Ascletis Submits Two IND Applications to the U.S. FDA for the Treatment of Obesity: ASC36 Once-Monthly Injection, a Peptide Amylin Receptor Agonist, and ASC36_35 FDC Once-Monthly Injection, a Co-Formulation of ASC36 Plus Peptide GLP-1R/GIPR Agonist ASC35

About this update from Ascletis Pharma, Inc.

HONG KONG, July 5, 2026 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today recent submissions of two Investigational New Drug (IND) applications to the U.S. 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. "Eloralintide in combination with tirzepatide recently demonstrated 29.0% weight loss at week 32[1]. However, two separate weekly injections are required; one for eloralintide and one for tirzepatide. In contrast, ASC36_35 FDC, a potentially first-in-class subcutaneous (SQ) injection co-formulation targeting amylin receptor, GLP-1R and GIPR, requires only one monthly injection," said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, "Equally exciting, ASC36_35 FDC demonstrated approximately 51% greater relative body weight reduction compared to the co-administration of eloralintide and tirzepatide in a head-to-head diet-induced obese (DIO) rat study. These animal models are highly predictive of human efficacy." Both ASC36 and ASC35 were discovered in-house utilizing Ascletis' 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 utilizing 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 SQ administration in humans. In NHP studies, ASC36_35 FDC SALD co-formulation demonstrated long observed half-lives for both ASC36 and ASC35, supporting once-monthly SQ administration in humans.

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