Ascletis Pharma Inc. (1672) announced a voluntary update on the co-formulation of ASC36, a once-monthly next-generation amylin receptor agonist, and ASC35, a once-monthly next-generation GLP-1R/GIPR dual agonist. Both candidates were developed in-house through proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery and Ultra-Long-Acting Platform technologies. The co-formulation was shown to have a comparable pharmacokinetic profile to separate doses of ASC36 and ASC35 in non-human primate studies, indicating potential for once-monthly subcutaneous administration.

In diet-induced obese rat and mouse studies, ASC36 monotherapy achieved approximately 32% greater relative body weight reduction than eloralintide, and ASC35 monotherapy delivered about 71% greater relative body weight reduction than tirzepatide. When combined, ASC36 and ASC35 demonstrated a roughly 51% greater relative body weight reduction compared with the co-formulation of eloralintide and tirzepatide in diet-induced obese rats. The new co-formulation also exhibited strong chemical and physical stability at neutral pH, avoiding issues such as precipitation and fibrillation.

An Investigational New Drug Application submission to the U.S. Food and Drug Administration for the co-formulation of ASC36 and ASC35 is expected in the second quarter of 2026. A conference call in Mandarin is scheduled for November 13, 2025, at 10:00 a.m. China Standard Time through Tencent Meeting/VooV Meeting (Meeting ID: 573-120-481).

Ascletis Pharma Inc. cautioned that there is no guarantee of ultimately developing, manufacturing, or commercializing pipeline products such as ASC35, ASC36, and ASC47 successfully.