By Fineline Cube 
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its investigational drug HRS-5965. The designation is for the treatment of primary IgA nephropathy, the most common primary glomerular disease leading to end-stage renal disease.
Drug Mechanism
HRS-5965 is a complement factor B inhibitor designed to reduce urinary protein and slow the progression of kidney disease. This mechanism of action offers a novel approach to managing IgA nephropathy, a condition with limited treatment options.
Global Comparator
Currently, Novartis’ Fabhalta (iptacopan), a complement factor B inhibitor, is the only comparable product approved for marketing outside of China. HRS-5965’s BTD underscores its potential to address unmet medical needs in patients with primary IgA nephropathy.-Fineline Info & Tech