Ascletis Pharma Inc. (Ascletis) has advanced its obesity franchise by selecting a fixed-dose combination (FDC) tablet—ASC30_39—for clinical development. The one-pill, once-daily regimen co-formulates two proprietary small molecules: ASC30, a Phase III-ready oral GLP-1 receptor (GLP-1R) agonist, and ASC39, an oral amylin-selective amylin receptor agonist.

Preclinical pharmacokinetic data. In a head-to-head study in dogs, ASC30_39 FDC delivered oral bioavailability, systemic exposure and a plasma half-life of up to 12 hours that were comparable with the individual monotherapies. The formulation, created with Ascletis’ proprietary technology, remained stable at room temperature and maintained a small pill size—features that support once-daily outpatient use.

Component profiles. • ASC30: Demonstrated a favorable gastrointestinal safety signal, showing approximately half the vomiting rate versus orforglipron under comparable weekly titration schedules. The molecule is positioned for Phase III evaluation. • ASC39: Exhibited eloralintide-like selectivity for the amylin receptor and achieved robust efficacy in preclinical obesity models, underpinning its selection for co-formulation.

Regulatory roadmap. Ascletis plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for ASC30_39 FDC in the third quarter of 2026, targeting obesity treatment.

Strategic significance. Management highlights the FDC as the first publicly disclosed oral co-formulation of a GLP-1 agonist with an amylin receptor agonist, positioning it as a potential best-in-class therapy by combining high bioavailability, extended half-life and improved gastrointestinal tolerability in a single daily tablet.

Risk disclosure. Ascletis reiterates that successful development, manufacturing and commercialization of ASC30_39 FDC, ASC30 and ASC39 are not guaranteed, in accordance with Hong Kong Listing Rule 18A.05.