Sino Biopharmaceutical's oral weight loss drug TQF3250 gets NMPA, FDA clinical trial approval

Sino Biopharmaceutical Limited announced its self-developed innovative drug, TQF3250 capsules, an orally administered, biased GLP-1 receptor agonist, has received clinical trial approval from both the China National Medical Products Administration (NMPA) and the United States Food and Drug Administration (FDA) for weight loss. The drug is designed to selectively activate the cAMP-biased GLP-1 receptor signaling pathway, promoting insulin secretion while reducing β-arrestin recruitment and receptor endocytosis, which is expected to prolong its therapeutic effect.

The company anticipates TQF3250 will offer improved glycemic and weight control, reduced gastrointestinal side effects, and enhanced patient convenience and adherence due to its oral administration route compared to injectable GLP-1 drugs. In addition to weight loss, TQF3250's clinical trial application for Type 2 diabetes treatment has also been approved by the NMPA, underscoring the group's focus on metabolic diseases.

The announcement highlights the growing global challenge of obesity, with the World Obesity Atlas 2025 projecting that the global prevalence of overweight and obese adults will reach 50% by 2030, affecting nearly 3 bn people. In China, 41% of adults are expected to have a high BMI (≥25kg/m²) and 9% to meet obesity criteria (BMI ≥30kg/m²) in 2025, with the number of adults with high BMI projected to reach 515m by 2030.