Domestic Biotech Shengen Bio Secures IND Approval for INHBE-Targeting siRNA Candidate SGB-7342 in Obesity Treatment

　　【Pharmaceutical Network Industry Dynamics】Obesity is a chronic metabolic disease caused by the interaction of multiple factors such as genetics, environment, and behavior. It also increases the risk of various chronic diseases such as cardiovascular disease, diabetes, and metabolic-associated steatohepatitis (MASH). In recent years, the rates of overweight and obesity among all age groups in China have shown a significant upward trend, and the disease burden of related chronic conditions has been increasingly exacerbated, posing severe challenges to the national healthcare system.
 

Data shows that the global obese population has exceeded 1 billion, with the prevalence rate continuously rising in most countries and regions. It is projected to reach approximately 1.37 billion by 2035. In China, around 180 million adults suffer from obesity. Therefore, it is urgent to strengthen innovation and research in relevant drugs.
 

Reportedly, currently, therapies represented by GLP-1 receptor agonists mainly achieve weight loss by acting on the central nervous system and suppressing appetite. However, limitations such as gastrointestinal reactions, muscle loss, and weight rebound after discontinuation still need to be addressed. There is an urgent clinical need for therapies with novel mechanisms of action. Among these, RNAi therapy offers a differentiated treatment strategy. Instead of relying on central appetite suppression, it precisely targets specific genes (such as INHBE) in the fat metabolism pathway, regulating fat metabolism at its source. The aim is to achieve selective fat reduction, maintain muscle mass, and improve metabolic health while potentially avoiding side effects associated with traditional therapies.
 

In the field of RNAi therapy, some pharmaceutical companies are making strategic moves. For instance, SANEGENEBIO announced on December 16, 2025, that its self-developed small interfering RNA (siRNA) candidate drug, SGB-7342, which targets the inhibin βE subunit (INHBE), has received tacit approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for clinical trial application to treat obesity.
 

Data shows that SGB-7342 is an siRNA candidate drug targeting INHBE for the treatment of obesity, utilizing SANEGENEBIO's next-generation GalNAc conjugation technology. Its mechanism of action involves precisely silencing the expression of INHBE mRNA in the liver through RNAi technology, reducing the levels of its encoded protein Activin E, thereby promoting fat breakdown without inducing muscle breakdown, ultimately improving metabolic abnormalities and insulin resistance. Preclinical trial data indicates that a single subcutaneous administration of SGB-7342 achieves potent and sustained knockdown of liver INHBE mRNA, with significant weight loss, improved body composition, and the anticipated effect of maintaining muscle observed in animal models, while demonstrating good safety and tolerability.
 

Alnylam, a company in the field of RNAi therapy development, has announced that it will develop an innovative RNAi therapy targeting the INHBE gene to treat obesity and cardiometabolic diseases. The long-acting RNAi therapy developed by the company can selectively silence the expression of INHBE in the liver, potentially requiring only one injection every six months to achieve weight control. Preclinical studies have shown that combining these long-acting RNAi therapies with low-dose semaglutide may reduce more fat while preserving muscle mass and mitigate weight rebound after discontinuing semaglutide.
 

Arrowhead Pharmaceuticals once announced the advancement of ARO-INHBE and ARO-ALK7 into clinical development. These two next-generation RNAi candidates aim to treat obesity and metabolic diseases. The two drugs possess a unique mechanism of reducing fat while preserving muscle. ARO-INHBE is designed to inhibit the expression of the INHBE gene in the liver and its encoded activin E, while ARO-ALK7 focuses on reducing the activity of activin receptor-like kinase 7 (ALK7) in adipose tissue. Both targets have been genetically confirmed, showing that their loss of function is closely associated with a reduced risk of obesity and metabolic diseases, such as type 2 diabetes.
 

Currently, the field of weight-loss therapies is experiencing a period of rapid development, with new treatments emerging continuously. As research data accumulates and more drugs enter clinical trials, the field of obesity treatment is expected to achieve continuous breakthroughs. For instance, although the global development of RNAi therapies for obesity is still in its early stages, a few candidate drugs have already entered clinical trials, providing preliminary validation of the significant potential of this therapy in the field of obesity treatment.
 

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