Novartis' LNP023 Capsule Receives NMPA Acceptance for Marketing Application

On March 3, the CDE announced that the marketing application for Novartis' LNP023 capsule had been accepted.

Screenshot source: CDE official website

LNP023 is an orally administered, specific "first-in-class" complement factor B inhibitor developed by Novartis. It can block intravascular and extravascular hemolysis by targeting the alternative complement signaling pathway. Currently, this innovative therapy is being tested in clinical trials for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), idiopathic membranous nephropathy, IgA nephropathy, primary IgA nephropathy, and C3 glomerulopathy, which has been recently approved.

The drug was approved for clinical trials in May 2020, with the indication under development being Idiopathic Membranous Nephropathy (IMN). IMN is a common renal disease clinically and also the most common pathological type of nephrotic syndrome in adults; 75%-80% of membranous nephropathy cases are idiopathic. In recent years, its incidence has increased, particularly markedly among younger patients. Prior to this, LNP023 also received tacit approval for clinical trials targeting IgA nephropathy.