Tonghua Dongbao's 'Liraglutide Injection' Declared for Listing

On June 9, the official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China announced that Tonghua Dongbao Pharmaceutical has submitted a marketing application for GLP-1 analog liraglutide injection, and it has been accepted. According to the public information of Tonghua Dongbao Pharmaceutical, the company plans to develop liraglutide injection for adults with type 2 diabetes.

Human glucagon-like peptide-1 (GLP-1) is a polypeptide hormone secreted by intestinal cells, which stimulates insulin secretion and inhibits glucagon secretion by binding to GLP-1 receptors , thereby promoting the metabolism of glucose. At the same time, it can also play a role in delaying gastric emptying and suppressing appetite. Natural GLP-1 is stimulated by glucose to be secreted after a meal. In patients with type 2 diabetes, the secretion level of GLP-1 is significantly decreased, which is one of the important reasons for poor blood sugar control in patients.

The original liraglutide drug was developed by Novo Nordisk. The drug is a GLP-1 analog that activates the human GLP-1 receptor and promotes insulin secretion from the pancreas. The original research drug of liraglutide (trade name: Novo) entered the Chinese market in 2011 and was approved for the control of blood sugar in adults with type 2 diabetes. In addition, liraglutide has a significant weight loss effect. In 2014, the FDA approved liraglutide injection for long-term weight management in overweight and obese adults.

Liraglutide injection developed by Tonghua Dongbao Pharmaceutical was approved for clinical use in 2018. Tonghua Dongbao Pharmaceutical has completed a Phase 3 clinical trial to compare the efficacy and safety of liraglutide injection and Novotel in patients with type 2 diabetes, according to the China Drug Clinical Trial Registration and Information Publicity Platform sex. According to the announcement of Tonghua Dongbao Pharmaceutical, the company has obtained the summary report of the Phase 3 clinical trial in October 2021.

According to the Global Diabetes Map (10th Edition) published by the International Diabetes Federation (IDF), 537 million adults aged 20-79 will have diabetes in 2021, equivalent to 1 in 10 people with diabetes. At present, China is still the country with the largest number of diabetic patients. In 2021, there will be 140 million diabetic patients among adults aged 20-79. There is still a huge unmet need for patients in clinical treatment.