China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 innovative polypeptide drug, RAY1225. This long-acting glucagon-like peptide-1 (GLP-1) drug features dual activation of the GLP-1 receptor and glucose-dependent insulin-promoting polypeptide (GIP) receptor.
Development and Pre-Clinical Findings
RAY1225 is being developed to lower blood sugar, reduce weight, and treat metabolic syndrome, among other applications. In pre-clinical studies, the drug demonstrated high activation activity on both GLP-1 and GIP receptors, showing good efficacy and safety profiles in experimental animals. It also exhibited superior pharmacokinetic characteristics compared to tirzepatide, according to the company. Additionally, RAY1225 is stable and easy to administer.
Market Context and Tirzepatide
Tirzepatide, the world’s first GLP-1/GIP dual agonist, was approved for marketing in the United States and other locations in 2022. It generated USD 482 million in sales following its market launch during the second quarter of that year, as reported by Eli Lilly. The GLP-1 market is projected to reach USD 28.3 billion by 2025 and USD 40.7 billion by 2030, presenting significant growth opportunities for RAY1225.
Significance of the Approval
The NMPA’s approval for the clinical study of RAY1225 marks a significant milestone for Guangdong Zhongsheng Pharmaceutical. This development positions the company to potentially capture a share of the expanding GLP-1 market and offer new treatment options for patients with diabetes and metabolic disorders.-Fineline Info & Tech