Ascletis Announces Co-formulation of ASC36, Once-Monthly Next-Generation Amylin Receptor Agonist and ASC35, Once-Monthly Next-Generation GLP-1R/GIPR Dual Agonist for Clinical Development
Thursday, November 13, 2025
On November 13, 2025, Ascletis Pharma Inc. (HKEX: 1672), a leading clinical-stage biotechnology company based in Hong Kong, unveiled a significant advancement in peptide drug development by announcing the co-formulation of ASC36, a next-generation once-monthly amylin receptor agonist, and ASC35, a once-monthly GLP-1R/GIPR dual agonist. This development leverages the company’s proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) platform and Ultra-Long-Acting Platform (ULAP) technologies. These technologies allow Ascletis to design and optimize a pipeline of ultra-long-acting injectable peptides with customizable slow-release profiles, extending dosing intervals substantially beyond current standards in metabolic disease management.
ASC35 and ASC36 are positioned at the forefront of a next era in peptide-based therapies, particularly for addressing metabolic and endocrine disorders such as type 2 diabetes and obesity. GLP-1R/GIPR dual agonists have recently gained momentum across the global biopharma landscape owing to their robust efficacy in glycemic control and weight loss; however, current therapies typically require weekly administration. By achieving a once-monthly dosing regimen via co-formulation with amylin receptor agonists, Ascletis aims to meaningfully enhance patient compliance and improve clinical outcomes. The proprietary design can tailor the release kinetics for each peptide, optimizing the delicate balance between efficacy, safety, and patient convenience.
This newly announced co-formulation integrates the ASC36 amylin receptor agonist, which plays a unique role in appetite and weight regulation, with the GLP-1R/GIPR dual action of ASC35, representing a convergence of two complementary hormonal signaling pathways. The ultimate objective is to deliver synergistic glucose-lowering and weight-reducing effects, offering a differentiated clinical profile and potential competitive edge in the surging global market for metabolic drugs. Ascletis expects to submit an Investigational New Drug (IND) application to the U.S. FDA for this co-formulation during the second quarter of 2026, highlighting the company's ambitious timelines and international aspirations.
Details of the co-formulation and its unique delivery technology are being shared in a Mandarin-language investor and stakeholder conference call at 10:00 a.m. China Standard Time on November 13, 2025. The event is accessible via Tencent Meeting and is expected to attract interest from pharmaceutical partners, clinical research organizations, and investors focused on next-generation treatment paradigms for diabetes and obesity. The news demonstrates Ascletis’s robust R&D capabilities and strategic intent to harness structural biology, peptide engineering, and artificial intelligence to generate disruptive assets for global metabolic disease markets.
Ascletis Pharma’s broader pipeline includes other investigational small molecule and peptide assets driven by its in-house platform innovations. With ASC35 and ASC36 leading the candidate portfolio for next-level dosing convenience, the company is well-positioned to expand its licensing, co-development, and commercialization partnerships both within China and globally. The application of advanced slow-release depot formulations in conjunction with next-gen pharmacology stands to reshape the future of chronic disease medications in Asia and beyond.
