis. According to previous announcements by Hengrui Medicine, HR19042 is an orally administered capsule that enhances the stability of endothelial cells, smooth muscle cells, and lysosomal membranes. It suppresses immune responses and reduces antibody synthesis, thereby decreasing the release and activity of allergic mediators such as histamine.
Hengrui Medicine is currently conducting two clinical studies on HR19042 capsules, as reported on the official website of the China Drug Clinical Trial and Information Disclosure Platform. One is a Phase II clinical study on the efficacy and safety for the treatment of autoimmune hepatitis, and the other is a Phase 2/3 clinical study for the treatment of primary IgA nephropathy.
Public information indicates that autoimmune hepatitis (AIH) is a chronic inflammatory liver disease mediated by abnormal autoimmune responses. Clinical features of patients include elevated serum aminotransferase levels, high immunoglobulin G, positive serum autoantibodies, and moderate to severe interface hepatitis in liver histology.
IgA nephropathy is a type of chronic nephritis, characterized by recurrent gross or microscopic hematuria, which may be accompanied by varying degrees of proteinuria. Some patients may develop severe hypertension or renal insufficiency. Currently, there is a lack of specific treatment methods for chronic kidney disease, and there is an urgent clinical need for new treatment options to meet unmet needs.- Flcube.com
