RCS - Hutchmed China Ltd - HUTCHMED Initiates Phase III Trial of HMPL-760

HUTCHMED (China)Announcement

23/03/2026 07:00

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RNS Number : 5736X  Hutchmed (China) Limited  23 March 2026

Press Release

 

HUTCHMED Initiates Phase III Trial of HMPL-760 in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma in China

 

Hong Kong, Shanghai & Florham Park, NJ -   Monday, March 23, 2026:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated a
registrational Phase III clinical trial of HMPL‑760 in combination with
R‑GemOx (rituximab, gemcitabine and oxaliplatin) in patients with
relapsed/refractory diffuse large B-cell lymphoma ("DLBCL") in China. The
first patient received the first dose on March 20, 2026.

 

DLBCL is the most common form of aggressive non-Hodgkin lymphoma ("NHL")
worldwide, accounting for approximately 40% of all NHL cases in China.(( 1 
(#_edn1) ))  In 2022, approximately 81,000 new cases of NHL are estimated to
have been diagnosed in China.(( 2  (#_edn2) )) Bruton's tyrosine kinase
("BTK") is considered a validated target for drugs that aim to treat certain
hemato-logical cancers. HMPL‑760 is a highly potent, selective, and
reversible inhibitor with long target engagement against BTK, including
wild-type and C481S-mutated BTK.

 

The trial is a randomized, double-blind, positive controlled Phase III study
to evaluate the efficacy, safety, and pharmacokinetics ("PK") of HMPL-760 in
combination with R-GemOx versus placebo in combination with R‑GemOx in DLBCL
patients who are relapsed or refractory after prior treatment with first-line
systemic chemotherapy, immunotherapy, or immunochemotherapy regimens and
ineligible for transplantation. Primary outcome measures include
investigator-assessed progression-free survival ("PFS") and overall survival
("OS"). Secondary outcome measures include independent review committee
("IRC")-assessed PFS, IRC- and investigator-assessed objective response rate
("ORR"), complete response rate ("CRR"), duration of response (DoR), clinical
benefit rate (CBR), time to response (TTR), safety and PK characteristics.
Additional details may be found at clinicaltrials.gov, using
identifier NCT07409428 (https://clinicaltrials.gov/study/NCT07409428) .

 

This registrational trial plans to enroll approximately 240 patients and is
being led by principal investigator Professor Weili Zhao, Vice President of
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
and Director of the Shanghai Institute of Hematology.

 

About HMPL-760

HMPL-760 is an investigational, non-covalent, third generation BTK inhibitor.
It is a highly potent, selective, and reversible inhibitor with long target
engagement against BTK, including wild-type and C481S-mutated BTK. BTK C481S
mutation plays an important role in resistance to certain BTK inhibitors(. 3 
(#_edn3) , 4  (#_edn4) )

 

A randomized, double-blind Phase II study (NCT06601504
(https://clinicaltrials.gov/study/NCT06601504) ) evaluating HMPL-760 in
combination with R‑GemOx in patients with relapsed/refractory DLBCL has
demonstrated encouraging improvements in ORR, CRR, PFS and OS compared to
R‑GemOx alone, with a manageable safety profile and no unexpected safety
signal. These encouraging results supported the initiation of this
registrational Phase III trial.

 

HUTCHMED currently retains all rights to HMPL-760 worldwide.

 

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 its expectations regarding the
therapeutic potential of HMPL-760 for the treatment of DLBCL and the further
development of HMPL‑760 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 a new drug
application submission of HMPL‑760 for the treatment of DLBCL or other
indications 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‑760, HUTCHMED's ability to fund, implement and
complete its further clinical development and commercialization plans for
HMPL‑760 and the timing of these events. In addition, as certain studies
rely on the use of other drug products such as R-GemOx as combination
therapeutics with HMPL-760, such risks and uncertainties include assumptions
regarding the safety, efficacy, supply and continued regulatory approval of
these therapeutics.  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 7779 436 689 (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

 

 1  (#_ednref1)   Li XQ, Li GD, Gao ZF, et al. Distribution pattern of
lymphoma subtypes in China: A nationwide multicenter study of 10002 cases. J
Diagn Concepts Pract. 2012; 11(02):111-115.

 2  (#_ednref2)   The Global Cancer Observatory, China fact
sheet. https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf
(https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf)
. Accessed December 3, 2025.

 3  (#_ednref3)   Woyach JA, Ruppert AS, Guinn D, et al. BTKC(481S)-Mediated
Resistance to Ibrutinib in Chronic Lymphocytic Leukemia. J Clin Oncol.
2017;35(13):1437-1443. doi:10.1200/JCO.2016.70.2282
(https://doi.org/10.1200/jco.2016.70.2282) .

 4  (#_ednref4)   Woyach JA, Huang Y, Rogers K, et al.  Resistance to
Acalabrutinib in CLL is Mediated Primarily by BTK
Mutations. Blood.  2019;134 (Supplement_1): 504.
doi:10.1182/blood-2019-127674 (https://doi.org/10.1182/blood-2019-127674) .

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