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Today (July 8), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that the investigational new drug SGB-3908 Injection, submitted by SANEGENEBIO, has been approved for clinical trials for the treatment of primary hypertension. According to publicly available information,This isSANEGENEBIO and Innovent Biologics jointly developedSmall nucleic acid (siRNA) drugs for the treatment of hypertension.It is worth noting that,According to the publicly available R&D pipeline information on Innovent Biologics' official website, this is the company's first siRNA therapy R&D project, with the R&D code IBI3016 at Innovent Biologics.
Screenshot source: CDE official website
With the aging population and the prevalence of risk factors such as obesity and unhealthy diet, the prevalence of hypertension is still increasing globally.Hypertension not only increases the risk of cardiovascular and cerebrovascular diseases but also may lead to complications such as kidney damage and vision loss.Currently, there are effective antihypertensive treatment methods in clinical practice, but antihypertensive drugs need to be taken daily. Since hypertension is not easily detectable when symptoms are not severe, patients may forget to take their medication, and poor compliance has become a major challenge in the current treatment of hypertension.Angiotensinogen (AGT)It is the most upstream precursor of the renin-angiotensin-aldosterone system (RAAS). The role of this target in blood pressure regulation has been confirmed, and inhibiting AGT has recognized antihypertensive effects.According to a previous press release from SANEGENEBIO,SGB-3908 is an siRNA drug targeting AGT.Regarding the treatment bottleneck of hypertension,siRNA drugs can directly reduce the expression of AGT, offering differentiated advantages such as long-lasting effects, good safety, and high patient compliance., which is expected to bring better treatment options and long-term benefits to patients.
It is reported that SGB-3908 adopts SANEGENEBIO's next-generation siRNA drug platform technology, which makes the drug exhibit superior activity and prolonged efficacy, with good safety and tolerability.Preclinical experimental data show that the product can significantly reduce the levels of AGT protein and related biomarkers (ANG I, ANG II) in the serum of hypertensive cynomolgus monkeys.Achieve significant and long-lasting blood pressure reduction., and no safety issues such as hypotension were observed.In December 2023, SANEGENEBIO and Innovent Biologics announced a strategic collaboration agreement to jointly develop the siRNA candidate drug SGB-3908 for the treatment of hypertension.At the same time,Innovent Biologics obtains exclusive option for future development, manufacturing, and commercialization of the drug.
SANEGENEBIO, founded in 2021, is a biopharmaceutical company dedicated to developing novel small nucleic acid drugs based on RNA interference (RNAi) technology. The company's founder and Chief Executive Officer (CEO) is Dr. Wang Weimin. In December last year, SANEGENEBIO announced the completion of an over USD 80 million (nearly RMB 600 million) Series A+ financing round led by Tencent Investment and OrbiMed.Financing，Attracting High Attention in the Industry. As of now, the company has three RNAi drugs approved for clinical trials. Previously, the companyRNAi Drugs Targeting Complement C3 ProteinSGB-9768、siRNA Therapy Targeting Hepatocyte PCSK9SGB-3403 has entered the clinical research stage.
References:
[1] Official Website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.Retrieved July 8，2024, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c
[2] SANEGENEBIO and Innovent Biologics Jointly Develop Small Nucleic Acid Drug for Hypertension: Clinical Trial Application in China Accepted. Retrieved May 08, 2024, from https://mp.weixin.qq.com/s/macpr3XZViBntuekrBMtUg
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