SanegeneBio Announces Positive Phase I Results for SGB-9768, a First-in-Class C3-Targeting siRNA Therapy for Complement-Mediated Diseases

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SANEGENEBIO Conducts a Phase I Study in New Zealand and China: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SGB-9768 in Healthy Subjects. The first subject was dosed in New Zealand and China in May and August 2024, respectively. As of December 1, 2024, a total of 55 subjects have been randomized to receive either SGB-9768 or placebo. Trial data show that after a single subcutaneous injection, SGB-9768 demonstrated favorable safety and tolerability, along with dose-dependent, significant, and sustained reductions in C3 levels and complement pathway activity. Compared with other siRNA products targeting the same pathway, SGB-9768 achieved higher target protein knockdown at equivalent doses.

Dr. Yuyan Jin, Senior Vice President of Clinical and Non-Clinical at SANEGENEBIOIndicates:“SGB-9768Adopted the unique technology of SANEGENEBIOGalNAcLiver Delivery Platform with Good Safety in Treating Complement-Related DiseasessiRNAIn a globally leading position in innovative drug development. The latest of this drugIPhase clinical trial data further reinforces its status as a breakthroughsiRNADrugs, with the potential to provide new treatment options for patients with complement-mediated nephropathy, ophthalmic diseases, and hematological disorders, also validate SANEGENEBIO's proprietary intellectual property.GalNAcThe platform's safety and efficacy in humans. We are deeply encouraged by this and look forward to the progress of subsequent clinical trials, believingSGB-9768Will continue to demonstrate its status as "the best in class"C3 siRNA"The Potential of the Drug."

About Complement-Mediated Kidney Diseases

The complement system is an important component of innate immunity, playing a regulatory role in adaptive immune responses and exerting crucial immune and physiological functions in the human body. It protects the body from infections and clears dead cells and apoptotic materials. However, once the complement system is dysregulated or excessively activated, it can induce inflammation and damage self-tissues, causing immune injury. This is closely related to the occurrence and development of some hematological diseases, ophthalmic diseases, and renal diseases. Chronic kidney disease (CKD) is a major public health issue globally and in China, with a prevalence rate of 10.8% in China, meaning one out of every ten adults suffers from CKD. Many renal diseases involve complement-mediated pathogenesis, including IgA nephropathy, C3 glomerulopathy, and immune complex-mediated membranoproliferative glomerulonephritis. Currently, treatment progress for complement-mediated renal diseases is limited, and many complement-targeting drugs are still in clinical research stages, indicating significant unmet clinical needs in this field. Complement inhibition holds promise as a new therapeutic target for treating complement-mediated renal diseases. Complement C3 is a key component connecting upstream activation pathways and terminal pathways in the complement system. Inhibition of C3 activity has been shown to have a significant complement-inhibitory effect, making it a powerful therapeutic target for such diseases. Therefore, developing safe and effective siRNA drugs targeting complement C3 holds substantial clinical application value for complement-mediated renal diseases.

About SGB-9768 Injection

SGB-9768 is a siRNA drug independently developed by SANEGENEBIO that targets the Complement 3 (C3) protein. It utilizes the company’s uniquely innovative next-generation LEAD™ GalNAc technology for delivery to liver cells, inhibiting C3 synthesis through the RNAi mechanism, thereby suppressing complement activation. It is intended for treating complement-mediated kidney diseases, including adult IgA nephropathy, C3 glomerulopathy, and immune complex-mediated membranoproliferative glomerulonephritis. Preclinical trial data show that SGB-9768 can be administered once every 3 or 6 months, effectively and continuously reducing C3 synthesis. Compared to competing products, it demonstrates superior efficacy and good safety and tolerability, with the advantages of less frequent dosing, better patient compliance, and long-lasting effects. It has the potential to become China's first and world-leading siRNA drug targeting Complement C3.

About SANEGENEBIO

SANEGENEBIO, founded in early 2021, is a biopharmaceutical company dedicated to developing novel small nucleic acid drugs based on RNA interference (RNAi) technology, with research and development centers in both China and the United States. The founding team consists of senior experts in the field of nucleic acid drugs, possessing years of experience in nucleic acid drug development and cutting-edge technical expertise in the industry. To date, the company has successfully established a globally leading nucleic acid drug platform with proprietary intellectual property, featuring chemical modification and intrahepatic and extrahepatic delivery technologies, accelerating the development of RNAi drugs with differentiated advantages. Among these, SGB-3403 for treating hypercholesterolemia, SGB-3908 for hypertension, and SGB-9768 for complement-mediated kidney diseases have entered clinical trials, while multiple other pipelines are also underway, covering disease areas such as cardiovascular and metabolic diseases, immune-mediated conditions, and neurological disorders. SANEGENEBIO is committed to scientific innovation, creating novel RNAi drugs to address unmet global medical needs and benefit patients and their families. For more information, please visit the SANEGENEBIO website at www.sanegenebio.com.

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