Lepu Medical(SZ:300003) Cai Jing Wang·2025-09-05 05:25Core Viewpoint - Lepu Medical has announced the completion of the first dosing of the subject in the Phase II clinical trial of MWN105 injection, an innovative drug developed by its subsidiary, Shanghai Minwei Biotechnology Co., Ltd, aimed at treating overweight or obesity [1][2] Group 1: Clinical Trial Progress - MWN105 injection is a GLP-1/GIP/FGF21 receptor triple agonist with global intellectual property rights [1] - The Phase II clinical trial has been approved by the National Medical Products Administration, with the first subject successfully dosed [2] - The trial aims to evaluate the efficacy and safety of different doses of MWN105 injection over 24 weeks compared to a placebo in overweight or obese participants without diabetes [2] Group 2: Preclinical Results - Preclinical results in db/db mouse models show that MWN105 injection significantly reduces random blood glucose, fasting blood glucose, and glycated hemoglobin levels, while increasing the proportion of pancreatic β-cells and improving glucose tolerance [1] - In DIO obese mouse models, MWN105 injection significantly reduces body weight, fat content, and liver weight, as well as lowers food intake, low-density lipoprotein cholesterol (DL-C), total cholesterol (TC), and improves liver function [1] - In MASH mouse models, MWN105 injection significantly reduces body weight, liver weight, and liver-to-body ratio, while improving plasma ALT, AST, CHOL, LDL-C levels, and liver cholesterol and triglyceride content [1] Group 3: Safety and Efficacy - In spontaneous MASH monkeys with metabolic abnormalities, MWN105 injection reduces body weight and HbA1c levels, significantly lowers liver fat content, NAS scores, and inhibits the progression of liver fibrosis [2] - Safety evaluation trials indicate that MWN105 injection has good safety profiles [2]