On December 1, the clinical trial application for Class 1 innovative drug TQF3250 capsules (an oral small-molecule biased GLP-1 receptor agonist, GLP-1RA) developed by Sino Biopharma (1177.HK) was approved by the U.S. Food and Drug Administration (FDA) for a proposed weight loss indication. On November 17, the clinical trial application for the treatment of patients with overweight/obesity was accepted by the China National Medical Products Administration (NMPA). TQF3250 has a unique biased mechanism. In addition to the weight loss field, its clinical trial application for the treatment of type 2 diabetes mellitus has also been officially approved recently. 

Worsening Overweight/Obesity Crisis, Urgent Medical Need

Overweight and obesity have become one of the most severe public health challenges of the 21st century. According to the "World Obesity Atlas 2025" report, the proportion of overweight and obese adults globally is projected to climb from 36% in 2000 to 50% in 2030, affecting nearly 3 billion people. In China, this trend is particularly pronounced. In 2025, 41% of adults in China already have a high BMI (≥25 kg/m2), and 9% of adults meet the criteria for obesity (BMI ≥30 kg/m2). By 2030, the number of adults with a high BMI in China is expected to reach 515 million, and men and the 40-65 age group are at higher risk^[1]. 

The health threat posed by obesity is far greater than imagined. In 2021, 16 million adults worldwide died prematurely from obesity-related diseases, and the burden of chronic non-communicable diseases caused by obesity accounted for 27% of the total global disease burden. Notably, about 55% of premature deaths from type 2 diabetes mellitus are closely related to obesity^[1]. Currently, there is still a huge gap in the global obesity prevention and treatment system. 

Advantages of the Oral Biased GLP-1 Mechanism

TQF3250 is an oral small-molecule biased GLP-1 receptor agonist independently developed by Chia Tai Tianqing, a subsidiary of Sino Biopharm. Compared to traditional GLP-1 drugs, TQF3250 selectively activates the cAMP-biased GLP-1R signaling pathway to promote insulin secretion, while reducing β-arrestin recruitment and receptor internalization, thereby extending the duration of its effect. This unique mechanism is expected to provide better control of blood sugar and weight while reducing gastrointestinal side effects. Furthermore, the oral administration of TQF3250 significantly improves patient convenience and long-term treatment adherence compared to the injectable formulations of mainstream GLP-1 drugs.

 
In June 2024, the approval of Liraglutide Injection (Beilelin^®) for marketing marked the company's official entry into the hypoglycemic field. In January 2025, the fixed-dose combination of insulin degludec and liraglutide was approved for clinical trials, aiding blood sugar management for patients with diabetes mellitus with its "two effects in one shot". As the company continues to deepen its focus and exploration in the fields of hypoglycemics and metabolic diseases, it will provide more treatment options for patients through a diversified product line in the future. 

References:
[1] World Obesity Federation.(2025).World Obesity Atlas 2025.London: World Obesity Federation.

Disclaimer:
1. This press release is intended to facilitate the communication and exchange of medical information and is for reference by healthcare professionals only. It is not for advertising purposes.
2. The company does not recommend any drugs and/or indications.
3. The information contained in this press release is for reference only and cannot replace professional medical guidance in any way, nor should it be considered as a diagnosis or treatment recommendation. If you wish to understand specific information about disease diagnosis and treatment, please follow the advice or guidance of a doctor or other healthcare professional. 

Forward-Looking Statements:
This press release contains certain forward-looking statements, including statements regarding the clinical development plan, expectations of clinical benefits and advantages, commercialization outlook, the likelihood of clinical benefit for patients, and potential commercial opportunities for [TQF3250 capsules]. Words such as "expect", "believe", "continue", "may", "estimate", "hope", "intend", "plan", "potential", "predict", "project", "should", "will", "propose", and similar expressions are intended to identify forward-looking statements, but not all forward-looking statements contain these identifying words. These forward-looking statements are predictions or expectations made by the company based on currently available data and information, and actual results may differ materially from these forward-looking statements due to uncertainties or risks such as policy, R&D, market, and regulatory factors. Current or potential investors are advised to carefully consider the potential risks and should not place undue reliance on the forward-looking statements in this press release, which contain information only as of the date of this press release. Unless required by law, the company undertakes no obligation to update or revise any forward-looking statements in this press release as a result of new information, future events, or other circumstances.