IND Approval: CMS’s Self-developed Innovative Drug Dual Agonist of Glucagon-like Peptide-1 Receptor/Glucagon Receptor CMS-D005 is Approved for Drug Clinical Trials

Date:
2024-11-27
Category:
Company News

China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce that innovative drug CMS-D005 injection (“CMS-D005”) self-developed by the Group has been granted approval for drug clinical trials by National Medical Products Administration of the People’s Republic of China (“NMPA”) on 27 November 2024. The NMPA grants the Group consent to conduct a clinical trial to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of CMS-D005 in healthy and overweight/obese adult subjects in China.

 

CMS-D005

 

CMS-D005 is a highly active and selective dual agonist of glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR). Activating glucagon-like peptide-1 (GLP-1) can reduce food intake through central appetite suppression and inhibit gastric emptying to increase satiety to achieve weight loss. Activating GLP-1R can enhance secretion of glucose-dependent insulin and inhibit secretion of glucagon to lower blood glucagon[1], while activating glucagon (GCG) can promote fat catabolism and enhance fat loss, especially the reduction of liver fat[2]. CMS-D005 can be developed in the future to treat obesity/overweight, metabolic dysfunction-associated steatohepatitis, type 2 diabetes and other metabolism-related diseases.

 

Overweight or obesity refers to excessive total accumulation of body fat and/or localized increase in content and abnormal distribution, often combined with dyslipidemia, fatty liver, hypertension, diabetes mellitus and many other diseases[3]. “Report on Nutrition and Chronic Disease Status of Chinese Residents 2020” showed that the overweight and obesity rates of adult residents in China are 34.3% and 16.4%, respectively[4]. The drugs that have been approved by the NMPA for treating obesity mainly target GLP-1.  Multi-target GLP-1 drugs are the current focus of development for obesity treatment[5]. The fat loss effect of the GCG pathway is very suitable for combining with the GLP-1 target to achieve a similar effect of diet and exercise, which is more beneficial to the weight loss benefit and long-term maintenance of the effect. Preclinical studies have shown that CMS-D005 has strong agonistic activity against GLP-1R and GCGR, with good weight loss effect and good safety, indicating promising prospects for the treatment of overweight or obesity.

 

Reference：

  1. Gudzune KA, et al. JAMA. 2024 Aug 20;332(7):571-584.
  2. Galsgaard KD, et al. Front Physiol. 2019 Apr 24;10:413.
  3. Guideline for primary care of obesity 2019. Chin J Gen Pract, 2020,19(02): 95-101.
  4. Report on nutrition and chronic disease status of Chinese residents 2020. China Medical News; 2020,35(24):15
  5. Baggio LL, et al. Mol Metab. 2021 Apr; 46:101090.

 

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