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SI-F019 is a recombinant human bivalent ACE2-Fc fusion protein therapeutic designed to neutralize SARS-CoV-2 (the virus responsible for COVID-19) and prevent viral entry into host cells. The drug consists of two angiotensin-converting enzyme 2 (ACE2) proteins fused to an engineered immunoglobulin Fc domain, which enhances binding avidity and extends half-life while eliminating immune activation that could lead to adverse effects. By mimicking the natural receptor for the SARS-CoV-2 spike protein, SI-F019 acts as a decoy, blocking viral attachment and infection of epithelial cells in the lungs and gastrointestinal tract. In addition to its antiviral activity, SI-F019 hydrolyzes angiotensin II (ANG-II) to ANG1-7, reducing vascular permeability and inflammatory response. The drug has demonstrated potent neutralization against multiple variants of concern—including Omicron—due to enhanced interaction with variant spike proteins compared with monoclonal antibodies[1][5][6][8]. It is being developed primarily for COVID-19 but is also under investigation for acute respiratory distress syndrome (ARDS) and pulmonary arterial hypertension (PAH)[1][3].
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