SanegeneBio Receives NMPA Approval to Initiate Clinical Trials of SGB-7342 for Obesity
Dec 16, 2025
-The Phase 1 clinical trial for SGB-7342 is scheduled to initiate in early 2026-
BOSTON, SHANGHAI, and SUZHOU – December 16, 2025, SanegeneBio, a clinical-stage biotechnology company developing innovative RNAi therapeutics, today announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application for SGB-7342. SGB-7342 is an experimental siRNA medicine targeting Inhibin Beta E (INHBE) for the treatment of obesity.
Obesity is a complex, chronic metabolic disease, and it's a major driver of noncommunicable diseases such as cardiovascular diseases, type 2 diabetes, and some types of cancer. It may also contribute to poorer treatment responses and prognosis of patients who have infectious diseases.
While current GLP-1 receptor agonists primarily achieve weight loss by acting on central nervous system to suppress appetite, they can cause gastrointestinal side effects, muscle loss, and weight rebound after discontinuation. These limitations underscore the need for next-generation therapies that employ a novel mechanism of action.
RNAi therapy has the potential to drive selective fat loss, preserves lean muscle, and improves overall metabolic health without the side effects of existing treatments.
SGB-7342 is a GalNAc-conjugated siRNA medicine targeting INHBE messenger RNA (mRNA) in hepatocytes. It is designed to suppress the protein expression of INHBE in the liver through an RNAi mechanism, thereby reducing circulating Activin E levels and inhibiting downstream signaling pathways involved in metabolism, ultimately improving metabolic abnormalities and insulin resistance. Preclinical data demonstrated that a single subcutaneous administration of SGB-7342 achieves potent and durable knockdown of INHBE mRNA in the liver. This was associated with significant reductions in body weight, improved body composition with preserved lean muscle mass in animal studies, along with a favorable safety and tolerability profile.
Dr. Weimin Wang, Founder and Chief Executive Officer of SanegeneBio, stated:
About Obesity
Obesity is a chronic metabolic disease caused by a combination of genetic, lifestyle, environmental, and social factors. Its core characteristic is the abnormal or excessive fat accumulation, which adversely affects health. This condition is a major driver of noncommunicable diseases such as cardiovascular diseases, type 2 diabetes, and some types of cancer. It may also contribute to poorer treatment responses and prognosis of patients who have infectious diseases. Currently, over 1 billion people are living with obesity globally, and prevalence is rising in nearly every country[1]. It is projected to reach approximately 1.37 billion by 2035. Obesity has emerged as a major global public health challenge.
About INHBE
INHBE is predominantly expressed in the liver, and its encoded secreted protein, Activin E, regulates fat metabolism by binding to the ALK7 receptor in adipose tissue. Human genetic studies have shown that individuals with a genetic loss-of-function in INHBE exhibit favorable metabolic characteristics, such as reduced abdominal fat and lower triglyceride levels[2]. This finding provides a rationale for targeting INHBE: inhibiting its activity aims to mimic this natural advantage, thereby selectively promoting lipolysis, reducing fat mass, and improving metabolic indicators while preserving lean body mass.
References:
1. NCD Risk Factor Collaboration. Worldwide trends in underweight and obesity from 1990 to 2022: a pooled analysis of 3663 population-representative studies with 222 million children, adolescentsm and adults. The Lancet 2024. Volume 403, Issue 10431, 1027 – 1050.
2. Deaton, A.M., Dubey, A., Ward, L.D. et al. Rare loss of function variants in the hepatokine gene INHBE protect from abdominal obesity. Nat Commun 13, 4319 (2022).
About SanegeneBio
SanegeneBio is a global, venture-backed, fully-integrated biotechnology company focused on developing RNAi-based therapeutics. Founded in 2021 and led by a team of RNAi veterans, the company has R&D operations in Boston, Shanghai and Suzhou. Their clear vision is that RNAi technology will power blockbuster medicines in diverse therapeutic areas, improving the quality and longevity of life for patients worldwide. This vision is being realized by advancing a fast-growing pipeline, which includes experimental medicines for autoimmune nephropathies, obesity, and cardiometabolic indications. SanegeneBio has initiated clinical trials for four experimental medicines to-date, and is committed to developing potential best-in-class and first-in-class therapeutics which leverage our industry-leading and differentiated LEAD™ tissue-selective RNAi delivery technology. For more information, please visit: www.sanegenebio.com and engage on LinkedIn.
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