Ascletis Announces Initiation of Two Phase I Studies in U.S. for the Treatment of Obesity: ASC36 Once-Monthly Injection, an Amylin Receptor Peptide Agonist, and ASC36_35FDC Once-Monthly Injection, a Co-Formulation of ASC36 and GLP-1R/GIPR Peptide Agonist ASC35

About this update from Ascletis Pharma, Inc.

-ASC36_35FDC, a once-monthly subcutaneous (SQ) fixed dose combination (FDC) injection of ASC36 and ASC35, is a potentially first-in-class drug candidate which targets three validated targets of amylin receptor, GLP-1R and GIPR. -ASC36 is a potentially first-in-class once-monthly to once-quarterly SQ injection which targets amylin receptor. -Investigational New Drug (IND) Applications for both ASC36 injection and ASC36_35FDC were recently cleared by the U.S. Food and Drug Administration (FDA). HONG KONG , Aug. 10, 2026 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that following the Investigational New Drug (IND) clearance by the U.S. Food and Drug Administration (FDA), it has initiated two Phase I studies in the U.S. for the treatment of obesity: ASC36, a once-monthly to once-quarterly next-generation amylin receptor peptide agonist and ASC36_35FDC, a once-monthly subcutaneous (SQ) fixed dose combination (FDC) injection of ASC36 and GLP-1R/GIPR peptide agonist ASC35. The Phase I study for ASC36_35FDC is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC36_35FDC injections following single and multiple ascending doses in participants with obesity (body mass index (BMI) ≥ 30.0 kg/m²) or overweight (BMI ≥ 27.0 kg/m²) with weight-related comorbidities. The Phase I study also evaluates two different FDC formulations: Injection A in 88 participants and Injection B in 88 participants. Both Injections A and B consist of two ultra-long-acting peptide agonists, the amylin receptor peptide agonist ASC36 and the GLP-1R/GIPR dual peptide agonist ASC35. The Phase I study for ASC36 is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC36 injections following single and multiple ascending doses in participants with obesity (BMI ≥ 30.0 kg/m²) or overweight (BMI ≥ 27.0 kg/m²) with weight-related comorbidities. The Phase I study also evaluates two different formulations: Injection A in 72 participants and Injection B in 72 participants. "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. This translates into eight injections per month. In contrast, ASC36_35FDC, a potentially first-in-class SQ, FDC injection which targets amylin receptor, GLP-1R and GIPR, requires only one injection per month. More exciting, ASC36_35FDC 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 ( Press release ). These animal models are highly predictive of human efficacy," said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, "As we have initiated a global Phase III program for the oral small molecule GLP-1 , ASC30, I am equally pleased with our significant progress in 2026 on our once-monthly SQ peptide pipeline, evidenced by initiation of three Phase I studies in the U.S. – ASC35, ASC36 and ASC36_35FDC." 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_35FDC once-monthly co-formulation are Self-Assembling Lipid Depot (SALD) formulations, developed in-house utilizing Ascletis' Ultra-Long-Acting Platform (ULAP) technology. SALD formulation is a low-viscosity solution which is composed of lipids, biocompatible organic solvents, and the active pharmaceutical ingredient (API). The low-viscosity solution can be easily administered into the subcutaneous tissue using an injection pen/auto-injector with a fine needle as thin as 29 gauge . After SQ administration, the solution transforms into a gel-like depot in the tissue. Under the action of enzymes in the tissue, the depot slowly degrades, releasing the API over a one-month or longer period. 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_35FDC SALD co-formulation demonstrated long observed half-lives for both ASC36 and ASC35, supporting once-monthly SQ administration in humans. Preclinical studies have established the superior efficacy of ASC36 injection and ASC36_35FDC injection co-formulation. In head-to-head DIO rat studies, which are highly predictive of human efficacy, ASC36 monotherapy, targeting amylin receptor, demonstrated approximately 91% and 32% greater relative body weight reduction compared to petrelintide and eloralintide monotherapies, respectively. In head-to-head DIO rat studies, ASC36_35FDC, targeting three targets of amylin receptor, GLP-1R and GIPR, demonstrated approximately 51% greater relative body weight reduction compared to the co-administration of eloralintide and tirzepatide. Both ASC36 injection formulation and ASC36_35FDC injection co-formulation exhibit excellent chemical and physical stability with no aggregation or precipitation caused by fibrillation at neutral pH. [1] Eli Lilly and Company. Safety, tolerability, pharmacokinetics and pharmacodynamics of eloralintide and tirzepatide co-administered as once-weekly subcutaneous injections [ Abstract accepted for presentation at EASD 2026 ] About Ascletis Pharma Inc. Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potentially best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies as well as Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has developed multiple drug candidates in-house, including both small molecules and peptides, such as its lead program, ASC30, a once-daily oral small molecule GLP-1R agonist for chronic weight management and diabetes; ASC30_48FDC, a once-daily oral small molecule dual agonist, a fixed dose combination of ASC30 (GLP-1R agonist) and ASC48 (GIPR agonist), ASC30_48_39FDC, a once-daily oral small molecule triple agonist, a fixed dose combination of ASC30 (GLP-1R agonist), ASC48 (GIPR agonist) and ASC39 (amylin receptor agonist (SARA)), ASC39, an eloralintide-like potent selective amylin receptor agonist (SARA) once-daily oral small molecule, ASC30_39FDC, a once-daily oral small molecule dual agonist, a fixed dose combination of ASC30 (GLP-1R agonist) and ASC39 (amylin receptor agonist (SARA)), ASC36, an amylin peptide, designed to be administered once monthly to once quarterly subcutaneously and once daily orally, ASC35, a once-monthly subcutaneously administered GLP-1R/GIPR dual peptide agonist, ASC36_35FDC, a once-monthly subcutaneous triple peptide agonist, a fixed combination of ASC36 (amylin receptor agonist) and ASC35 (GLP-1R/GIPR agonist), ASC37, a GLP-1R/GIPR/GCGR triple peptide agonist, designed to be administered once monthly subcutaneously and once daily orally, and ASC36_37FDC, a once-monthly subcutaneous quadruple peptide agonist, a fixed dose combination of ASC36 (amylin receptor agonist) and ASC37 (GLP-1R/GIPR/GCGR agonist), for chronic weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK). For more information, please visit www.ascletis.com . Contact： Peter Vozzo ICR Healthcare 443-231-0505 (U.S.) [email protected] Ascletis Pharma Inc. PR and IR Teams +86-181-0650-9129 (China) [email protected] [email protected] View original content to download multimedia: https://www.prnewswire.com/news-releases/ascletis-announces-initiation-of-two-phase-i-studies-in-us-for-the-treatment-of-obesity-asc36-once-monthly-injection-an-amylin-receptor-peptide-agonist-and-asc3635fdc-once-monthly-injection-a-co-formulation-of-asc36-and-glp-302847051.html SOURCE Ascletis Pharma Inc.

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