On the evening of April 1, 2025, Huadong Medicine Co., Ltd. (stock code: 000963.SZ, hereinafter referred to as "Huadong Medicine") issued an announcement stating that the company's wholly-owned subsidiary Hangzhou Sino-US Huadong Pharmaceutical Jiangdong Co., Ltd. (hereinafter referred to as "Jiangdong Company") received the "Acceptance Notice" issued by the National Medical Products Administration (NMPA), and the application for marketing authorization of semaglutide injection was accepted. The indication for this application is blood sugar control in adult patients with type 2 diabetes.

In addition, the clinical trial application for the fluid re-management indication of semaglutide injection was approved by NMPA in September 2024, and the first subject was enrolled in the Phase III clinical trial in December 2024. Due to the excellent and popular hypoglycemic and weight loss effects of semaglutide, its biosimilars will face huge market opportunities when they are launched.

Semaglutide becomes the "King of GLP-1 Drugs" and has great potential in the diabetes market

Public information shows that semaglutide is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist with 94% sequence homology with human GLP-1. It is mainly used clinically for blood sugar control in patients with type 2 diabetes and long-term weight management in obese or overweight patients. Semaglutide lowers blood glucose by stimulating insulin secretion and reducing glucagon secretion, a mechanism that involves a slight delay in early postprandial gastric emptying. At the same time, semaglutide can reduce appetite and food intake, induce weight loss, and significantly reduce the risk of major cardiovascular events (MACE) in patients with type 2 diabetes.

As the most watched GPL-1 receptor agonist in the world, the original drug company Novo Nordisk's semaglutide injection has driven the penetration rate and market size of GLP-1 drugs to achieve sustained and substantial growth with its good glucose-lowering and weight-reducing effects. According to Novo Nordisk's 2024 financial report, the global sales of Ozempic® (diabetes indication) in 2024 will be 120.342 billion Danish kroner (about 124.554 billion yuan); the global sales of Wegovy® (weight management indication) in 2024 will be 58.206 billion Danish kroner (about 60.243 billion yuan).

According to Huadong Medicine's announcement, the company's semaglutide completed a Phase III clinical study for type 2 diabetes indications in October 2024. In this Phase III trial, the effectiveness and safety of HDG1901 and the control drug Novotel® were compared in patients with type 2 diabetes who had poor blood sugar control after metformin treatment. The results showed that the company's semaglutide injection was equivalent to Novotel® in efficacy, and the results achieved equivalence, and the safety was good. The incidence of adverse events (TEAEs), any level of treatment-related adverse events (TRAEs), and serious adverse events (SAEs) during treatment in the HDG1901 group was numerically slightly lower than that in the Novotel® group. The results of this study and the HDM1002-102 study of Huadong Medicine's self-developed oral small molecule GLP-1 agonist were selected for the POSTER Presentation of the 85th American Diabetes Association (ADA) Scientific Conference in 2025. In addition, the company's self-developed GLP-1/GIP dual-target long-acting agonist HDM1005 injection was selected for the Oral Presentation of the conference. It is reported that the ADA Scientific Conference is one of the most influential annual academic events in the field of diabetes worldwide. Huadong Medicine will present its research results at the conference from June 20 to 23, 2025.

As we all know, the global diabetes market is in a growing state and has huge potential. The Lancet shows that the global prevalence of diabetes has increased significantly over the past three decades. From 1990 to 2022, the number of adults aged ≥18 years with diabetes worldwide surged from approximately 200 million in 1990 to 828 million. In 2022, the number of adult diabetes patients in my country will be approximately 148 million, accounting for 18% of the total number of adult diabetes in the world, ranking second in the world. Among them, the number of untreated people is 78 million, and the untreatment rate reaches 52.7%. According to the International Diabetes Federation (IDF) Global Diabetes Map, my country has low diabetes awareness, treatment and control rates. In the future, the clinical diagnosis and treatment rates of diabetes will continue to increase, and the diabetes treatment market will continue to grow accordingly.

Huadong Medicine has a comprehensive layout to build a differentiated innovative pipeline around GLP-1

In the field of diabetes medication, Huadong Medicine has been deeply engaged in it for nearly 20 years, and has formed a comprehensive layout of innovative drugs and differentiated generic drug product pipelines in mainstream therapeutic targets. Currently, there are more than 20 commercialized and researched products. Existing and subsequent upgraded products cover α-glucosidase inhibitors, DPP-4 inhibitors, SGLT-2 inhibitors, GLP-1 receptor agonists, dual-target and triple-target agonists, insulin and its analogs and other clinical mainstream targets. The company's degludec insulin injection completed Phase III clinical research in August 2024, and its marketing authorization application for the treatment of type 2 diabetes in adults was accepted in February 2025.

In addition to the semaglutide injection that was accepted this time, Huadong Medicine has built a comprehensive and differentiated product pipeline around the GLP-1 target, including long-acting and multi-target global innovative drugs and biosimilars including oral and injectable drugs, including the already-marketed liraglutide injection, which has been approved for the treatment of type 2 diabetes, obesity or overweight in adults. It is the first liraglutide biosimilar approved for marketing in China.

The products under development include the globally innovative oral small molecule GLP-1 receptor agonist HDM1002, the dual-target agonist HDM1005, the long-acting triple-target agonist DR10624 and many other products, and the research and development work is progressing steadily.

HDM1002 has obtained IND approval in China and the United States, and is conducting Phase II clinical studies for diabetes indications in China. Phase III clinical studies for weight management indications have been initiated in March 2025. The Chinese clinical application for the dual-target agonist HDM1005 for weight management indications in type 2 diabetes and overweight or obese people was approved in March 2024.

At present, HDM1005 injection has achieved positive results in Phase Ia and Ib clinical trials in China, and is actively promoting related work for Phase II clinical trials. The Phase II clinical trial for weight management indications has completed the first subject dosing in February 2025. It is worth mentioning that HDM1005 metabolic-associated fatty liver disease (MAFLD)/metabolic-associated steatohepatitis (MASH), "treatment of obstructive sleep apnea (OSA) combined with obese or overweight adult patients" and "treatment of heart failure with preserved ejection fraction (HFpEF) combined with obese or overweight adult patients" have been approved in China for multiple indications. At the same time, the US clinical trial applications for four indications of weight management, metabolic-associated steatohepatitis, "treatment of OSA combined with obese or overweight patients", and "treatment of HFpEF combined with obese patients" have all been approved by the FDA.
In addition, DR10624, a multiple agonist of FGF21R/GCGR/GLP-1R targets, has currently started a Phase II clinical study for the treatment of metabolic-related fatty liver disease with a high risk of liver fibrosis. Another previously launched Phase II clinical study of DR10624 for the treatment of severe hypertriglyceridemia has completed the enrollment of all patients.

Faced with the huge blue ocean of the GLP-1 track, Huadong Medicine has become a strong competitor in the field of domestic blood sugar reduction and weight loss with its strong foundation. As Huadong Medicine's comprehensive competitiveness in the GPL-1 field continues to improve, coupled with its advantage of the most comprehensive layout in the GLP-1 field, Huadong Medicine is expected to occupy a leading position in the future and become one of the leading companies in the GLP-1 field.

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