Otsuka Pharmaceutical's anti-APRIL monoclonal antibody VIS649 applied for clinical application in China

On March 8, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that Otsuka Pharmaceutical applied for the clinical trial application of VIS649 and was accepted

Screenshot source: CDE official website

Immunoglobulin A (IgA) nephropathy is a chronic, progressive autoimmune disease associated with progressive kidney damage and is a major cause of chronic kidney disease and renal failure

VIS649 is an anti-proliferation-inducing ligand (APRIL) mAb

According to the official website of ClinicalTrials, Otsuka Pharmaceutical is currently conducting two phase 2/3 clinical studies for VIS649, one of which is to evaluate the efficacy and safety of the drug in the treatment of patients with IgA nephropathy, and the other is open for 2/3 The label study was designed to evaluate the long-term safety, tolerability and efficacy of the drug in patients with IgA nephropathy

It is expected that this innovative anti-APRIL monoclonal antibody will progress smoothly in clinical research and bring better treatment options to patients as soon as possible

References:

[1] The official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China.

[4] ClinicalTrials official website.