June 27, 2024 Source: drugdu 95
On June 25, Chiatai Tianqing received the Certificate of Drug Registration approved by the State Drug Administration, and the company's liraglutide injection was approved to be listed in the market, which is used for controlling blood glucose in adult patients with type 2 diabetes mellitus. This is the ninth new product (including new indications) approved by Chiatai Tianqing since this year. The approval of this product also marks Chiatai Tianqing's formal entry into the field of biopharmaceutical glycemic control.
Liraglutide is a long-acting analog of glucagon-like peptide-1 (GLP-1) with 97% homology to natural GLP-1, an endogenous enteric insulinotropic hormone that enhances glucose-dependent insulin secretion from pancreatic β-cells. In addition to pancreatic islet cells, GLP-1 receptors are widely present in gastrointestinal, lung, brain, kidney, cardiovascular system and other organs and tissues. Liraglutide prolongs the half-life of GLP-1 on the basis of retaining the physiological action characteristics of GLP-1, and needs to be administered only once daily. In addition to type 2 diabetes mellitus, liraglutide has shown clinical benefit in the treatment of obese patients with weight control, cardiovascular system disorders and neurological disorders.
Currently, liraglutide has been incorporated into several guidelines, including the American Diabetes Association (ADA) Diabetes Diagnostic and Treatment Criteria (2024 Edition), the Chinese Guidelines for the Prevention and Control of Type 2 Diabetes Mellitus (2020 Edition), and the Expert Consensus on the Clinical Application of Glucose-Lowering Drugs for Adults with Type 2 Diabetes Mellitus Combined with Patients with Cardiac and Kidney Diseases in China.
According to the data of Mine.com, in 2023, the sales of liraglutide injection in China exceeded 1.7 billion yuan, and it is the second largest variety of GLP-1 market share in China. Chiatai Tianqing has its own API production capacity, which may bring certain advantages for the company's competition in this field. Liraglutide API production and preparation process is long, complex and difficult to quality control. Chiatai Tianqing has improved the controllability of API process, quality and cost through the development of the whole process and the production of key instrumental enzymes and acylation modifiers, and is equipped with a number of sets of upgraded bioreactors with sufficient production capacity, which ensures the stable production and supply of drugs.
GLP-1 is currently the hottest target for glucose reduction and weight loss in the world. In this field, in addition to liraglutide, Chiatai Tianqing Simeglutide Injection is undergoing Phase III clinical trials, which is expected to bring more treatment options for patients.
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