--SanegeneBio's CFB-targeted siRNA candidate SGB-3383 shows potential as a best-in-class therapy for complement-mediated kidney diseases.
--SGB-3383 has demonstrated excellent preclinical results and is advancing rapidly in clinical studies, potentially addressing unmet medical needs in complement-mediated diseases.
June 30, 2025 – SanegeneBio, a clinical-stage biotech company focused on developing innovative RNAi therapeutics, announced that the first patient has recently been dosed in its Phase I clinical trial of SGB-3383 injection at Peking University Third Hospital. SGB-3383 is an siRNA drug candidate targeting complement Factor B (CFB) for treating complement-mediated kidney diseases and related systemic conditions.
This randomized, double-blind, placebo-controlled, single-ascending-dose Phase I clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SGB-3383 in healthy volunteers. Preclinical data demonstrated that SGB-3383 achieves significant and sustained reduction of CFB levels in the liver and bloodstream, while exhibiting favorable safety and tolerability profiles.
Dr. Yuyan Jin, Senior Vice President of Clinical and Non-Clinical Development at SanegeneBio, stated:" The first subject dosing of SGB-3383 was successfully initiated and rapidly advanced, thanks to the strong support from the research team at Peking University Third Hospital and the dedicated efforts of our project team. SanegeneBio is accelerating clinical trials for two complement-targeting drug candidates, aiming to provide groundbreaking treatment options for patients with complement-mediated diseases and address unmet medical needs in this field as soon as possible."
About Complement-Mediated Kidney Diseases
The complement system, a key component of innate immunity, serves critical immunological and physiological roles, protecting against infections and clearing cellular debris and apoptotic material. There are three pathways of complement activation: the classical pathway, the alternative pathway, and the lectin pathway. CFB plays a crucial role in the alternative pathway activation, and its inhibition effectively reduces cell damage and inflammation. CFB is involved in the occurrence and development of various diseases, including atypical hemolytic uremic syndrome, age-related macular degeneration, cardiovascular disease, tumors, and other diseases. CFB-targeted therapies, by regulating complement activation, may treat diseases caused by alternative pathway dysfunction without affecting the immune responses to microbial invasion mediated by other complement pathways, showing potential therapeutic effects in reducing the risk of infection in patients.
About SGB-3383
SGB-3383 is an siRNA drug candidate targeting complement Factor B (CFB) mRNA for the treatment of complement-mediated kidney diseases, including IgA nephropathy (IgAN), C3 glomerulopathy (C3G), Immune complex-mediated membranoproliferative glomerulonephritis (IC-MPGN), atypical Haemolytic Uraemic Syndrome (aHUS), etc. The candidate leverages SanegeneBio's proprietary GalNAc platform to achieve liver-specific delivery, thereby inhibiting CFB expression and attenuating complement hyperactivation. Preclinical data demonstrated that SGB-3383 can effectively and continuously inhibit the production of CFB in the liver and bloodstream, while exhibiting favorable safety and tolerability profiles. Currently, no siRNA drugs targeting the complement system have been approved globally. SGB-3383 has the potential to become the best-in-class, world-leading siRNA drug targeting CFB.
About SanegeneBio
SanegeneBio is an emerging RNAi-based company developing innovative RNA interference (RNAi) therapeutics driven by the cutting-edge delivery technology. Founded in 2021, SanegeneBio was led by a team of industry-leading experts and has operations in both the US and China. Since its incorporation, SanegeneBio has successfully established proprietary chemical modification platform, hepatic and extrahepatic delivery platforms, enabling tissue-specific delivery of a wide range of RNA therapeutics to efficiently knock down disease-causing genes. Our fast-growing RNAi portfolio covers a broad range of therapeutic areas including cardiovascular and metabolic diseases, immunology-related diseases, and nervous system diseases. Among them, our four RNAi drugs have entered into the clinical stage, and several pipelines are in progress simultaneously. SanegeneBio is committed to developing transformational RNAi medicines through striving for scientific innovation to address unmet medical needs worldwide and change the lives of patients and families. For further information, please visit: www.sanegenebio.com and engage with us on LinkedIn.
