RCS - Hutchmed China Ltd - HUTCHMED Initiates Global Trial of ATTC Candidate

HUTCHMED (China)Announcement

04/03/2026 08:30

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RNS Number : 2871V  Hutchmed (China) Limited  04 March 2026

Press Release

 

HUTCHMED Initiates Global Trial of PI3K/PIKK-EGFR ATTC Candidate HMPL-A580 in Patients with Solid Tumors

 

- Second clinical candidate from HUTCHMED's next-generation ATTC platform -

- Leveraging synergy through simultaneous inhibition of PAM pathway and EGFR
signaling -

Hong Kong, Shanghai & Florham Park, NJ - Wednesday, March 4, 2026:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated a Phase I/IIa
clinical trial of HMPL-A580, HUTCHMED's second novel Antibody-Targeted Therapy
Conjugate ("ATTC"), in patients with unresectable, advanced or metastatic
solid tumors in China and the US. The first patient received the first dose on
March 4, 2026.

 

HMPL-A580 is a first-in-class ATTC comprising a highly selective and potent
PI3K/PIKK small-molecule inhibitor payload linked to an anti-EGFR antibody via
a cleavable linker, HUTCHMED's second ATTC based on this highly novel
PI3K/PIKK inhibitor payload. EGFR is highly expressed in multiple types of
solid tumors and is well recognized as a driving force in tumorigenesis and
disease progression. Preclinical data have shown that PAM pathway inhibition
synergizes with anti-EGFR therapy to enhance anti-tumor activity, and will be
presented at an upcoming scientific conference.

 

This first-in-human Phase I/IIa, multicenter, open-label study evaluates the
safety, tolerability, pharmacokinetics, immunogenicity and preliminary
efficacy of HMPL-A580. The study consists of two parts. In the Phase I dose
escalation part, patients will receive HMPL-A580 intravenously at predefined
dose levels to determine the maximum tolerated dose and recommended dose for
expansion. The subsequent Phase IIa dose expansion/optimization part is to
further characterize the safety, tolerability and preliminary anti-tumor
activity of HMPL-A580 in selected solid tumors, and to determine the
recommended dose for the next phase. Additional details may be found at
clinicaltrials.gov, using identifier NCT07396584
(https://clinicaltrials.gov/study/NCT07396584) .

 

About the ATTC Platform

HUTCHMED's ATTC platform represents a next-generation approach to precision
oncology, combining monoclonal antibodies with proprietary small-molecule
inhibitor payloads to deliver dual mechanisms of action. Unlike traditional
cytotoxin-based Antibody Drug Conjugates, ATTCs combine targeted therapies to
achieve synergistic anti-tumor activity and durable responses in preclinical
models, outperforming standalone antibody or small-molecule inhibitor
components in efficacy and safety.

 

Built on over 20 years of targeted therapy expertise, the platform enables
development of drug candidates for diverse cancer types. By leveraging
antibody-guided delivery and tumor-specific payload release, ATTCs improve the
accessibility to tumors and reduce off-tumor toxicity. This overcomes
challenges of traditional small-molecule inhibitors, ensures safer long-term
use, and supports combinations with chemotherapy and immunotherapy, unlocking
potential for early-line treatments.

 

HUTCHMED has demonstrated how its partnerships leverage the expertise of
multinational pharmaceutical companies to accelerate bringing novel medicines
to address large unmet needs around the world, and plans to apply this
strategy to its ATTC technology this year.

 

About the PAM Pathway and HMPL-A580

The PI3K/AKT/mTOR ("PAM") pathway is a critical intracellular network involved
in cell growth, survival, and division. Alterations in the PAM pathway are
frequently associated with poor prognosis and resistance to treatment across
various cancers. However, existing PAM-targeted drugs face significant
challenges, including on-target toxicities that restrict dosing, feedback
loops that enable pathway reactivation, and insufficient tumor-specific
delivery.

 

By conjugating this highly novel payload to an anti-EGFR antibody, HMPL-A580
is designed to deliver targeted pathway inhibition directly into
EGFR-expressing tumor cells, thereby potentially overcoming the systemic
toxicity and narrow therapeutic index historically associated with PI3K/PIKK
inhibitors. This approach aims to achieve deeper and more durable target
inhibition while improving the overall tolerability profile.

 

About HUTCHMED

HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage,
biopharmaceutical company. It is committed to the discovery and global
development and commercialization of targeted therapies and immunotherapies
for the treatment of cancer and immunological diseases. Since inception it has
focused on bringing drug candidates from in-house discovery to patients around
the world, with its first three medicines marketed in China, the first of
which is also approved around the world including in the US, Europe and Japan.
For more information, please visit: www.hutch‑med.com
(https://www.hutch-med.com/) or follow us on LinkedIn
(https://www.linkedin.com/company/hutchmed/) .

 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of
the "safe harbor" provisions of the U.S. Private Securities Litigation Reform
Act of 1995. These forward-looking statements reflect HUTCHMED's current
expectations regarding future events, including its expectations regarding the
therapeutic potential of HMPL‑A580 and other drug candidates from the ATTC
platform and the further development of HMPL‑A580 and other drug candidates
from the ATTC platform in this and other indications. Forward-looking
statements involve risks and uncertainties. Such risks and uncertainties
include, among other things, assumptions regarding the timing and outcome of
clinical studies and the sufficiency of clinical data to support an new drug
application submission of HMPL‑A580 and other drug candidates from the ATTC
platform in China or other jurisdictions, its potential to gain approvals from
regulatory authorities on an expedited basis or at all, the efficacy and
safety profile of HMPL‑A580 and other drug candidates from the ATTC
platform, HUTCHMED's ability to fund, implement and complete its further
clinical development and commercialization plans for HMPL‑A580 and other
drug candidates from the ATTC platform and the timing of these events.
Existing and prospective investors are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the date hereof.
For further discussion of these and other risks, see HUTCHMED's filings with
the US Securities and Exchange Commission, The Stock Exchange of Hong Kong
Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the
information contained in this press release, whether as a result of new
information, future events or circumstances or otherwise.

 

CONTACTS
 Investor Enquiries                                  +852 2121 8200 / ir@hutch-med.com (mailto:ir@hutch-med.com)

 Media Enquiries
 FTI Consulting -                                    +44 20 3727 1030 / HUTCHMED@fticonsulting.com
                                                     (mailto:HUTCHMED@fticonsulting.com)
    Ben Atwell / Tim Stamper                            +44 7771 913 902 (Mobile) / +44 7421 898 348 (Mobile)
 Brunswick - Zhou Yi                                 +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                     (mailto:HUTCHMED@brunswickgroup.com)

 Panmure Liberum                                     Nominated Advisor and Joint Broker
 Atholl Tweedie / Emma Earl / Rupert Dearden         +44 20 7886 2500

 Cavendish                                           Joint Broker
 Geoff Nash / Nigel Birks                            +44 20 7220 0500

 Deutsche Numis                                      Joint Broker
 Freddie Barnfield / Jeffrey Wong / Duncan Monteith  +44 20 7260 1000

 

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