● SGB-9768 is the first siRNA candidate drug targeting complement C3 to enter Phase II clinical trials in China, underscoring SanegeneBio's leading position in this field.
● Based on the promising data obtained from the Phase I clinical trial, SanegeneBio initiated Phase II clinical trials for SGB-9768 in indications such as IgAN, C3G, and IC-MPGN.
On March 7, 2025, SanegeneBio, a company dedicated to the development of innovative RNAi therapeutics, announced the initiation of Phase II clinical trials in China for its self-developed siRNA drug, SGB-9768 injection, which targets complement C3. This study is spearheaded by Peking University First Hospital and will be conducted across multiple centers in China. This significant advancement marks a crucial step forward in the development of SGB-9768, bringing potential new treatment option for patients with complement-related diseases worldwide.
Developed based on SanegeneBio's proprietary GalNAc platform, SGB-9768 is delivered to liver cells to knock down the protein expression of complement factor C3. This mechanism aims to treat a range of complement-related diseases, including IgA nephropathy (IgAN), C3 glomerulopathy (C3G), immune complex-mediated membranoproliferative glomerulonephritis (IC-MPGN), dry age-related macular degeneration (dry AMD), paroxysmal nocturnal hemoglobinuria (PNH), as well as other nephrological and hematological disorders.
The Phase II clinical trial is a multicenter, open-label study designed to evaluate the efficacy and safety of SGB-9768 in patients with primary IgAN, C3G, and IC-MPGN. In December 2024, SanegeneBio presented promising preclinical and Phase I clinical trial results for SGB-9768 at the 8th Complement-Based Drug Development Summit held in Boston, USA. The clinical trial data demonstrated a dose-dependent, significant, and sustained reduction in C3 levels and complement pathway activity after a single subcutaneous injection. Compared to other siRNA products targeting the same pathway, SGB-9768 achieved greater target protein knockdown and longer duration at equivalent doses, as well as maximum knockdown level with higher dose levels. In addition, SGB-9768 showed good safety and tolerability. The encouraging results from the Phase I clinical trial support the advancement of SGB-9768 into Phase II clinical development.
Dr. Weimin Wang, Founder and Chief Executive Officer of SanegeneBio, stated: " The clinical data obtained from the Phase I trial of SGB-9768 has been highly encouraging, which not only shows excellent safety and tolerability but also holds significant therapeutic potential. With the initiation of the Phase II clinical trial in China, we will continue to expedite the development of this program, striving to provide effective treatment options for patients with complement-related diseases as soon as possible. Additionally, the experience gained from the clinical development of SGB-9768 will lay a solid foundation for the company to push more siRNA drug candidates into later clinical development stage in the future."
About complement-mediated kidney diseases
The complement system is an important component of innate immunity, which regulates the adaptive immune response and plays an important role in the immunological and physiological functions in the human body, protecting the body from infections and removing dead cells and apoptotic material. However, dysregulation or overactivation of the complement system can induce inflammation and destroy self-tissues, causing immune damage, which is closely related to the occurrence and development of certain hematologic, ophthalmic, and kidney diseases. Chronic kidney disease (CKD) is a major public health concern worldwide, and in China, the prevalence of CKD is 10.8% among adults, meaning 1 in 10 adults has CKD. Complement is involved in the pathogenesis of many kidney diseases, such as IgAN, C3G, and IC-MPGN. Currently, there are limited options in the treatment of complement-mediated kidney diseases, with many complement-targeting drugs still in clinical stages, indicating significant unmet medical needs in this field. C3 is a critical component protein connecting upstream activation pathways to terminal pathways in the complement system. Inhibiting C3 activity has been validated to significantly suppress complement activation, making it a potent therapeutic target for the complement-mediated kidney diseases. Therefore, developing safe and effective siRNA drugs targeting C3 has important clinical value and great potential for treating such kidney diseases.
About SGB-9768
SGB-9768 is an siRNA drug candidate targeting the complement component 3 (C3) mRNA for the treatment of complement-mediated kidney diseases, including IgA nephropathy (IgAN), C3 glomerulopathy (C3G), Immune complex-mediated membranoproliferative glomerulonephritis (IC-MPGN). SGB-9768 is developed using SanegeneBio's proprietary GalNAc platform, to reduce C3 through RNA interference, thereby inhibiting the complement pathway activity. Preclinical studies have demonstrated that SGB-9768 could be administered every 3 or 6 months and continuously reduce the C3 level, and has superior potency than benchmark compounds, with good safety and tolerability profile. SGB-9768 has the advantages of low dosing frequency and long-term efficacy, and could potentially become the leading siRNA drug targeting C3.
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 three 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.
