On October 7, 2023, the website of China Center for Drug Evaluation (CDE) shows that SGB-3403 injection, a Class-1 innovative drug developed by SanegeneBio, obtained an implicit approval of clinical trial application for the treatment of hypercholesterolemia(acceptance number CXHL2300741).

SGB-3403 is a RNAi drug targeting PCSK9. This is SanegeneBio’s first innovative RNAi drug and has previously been approved for phase I clinical trial in Australia. The superior potency and efficacy duration of SGB-3403 in pre-clinical studies showed that it has the potential to be the best-in-class RNAi drug targeting PCSK9.

"The approval of the clinical trial application for SGB-3403 in China is another important milestone following its clinical study in Australia, once again demonstrating the company's execution efficiency and strategic layout of SGB-3403. We will continue to advance the further clinical development of SGB-3403 quickly, aiming to provide the innovative and accessible RNAi therapeutics to patients in need as soon as possible." said Dr. Weimin Wang, founder and chief executive officer of SanegeneBio.

About SGB-3403

SGB-3403, an siRNA-GalNAc conjugate targeting PCSK9, is delivered to hepatocyte using Sanegene's proprietary novel GalNAc platform technology to inhibit the synthesis of PCSK9 in the liver through RNA interference. The advantages of GalNAc platform have been also fully verified, including safety, effectiveness, and stability. SGB-3403 has been shown in preclinical studies with good safety and tolerability, superior efficacy than benchmark products in multiple animal disease models (including the hyperlipidemic cynomolgus monkey model), and it can reduce LDL-C by up to 40% - 70% even with lower dose and less frequency of administration, showing its potential to be the best-in-class RNAis drug targeting PCSK9.

In May 2023, SGB-3403 entered phase I clinical trial in Australia, aiming to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of SGB-3403 when administered subcutaneously in healthy participants and participants with elevated LDL-C.

About Cardiovascular disease

Cardiovascular disease has been the "first killer" threatening human health worldwide. In China, for example, cardiovascular disease was the leading cause of death among urban and rural residents in 2018. The prevalence and mortality of cardiovascular diseases will continue to rise with the increasing number of people with hypertension, dyslipidemia, diabetes, and obesity. LDL-C is a pathogenic risk factor for cardiovascular disease and needs to be closely monitored and reduced in clinical practice to prevent and treat cardiovascular disease. Currently, statins are the standard of choice for lowering LDL-C levels, however many high-risk cardiovascular diseases patients cannot achieve ideal LDL-C levels after taking statin drugs in practice. Therefore, there is a huge and urgent unmet medical need for a more effective and innovative treatment choice to better manage the LDL-C levels.

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 propelled by a team of industry-leading experts and has operations in both the US and China. Since its inception, 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 first RNAi drug has entered the clinical stage, and several pipelines are in progress simultaneously. SanegeneBio is committed to creating 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: http://www.sanegenebio.com