– In comparative studies using non-human primates (NHP), ASC37 demonstrated an average observed half-life of about 17 days, which is seven times longer than that of retatrutide, supporting a once-monthly subcutaneous (SQ) dosing regimen in humans.
– On average, ASC37 exhibited in vitro potency that was roughly 5, 4, and 4 times greater than retatrutide at the GLP-1R, GIPR, and GCGR receptors, respectively.
– The submission of an Investigational New Drug Application (IND) for the ASC37 injection to the U.S. Food and Drug Administration (FDA) is anticipated during the second quarter of 2026.
HONG KONG, Jan. 20, 2026 — Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) today announced the selection of ASC37 injection, a next-generation, once-monthly, subcutaneous GLP-1R/GIPR/GCGR[1] triple peptide agonist, as a candidate for clinical development. The company plans to file an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) for ASC37 injection as a treatment for obesity in Q2 2026.
ASC37 was internally discovered and developed using Ascletis’ proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies. The candidate showed average in vitro activity that was approximately 5, 4, and 4 times more potent than retatrutide at the GLP-1R, GIPR, and GCGR receptors. Designed for an extended half-life (measured by time to 50% Cmax) compared to the once-weekly retatrutide, ASC37 is intended for once-monthly subcutaneous (SQ) administration with an injection volume of one milliliter or less. These design features also offer benefits for manufacturing scalability.
In direct comparative NHP studies, proprietary SQ depot formulations of ASC37 achieved an average observed half-life of around 17 days, which is seven times longer than retatrutide administered in a standard liquid formulation.
The combination of greater in vitro potency and a longer half-life than retatrutide underscores ASC37 injection’s promise as a next-generation obesity therapy.
“By progressing ASC37, we are moving a potentially more powerful, next-generation triple agonist into clinical trials that allows for monthly dosing,” stated Dr. Jinzi Jason Wu, Founder, Chairman and CEO of Ascletis. “The planned start of our Phase I study in the latter half of 2026 represents a further milestone in our broad strategy to enhance treatment choices for individuals with obesity.”
Potential Combination Studies with ASC37 Injection
ASC37 injection is under development both as a standalone treatment and as part of combination therapies for cardio-metabolic conditions such as obesity, diabetes, and metabolic dysfunction-associated steatohepatitis (MASH). Ascletis intends to combine ASC37, its GLP-1R/GIPR/GCGR triple peptide agonist, with ASC36, its once-monthly subcutaneous amylin receptor peptide agonist, to address obesity, diabetes, and other metabolic disorders.
The Company’s AISBDD and ULAP technologies allow it to design, optimize, and produce several once-monthly SQ ultra-long-acting peptides, including ASC35, ASC36, and ASC37. Leveraging peptide properties, Ascletis can use its ULAP technology to engineer specific slow-release constants (k) for peptides within SQ depots. This enables precise release over target dosing intervals to minimize peak-to-trough ratios and enhance clinical results.
[1] GLP-1R: glucagon-like peptide 1 receptor, GIPR: gastric inhibitory polypeptide receptor, GCGR: glucagon receptor
About Ascletis Pharma Inc.
Ascletis Pharma Inc. is a fully integrated biotechnology company dedicated to creating and commercializing potential best-in-class and first-in-class therapies for metabolic diseases. By employing its proprietary technologies—Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD), Ultra-Long-Acting Platform (ULAP), and Peptide Oral Transport ENhancement Technology (POTENT)—Ascletis has built a pipeline of in-house drug candidates comprising small molecules and peptides. Key programs include ASC30, a small molecule GLP-1R agonist intended for once-daily oral or once-monthly to once-quarterly subcutaneous administration for chronic weight management; ASC36, a once-monthly subcutaneous amylin receptor peptide agonist; ASC35, a once-monthly subcutaneous GLP-1R/GIPR dual peptide agonist; and ASC37, a GLP-1R/GIPR/GCGR triple peptide agonist for chronic weight management. Ascletis is traded on the Hong Kong Stock Exchange (1672.HK).
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