Tides Express | Shengen Bio and Innovent Biologics' siRNA Drug for Hypertension Receives IND Approval in China

July 9, 2024DaySUZHOU SANEGENEBIO MEDICINE CO., LTD. ("SANEGENEBIO") announced that the clinical trial application for SGB-3908 injection, a small nucleic acid (siRNA) drug for the treatment of hypertension jointly developed with INNOVENT BIO, has received tacit approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) (Acceptance No.: CXHL2400426) for the treatment of hypertension. This is the third siRNA drug for which SANEGENEBIO has applied to conduct clinical trials in China, following SGB-3403 injection and SGB-9768 injection.

SGB-3908 is an siRNA drug targeting angiotensinogen (AGT) for the treatment of hypertension. Preclinical trial data show that SGB-3908 significantly reduces AGT protein and related biomarkers (ANG I, ANG II) in the serum of hypertensive cynomolgus monkeys, achieving a marked blood pressure-lowering effect with long-lasting action, and no safety issues such as hypotension were observed. SGB-3908 utilizes SANEGENEBIO's uniquely innovative next-generation siRNA drug platform technology, which enhances the drug’s superior activity and prolonged efficacy while maintaining good safety and tolerability.

About AGT

AGT is the most upstream precursor of the renin-angiotensin-aldosterone system (RAAS), and its role in blood pressure (BP) regulation has been confirmed. Inhibition of AGT has a recognized antihypertensive effect.

AboutHypertension

Hypertension is a common chronic disease, with over 1 billion people worldwide currently affected. Hypertension not only increases the risk of cardiovascular and cerebrovascular diseases but can also lead to complications such as kidney damage and vision loss. With the aging population and the prevalence of risk factors like obesity, physical inactivity, and unhealthy diets, the global prevalence of hypertension continues to rise.

About SGB-3908 Injection

SGB-3908 is an siRNA drug targeting angiotensinogen (AGT) for the treatment of hypertension. It is developed based on the company's proprietary small nucleic acid drug development platform, LEAD™ (Ligand and Enhancer Assisted Delivery), and inhibits the synthesis of AGT through RNAi. Preclinical trial data show that SGB-3908 can inhibit the synthesis of AGT in the liver, potentially leading to a sustained reduction in AGT protein, further resulting in decreased levels of angiotensin (Ang) II, ultimately achieving vasodilation and blood pressure reduction. In December 2023, SANEGENEBIO and Innovent Bio jointly announced the collaborative development of SGB-3908, with Innovent Bio obtaining the option for future development, manufacturing, and commercialization of the drug in different regions.

About RNAi Therapy

RNA molecules have characteristics such as high charge and poor cell membrane penetration, which limit their potential as a drug class for wide application across various disease indications. To deliver RNAi molecules to target organs while ensuring ideal pharmacodynamic/pharmacokinetic properties, and to fully unlock the potential of RNAi therapies across a broad range of diseases, these obstacles need to be overcome one by one.

SANEGENEBIO has established a robust proprietary small nucleic acid drug development LEAD™ (Ligand and Enhancer Assisted Delivery) platform. Through innovative design in three key modules—tissue-specific delivery ligands, delivery enhancers, and optimized chemical modifications—the company has built a strong engine for RNAi drug development to overcome multiple barriers in RNAi drug discovery. Our LEAD™ platform enables the efficient design, screening, identification, and development of novel RNAi molecules with enhanced tissue distribution, significant efficacy, and high safety. The innovative technology of the LEAD™ platform expands the therapeutic scope of RNAi therapies from liver tissues to extrahepatic tissues and targets multiple non-liver disease treatment sites, fully unlocking the application potential of RNAi technology and addressing unmet medical needs in various disease areas.

AboutSANEGENEBIOSANEGENEBIO

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 seasoned experts in the field of nucleic acid drugs, possessing years of experience in nucleic drug development and cutting-edge technical capabilities within the industry. To date, the company has successfully established a globally leading nucleic acid drug platform with proprietary intellectual property, encompassing chemical modification and intrahepatic/extrahepatic delivery technologies, accelerating the development of RNAi drugs with differentiated advantages. Two core products have entered clinical trials, while multiple pipelines are being advanced in parallel, covering disease areas such as cardiovascular and cerebrovascular diseases, metabolic disorders, immune-mediated conditions, and neurological diseases.