Integrated biotechnology company Ascletis Pharma Inc (HKEX: 1672) has announced the submission of two Investigational New Drug (IND) applications to the US Food and Drug Administration (FDA) for ASC36, a once-monthly to once-quarterly next-generation peptide amylin receptor agonist, and ASC36_35 FDC, a once-monthly injection co-formulation of ASC36 plus peptide GLP-1R/GIPR agonist ASC35, for the treatment of obesity.

The company says that both ASC36 and ASC35 were discovered in-house utilising its Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD). Both ASC36 once-monthly to once-quarterly formulation and ASC36_35 FDC once-monthly co-formulation are Self-Assembling Lipid Depot (SALD) formulations, developed in-house utilising Ascletis' Ultra-Long-Acting Platform (ULAP) technology.

In head-to-head non-human primate (NHP) studies, ASC36 SALD formulation demonstrated approximately 6-fold longer observed half-life than eloralintide, supporting once-monthly to once-quarterly subcutaneous (SQ) administration in humans.

The two IND submissions build on the recent milestone achieved by ASC35 once-monthly SALD formulation. In June 2026, Ascletis announced US FDA IND clearance to initiate a Phase I clinical trial for ASC35 as a once-monthly SQ treatment for obesity.