Chinese biotechnology company Ascletis Pharma Inc (HKEX:1672) announced on Wednesday 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, for clinical development.

The company expects to submit an Investigational New Drug Application (IND) to the US Food and Drug Administration (FDA) for co-formulation of ASC36 and ASC35 for the treatment of obesity in the second quarter of 2026.

Both products were discovered by Asceltis and developed in-house using the company's Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies.

Ascletis says that it has successfully co-formulated ASC36 and ASC35 in the proprietary ultra-long-acting formulation to enable once monthly subcutaneous (SQ) administration using its ULAP technology. It claims that co-formulation of ASC36 and ASC35 had excellent chemical and physical stability with no aggregation or precipitation caused by fibrillation at neutral pH. Some of the amylin receptor peptide agonists aggregate or precipitate at neutral pH, which leads to loss of potency, turbidity/particles, device clogging, and higher immunogenicity risk.