The first targeted drug Nefecon for IgA nephropathy (Naofukang) landed in Hainan Ruijin Hospital

In our country, chronic nephritis is a high incidence of diseases, in which primary glomerular diseasemajority, accounted71%Left and right, primary glomerular disease, andIgANephropathy is the most common, accounting for up35%~50%, nationalIgAPatients with kidney disease are estimated to have500About ten thousand people. At present, it is generally believed thatIgAThe pathogenesis of nephropathy is associated with abnormal immune cell function at the mucosal surface. Studies have shown that inIgAIn patients with kidney disease, located in the terminal ileumPeyer’sMucosal lymph on lymph nodesBcells secrete a galactose-deficient immunoglobulin(IgA1),IgA1into the bloodAfter andIgGprotein antibody binding,Formation of large immune complexes(GdIgA1),The immune complexCanDeposition on the surface of the glomerular mucosa and induce abnormal proliferation of glomerular surface cells, release of inflammatory cytokines leading to proteinuria and renal cell fibrosis, and furtherlead to abnormal renal functionand evenUremia.

Budesonide is a highly effective anti-inflammatory glucocorticoid, which can inhibit the immune response and reduce the production of antibodies.IgANephropathyThe treatment. However, long-term use of glucocorticoids may lead to serious systemic side effects such as osteoporosis and Cushing's syndrome. Therefore, budesonide and other glucocorticoids are often used in the treatment of acute symptoms in clinical practice, and long-term use is not recommended. But...IgANephropathyAs a lifelong chronic disease, long-term treatment is needed to reduce the occurrence of proteinuria and renal cell fibrosis in order to delay the progression of the disease. based on the pairIgANephropathyIn the study of pathogenesis, if budesonide can be delivered to the disease target, it may reduce the systemic side effects without affecting the therapeutic effect.

AndNefecon(Naofukang) is such an ideal drug, which uses enteric-coated materials to coat the pill core containing budesonide to avoid the release of budesonide in the stomach and target the release in the intestinal tract, which can effectively targetIgANephropathyplay an anti-inflammatory role, thereby reducing the occurrence of proteinuria and renal cell fibrosis. In addition to theoretical feasibility, it has been verified by a multicenter, randomized, double-blind, placebo-controlled large-scale clinical trial,NefeconNot only has a good therapeutic effect, but also does not increase the risk of infection in patients, and there are no cases of hospitalization due to serious infection.^[1]with traditional glucocorticoid therapyIgASeveral large trials in nephropathy were in stark contrast.

previously,NefeconIt has been approved for listing in the United States and the European Union.2022Year10The application for new drug marketing authorization was submitted to China for priority review in January, and in.2023Year4Month24It was approved by the Hainan Provincial Drug Administration on the 1st and will be used for clinical use in Hainan Hospital, Ruijin Hospital, Shanghai Jiaotong University School of Medicine. As the world's firstIgANephropathytargeted drugs,NefeconThe introduction will fundamentally change our country.IgANephropathyThe plight of patients lacking targeted therapies. Of course, due to the huge cost of new drug development and large clinical trials, the currentNefeconThe price is very expensive and may be difficult for ordinary patients to afford, but based on domesticIgANephropathyThe huge number, I believe that all kinds of medical security and related policies will be tilted. in addition,NefeconAuthorized patents in China (CN102088962B, a composition for oral administration of corticosteroids) will be issued on2029Year5Month7At that time, the listing of many generic drugs will also make.NefeconThe price has been reduced.