Cinda Biotech (01801): The world's first GCG/GLP-1 dual receptor agonist weight loss drug, Xinermei® (Maxidopeptide Injection) was approved as the first long-term weight control indication
Zhitong Finance App News, Cinda Biotech (01801) announced that the new drug marketing application (NDA) for the glucagon (GCG) /glucagon-like peptide-1 (GLP-1) double receptor agonist Xinermei® (MSD peptide injection) has been approved for marketing by the China National Drug Administration (NMPA) for long-term weight control in adult obese or overweight patients. Xinermei ® is the world's first GCG/GLP-1 dual receptor agonist weight loss drug. Its unique mechanism of action can not only increase weight loss effects, but also directly reduce visceral fat content, bringing comprehensive metabolic benefits, and was rated as one of the top ten most anticipated drugs in the world in 2025 (FIERCE Pharma 2025).
Currently, there is no time to delay the situation of overweight and obese people in China. In April 2025, the National Health and Health Commission officially added the “Healthy Weight Management Action” to the “Healthy China 2030 Campaign”. The goal is that by 2030, the rising trend of overweight and obesity among the population has initially been reduced, and abnormal weight conditions of some people have improved. Xinermei ® is the world's first and only approved GCG/GLP-1 dual-receptor weight-loss drug that will reshape the current state of clinical treatment of overweight and obesity diseases in China. As an innovative pharmaceutical company striving to become an innovative pharmaceutical company in the metabolic and cardiovascular fields in China, the company will soon benefit patients with this “dual-target weight loss, fat burning and liver protection, and comprehensive benefits”, to help patients lose weight and improve their healthy lives, and respond to the national “Year of Weight Management” plan.
GCG receptors are mainly expressed in the liver. After GCG receptors are stimulated, they can inhibit liver fat synthesis and promote liver lipolysis, thereby further reducing body weight. As a GCG/GLP-1 dual receptor agonist weight loss drug, Xinermei ® can bring more significant weight loss effects and overall metabolic benefits to overweight or obese people.
The approval was mainly based on the results of a phase III registered clinical study (GLORY-1) conducted in overweight or obese subjects. The study successfully reached the main study endpoints and all key secondary endpoints in 2024. The study results showed that both Xinermei® 4 mg and 6 mg were superior to the placebo group in terms of the percentage change in body weight relative to the baseline in weeks 32 and 48 and the proportion of subjects with a weight loss of ≥ 5%, ≥ 10%, and ≥ 15% compared to the baseline.
Based on the efficacy goals, at week 48, the mean percentage changes in body weight relative to baseline were -12.0%, -14.8%, and -0.5% in weight in the placebo group; the proportion of subjects with a body weight loss of at least 5% compared to baseline was 73.5%, 82.8%, and 11.5%, respectively; the proportion of subjects with a body weight loss of at least 15% relative to baseline was 37.0%, 50.6%, and 2.1%, respectively; the mean values of changes in waist circumference were -9.5cm, -11.0cm and-, respectively 1.5cm
Additionally, Xinermei ® significantly reduced liver fat content in overweight or obese subjects. Among subjects with a baseline liver fat content of at least 10%, the mean percentage changes in the average total liver fat content of 4 mg, 6 mg and placebo subjects were -65.85%, -80.24%, and -5.27%, respectively, at week 48.
The GLORY-1 study results were presented at the American Diabetes Association Annual Meeting (ADA) and published online in the “New England Journal of Medicine”, receiving widespread attention from industry experts and scholars.
The clinical application of Xinermei ® can not only meet the clinical needs of overweight and obese patients for weight loss and improvement of cardiovascular metabolic indicators, but is also of great significance in reducing the country's social and economic burden. The approval of Xinermei ® is another milestone in the cardiovascular and metabolic fields. It is hoped that Xinermei® will bring better treatment options to overweight or obese people in China, improve the quality of life of this vast population, and reduce the burden on our society. Facing the future, the company will continue to be deeply involved in the four major treatment fields of oncology, autoimmunity, metabolism, cardiovascular, and ophthalmology, and carry out the corporate mission of “developing high-quality biopharmaceuticals that ordinary people can use”.