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Today (November 28), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that NNC0519-0130 Injection, a Class 1 new drug from Novo Nordisk, has received tacit approval for clinical trials, intended for development to treatType 2 Diabetes. According to publicly available information from Novo Nordisk, this is a product under research by the company.A dual-target GIP/GLP-1 receptor agonist administered once weekly via subcutaneous injection is currently undergoing Phase 2 clinical trials internationally for individuals with type 2 diabetes and obesity.. This is the first time that the product has been approved for clinical use in China.
Screenshot source: CDE official website
According to the pipeline information on Novo Nordisk's official website, the company plans to develop this GIP/GLP-1 receptor agonist for type 2 diabetes and weight loss.ClinicalTrialsOfficial website, Novo Nordisk has previously launched in the United States, Japan, Australia, South Korea, and other places.NNC0519-0130 Injection: Multiple Phase 1 andPhase 2 clinical study, planned to evaluate the pharmacokinetics, safety, and efficacy of NN0519-0130 in healthy individuals, as well as those with type 2 diabetes and obesity.Among them, there are two international multicenterPhase 2Clinical studies have now been initiated, respectively:- OneComparison of Six Different Doses of NN0519-0130 Against the Control DrugHypoglycemic Effect in Patients with Type 2 DiabetesThe study, which is planned to last approximately 40 weeks, aims to enroll 288 participants internationally.
- A Comparison of Six Different Doses of NN0519-0130 Against a Control DrugHelp Overweight People Lose WeightThe study, which is planned to last approximately 42 weeks, aims to enroll 355 participants internationally.
This timeNNC0519-0130Approval for clinical trials in China means that it will initiate clinical research in China.Public information shows that glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) are hormones that regulate blood sugar.GIP is an incretin that can complement the action of GLP-1 receptor agonists. Studies have shown that GIP reduces food intake and increases energy expenditure, thereby reducing body weight. When combined with GLP-1 receptor agonists, it may have a greater impact on glucose levels and body weight.Dual receptor agonist of GIP and GLP-1YesIntegrating the effects of these two incretins into a single molecule to achieve glucose-lowering and weight-reducing effects.▲Novo Nordisk's Next-Generation Diabetes Innovation Pipeline (Screenshot Source: Novo Nordisk Official Website)
Notably, according to information on Novo Nordisk's official website, in addition to this once-weekly GIP/GLP-1 dual-target agonist, Novo Nordisk has also developedOnce-Monthly (OM) Subcutaneous Injection of GIP/GLP-1 Dual Agonist(Research and development code: NN9650) is expected to further enhance the convenience of drug administration. The phase 1 clinical trial results for this product are anticipated to be available in 2025.
References:
[1] Website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) of China. Retrieved Nov 28, 2024, from https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c
[2] Novo Nordisk Official Website. From https://www.novonordisk.com/content/dam/nncorp/global/en/investors/irmaterial/cmd/2024/P2-Research-and-Early-Development.pdf
[3] Novo Nordisk R&D Pipeline. From https://www.novonordisk.com/science-and-technology/r-d-pipeline.html
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