SanegeneBio Announces Interim Phase 2 Results of SGB-9768 in Patients with IgAN, C3G, and Primary IC-MPGN Presented at ASN 2026
Oct 23, 2026
- Two subcutaneous doses of SGB-9768 administered 12 weeks apart resulted in significant reductions in UPCR across IgAN, C3G, and primary IC-MPGN participants, with kidney function remaining stable during follow-up-
- Significant and durable reductions in serum C3 and alternative pathway (AP) activity were observed, while classical pathway (CP) activity was partially preserved-
- SGB-9768 was well tolerated with no reported treatment-related serious AEs or discontinuations due to AEs-
BOSTON, SHANGHAI, and SUZHOU – October 23, 2026, SanegeneBio, a clinical-stage biotechnology company developing innovative RNAi therapeutics, announced that interim Phase 2 results of SGB-9768, its investigational RNAi therapeutic targeting complement C3, were presented as a Late-Breaking Research Poster at ASN Kidney Week 2026.
As of July 9, 2026, a total of 44 participants were enrolled at sites in China, including 30 patients with IgAN, 8 with C3G, and 6 with primary IC-MPGN. The IgAN cohorts received SGB-9768 at doses of 300 mg (n=15) or 600 mg (n=15), while the C3G/ primary IC-MPGN cohort received 600 mg. All participants received two subcutaneous doses of SGB-9768 administered 12 weeks apart.
Results
39 patients (IgAN, n=30; C3G, n=5; primary IC-MPGN, n=4) completed Week 24 follow-up.
Significant reductions in UPCR were observed across the IgAN and C3G/IC-MPGN cohorts
At Week 24, reductions in 24-hour urinary protein-to-creatinine ratio (UPCR) were 58.6% and 74.1% for 300mg and 600mg IgAN cohorts respectively, and 63.5% for 600mg C3G/ primary IC-MPGN cohort.
Estimated glomerular filtration rate (eGFR) remained generally stable through Week 24 across all cohorts.
Sustained suppression of serum C3 and AP activity for up to six months following two doses, with partial preservation of CP activity
Serum C3 declined rapidly with mean reductions >92% within 4 weeks. Inhibition of AP activity exceeded 95% at Week 4. The effects were maintained through Week 24.
Complement CP activity was partially preserved.
SGB-9768 was well tolerated, with no treatment-related serious AEs or discontinuations due to AEs
SGB-9768 was well tolerated in participants with IgAN, C3G and primary IC-MPGN.
All treatment-related adverse events (TRAEs) were mild or moderate. No serious AE, discontinuation or death was reported.
TRAEs were predominantly injection site reactions and asymptomatic transaminase elevations (ALT >3 × ULN in 1 participant, resolved). All resolved or were resolving.
No infections with encapsulated organisms.
Overall, two administrations of SGB-9768 were well tolerated and associated with significant and clinically meaningful reductions in proteinuria across IgAN, C3G, and primary IC-MPGN, accompanied by stable kidney function through week 24.
Professor Minghui Zhao, Principal Investigator of the study and Professor at Peking University First Hospital, stated:
Professor Hong Zhang, Principal Investigator of the study and Professor at Peking University First Hospital, stated:
Dr. Yuyan Jin, Chief Development Officer of SanegeneBio, stated:
About the Phase 2 Study of SGB-9768 (SGB-9768-003)
Study SGB-9768-003 is a phase 2, multicenter, open-label study to evaluate the efficacy and safety of SGB-9768 in patients with IgAN and in patients with C3G or primary IC-MPGN. The primary endpoint is percent change from baseline in 24-hour UPCR at Week 24. Secondary endpoints include changes in proteinuria and eGFR, as well as assessments of safety, pharmacokinetics, pharmacodynamics, and immunogenicity.
About SGB-9768
SGB-9768 is an investigational GalNAc-conjugated RNAi therapeutic designed to selectively silence C3 mRNA in hepatocytes, reducing hepatic C3 production and downstream complement activity. C3 is a central component shared by the alternative, classical, and lectin pathways, providing a rationale for broad complement inhibition. SGB-9768 is being developed for complement-mediated kidney diseases and hematologic disorders, including IgA nephropathy (IgAN), C3 glomerulopathy (C3G), primary immune complex-mediated membranoproliferative glomerulonephritis (IC-MPGN), paroxysmal nocturnal hemoglobinuria (PNH), and atypical hemolytic uremic syndrome (aHUS).
Phase 1 clinical trials demonstrated robust, dose-dependent, and sustained reductions in serum C3 levels and potent inhibition of complement activity following a single subcutaneous dose, supporting the potential for infrequent dosing. These findings, alongside the favorable safety and tolerability profile observed to date, support its potential as a differentiated RNAi therapeutic for complement-mediated diseases. Learn more about Phase 1 Clinical Data for SGB-9768
SGB-9768 is currently in Phase 2 clinical development and has received U.S. FDA Orphan Drug Designations for C3G and IC-MPGN.
About SanegeneBio
SanegeneBio is a global, venture-backed, fully-integrated biotechnology company focused on developing RNAi-based therapeutics. Founded in 2021 and led by a team of RNAi veterans, the company has R&D operations in Boston, Shanghai and Suzhou. Their clear vision is that RNAi technology will power blockbuster medicines in diverse therapeutic areas, increasing the quality and longevity of life for patients worldwide. This vision is being realized by advancing a fast-growing pipeline, which includes experimental medicines for autoimmune, cardiovascular, obesity and metabolic diseases. SanegeneBio has initiated clinical trials for four experimental medicines to-date, and is committed to developing potential best-in-class and first-in-class therapeutics which leverage our industry-leading and differentiated LEAD™ tissue-selective RNAi delivery technology. For more information, please visit: www.sanegenebio.com and engage with us on LinkedIn.
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