Becoming the first and only fully FDA-approved treatment for focal segmental glomerulosclerosis (FSGS), Travere Therapeutics Inc.’s Filspari (sparsentan) has gained access to a second lucrative market with a regulatory package that validates proteinuria as a surrogate endpoint.
CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials with SYH-2061 injection for the treatment of IgA nephropathy and other complement-mediated diseases.
Climb Bio Inc. has announced results from a completed nonhuman primate (NHP) study of CLYM-116, an anti-APRIL monoclonal antibody (mAb) in development for IgA nephropathy.
The recombinant fusion protein drug telitacicept from Remegen Co. Ltd. and Vor Bio Inc. has notched a phase III win in treating adults with IgA nephropathy. The clinical trial of the fusion protein hit the primary endpoint, reducing proteinuria, too much protein in patients’ urine, in stage A of the study in China.
The recombinant fusion protein drug telitacicept from Remegen Co. Ltd. and Vor Bio Inc. has notched a phase III win in treating adults with IgA nephropathy. The clinical trial of the fusion protein hit the primary endpoint, reducing proteinuria, too much protein in patients’ urine, in stage A of the study in China.
IgA nephropathy is a progressive kidney disease characterized by the deposition of immune complexes containing IgA, where a proliferation-inducing ligand (APRIL) drives the production of pathogenic IgA. Jade Biosciences Inc. has developed a novel APRIL-binding therapeutic, JADE-101, for the treatment of IgA nephropathy.
Suzhou Sanegene Bio Inc. has gained clinical trial approval in China for SGB-3383 for the treatment of complement-mediated kidney diseases, including IgA nephropathy, C3 glomerulopathy, immune complex-mediated membranoproliferative glomerulonephritis and atypical hemolytic uremic syndrome.
Biocity Biopharmaceutics Co. Ltd.’s selective endothelin receptor type A antagonist, SC-0062, met the primary endpoint of reducing proteinuria in a phase II diabetic kidney disease cohort. Conducted at 40 sites across China, the 2-Succeed phase II trial is designed to evaluate the efficacy and safety of SC-0062 in patients with chronic kidney disease with proteinuria.
