QLS7305 injection is a chemically synthesized double-stranded small interfering RNA (siRNA) targeting complement C3, covalently linked to a ligand containing N-acetylgalactosamine (GalNAc) residues. After subcutaneous (SC) administration, it can inhibit C3 synthesis through the RNA interference (RNAi) mechanism, reduce circulating C3 protein levels, decrease the generation of complement-activated C5 convertase, and inhibit complement pathway activation. It is expected to become an effective treatment for complement-mediated kidney diseases and hematological disorders.
Body weight ≥ 40 kg, Body Mass Index (BMI) < 32.5 kg/m²
Within the five years prior to screening, patients must have been diagnosed with primary IgAN or PMN through renal biopsy, or within one year prior to screening, diagnosed with C3G or IC-MPGN through renal biopsy, accompanied by glomerular C3 deposition; if a renal biopsy has not been previously performed, a renal biopsy must be conducted during the screening period to confirm eligibility criteria.
Participants with IgAN and C3G/IC-MPGN: During the screening period, morning urine UPCR or 24-hour UPCR ≥0.75 g/g or 24-hour UP ≥1 g/day, with the average of two 24-hour UPCR measurements at baseline ≥0.75 g/g; PMN participants: During the screening period, morning urine or 24-hour UP ≥3.5 g/day, with the average of two 24-hour UP measurements at baseline ≥3.5 g/day.
During the screening and baseline periods, eGFR ≥ 30 ml·min-¹·1.73 m-² (using the CKD-EPI formula)
Renal biopsy pathology indicates tubular atrophy or interstitial fibrosis exceeding 50%.
Renal biopsy pathology indicates crescent formation in more than 50% of glomeruli, or clinical presentation suggests the possibility of rapidly progressive glomerulonephritis (RPGN) (eGFR decline ≥50% within 3 months).
Participants were evaluated by the investigator as having IgAN, C3G, IC-MPGN, or PMN secondary to conditions such as infection, autoimmune diseases, or monoclonal immunoglobulin-associated diseases.
Participants were evaluated by the investigator as having other systemic diseases or other kidney diseases that could lead to proteinuria, such as diabetic nephropathy, IgA vasculitis, lupus nephritis, or ANCA-associated small vessel vasculitis.
Parallel
QLS7305 Injection
DrugRoute of administration: subcutaneous injection
Change from Baseline in the 24h-UPCR at week 12
Change from Baseline in the 24h-UPCR at week 24/36
Change from Baseline in the 24h-UACR at week 12/24/36
Change from Baseline in the Scr at each visit
Number of Participants with Adverse Events as Assessed by CTCAE v6.0
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