SINO BIOPHARM(01177): TQF3250 "Orally predominant GLP-1 receptor agonist" clinical trial application approved by NMPA and FDA.

SINO BIOPHARM (01177) announced that the clinical trial application for the self-developed innovative drug TQF3250 capsule, an oral biased GLP-1 receptor agonist, has been approved by China's National Medical Products Administration (NMPA) and the United States Food and Drug Administration (FDA) for weight loss. TQF3250 is an oral small molecule biased GLP-1 receptor agonist. Compared to traditional GLP-1 drugs, TQF3250 selectively activates the cAMP-biased signaling pathway of the GLP-1 receptor, promoting insulin secretion while reducing -arrestin recruitment and receptor internalization, thus prolonging the duration of drug efficacy. With its unique mechanism of action, TQF3250 is expected to achieve better blood sugar and weight control, as well as significantly reduce gastrointestinal side effects. Compared to mainstream GLP-1 injectable drugs, its oral administration method can greatly improve patient convenience and long-term treatment compliance. Obesity and overweight have become one of the most severe public health challenges of the 21st century. According to the "Global Obesity Map 2025" report, the global adult overweight and obesity rate is expected to rise from 36% in 2000 to 50% in 2030, affecting nearly 3 billion people. In China, this trend is particularly noticeable, with 41% of adults already having a high BMI (25kg/m) by 2025, and 9% meeting the criteria for obesity (BMI 30kg/m). It is estimated that by 2030, the number of adults with a high BMI in China will reach 515 million. In addition to the indication for weight loss, the clinical trial application for TQF3250 in the treatment of type 2 diabetes has been approved by the NMPA. Metabolic diseases are one of the core therapeutic areas that the group focuses on, and the group will provide patients with a more diverse range of treatment options through a diversified product pipeline.