Changchun High-Tech Industries (000661.SZ) announced that recently, its subsidiary, Changchun Gensai Pharmaceutical Co., Ltd. ("Gensai Pharmaceutical"), received the approved clinical trial approval document from the National Medical Products Administration for its GenSci120 injection.
According to the announcement, autoimmune diseases are caused by the immune system mistakenly attacking its own cells, tissues, or organs, resulting in excessive activation of immune cells, release of cytokines, or production of autoantibodies, leading to cell destruction and organ damage, ultimately causing a series of complex diseases affecting multiple systems in the body. Programmed cell death receptor 1 (PD-1) and its ligands are important immune checkpoint pathways. Activation of this pathway can inhibit the continuous activation of T cells, allowing the body to restore immune homeostasis. GenSci120 is a humanized anti-PD-1 monoclonal antibody developed by Gensai Pharmaceuticals, with an antibody type of IgG1. By binding to PD-1 and activating the inhibitory PD-1 signaling pathway and ADCC effect, it can inhibit or kill pathogenic T cells, exerting a relatively specific targeted immune suppression effect.
If the subsidiary's clinical trial application progresses smoothly, it will benefit the company in expanding its business structure, optimizing its product structure, enriching and improving its strategic product line layout, and enhancing the company's core competitiveness.