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As announced by Ganli Pharmaceutical on December 30th, the company's independently developed GZR18 is undergoing Phase III clinical trials in China and has recently successfully completed the first subject administration.

 

 

 

According to the data, GZR18 is a long-term receptor agonist of glucagon like peptide-1 (GLP-1) independently developed by Ganli Pharmaceutical, aiming at the treatment of adult type 2 diabetes and weight management of obese/overweight individuals. Currently, a phase III clinical trial is being conducted for the indication of obesity/overweight. The clinical data of this drug shows comparable or even better weight loss effects compared to similar products already on the market, and its safety and tolerability meet the characteristics of GLP-1 drugs.

 

 

 

Huadong Pharmaceutical announced that on December 17, 2024, its wholly-owned subsidiary Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as "Zhongmei Huadong") received a notification from the US Food and Drug Administration (hereinafter referred to as "FDA") that the clinical trial application for HDM1005 injection solution submitted by Zhongmei Huadong has been approved by the FDA and can conduct Phase I clinical trials in the United States.

 

 

 

According to the data, HDM1005 injection is a Class 1 chemical new drug developed by East China and the United States, with global intellectual property rights. It is a dual target long-acting agonist of the human GLP-1 (glucagon like peptide-1) receptor and GIP (glucose dependent insulinotropic polypeptide) receptor. Preclinical studies have shown that HDM1005 can activate GLP-1 and GIP receptors, promote the production of cyclic adenosine monophosphate (cAMP), increase insulin secretion, suppress appetite, delay gastric emptying, improve metabolic function, thereby improving plasma volume, reducing oxidative stress and systemic inflammation, and enhancing cardiovascular adaptability; It has the effects of lowering blood sugar, reducing weight, improving metabolic associated steatohepatitis (MASH), and preserving ejection fraction in heart failure (HFpEF).

 

 

 

The approval of the clinical trial of HDM1005 injection is another important progress in the development process of this product, which will further enhance the company's core competitiveness in the field of endocrine therapy.

 

 

 

On December 11th, Hengrui Pharmaceutical announced that HRS-4729 injection has been approved for clinical trials. According to the data, HRS-4729 injection is a peptide drug independently developed by the company, which is a glucagon like peptide-1 receptor (GLP-1R)/glucose dependent insulinotropic polypeptide receptor (GIPR)/glucagon receptor (GCGR) triple agonist. Compared with GLP-1/GIP dual targets, triple receptor agonists increase GCG target activation, promote energy expenditure, lower blood lipids, and better exert weight loss effects by regulating glucose and lipid metabolism and suppressing appetite in the body.

 

 

 

On December 6th, Tonghua Dongbao announced that its wholly-owned subsidiary, Dongbao Zixing, has completed a Phase I clinical study evaluating the safety, tolerability, pharmacokinetics, and pharmacological characteristics of THDBH120 for injection in healthy adults in China: randomized, double-blind, placebo-controlled, single and multiple dose escalation. The study achieved its primary endpoint goal after obtaining approval for the clinical trial of THDBH120 for injection.

 

 

 

The results showed that THDBH120 for injection has good safety and tolerability, and its half-life is significantly prolonged compared to the same target product, tilpotide. This fully supports the use of once a week administration and is expected to achieve once every two weeks or longer dosing intervals. Tonghua Dongbao stated that the achievement of the main clinical endpoint for THDBH120 injection is a positive progress in the company's innovative research and development of GLP-1RA, fully demonstrating the company's ability and confidence in continuously improving research and development efficiency and innovation, laying a solid foundation for subsequent research and development work, and further enhancing the company's competitiveness in the field of endocrine therapy.

 

 

 

According to the data, THDBH120 for injection is a dual target agonist of glucagon like peptide-1 (GLP-1) receptor and glucose insulinotropic polypeptide (GIP) receptor, which is a key research focus of Tonghua Dongbao. It belongs to a class of innovative drugs.

 

 

 

Domestic pharmaceutical companies have made rapid progress in the research and development of GLP-1 drugs. According to data, as of December 3, 2024, there are currently over 70 domestic GLP-1 receptor agonist research projects with indications for "obesity", of which more than 40 projects were newly added in 2024, showing a further acceleration trend. Industry insiders say that in the hot GLP-1 track, overseas top performers continue to exceed expectations, while domestic research and development progress accelerates. Long acting, multi-target, and oral drug development are currently the main research and development directions of the GLP-1 track.