Sino Biopharmaceutical's diabetes drug TQF3250 advances to clinical trials

Sino Biopharmaceutical Limited announced its investigational new drug (IND) application for TQF3250 capsules, a National Class 1 innovative GLP-1 receptor agonist, has been accepted by China's National Medical Products Administration (NMPA). TQF3250 is an orally administered small-molecule drug developed for type 2 diabetes. It is designed to promote insulin secretion and prolong therapeutic effects by selectively activating the CAMP-biased GLP-1R signaling pathway.

Preclinical studies showed TQF3250's effectiveness, improving glucose tolerance at doses as low as 1 mg/kg in mouse models. In crab-eating macaques, it achieved a no-observed-adverse-effect level (NOAEL) of 24 mg/kg/day, with no significant cardiac toxicity or genotoxicity. The global GLP-1RA market is projected to exceed $150 bn by 2031, with TQF3250 offering advantages in patient compliance, 24-month storage stability at 25°C, and low risk of drug interactions due to its metabolism by CYP3A enzymes.

The company plans to expedite clinical development, aiming to provide a more convenient and effective treatment option for type 2 diabetes patients. Currently, only one other orally administered GLP-1RA has global marketing approval.