China's GLP-1 Antidiabetic Drug Market Attracts Fierce Domestic and Global Competition

　　【Pharmaceutical Network Industry DynamicsRecently, "Nature Medicine" released the results of a large-sample trial of Eli Lilly's重磅降糖药Tirzepatide, primarily involving Chinese patients with type 2 diabetes. The SURPASS-AP-Combo study compared Tirzepatide with dose-titrated insulin glargine. The results showed that, compared to insulin glargine, Tirzepatide demonstrated better reductions in HbA1c (glycated hemoglobin) and body weight in the Chinese type 2 diabetes population, with overall good safety and tolerability.
 

It is reported that Tirzepatide, developed by Eli Lilly and Company, is a next-generation dual GIP/GLP-1 receptor agonist administered as a once-weekly injection. It acts as both a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist. The product received approval from the U.S. FDA in May 2022. In September 2022, Eli Lilly and Company submitted a registration application for the drug to the Center for Drug Evaluation (CDE) of the National Medical Products Administration in China.
 

In terms of indications, Eli Lilly stated that apart from lowering blood sugar and weight loss, Tirzepatide will also expand its indications to include non-alcoholic steatohepatitis (NASH), heart failure with preserved ejection fraction (HFpEF), and more in the future.
 

Behind Eli Lilly's active submission of the Tirzepatide registration application to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), one can see its determination to establish a presence in China's diabetes market, particularly in the GLP-1 class of novel hypoglycemic drugs.
 

GLP-1 drugs are therapeutic agents for metabolic diseases and can be used in treatment areas such as blood sugar reduction and weight loss. Relevant data shows that the global hypoglycemic drug market size was $59.6 billion in 2022, wherein the sales of GLP-1 receptor agonists (GLP-1RA) surpassed insulin for the first time, indicating a broad market prospect. According to statistics from CCID Consulting, the global GLP-1 receptor agonist drug market size reached $13.1 billion in 2020 and is expected to grow to $40.7 billion by 2030.
 

Currently, in China, two blockbuster products of Novo Nordisk, Liraglutide and Semaglutide, have been approved for diabetes indications. If Eli Lilly's Tirzepatide is successfully approved, it is expected to become the next "blockbuster" in this field.
 

In fact, not only Eli Lilly, but also a large number of multinational pharmaceutical companies have been increasing their investments in China's GLP-1 drug market in recent years. For example, in May this year, Sanofi's innovative hypoglycemic drug Soliqua (insulin glargine and lixisenatide injection (I)/(II)) was officially launched in China. This product is a compound preparation of insulin glargine (basal insulin analog) and lixisenatide (GLP-1RA). It is currently suitable for adult patients with type 2 diabetes mellitus (T2DM) who have poor blood glucose control. Combined with other oral hypoglycemic drugs on the basis of diet and exercise, it can improve blood glucose control.
 

Besides multinational pharmaceutical companies, domestic pharmaceutical companies in China are also gearing up. For instance, on January 31 this year, BrightGene Bio-Medical Technology announced that the IND application for its BGM0504 injection had been approved. It is intended for clinical trials for weight loss and Type 2 diabetes indications, making it the second GLP-1R/GIPR agonist in China to be approved for clinical trials for both Type 2 diabetes and overweight or obesity. Additionally, Hengrui Medicine's multi-target innovative GLP-1 drug, Noliglapeptide, indicated for Type 2 diabetes, is already in Phase III clinical trials, while another new drug, HRS9531, is in Phase II clinical trials. IBI362 from Innovent Biologics/Eli Lilly has also entered Phase II clinical trials.
 

At the same time, as Novo Nordisk's original drug liraglutide patent in China has expired, Huadong Medicine, Hanmi Medicine, and Tonghua Dongbao have all accelerated the development of liraglutide biosimilar drugs. Among them, Huadong Medicine has submitted an obesity indication marketing application. In addition, the Chinese patent for semaglutide will expire in 2026, and Jiuyuan Gene, Sino-American Huadong, Lizhu Group, Notech Biotech, and Tianji Biotech are also stepping up their research and development of generic drugs. It can be foreseen that competition in the GLP-1 drug market may become increasingly fierce in the future.
 

Disclaimer: In any case, the information or opinions expressed in this article do not constitute investment advice to any person.