— Phase II study evaluates efficacy and safety in complement-mediated kidney diseases —
BOSTON, SHANGHAI, and SUZHOU – March 7, 2025, SanegeneBio, a clinical-stage biotechnology company developing innovative RNAi therapeutics, today announced the initiation of a Phase II clinical trial in China for SGB-9768, its investigational siRNA targeting complement component 3 (C3). The trial is being led by Peking University First Hospital and will enroll patients across multiple centers.
SGB-9768 is the first RNAi medicine targeting C3 to enter Phase II in China, reinforcing SanegeneBio’s leadership in complement-targeted RNAi drug development. The multicenter, open-label study will evaluate efficacy and safety in patients with IgA nephropathy (IgAN), C3 glomerulopathy (C3G), and IC-MPGN.
Developed using SanegeneBio’s proprietary GalNAc platform, SGB-9768 delivers RNAi specifically to hepatocytes to suppress C3 expression, thereby downregulating complement activation. Preclinical and Phase I data presented at the 2024 Complement-Based Drug Development Summit demonstrated:
- Robust, dose-dependent, and sustained reduction in C3 levels following a single subcutaneous dose
- Superior knockdown potency and durability compared to benchmark siRNAs
- Favorable safety and tolerability profile
“The strong Phase I data support advancing SGB-9768 into Phase II development,”
said Dr. Weimin Wang, Founder and CEO of SanegeneBio.
“This milestone brings us closer to delivering a new treatment option for patients with complement-driven kidney diseases and strengthens our foundation for advancing additional RNAi programs.”
About Complement-Mediated Kidney Diseases
The complement system is a key part of innate immunity. Dysregulation of the C3-dependent pathway contributes to kidney and systemic diseases including IgAN, C3G, and IC-MPGN. Targeting C3 offers a strategic point of intervention to broadly modulate complement activity upstream, addressing a significant unmet medical need in chronic kidney disease (CKD), which affects over 10% of adults in China.
About SGB-9768
SGB-9768 is a GalNAc-conjugated experimental RNAi-based medicine designed to silence C3 mRNA in liver cells. It has demonstrated potent, sustained C3 suppression in preclinical models, with the potential for infrequent dosing and long-term efficacy. With a favorable safety profile and greater durability than comparator molecules, SGB-9768 may become a best-in-class RNAi therapeutic for complement-mediated diseases.