Staidson’s Anti-C5a Monoclonal Antibody STSA-1002 Accepted for NMPA Review

China-based Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204) has announced that the clinical trial filing for its injectable STSA-1002, an anti-human complement protein C5a (hC5a) monoclonal antibody (mAb) for use in acute respiratory distress syndrome (ARDS), has been accepted for review by the National Medical Products Administration (NMPA).

About ARDS and STSA-1002
ARDS refers to diffuse pulmonary interstitial and alveolar edema caused by various intrapulmonary and extrapulmonary pathogenic factors other than cardiogenic. The pathogenesis of ARDS is complex, involving immune cell activation, coagulation, vascular endothelial permeability regulation, endothelial and epithelial cell barrier effects, and ion channel function regulation. Inhibiting C5a, a multi-effect factor, can effectively block its chemotaxis to neutrophils, the formation of NETs, and the production of fibrin.

STSA-1002 has been approved for clinical studies in severe COVID-19 cases in both the US and China and is currently undergoing Phase I clinical trials. In November last year, the drug was also approved for a clinical trial in the US for ANCA-associated vasculitis. The acceptance of the clinical trial filing by the NMPA marks a significant step forward in the development of STSA-1002 for ARDS.-Fineline Info & Tech

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