Ascletis Announces Co-Formulation of Once-Monthly Peptides ASC36 and ASC35 for Obesity Treatment; IND Filing Planned for Q2 2026

Highlights

• Once-monthly co-formulation of amylin receptor agonist ASC36 and dual GLP-1R/GIPR agonist ASC35 developed using Ascletis’ Ultra-Long-Acting Platform (ULAP).
• 51% greater body weight reduction compared to the co-formulation of eloralintide and tirzepatide in DIO rat studies.
• Stable formulation with no aggregation or precipitation at neutral pH.
• IND submission to the U.S. FDA expected in Q2 2026.

Co-Formulation Achieves Robust Efficacy and Stability

Ascletis Pharma Inc. (HKEX: 1672) announced the successful co-formulation of ASC36, a once-monthly amylin receptor agonist, and ASC35, a once-monthly GLP-1R/GIPR dual agonist. The combination was developed using Ascletis’ proprietary Ultra-Long-Acting Platform (ULAP) technology.

In head-to-head non-human primate studies, the co-formulation demonstrated a comparable pharmacokinetic (PK) profile to ASC36 and ASC35 when dosed individually, supporting once-monthly subcutaneous administration.

Further, the co-formulation showed excellent chemical and physical stability, with no aggregation or fibrillation at neutral pH—addressing a common issue seen in amylin receptor peptide agonists that can reduce potency and increase immunogenicity risk.

Significant Weight Reduction in Preclinical Models

In preclinical diet-induced obese (DIO) animal studies:

• ASC36 monotherapy reduced body weight 32% more than eloralintide in DIO rats.
• ASC35 monotherapy achieved 71% greater body weight reduction than tirzepatide in DIO mice.
• Co-formulation of ASC36 and ASC35 resulted in 51% greater weight loss compared to the co-formulation of eloralintide and tirzepatide in DIO rats.

 “These encouraging data suggest our ASC36–ASC35 co-formulation could deliver greater weight loss in people with obesity than single-agent therapies,” said Dr. Jinzi Jason Wu, Founder, Chairman, and CEO of Ascletis. “Our ULAP and AI-assisted drug design platforms are enabling a new generation of once-monthly peptide therapies.”

Platform-Driven Peptide Innovation

Both ASC36 and ASC35 were discovered and developed in-house using Ascletis’ Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and ULAP technologies. ULAP allows precise control of peptide release rates in subcutaneous depots, minimizing peak-to-trough variations and improving tolerability.

Ascletis plans to file an Investigational New Drug (IND) application with the U.S. FDA for the co-formulation in Q2 2026.

ASC36: The Cornerstone of Monthly Obesity Therapies

Ascletis is positioning ASC36 as a foundational component of its cardio-metabolic disease portfolio, targeting obesity and related disorders. In addition to its combination with ASC35, the company is evaluating co-formulation opportunities with ASC47, an adipose-targeted thyroid hormone receptor beta (THRβ) agonist.

Conference Call

Ascletis will host a conference call in Mandarin on November 13, 2025, at 10:00 a.m. China Standard Time via Tencent Meeting/VooV Meeting.

• Meeting ID: 573-120-481
• China Mainland: Tencent Meeting Link
• International: VooV Meeting Link

About Ascletis Pharma Inc.

Ascletis Pharma Inc. (HKEX: 1672) is a fully integrated biotechnology company focused on developing first-in-class and best-in-class therapeutics for metabolic diseases. Leveraging AISBDD and ULAP technologies, Ascletis has built a diverse in-house pipeline of small molecules and peptides, including:

• ASC30: Small-molecule GLP-1R agonist (oral and subcutaneous formulations)
• ASC35: Once-monthly GLP-1R/GIPR dual peptide agonist
• ASC36: Once-monthly amylin receptor peptide agonist

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