Ascletis Pharma Inc., listed on the Hong Kong Stock Exchange, is a leading biotechnology company focused on the development and commercialization of innovative treatments for metabolic diseases. The company has recently made a significant breakthrough by selecting ASC37, its first oral GLP-1R/GIPR/GCGR triple peptide agonist, for clinical development, aiming to address the growing needs in obesity treatment.

Key Insights:

• ASC37, developed with Ascletis' proprietary Peptide Oral Transport ENhancement Technology (POTENT), has demonstrated promising results in non-human primate studies, showing an average absolute oral bioavailability of 4.2%, significantly outperforming competitors.
• The drug exposure of ASC37 was approximately 57 times that of retatrutide, with a half-life of about 56 hours, indicating potential for less frequent dosing.
• Ascletis plans to submit an Investigational New Drug Application (IND) to the U.S. FDA for ASC37 in the second quarter of 2026, highlighting its commitment to addressing unmet needs in obesity treatment.

ASC37's development leverages Ascletis' proprietary Peptide Oral Transport ENhancement Technology (POTENT), showcasing an average absolute oral bioavailability of 4.2%, which significantly surpasses that of semaglutide, tirzepatide, and retatrutide in oral SNAC formulation by 9-, 30-, and 60-fold, respectively. This remarkable achievement underscores ASC37's strong potential in the competitive obesity treatment market. The drug's exposure level was approximately 57 times that of retatrutide, and it exhibited a half-life of about 56 hours, supporting the possibility of less frequent dosing—a feature often preferred by patients.

Ascletis' strategic move to submit an Investigational New Drug Application (IND) to the U.S. FDA for ASC37 in the second quarter of 2026 reflects the company's dedication to fulfilling the unmet needs in obesity treatment through its robust R&D capabilities and innovative technology platforms, including AISBDD and POTENT. Dr. Jinzi Jason Wu, Founder, Chairman, and CEO of Ascletis, emphasized the company's commitment to leveraging its R&D strengths and proprietary technologies to address the critical needs in obesity treatment. Ascletis is set to host a conference call in Mandarin on December 1, 2025, to discuss this significant development further. The call will be accessible via Tencent Meeting/VooV Meeting, providing an opportunity for stakeholders to gain deeper insights into ASC37's development and Ascletis' strategic direction in the obesity treatment landscape.