Ascletis Selects a Best-in-Class Once-Monthly Subcutaneously Administered Amylin Receptor Agonist, ASC36, for Clinical Development

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-In head-to-head non-human primate (NHP) studies, average observed half-life of ASC36 was approximately 15 days, 3-fold longer than petrelintide, which supports once-monthly subcutaneous (SQ) dosing in humans.

-ASC36 demonstrated approximately 91% greater relative body weight reduction compared to petrelintide in a head-to-head diet-induced obese (DIO) rat study.

-ASC36 has excellent chemical and physical stability with no fibrillation around neutral pH, allowing for co-formulation with other peptides including ASC35, a GLP-1R/GIPR dual agonist.

-Submission of an Investigational New Drug Application (IND) for ASC36 to the U.S. Food and Drug Administration (FDA) is expected in the second quarter of 2026.

-The Company will host a conference call in Mandarin at 10:00 a.m. China Standard Time on October 30, 2025. 

HONG KONG, Oct. 30, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces that it has selected ASC36, a once-monthly, potentially best-in-class subcutaneously administered amylin receptor agonist, as a clinical development candidate. Ascletis expects to submit an Investigational New Drug Application (IND) for ASC36 for the treatment of obesity to the U.S. Food and Drug Administration (FDA) in the second quarter of 2026.

ASC36, an amylin receptor peptide agonist, was discovered and developed in-house utilizing Ascletis' Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies. ASC36 is engineered for a longer observed half-life (as measured by time to 50% C_max) and higher bioavailability per milligram of peptide to support once-monthly subcutaneous (SQ) dosing, with injection volume of one milliliter or less. These engineered properties also allow for scalability advantages in manufacturing. 

In head-to-head non-human primate (NHP) studies, ASC36 slow-release SQ depot formulations had an average observed half-life of approximately 15 days, 3-fold longer than petrelintide, supporting ASC36 as a potential once-monthly treatment for obesity in humans.

In a head-to-head diet-induced obese (DIO) rat study, which is well established as being highly predictive of human efficacy, dosed with equal molar concentrations of ASC36 and petrelintide, ASC36 reduced body weight by 10.01%, compared to 5.25% for petrelintide, a relative increase in efficacy of 91% (Table 1). This superior weight loss per milligram of peptide may also provide scalability advantages in manufacturing.

Table 1. ASC36 demonstrated statistically and significantly more weight loss than petrelintide in DIO rats after 7-day treatment

ASC36 has excellent chemical and physical stability with no fibrillation around neutral pH, allowing for co-formulation with other peptides including ASC35, a GLP-1R/GIPR dual agonist.

ASC36's longer observed half-life, better SQ bioavailability and greater weight loss demonstrate its potential as a best-in-class once-monthly treatment for obesity.

"Our focus has always been on developing novel approaches to expand options for the treatment of obesity and other metabolic diseases," said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, "The preclinical characterization of ASC36 suggests potential best-in-class efficacy with once-monthly dosing resulting in superior weight loss and a more versatile and patient friendly titration schedule."

Monotherapy and Combination Studies with ASC36

ASC36 monotherapy is being developed as a cornerstone therapy for the treatment of cardio-metabolic diseases including obesity, meanwhile ASC36-based combination therapies are being developed. Ascletis plans to combine ASC36, an amylin receptor agonist, with its once-monthly subcutaneously administered ASC35, a GLP-1R/GIPR dual agonist, to treat obesity.

Ascletis' AISBDD and ULAP technologies enable the Company to design, optimize and develop multiple once-monthly SQ ultra-long-acting peptides, including ASC35 and ASC36. Based on the properties of peptides, the Company can design, through its proprietary ULAP technology, various slow-release constants (k) for peptides in SQ depots to precisely release injected peptides over desired dosing intervals to reduce peak-to-trough ratios and improve clinical outcomes.

Conference Call

Ascletis will host a conference call in Mandarin at 10:00 a.m. China Standard Time on October 30, 2025. A live webcast of the call will be available via Zoom, with the Meeting ID: 978 3932 9387, or access link of: https://zoom.us/j/97839329387.

About Ascletis Pharma Inc.

Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potential 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, Ascletis has developed multiple drug candidates in-house, including its lead program, ASC30, a small molecule GLP-1R agonist designed to be administered once daily orally and once monthly to once quarterly subcutaneously as a treatment therapy and a maintenance therapy 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]

SOURCE Ascletis Pharma Inc.