Ascletis has submitted two Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA) for obesity treatment: ASC36, a once-monthly peptide amylin receptor agonist, and ASC36_35, a once-monthly fixed-dose combination of ASC36 with ASC35, a peptide GLP-1R/GIPR agonist.

ASC36_35 FDC is a once-monthly subcutaneous fixed-dose combination of ASC36 and ASC35, and has the potential to become a first-in-class candidate drug targeting three clinically validated pathways: the amylin receptor, GLP-1R, and GIPR.

In head-to-head diet-induced obesity (DIO) rat studies, ASC36_35 FDC demonstrated approximately a 51% greater weight-loss effect compared to the combination of eloralintide and tirzepatide.

ASC36 has the potential to become a first-in-class, once-monthly to once-quarterly subcutaneous amylin receptor agonist.

In a head-to-head diet-induced obesity (DIO) rat study, ASC36 monotherapy demonstrated approximately 91% and 32% greater weight loss efficacy compared to petrelintide monotherapy and eloralintide monotherapy, respectively.

Hong Kong, July 6, 2026 – Ascletis Pharma Inc. (HKEX: 1672, 'Ascletis') today announced that it has recently submitted two Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA): one for ASC36, a next-generation amylin receptor agonist administered once monthly to once quarterly, and another for ASC36_35 FDC, a once-monthly injectable fixed-dose combination of ASC36 and ASC35, a peptide GLP-1R/GIPR agonist, for the treatment of obesity.

Dr. Jinzi J. Wu, Founder, Chairman, and CEO of Ascletis, stated:

Recent data for the combination of eloralintide and tirzepatide showed a 29.0% body weight reduction at week 32 [1]. However, this regimen requires two weekly injections—one of eloralintide and one of tirzepatide. In contrast, ASC36_35 FDC, a once-monthly subcutaneous fixed-dose combination therapy targeting amylin receptors, GLP-1R, and GIPR—potentially the first-in-class—delivered even more encouraging results: in a head-to-head diet-induced obesity (DIO) rat study, ASC36_35 FDC achieved approximately 51% greater weight loss efficacy compared to the eloralintide plus tirzepatide combination. These animal models are highly predictive of human therapeutic outcomes.

Both ASC36 and ASC35 were independently developed by Ascletis using its proprietary AI-assisted structure-based drug discovery (AISBDD) platform. The once-monthly to once-quarterly formulation of ASC36 and the once-monthly fixed-dose combination formulation of ASC36_35 FDC are both self-assembling lipid depot (SALD) formulations developed using Ascletis’s proprietary Ultra-Long Acting Platform (ULAP) technology.

In head-to-head non-human primate studies, the apparent half-life of the ASC36 SALD formulation was approximately six times longer than that of eloralintide, supporting once-monthly to once-quarterly subcutaneous dosing in humans. In non-human primate studies, both ASC36 and ASC35 in the ASC36_35 FDC SALD formulation exhibited prolonged apparent half-lives, supporting once-monthly subcutaneous administration in humans.

Preclinical studies have established the superior efficacy of both ASC36 injection and the ASC36_35 FDC combination injection. In head-to-head DIO rat studies—which are highly predictive of human efficacy—ASC36 monotherapy, which targets the amylin receptor, demonstrated approximately 91% and 32% greater weight loss efficacy compared to petrelintide and eloralintide monotherapies, respectively. In another head-to-head DIO rat study, the ASC36_35 FDC combination therapy, which targets amylin receptors, GLP-1R, and GIPR, showed approximately 51% greater weight loss efficacy compared to the combination of eloralintide and tirzepatide.

Both ASC36 injection and ASC36_35 FDC combination injection exhibit excellent physicochemical stability, with no aggregation or precipitation due to fibrillation near neutral pH.

Building on the recent milestone achieved with the ASC35 SALD monthly formulation, we have now submitted two IND applications: one for the ASC36 monthly injection and another for the ASC36_35 monthly combination injection. In June 2026, Ascletis announced that the U.S. FDA had granted IND clearance for its Phase I clinical trial of once-monthly subcutaneous ASC35 for the treatment of obesity (Press Release), highlighting the company’s strong clinical development execution capabilities and the potential of its ULAP technology.

[1] Eli Lilly and Company. Safety, tolerability, pharmacokinetics and pharmacodynamics of eloralintide and tirzepatide co-administered as once-weekly subcutaneous injections [Abstract accepted for presentation at EASD 2026]

About Ascletis Pharma Inc.

Ascletis Pharma Inc. is a fully integrated biotechnology company focusing on the development and commercialization of potential best-in-class and first-in-class drugs for metabolic diseases. Leveraging its proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD), Ultra-Long-Acting Platform (ULAP) technology, and Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has independently developed multiple small molecule and peptide drug candidates, including its core project ASC30, an investigational small molecule GLP-1R agonist that can be administered orally once daily or via subcutaneous injection once monthly to once quarterly as a weight loss treatment and maintenance therapy for long-term weight management; ASC36, a peptide amylin receptor agonist; ASC35, a once-monthly subcutaneous injectable GLP-1R/GIPR dual-target agonist peptide; ASC37, a GLP-1R/GIPR/GCGR triple-target agonist peptide; ASC39, a potent oral small molecule amylin receptor agonist selective for amylin, similar to eloralintide; and ASC30_39 FDC, a fixed-dose combination (FDC) of ASC30 (GLP-1RA) and ASC39 (amylin receptor agonist) for long-term weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK).

For more information, please visit the website:www.ascletis.com。

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