Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of its self-developed drug, GenSci136, aimed at treating Immunoglobulin A Nephropathy (IgAN) [1] Group 1 - GenSci136 is a class 1 therapeutic biological product designed to treat IgAN, showcasing innovative molecular design that mimics the natural extracellular domain of B-cell maturation antigen (BCMA) [1] - The drug enhances the blocking activity against various endogenous ligands, potentially impacting the survival and differentiation of B lymphocytes and plasma cells, thus addressing multiple autoimmune diseases caused by pathogenic antibodies [1] - GenSci136 is engineered with an anti-human serum albumin heavy chain single-domain antibody to extend its half-life in the body, suggesting a potential for effective and long-lasting treatment with improved convenience for patients [1] Group 2 - The drug is expected to provide a new, safe, and long-term targeted treatment option for IgAN patients without the need for prophylactic anti-infection therapy, aiming to significantly improve the long-term prognosis of these patients [1]
长春高新:金赛药业注射用GenSci136境内生产药品注册临床试验申请获得批准