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Tonghua Dongbao: Marketing application for GLP-1RA liraglutide injection accepted
Date：2022-06-09
Author：东宝
Views：2
Recently, Tonghua Dongbao Pharmaceutical Co., Ltd. (hereinafter "Tonghua Dongbao" or "the Company") received the notification of acceptance from the National Medical Products Administration (NMPA) on the marketing application for its liraglutide injection. The acceptance number is CXSS2200058 Guo.
If approved for marketing, liraglutide injection, as a hypoglycemic drug targeting GLP-1 receptor, will further enrich the Company's product portfolio, providing patients with more medication options and creating a new growth point for the Company. The Company is the first manufacturer other than the original drug developer to have its marketing application accepted in China. It is expected to be one of the first Chinese manufacturers approved for manufacturing liraglutide biosimilars.
Liraglutide is a glucagon-like peptide (GLP-1) analog that activates the human GLP-1 receptor and promotes insulin secretion from the pancreas. Developed by Novo Nordisk, it was introduced into the Chinese market in 2011, and approved for blood glucose control in adults with type 2 diabetes. In addition, liraglutide can induce significant weight loss, and its weight loss medicine (Saxenda) was launched in the US in December 2014.
With a vast market, GLP-1 drugs have seen rapidly growing sales worldwide. According to the IDF Diabetes Atlas 10th edition, there were 537 million adults aged 20-79 years with diabetes worldwide in 2021. Currently, China still has the largest number of diabetic patients, with 140 million adults aged 20-79 living with diabetes in 2021. In recent years, GLP-1 receptor agonists are playing an increasingly important role in diabetes treatment, and the market is expanding rapidly. Novo Nordisk's liraglutide injection (Victoza) achieved global sales of DKK 15.054 billion (about RMB 14.618 billion) in 2021. Specifically, the sales in China hit DKK 1.544 billion (about RMB 1.499 billion), up about 45% year-on-year. If approved for marketing, the liraglutide injection will provide a strong impetus for the Company's future growth.
As a veteran player in China's diabetes treatment market, the Company boasts the broadest portfolio of products on offer and under development, including long-acting, intermediate-acting, rapid-acting, and ultra-rapid-acting insulins, dual insulin compound preparations, GLP-1RA, long-acting GLP-1RA, insulin analog and GLP-1RA co-formulations, and multi-target Class 1 novel drugs, which can meet the needs of different diabetic patients in the market. The market for our products will continue to expand. Going forward, the Company will continue to launch quality products to achieve high-quality development and maintain its lead in the industry.
