–\u00a0 Utilizing Ascletis’ Peptide Oral Transport ENhancement Technology (POTENT), ASC37 oral tablets achieved average absolute oral bioavailability of 4.2%, approximately 9<\/i>–<\/i>, 30<\/i>–<\/i>, <\/i>and <\/i>60-fold higher than semaglutide, tirzepatide, and retatrutide<\/i> in the oral SNAC formulation, respectively, in head-to-head non-human primate (NHP) studies.<\/i><\/p>\n
–\u00a0 ASC37 oral tablets’ drug exposure, as measured by the <\/i>a<\/i>rea <\/i>u<\/i>nder <\/i>c<\/i>urve<\/i> (<\/i>AUC<\/i>),<\/i> was approximately 57-fold of retatrutide’s drug exposure in head-to-head NHP studies<\/i>.<\/i><\/p>\n
–\u00a0 Average observed half-life of ASC37 oral tablets was approximately 56 hours in NHP studies, supporting once daily and less frequent oral dosing. <\/i><\/p>\n
–\u00a0 ASC37 in vitro activity was approximately 5-, 4- and 4-fold more potent than retatrutide for GLP-1R, GIPR and GCGR, respectively.<\/i><\/p>\n
–\u00a0 Submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for ASC37 oral tablets is expected in the second quarter of 2026.<\/i><\/p>\n
–\u00a0 The Company will host a conference call in Mandarin at 10:00 a.m.<\/span> China Standard Time on December 1, 2025<\/span>. <\/i><\/p>\n HONG KONG<\/span><\/span>, Nov. 30, 2025<\/span><\/span> \/PRNewswire\/ — Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) announces that it has selected ASC37 oral tablets, its first oral GLP-1R\/GIPR\/GCGR[1]<\/sup> triple peptide agonist, as a clinical development candidate. Ascletis expects to submit an Investigational New Drug Application (IND)\u00a0to the U.S. Food and Drug Administration\u00a0(FDA) for ASC37 oral tablets for the treatment of obesity\u00a0in the second quarter of 2026.<\/p>\n ASC37 oral tablets is the Company’s first incretin drug candidate developed with its proprietary Peptide Oral Transport ENhancement Technology (POTENT).\u00a0<\/p>\n ASC37, a GLP-1R, GIPR, and GCGR\u00a0triple peptide agonist, was discovered and optimized in-house utilizing Ascletis’\u00a0Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD). ASC37 in vitro<\/i> activity was approximately 5-, 4-, and 4-fold more potent than retatrutide for GLP-1R, GIPR and GCGR, respectively.<\/p>\n Utilizing Ascletis’ POTENT technology, ASC37 oral tablets achieved average absolute oral bioavailability[2]<\/sup> of 4.2%, which was approximately 9-, 30-, and 60-fold higher than semaglutide, tirzepatide, and retatrutide in the oral SNAC [3]<\/sup> formulation, respectively, in head-to-head non-human primate (NHP) studies. Furthermore, after oral administration, ASC37 oral tablets’ drug exposure, as measured by the area under curve (AUC), with the POTENT formulation was approximately\u00a057-fold of retatrutide’s drug exposure with the oral SNAC formulation, in head-to-head NHP studies.<\/p>\n Average observed half-life of ASC37 oral tablets was approximately 56 hours in NHP\u00a0studies, supporting once daily and less frequent oral dosing.<\/p>\n \u00a0“Selection of ASC37, a promising oral GLP-1R\/GIPR\/GCGR triple peptide agonist, for clinical development once again demonstrates our strong R&D capabilities and our commitment to address the unmet needs for the treatment of obesity,” said Jinzi Jason Wu<\/span>, Ph.D., Founder, Chairman and CEO of Ascletis, “Leveraging our proprietary technology platforms, including AISBDD\u00a0and POTENT, Ascletis has successfully established a highly competitive, differentiated and diverse pipeline portfolio which can potentially effectively address the various treatment needs of patients with obesity and other metabolic diseases.”<\/p>\n