歌礼制药公布每周一次口服减重多肽临床前积极数据，ASC36o美国I期已启动

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Ascletis Pharma Inc.
歌禮製藥有限公司

(incorporated in the Cayman Islands with limited liability)

(Stock Code: 1672)

VOLUNTARY ANNOUNCEMENT
ASCLETIS ANNOUNCES POSITIVE PRECLINICAL DATA FOR THE MOST
COMPREHENSIVE ONCE-WEEKLY ORAL PEPTIDE PIPELINE FOR THE
TREATMENT OF OBESITY
–

Ascletis ’ industry-leading once-weekly oral peptide pipeline covers all four validated targets,
with multiple first-in-class fixed-dose combinations.

–

ASC36o, a once-weekly oral amylin receptor peptide agonist, is the most advanced drug
candidate of Ascletis ’ once-weekly oral peptide pipeline and its Phase I study has started in
the U.S.

–

ASC36o demonstrated a half-life of approximately 7 days and oral bioavailability of 6% to
8% in non-human primates (NHPs), supporting once-weekly oral administration.

–

Using ASC36o as a cornerstone, Ascletis has developed two first-in-class once-weekly oral
peptide fixed-dose combinations (FDCs), ASC36_37o FDC (amylin/GLP-1/GIP/GCG) and
ASC36_35o FDC (amylin/GLP-1/GIP).

–

Ascletis ’ once-weekly oral peptide pipeline was developed by its Peptide Oral Transport
ENhancement Technology (POTENT) that increased oral bioavailability through both gastric
and intestinal absorption and reduced within-subject and between-subject variability.

This announcement is made by Ascletis Pharma Inc. (the “Company” or “Ascletis”, together with
its subsidiaries, the “Group”) on a voluntary basis for the purpose of keeping the shareholders of
the Company and potential investors abreast of the latest business development of the Group.
The board (the “ Board ” ) of directors (the “ Directors ” ) of the Company announced positive
preclinical data demonstrating the long half-lives and superior bioavailability of its industry-leading
once-weekly oral peptide pipeline.

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The industry’s most comprehensive once-weekly oral peptide pipeline
The foundation of Ascletis ’ industry-leading once-weekly oral peptide pipeline (Table 1) for
the treatment of obesity and other metabolic diseases is a first-in-class once-weekly oral amylin
receptor peptide agonist ASC36o (tablet) which is currently in a Phase I study in the U.S. The
topline human pharmacokinetic (PK) data of ASC36o are expected by the end of 2026. At steady
state in non-human primates (NHPs), ASC36o tablets reached a half-life of up to 167 hours
(approximately 7 days) and oral bioavailability of 6% to 8%. In a head-to-head diet-induced
obesity (DIO) rat study comparing ASC36 to eloralintide and petrelintide, ASC36 demonstrated
32% and 91%, respectively, greater body weight reduction.
Table 1. Ascletis’ once-weekly oral peptide pipeline covers all four validated targets, alone
and in combination:
Program

Amylin R
✓

GLP-1R

ASC36_37o FDC

✓

✓

✓

ASC36_35o FDC

✓

✓

✓

ASC37o

✓

✓

ASC35o

✓

✓

ASC36o

GIPR

GCGR

Status
U.S. Phase I

✓

FDA IND submission expected 4Q2026
FDA IND submission expected 4Q2026

✓

FDA IND submission expected 4Q2026
FDA IND submission expected 4Q2026

Notes:
FDC: fixed-dose combination; R: receptor; GLP-1R: glucagon-like peptide 1 receptor; GIPR: gastric inhibitory
polypeptide receptor; GCGR: glucagon receptor; FDA: the U.S. Food and Drug Administration; IND: Investigational
New Drug.

First-in-class once-weekly oral fixed-dose combination (FDC) peptides
Ascletis’ two FDC oral peptides combine its amylin receptor agonist with incretin agonists in a
single once-weekly pill:
•

ASC36_37o FDC (tablet), a once-weekly oral quadruple peptide agonist (amylin receptor +
GLP-1R/GIPR/GCGR)

•

ASC36_35o FDC (tablet), a once-weekly oral triple peptide agonist (amylin receptor +
GLP-1R/GIPR)

In NHPs, combining the peptides extended the half-lives beyond that observed with the single
agent. The half-life of ASC36o increased from approximately 7 days as monotherapy to
approximately 8.8 days in an FDC of ASC36_35o, and approximately 8.3 days in an FDC of
ASC36_37o. ASC36o oral bioavailability also rose, from 6% to 8% alone to ≥10% in both FDCs
(Table 2).
Furthermore, the Company’s pipeline includes a once-weekly oral GLP-1/GIP/GCG triple peptide
agonist, ASC37o, and a once-weekly oral GLP-1/GIP dual peptide agonist, ASC35o (Table 1).
This pipeline gives Ascletis a unique competitive position to significantly expand the population
that can be treated with oral agents.

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Industry-leading oral bioavailability across our once-weekly oral peptide pipeline
All five of Ascletis’ once-weekly oral peptides/fixed-dose combinations utilize Ascletis proprietary
Peptide Oral Transport Enhancement Technology (POTENT). In both dogs and NHPs, POTENT
increases oral bioavailability through absorption in both the stomach and the intestines. POTENT
also significantly reduces within-subject and between-subject variability after oral dosing. This
technology allowed for oral bioavailability of Ascletis’ once-weekly oral peptides of up to > 10%
at the steady state, with half-lives up to approximately 8.8 days in NHPs (Table 2). These high
rates of oral bioavailability combined with extremely long half-lives allows for commercially
viable once-weekly dosing of its oral peptides.
Table 2. Half-life and bioavailability of oral peptide pipeline at steady state in NHPs
Tablet

Half-life

Oral bioavailability

ASC36o

Up to 167 hours (approx. 7 days)

6% to 8%

ASC36_37o FDC

ASC36: up to 200 hours (approx. 8.3 days)
ASC37: up to 96 hours (4 days)

ASC36: >10%
ASC37: ≥9.1%

ASC36_35o FDC

ASC36: up to 212 hours (approx. 8.8 days)
ASC35: up to 158 hours (approx. 6.6 days)

ASC36: ≥10%
ASC35: ≥9.3%

ASC37o

Up to 79 hours (approx. 3.3 days)

3.5% to 7.9%

ASC35o

Up to 83 hours (approx. 3.5 days)

Similar to ASC37o

Notes:
NHPs: non-human primates; FDC: fixed-dose combination; approx.: approximately.

“With the start of our U.S. Phase I study, our once-weekly oral peptide platform has crossed
another milestone. ” said Jinzi Jason Wu, Ph.D., Founder, Chairman of the Board and chief
executive officer of Ascletis, “Our two FDC tablets are, to our knowledge, the first once-weekly
oral fixed-dose combinations of peptides. Together with ASC37o and ASC35o, they give Ascletis
what we believe is the most comprehensive once-weekly oral peptide pipeline in the industry,
covering all four validated targets: amylin, GLP-1, GIP and GCG receptors. Our POTENT
platform increased absorption in both the stomach and the intestine and reduced variability within
and between animal subjects, and our unique combinations improved both even further. We look
forward to the topline human PK data of ASC36o (tablet) and the submission of Investigational
New Drug applications (INDs) for our four additional once-weekly oral peptide programs by
year-end.”
About POTENT
Peptide Oral Transport ENhancement Technology (POTENT) is Ascletis’ proprietary oral peptide
delivery platform. It is designed to increase oral bioavailability and reduce within-subject and
between-subject PK variability, so that peptides can be dosed orally once weekly. In NHPs and
dogs, POTENT increased peptide absorption at both gastric and intestinal sites.

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Cautionary Statement required by Rule 18A.05 of the Rules Governing the Listing of
Securities on The Stock Exchange of Hong Kong Limited: We cannot guarantee that we will
be able to ultimately develop, manufacture and/or commercialize ASC36o, ASC36_37o FDC,
ASC36_35o FDC, ASC37o and/or ASC35o successfully.
By order of the Board
Ascletis Pharma Inc.
歌禮製藥有限公司
Jinzi Jason WU
Chairman
Hong Kong
October 20, 2026

As at the date of this announcement, the Board comprises Dr. Jinzi Jason WU and Mrs. Judy
Hejingdao WU, as executive Directors; and Dr. Yizhen WEI, Mr. Jiong GU and Ms. Lin HUA, as
independent non-executive Directors.

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