RCS - Hutchmed China Ltd - Updates from R&D Event

HUTCHMED (China)Announcement

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RNS Number : 7613F  Hutchmed (China) Limited  03 November 2025

Press Release

 

HUTCHMED Highlights Pipeline and Business Progress at R&D Updates Event

 

- HUTCHMED unveils its innovative ATTC platform, potentially providing
precision oncology with synergistic dual-mechanism of action -

 

- Lead candidate HMPL-A251 harnesses a selective PI3K/PIKK inhibitor payload,
demonstrating promising preclinical efficacy and safety -

 

- Progress in global and China trials, including FRUSICA-2, SANOVO,
surufatinib's PDAC and fanregratinib's IHCC studies, advances HUTCHMED's
late-stage pipeline -

 

Hong Kong, Shanghai & Florham Park, NJ - Monday, November 3, 2025:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM: HCM; HKEX: 13) announced key research and development (R&D)
and business updates presented during its R&D Updates event held on
October 31, 2025. The event highlighted HUTCHMED's progress in advancing
innovative cancer and immunology treatments, including the introduction of its
next-generation Antibody-Targeted Therapy Conjugate ("ATTC") platform,
alongside updates on late-stage pipeline candidates.

 

"Our commitment to advancing innovative therapies drives HUTCHMED's mission to
address critical unmet needs in oncology and immunology," said Dr. Michael
Shi, Head of R&D and Chief Medical Officer of HUTCHMED. "The ATTC
platform's potential to redefine precision oncology, combined with our robust
pipeline and partnership strategy, positions us to deliver potentially
transformative cancer and immunology treatments to patients around the world."

 

Breakthrough ATTC Platform and Lead Candidate HMPL-A251

 

The ATTC platform represents potentially a groundbreaking approach to
precision oncology, integrating monoclonal antibodies with proprietary
small-molecule inhibitor payloads to deliver dual mechanisms of action. The
ATTC platform integrates monoclonal antibodies with proprietary small-molecule
inhibitor payloads to deliver dual mechanisms of action. In contrast to
traditional cytotoxin-based antibody-drug conjugates ("ADC"), ATTCs leverage
targeted therapies to achieve synergistic anti-tumor activity and durable
responses, as demonstrated in preclinical models. These conjugates have shown
superior efficacy and safety profiles compared to standalone antibody or small
molecule inhibitor components.

 

Overcoming Cancer Challenges with PAM-Targeting Payload: The first wave of
ATTC candidates focuses on payloads targeting the PI3K/AKT/mTOR ("PAM")
signaling pathway. The 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 limitations, including on-target toxicities that restrict dosing,
feedback loops that enable pathway reactivation, and insufficient
tumor-specific delivery. The ATTC strategy tries to address these challenges
by enhancing targeted delivery of PAM inhibitors directly to tumor cells,
maximizing therapeutic benefit while minimizing systemic exposure.

 

HUTCHMED's Lead ATTC Candidate, HMPL-A251: HMPL-A251 is a PAM-HER2 ATTC
consisting of a highly selective and potent PI3K/PIKK inhibitor payload
conjugated to a humanized anti-HER2 IgG1 antibody via a cleavable linker.
Preclinical data for HMPL-A251 was recently presented at the 2025
AACR-NCI-EORTC International Conference (https://www.hutch-med.com/eortc25/)
on Molecular Targets and Cancer Therapeutics. In vitro, the PI3K/PIKK
inhibitor payload exhibited high selectivity, potency, and robust anti-tumor
activity across a diverse panel of tumor cell lines. HMPL-A251 demonstrated
HER2-dependent antitumor activity, with potent inhibition of HER2-positive
tumor cell growth regardless of PAM pathway alterations, and moderately
reduced activity in HER2-low, PAM-altered lines. Notably, HMPL-A251 exhibited
a strong bystander effect, impacting HER2-null cells when co-cultured with
HER2-positive cells. In vivo evaluations showed superior anti-tumor efficacy
and tolerability compared to the naked antibody and payload administered
separately. When benchmarked against trastuzumab deruxtecan (T‑-DXd), a
leading HER2-directed ADC, HMPL-A251 achieved comparable or superior efficacy
at equivalent doses in most models tested. Furthermore, payload-related
toxicities are anticipated to be improved, with plasma exposure of the free
payload being significantly lower than that of HMPL-A251.

 

Encouraged by these promising preclinical results in both HER2-positive and
HER2-low models, with or without PAM alterations, HUTCHMED plans to advance
HMPL-A251 into clinical development starting in late 2025 using a data-driven
strategy. Initial studies will evaluate the candidate across various cancer
types with diverse HER2 and PAM alteration statuses.

 

Adaptable Payload and Antibody Design Unlocks Versatile Mechanisms: Beyond
HER2-targeted antibodies, HUTCHMED aims to explore a broader range of antibody
selections that synergize with the payload's signaling pathways, leveraging
the antibody as a delivery vehicle to enhance combination effects. Payload
options are also adaptive, targeting a wide array of signaling pathways,
positioning ATTCs as a versatile tool in overcoming resistance and improving
treatment outcomes. Additionally, ATTC shows potential for combination with
chemotherapy-based frontline standard-of-care treatments or as a
chemotherapy-free adjuvant for long-term use, enhancing its possible
application as combination therapy in early-line settings. Successful
development of multiple ATTC molecules is expected to lead to collaboration
and licensing opportunities in the future. Initial responses from potential
partners are very positive.

 

Significant Progress from Late-stage Programs

 

In addition to the ATTC platform, the R&D Updates featured updates on some
of the late-stage programs:

 

·      Fruquintinib FRUSICA-2 Study: Data from the Phase III trial of
fruquintinib in combination with sintilimab for second-line renal cell
carcinoma was presented at ESMO Congress 2025
(https://www.hutch-med.com/esmo25-frusica2/) . The combination achieved a
progression-free survival (PFS) of 22.2 months versus 6.9 months with
standard-of-care axitinib or everolimus (hazard ratio  HR : 0.37;
p<0.0001). The objective response rate more than doubled to 60.5% versus
24.3%, with a median duration of response of 23.7 months compared to 11.3
months.

·      Savolitinib Registration Studies: Recruitment has been completed
for the SANOVO China Phase III study in first-line EGFR-mutated non-small cell
lung cancer ("NSCLC") with MET overexpression. Recruitment for the SAFFRON
global Phase III study for second-line EGFR-mutated NSCLC patients with MET
amplification or overexpression is progressing well, with enrollment
completion expected in late 2025.

·      Surufatinib for Pancreatic Cancer: The Phase II/III study of
surufatinib combined with Hengrui's camrelizumab (a PD-1 antibody),
nab-paclitaxel, and gemcitabine for first-line treatment of metastatic
pancreatic ductal adenocarcinoma (PDAC) remains on track. Results from the
Phase II portion will be presented at an upcoming scientific conference.

·      Sovleplenib for ITP and wAIHA: Preparations for the resubmission
of the new drug application for second-line immune thrombocytopenia (ITP) are
progressing as outlined in the 2025 interim report, with resubmission planned
for the second quarter of 2026. The ESLIM-02 study in second-line warm
autoimmune hemolytic anemia (wAIHA) has completed enrollment, with topline
results expected in early 2026.

·      Fanregratinib in China: Recruitment for the registrational Phase
II study in patients with advanced intrahepatic cholangiocarcinoma (IHCC) in
China has been completed, with new drug application submission preparation
underway for the first half of 2026.

 

For more information on the R&D updates presentation, please visit
www.hutch-med.com/event/ (https://www.hutch-med.com/event/) .

 

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 US Private Securities Litigation Reform
Act of 1995. These forward-looking statements reflect HUTCHMED's current
expectations regarding future events, including but not limited to its
expectations regarding the therapeutic potential of HMPL‑A251 or other drug
candidates from the ATTC platform, fanregratinib, fruquintinib, savolitinib
and surufatinib, the further clinical development for HMPL‑A251 or other
drug candidates from the ATTC platform, fanregratinib, fruquintinib,
savolitinib and surufatinib , its expectations as to whether any studies on
HMPL‑A251 or other drug candidates from the ATTC platform, fanregratinib,
fruquintinib, savolitinib and surufatinib would meet their primary or
secondary endpoints, and its expectations as to the timing of the completion
and the release of results from such studies. Such risks and uncertainties
include, among other things, assumptions regarding enrollment rates and the
timing and availability of subjects meeting a study's inclusion and exclusion
criteria; changes to clinical protocols or regulatory requirements; unexpected
adverse events or safety issues; the ability of HMPL‑A251 or  other drug
candidates from the ATTC platform, fanregratinib, fruquintinib, savolitinib
and surufatinib, including as combination therapies, to meet the primary or
secondary endpoint of a study, to obtain regulatory approval in different
jurisdictions and to gain commercial acceptance after obtaining regulatory
approval; the potential markets of HMPL‑A251 or other drug candidates from
the ATTC platform, fanregratinib, fruquintinib, savolitinib and surufatinib
for a targeted indication, and the sufficiency of funding. 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 / Alex Shaw                              +44 7771 913 902 (Mobile) / +44 7779 545 055 (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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