— CFB-targeting RNAi-powered experimental medicine set to enter first-in-human studies in China —
BOSTON, SHANGHAI, and SUZHOU – May 20, 2025, SanegeneBio, a clinical-stage biotechnology company focused on RNAi therapeutics, today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved the company’s Investigational New Drug (IND) application for SGB-3383, an experimental RNAi medicine targeting complement factor B (CFB).
SGB-3383 is being developed for the treatment of complement-mediated diseases. SGB-3383 incorporates SanegeneBio proprietary chemistry to selectively silence CFB expression in the liver and suppress complement alternative pathway (AP) overactivation.
Preclinical studies showed potent and sustained silencing of CFB mRNA in both liver and in circulation, with a favorable safety and tolerability profile. No RNAi-based medicines targeting the complement system have been approved globally, and SGB-3383 is positioned as a potential first- and best-in-class candidate.
“The IND approval of SGB-3383 reinforces our company’s leadership position in RNAi innovation for complement-related diseases,”
said Dr. Weimin Wang, Founder and CEO of SanegeneBio.
“With four GalNAc-based candidates now in clinical development, we are continuing to build a differentiated pipeline targeting both hepatic and extrahepatic diseases.”
SanegeneBio is also advancing SGB-9768, a second siRNA targeting the complement cascade, which has entered Phase II trials following positive Phase I data demonstrating superior potency and durability.