The clinical trial application of an siRNA drug developed by SanegeneBio and Innovent for the treatment of hypertension has been accepted by the CDE

On May 8, 2024, Suzhou Sanegene Bio Inc. (SanegeneBio) announced that the clinical trial application of SGB-3908 injection, an siRNA drug for the treatment of hypertension, has recently been officially accepted by the China Center for Drug Evaluation (CDE) of the National Medical Products Administration.

SGB-3908 is an siRNA drug targeting Angiotensinogen (AGT) for the treatment of hypertension. The preclinical trial data showed that SGB-3908 significantly reduced the AGT protein and related biomarkers (ANG I, ANG II) in the serum of cynomolgus monkeys with hypertension, achieving a significant long-term antihypertensive efficacy without safety issues such as low blood pressure. SGB-3908 utilizes SanegeneBio's proprietary innovative siRNA drug platform technology, providing the drug with excellent potency and duration, as well as good safety and tolerability.

“We are delighted that SGB-3908 has reached another important milestone, which demonstrates the execution efficiency of our team and further enriches SanegeneBio's product portfolio in cardiovascular and metabolic diseases. It is the close cooperation and concerted effort of both parties in the past months that drives the rapid progress of this project. We look forward to keeping the momentum of great cooperation between both parties to accelerate the clinical trial of SGB-3908, and benefit the hypertensive patients as soon as possible with better treatment options.” said Dr. Weimin Wang, Founder and Chief Executive Officer of SanegeneBio.

About Hypertension

Hypertension is a common chronic disease that currently affects over 1 billion people worldwide. It not only increases the risk of cardiovascular and cerebrovascular diseases while also potentially leads to complications such as kidney damage and impaired vision. With the aging population and the rising prevalence of risk factors such as obesity, lack of physical exercise, and unhealthy diet, the incidence of hypertension is still increasing globally. There are effective anti-hypertension treatments in clinical practice, however, these treatments have some disadvantages. For example the anti-hypertension drugs need to be taken every day, and hypertension is difficult to perceive when symptoms are not severe, which can lead to noncompliance in taking medicines. Poor compliance has become a major challenge in the treatment of hypertension, with less than 20% of hypertension patients achieving long-term effective control. As an alternative solution to address this challenge in the treatment of hypertension, siRNA drugs can directly knockdown the expression of AGT, with the advantages of long efficacy duration, good safety, and high compliance, thus is expected to bring better treatment options and long-term benefits to the hypertensive patients.

About SGB-3908

SGB-3908, an siRNA-GalNAc conjugate targeting Angiotensinogen (AGT) for the treatment of hypertension, is delivered to liver using SanegeneBio's novel LEAD™ GalNAc platform to inhibit the synthesis of AGT in the liver through RNA interference. SGB-3908 can inhibit the synthesis of AGT in the liver, potentially leading to durable reductions of AGT protein, further causing a decrease in angiotensin (Ang) II, and ultimately resulting in vasodilation and lowering blood pressure. In December 2023, SanegeneBio and Innovent jointly announced that they entered into a collaboration agreement to co-develop SGB-3908, and Innovent obtained an exclusive option to license in the future development, manufacturing and commercialization rights of SGB-3908 in different regions.

About AGT

AGT is the upstream precursor in the Renin-Angiotensin-Aldosterone System (RAAS), a cascade which has demonstrated function in blood pressure regulation, and the inhibition of AGT has shown well-established anti-hypertension effects.

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