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

-  Using Ascletis' proprietary Ultra-Long-Acting Platform technology, co-formulation of ASC36, a once-monthly subcutaneously administered amylin receptor peptide agonist and ASC35, a once-monthly subcutaneously administered GLP-1R/GIPR dual peptide agonist, demonstrated a comparable pharmacokinetic (PK) profile to ASC36 and ASC35 dosed alone in head-to-head non-human primate studies.

-  ASC36 monotherapy demonstrated approximately 32% greater relative body weight reduction compared to eloralintide monotherapy in a head-to-head diet-induced obese (DIO) rat study, while ASC35 monotherapy demonstrated approximately 71% greater relative body weight reduction compared to tirzepatide monotherapy in a head-to-head DIO mouse study.

-  Co-formulation of ASC36 and ASC35 demonstrated approximately 51% greater relative body weight reduction compared to the co-formulation of eloralintide and tirzepatide in a head-to-head DIO rat study.

-  Co-formulation of ASC36 and ASC35 had excellent chemical and physical stability with no aggregation or precipitation caused by fibrillation at neutral pH.

-  Submission of an Investigational New Drug Application to the U.S. Food and Drug Administration for co-formulation of ASC36 and ASC35 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 November 13, 2025. 

HONG KONG, Nov. 13, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces the co-formulation of ASC36, a once-monthly next-generation amylin receptor agonist and ASC35, a once-monthly next-generation GLP-1R/GIPR dual agonist for clinical development. Ascletis expects to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for co-formulation of ASC36 and ASC35 for the treatment of obesity in the second quarter of 2026.

Both ASC36, a once-monthly next-generation amylin receptor agonist, and ASC35, a once-monthly next-generation GLP-1R/GIPR dual agonist, were discovered and developed in-house utilizing Ascletis' Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies. Ascletis has successfully co-formulated ASC36 and ASC35 in the proprietary ultra-long-acting formulation to enable once monthly subcutaneous (SQ) administration using its ULAP technology. Co-formulation of ASC36 and ASC35 had excellent chemical and physical stability with no aggregation or precipitation caused by fibrillation at neutral pH. Some of amylin receptor peptide agonists aggregate or precipitate at neutral pH, which leads to loss of potency, turbidity/particles, device clogging, and higher immunogenicity risk.

In head-to-head non-human primate (NHP) studies, co-formulation of ASC36 and ASC35 demonstrated a comparable pharmacokinetic profile to ASC36 and ASC35 dosed alone, supporting once-monthly SQ dosing.

ASC36 monotherapy demonstrated approximately 32% greater relative body weight reduction compared to eloralintide monotherapy in a head-to-head diet-induced obese (DIO) rat study. ASC35 monotherapy demonstrated approximately 71% greater relative body weight reduction compared to tirzepatide monotherapy in a head-to-head DIO mouse study (press release). The co-formulation of ASC36 and ASC35 demonstrated approximately 51% greater relative body weight reduction compared to the co-formulation of eloralintide and tirzepatide in a head-to-head DIO rat study (Table 1).

Table 1. ASC36 monotherapy and co-formulation of ASC36 and ASC35 demonstrated statistically and significantly more weight loss than eloralintide monotherapy and the co-formulation of eloralintide and tirzepatide in DIO rats after 7-day treatment

Note: DIO rats/obese rats: diet-induced obese rats; SQ: subcutaneous; Q2D: once every two days. 

"Based on these encouraging preclinical data, we believe the co-formulation of ASC36 and ASC35 has the potential to lead to greater weight loss reduction in people with obesity than single-agent therapies can achieve alone," said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, "The growing body of evidence reinforces our platform technologies' ability to design, optimize and develop multiple once-monthly SQ ultra-long-acting peptides."

Monotherapy and Co-formulation Therapies with ASC36

Ascletis is developing ASC36 as the cornerstone of its once-monthly therapies for the treatment of cardio-metabolic diseases including obesity. With the potential for better efficacy and improved tolerability to GLP-1 therapies, ASC36 is an ideal drug candidate to develop as a monotherapy and co-formulations with other long-acting agents such as ASC35 and potentially ASC47, an adipose-targeted thyroid hormone receptor beta (THRβ) agonist. 

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 November 13, 2025. A live webcast of the call will be available via Tencent Meeting/ VooV Meeting, with the Meeting ID: 573-120-481, or access links of:

Chinese Mainland: https://meeting.tencent.com/dm/uIyhG5Mtu3op; or

International: https://voovmeeting.com/dm/uIyhG5Mtu3op.

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 both small molecules and peptides, such as 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; ASC36, a once-monthly subcutaneously administered amylin receptor peptide agonist and ASC35, a once-monthly subcutaneously administered GLP-1R/GIPR dual peptide 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] 

SOURCE Ascletis Pharma Inc.