SanegeneBio Announces First-in-Human Dosing of SGB-3383, a CFB-Targeting siRNA Therapeutic for Complement-Mediated Diseases
SANEGENEBIO
Small Nucleic Acid Drug Developer
▷ SGB-3383, as an siRNA drug targeting CFB, has the potential to become the best-in-class, offering an innovative solution for complement-mediated kidney-related diseases.
▷ SGB-3383 shows excellent preclinical data, and its clinical research is currently advancing rapidly, which will accelerate the fulfillment of unmet clinical needs in complement diseases.
On June 30, 2025, SANEGENEBIO, a company focused on innovative RNAi drug development, announced that the Phase I clinical study in China of its self-developed small nucleic acid (siRNA) drug SGB-3383 injection targeting CFB has recently completed the first subject dosing at Peking University Third Hospital. SGB-3383 is an siRNA drug targeting Complement Factor B (CFB) for the treatment of complement-mediated kidney-related diseases.
▲SANEGENEBIO's CFB-targeted siRNA Candidate Drug SGB-3383
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This clinical study is a Phase I, randomized, double-blind, placebo-controlled, single-dose escalation trial. Its primary objective is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SGB-3383 in healthy subjects. Preclinical trial data indicate that SGB-3383 significantly and persistently reduces CFB levels in the liver and blood while demonstrating favorable safety and tolerability.
The dosing of the first subject in the SGB-3383 trial has been initiated and advanced rapidly, thanks to the strong support from the research team at Peking University Third Hospital, as well as the joint efforts of the project team. SANEGENEBIO is accelerating the clinical trials of two candidate drugs in the complement field, which will bring potential transformative treatment options to patients with complement-related diseases, aiming to fill the urgent unmet clinical needs in this disease area as soon as possible.
About Complement-Mediated Kidney Diseases
The Complement System: A Key Component of Innate ImmunityThe complement system is an essential part of the body's innate immune system, playing a critical role in immune and physiological functions. It protects the body from infections and helps clear dead cells and apoptotic materials. The activation of the complement system occurs through three pathways: the classical pathway, the alternative pathway, and the lectin pathway. Complement Factor B (CFB), a crucial component of the alternative pathway, is a key element involved in complement activation and plays a significant role in cellular injury and inflammatory processes. CFB has been implicated in the development and progression of various diseases. Current research shows that CFB is associated with atypical hemolytic uremic syndrome, age-related macular degeneration, cardiovascular diseases, cancer, and more. Therapies targeting CFB, by modulating complement activation, may treat diseases caused by dysfunctions in the alternative pathway without affecting other complement pathway-mediated immune responses to microbial invasion, demonstrating potential therapeutic benefits in reducing patients' infection risks.
About SGB-3383 Injection
SGB-3383 is a siRNA drug independently developed by SANEGENEBIO that targets CFB. It utilizes the company's uniquely innovative next-generation LEAD™ GalNAc liver delivery platform to deliver to hepatocytes, inhibiting the expression of CFB in the liver through RNAi, thereby treating complement-mediated kidney diseases, including IgA nephropathy, C3 glomerulopathy, immune complex-mediated membranoproliferative glomerulonephritis, and atypical hemolytic uremic syndrome, among others. Preclinical trial data show that SGB-3383 can significantly and durably reduce the levels of CFB in the liver and blood while demonstrating good safety and tolerability. Currently, no siRNA drugs targeting the complement system have been approved globally, and SGB-3383 is expected to become the best-in-class, globally leading siRNA drug targeting CFB.
| SANEGENEBIO's Differentiated Advantages |Frequently Recognized |
| SGB-3403 Hypercholesterolemia |
| SGB-9768 Complement-Mediated Kidney Disease |
SANEGENEBIO is a clinical-stage global biotechnology company focused on the development of RNAi therapies. It has established a multi-pipeline portfolio of innovative drugs targeting obesity, cardiometabolic diseases, and immune-mediated conditions. Founded in 2021 by a team of seasoned experts in RNAi drug development, the company operates research centers in both China and the United States. Leveraging its proprietary LEAD™ (Ligand and Enhancer Assisted Delivery) technology platform, SANEGENEBIO addresses the challenge of multi-tissue delivery for RNAi drugs, achieving liver/adipose/muscle/immune cell targeting, long-term gene silencing with a single dose, and high safety and efficacy validated through preclinical and clinical studies. SANEGENEBIO is committed to pioneering transformative RNAi therapies through original innovation to address significant unmet clinical needs worldwide. For more information, please visit SANEGENEBIO's official website: www.sanegenebio.com