-ASC37 demonstrated statistically significant 88% greater relative body weight reduction compared to tirzepatide in the diet-induced obese (DIO) mouse model.
-Both ASC37 once-monthly subcutaneous (SQ) formulation and oral formulation will be submitted to the U.S. Food and Drug Administration (FDA) via a biologics license application (BLA).
HONG KONG, July 27, 2026 /PRNewswire/ — Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) announces that ASC37, a next-generation GLP-1R/GIPR/GCGR[1] triple peptide agonist, demonstrated superior weight loss to tirzepatide in a diet-induced obese (DIO) mouse model. Following 11-day administration of ASC37 and tirzepatide at the same dose of 1 nmol/kg in DIO mice, ASC37 had statistically significant 88% greater relative body weight reduction compared to tirzepatide (Table 1). Furthermore, ASC37 demonstrated up to 41.5% weight loss in a dose-dependent fashion in the DIO mice (Table 1).
Table 1. ASC37 demonstrated statistically and significantly more weight loss than tirzepatide in DIO mice following 11-day administration
|
Dosing |
Total body weight change |
Greater relative weight loss |
|
1 nmol/kg tirzepatide SQ, QD |
-7.5 % |
– |
|
1 nmol/kg ASC37 SQ, QD |
-14.1 % |
88% (p = 0.0279 vs tirzepatide) |
|
10 nmol/kg ASC37 SQ, QD |
-30.1 % |
301% (p < 0.0001 vs tirzepatide) |
|
30 nmol/kg ASC37 SQ, QD |
-41.5 % |
453% (p < 0.0001 vs tirzepatide) |
Note: DIO mice: diet-induced obese mice; SQ: subcutaneous; QD: once daily.
ASC37 was engineered to have 41 alpha amino acids, which qualifies it as a biologic. The Investigational New Drug (IND) application of both ASC37 once-monthly subcutaneous (SQ) formulation and oral formulation will be submitted in the third quarter of 2026. Biologics license applications (BLAs) for both ASC37 once-monthly SQ formulation and oral formulation will be submitted to the FDA after Phase III completion. ASC35, a next-generation GLP-1R/GIPR dual peptide agonist, also has 41 alpha amino acids and will be submitted as a BLA as well.
Compared to retatrutide, another triple peptide agonist, in non-human primate (NHP) studies, ASC37 SQ Self Assembly Lipid Depot (SALD) formulation had an average observed half-life of approximately 17 days compared to 2.5 days for retatrutide. This approximately 7-fold longer half-life for ASC37 confirms once-monthly or less dosing frequency.
“Based on these encouraging preclinical data, we believe ASC37 has the potential to be a first-in-class once-monthly SQ triple peptide agonist for people living with severe obesity, also with the added advantage of being submitted under the BLA regulatory process,” said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis. “Qualification of ASC37 as a biologic offers a number of benefits, including longer statutory exclusivity periods and extended protection from government price negotiation compared to small molecules.”
Under the Inflation Reduction Act, biologics benefit from a longer exemption period of 13 years following FDA approval, instead of nine years for small molecules, before being subject to government price negotiations. There is also no regulatory path for biologics to be compounded by third-party pharmacies. This limits the ability of compounding pharmacies from potentially offering a lower-price version of ASC37 and ASC35.
|
[1] GLP-1R: glucagon-like peptide 1 receptor, GIPR: gastric inhibitory polypeptide receptor, GCGR: glucagon receptor |
About Ascletis Pharma Inc.
Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potentially 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 as well as Peptide Oral Transport ENhancement Technology (POTENT), 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, an amylin receptor peptide agonist, ASC35, a once-monthly subcutaneously administered GLP-1R/GIPR dual peptide agonist and ASC37, a GLP-1R/GIPR/GCGR triple peptide agonist, ASC39, an eloralintide-like potent and amylin-selective oral small molecule amylin receptor agonist, ASC30_39 FDC, a fixed-dose combination (FDC) of ASC30 (GLP-1 RA) and ASC39 (amylin RA), ASC30_48 FDC, a fixed-dose combination (FDC) of ASC30 (GLP-1 RA) and ASC48 (GIP RA), 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.)
Peter.vozzo@icrhealthcare.com
Ascletis Pharma Inc. PR and IR Teams
+86-181-0650-9129 (China)
pr@ascletis.com
ir@ascletis.com
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