Shengen Bio and Innovent Biologics Announce CDE Acceptance of IND Application for siRNA Drug SGB-3908 Targeting Hypertension

On May 8, 2024, Suzhou Sanegenbio Biomedical Co., Ltd. (hereinafter referred to as "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 been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.

▲Source: CDE official website

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 (ANGI, ANGII) 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 provides the drug with superior activity, prolonged efficacy, and excellent safety and tolerability.

We are very pleased that SGB-3908 has reached another significant milestone, demonstrating the execution efficiency of the SANEGENEBIO team and further enriching the company’s innovative drug pipeline in the cardiovascular and metabolic disease fields. The rapid progress of this project is due to the close collaboration and concerted efforts of both teams over the past few months. We look forward to both parties maintaining this excellent cooperative spirit, accelerating the clinical trials of SGB-3908, achieving positive progress, and benefiting a wide range of hypertension patients as soon as possible by providing more and better treatment options.

About Hypertension

Hypertension is a common chronic disease, with over 1 billion people currently affected worldwide. Hypertension not only increases the risk of cardiovascular and cerebrovascular diseases but also may lead to complications such as kidney damage and vision loss. With the aging population and the prevalence of risk factors like obesity, lack of physical activity, and unhealthy diet, the global prevalence of hypertension continues to rise. Although there are effective antihypertensive treatments available in clinical practice, antihypertensive drugs need to be taken daily, and since hypertension can be asymptomatic when not severe, patients may forget to take their medication. Poor adherence has become a major challenge in the current treatment of hypertension, resulting in less than 20% of hypertensive patients achieving long-term effective control. Addressing this treatment bottleneck, siRNA drugs can directly reduce the expression of AGT, offering advantages such as long-lasting effects, good safety, and high patient compliance, which are expected to provide better treatment options and long-term benefits for patients.

About SGB-3908

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 a collaboration to develop SGB-3908. Meanwhile, Innovent Bio obtained exclusive options for future development, manufacturing, and commercialization of the drug in different regions.

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.

▲AGT Mechanism of Action

Editor: Muyan

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