Guangdong Zhongsheng Pharmaceutical Co.,Ltd. (002317.SZ) announced that its subsidiary, Guangdong Zhongsheng Ruichuang Biotechnology Co., Ltd., has received approval from the National Medical Products Administration for a new clinical trial of its self-developed Class 1 innovative peptide drug RAY1225 Injection. The trial will evaluate its efficacy in treating metabolic dysfunction-associated steatohepatitis (MASH).

RAY1225 Injection is a novel peptide drug with global intellectual property rights, exhibiting dual agonist activity targeting both GLP-1 and GIP receptors. Due to its superior pharmacokinetic properties, it has the potential to be administered biweekly as a long-acting therapeutic.

Currently, the Phase III clinical trial (REBUILDING-2 study) assessing the safety and efficacy of RAY1225 Injection in Chinese patients with obesity or overweight has successfully commenced and completed participant enrollment. Additionally, two other Phase III trials—SHINING-2 (evaluating RAY1225 as monotherapy for type 2 diabetes) and SHINING-3 (assessing RAY1225 in combination with oral hypoglycemic drugs versus semaglutide injection)—are progressing smoothly in participant recruitment.

MASH, characterized by liver inflammation due to excessive fat accumulation, can lead to progressive fibrosis and cirrhosis. With no approved MASH-specific treatments currently available in China, there remains a significant unmet clinical need. RAY1225’s ability to selectively activate GLP-1 and GIP receptors enables glucose-dependent insulin secretion, glucagon suppression, appetite reduction, weight loss, and improved hepatic steatosis.

Preclinical studies demonstrate that RAY1225 improves NAS scores (evaluating liver inflammation, necrosis, and fibrosis), reduces body weight, enhances metabolic parameters, and lowers hepatic fat levels in MASH animal models, showing dose-dependent efficacy. These findings support its potential as a promising therapeutic candidate for MASH.