Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its STSA-1301 subcutaneous injection. The drug is targeted for the treatment of primary immune thrombocytopenia (ITP), a condition characterized by a low platelet count due to immune dysfunction.
STSA-1301: Mechanism of Action
STSA-1301 is a Category 1 drug and a recombinant humanized IgG4 monoclonal antibody (mAb) with high affinity against the human Fc receptor (FcRn). It works by specifically binding to FcRn, thereby preventing the binding of IgG, accelerating the degradation of IgG, and not affecting other types of antibodies such as IgM and IgA. This mechanism has the potential to treat autoimmune diseases mediated by pathogenic IgG autoantibodies, including ITP.
ITP Pathogenesis and Treatment Approach
The main pathogenesis of ITP involves immune intolerance to self-antigens, leading to an abnormal increase in pathogenic antiplatelet autoantibodies, increased immune-mediated platelet destruction, and insufficient platelet production by megakaryocytes. Since antiplatelet antibodies are primarily IgG, blocking the binding of FcRn to IgG and accelerating the clearance of IgG, especially pathogenic IgG, is expected to be an effective treatment method for autoimmune diseases like ITP.-Fineline Info & Tech
