GDB shifts SHX-021 to weekly dose

GDB has decided to shift the development ofits daily oral semaglutide to a weekly oral program (SHX-021). This decision isbased on internal data demonstrating superior pharmacokinetic profiles that support weekly dosing. SHX-021 has shown significantly enhanced oralbioavailability and reduced variability in absorption.

Weekly oral administration of semaglutide would greatly improve convenience and patient compliance. Furthermore, the enhanced bioavailability and less frequent dosing allow for the use of lower amounts of the drug and excipients, thereby reducing medication costs and improving accessibility for patients with type 2 diabetes or those who are overweight.

SHX-021 is currently in the IND-enabling stage, with plans to file an IND application with the FDA. We are alsopreparing for further pre-IND (PIND) meetings with the FDA to discuss theclinical development pathway for U.S. registration following the switch from adaily to a weekly dosing regimen.