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

(Moderate)

(Positive)

Rhea-AI Summary

HUTCHMED (Nasdaq/AIM: HCM) initiated a registrational Phase III trial of HMPL-760 plus R-GemOx in relapsed/refractory diffuse large B-cell lymphoma in China; first patient dosed on March 20, 2026.

The randomized, double-blind study (NCT07409428) plans to enroll ~240 patients, with primary endpoints of investigator-assessed PFS and OS, and secondary measures including ORR, CRR, DoR, safety and PK.

Positive

Registrational Phase III initiated for HMPL-760 plus R-GemOx
First patient dosed on March 20, 2026
Planned enrollment of ~240 patients
Primary endpoints include PFS and OS

Negative

No clinical efficacy results yet; outcomes pending
Study limited to China, which may restrict immediate global registration

News Market Reaction – HCM

+0.43%

+0.43% Session close to close

In the Mar 23 session, HCM gained 0.43%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement adds another late-stage study to HUTCHMED’s hematology pipeline, with a registrati...

Analysis

This announcement adds another late-stage study to HUTCHMED’s hematology pipeline, with a registrational Phase III trial of HMPL-760 plus R-GemOx in relapsed/refractory DLBCL and a planned enrollment of 240 patients. It builds on a series of prior clinical updates across solid and hematologic tumors. Investors may watch for recruitment progress, interim PFS and OS signals, and how this BTK inhibitor positions against existing DLBCL standards of care.

Key Figures

DLBCL share of NHL: 40% of NHL cases New NHL cases China: 81,000 cases Planned enrollment: 240 patients +1 more

4 metrics

DLBCL share of NHL 40% of NHL cases Proportion of aggressive NHL accounted for by DLBCL in China

New NHL cases China 81,000 cases Estimated new non-Hodgkin lymphoma cases in China in 2022

Planned enrollment 240 patients Planned sample size for Phase III HMPL-760 + R-GemOx DLBCL trial

First dose date March 20, 2026 Date first patient received first dose in HMPL-760 Phase III trial

Previous Clinical trial Reports

5 past events · Latest: Jan 13 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jan 13	Phase III publication	Positive	+2.3%	Publication of positive SACHI Phase III results in The Lancet.
Jan 06	Positive Phase III data	Positive	+6.6%	Phase III ESLIM-02 trial met primary endpoint in wAIHA.
Jan 04	Phase III initiation	Positive	-2.0%	Initiation of Phase III stage for pancreatic cancer combo regimen.
Dec 16	ATTC trial start	Positive	+0.5%	Global Phase I/IIa start for ATTC candidate HMPL-A251.
Nov 26	Conference data preview	Positive	+0.7%	Announcement of multiple clinical data presentations at ESMO Asia and ASH.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Clinical trial news for HUTCHMED has generally led to modest positive moves, with occasional divergences even on constructive data.

Recent Company History

Over the past months, HUTCHMED has repeatedly advanced its pipeline with multiple Phase I–III clinical updates and data disclosures. Prior clinical milestones, such as positive Phase III readouts for sovleplenib and the SACHI publication, saw mostly positive price reactions, though one Phase III initiation drew a negative move. Today’s Phase III HMPL-760 trial start in relapsed/refractory DLBCL continues this pattern of late-stage development activity.

Key Terms

phase iii, randomized, double-blind, pharmacokinetics, progression-free survival, +4 more

8 terms

phase iii medical

"initiated a registrational Phase III clinical trial of HMPL-760 in combination"

A Phase III trial is the late-stage clinical study that tests whether a medical treatment works and is safe in a large group of patients, often comparing it to standard care. Think of it as a final dress rehearsal or full-scale road test before regulators decide on approval; positive or negative results strongly influence a drug maker’s chance to sell the treatment, future revenue, and investment risk.

randomized, double-blind medical

"The trial is a randomized, double-blind, positive controlled Phase III study"

A randomized, double-blind study is a clinical trial design where participants are assigned by chance to different groups (for example, a new treatment or a control) and neither the participants nor the researchers know who is in which group. This setup reduces conscious or unconscious bias—think of it like a blind taste test—so results are more reliable and investors can have greater confidence that reported effects reflect the treatment itself rather than expectations or selective reporting.

pharmacokinetics medical

"to evaluate the efficacy, safety, and pharmacokinetics (“PK”) of HMPL-760"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

progression-free survival medical

"Primary outcome measures include investigator-assessed progression-free survival (“PFS”)"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

overall survival medical

"Primary outcome measures include investigator-assessed progression-free survival (“PFS”) and overall survival (“OS”)."

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

objective response rate medical

"Secondary outcome measures include ... objective response rate (“ORR”), complete response rate"

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.

complete response rate medical

"include ... objective response rate (“ORR”), complete response rate (“CRR”), duration"

Complete response rate is the percentage of patients in a clinical trial whose measurable signs of disease disappear after treatment, as judged by predefined medical tests. For investors, a higher complete response rate is a strong signal that a drug works well in the trial setting, improving chances of regulatory approval and commercial success — like seeing most lightbulbs in a new batch actually turn on before deciding to buy the factory.

bruton’s tyrosine kinase medical

"Bruton’s tyrosine kinase (“BTK”) is considered a validated target for drugs"

A cellular enzyme that acts like a light switch controlling growth and activity of certain immune cells called B cells; when it’s overactive it can drive blood cancers and immune disorders. Investors care because drugs that block this enzyme can become prescription treatments or face clinical trial and regulatory risk, making pipeline progress, approval decisions, and safety results key value drivers for healthcare companies.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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03/22/2026 - 08:00 PM

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., March 23, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (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 In 2022, approximately 81,000 new cases of NHL are estimated to have been diagnosed in China.² Bruton’s tyrosine kinase (“BTK”) is considered a validated target for drugs that aim to treat certain hematological 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.

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^,⁴

A randomized, double-blind Phase II 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 or follow us on LinkedIn.

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

Media Enquiries
FTI Consulting –	+44 20 3727 1030 / 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

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	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	The Global Cancer Observatory, China fact sheet. https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf. Accessed December 3, 2025.
³	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.
⁴	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.

FAQ

What is the design of HUTCHMED's Phase III HMPL-760 trial (HCM) started March 2026?

It is a randomized, double-blind, positive-controlled Phase III study. According to the company, the trial compares HMPL-760 plus R-GemOx versus placebo plus R-GemOx in relapsed/refractory DLBCL patients.

How many patients will the HMPL-760 Phase III trial (HCM) enroll and when did dosing begin?

The registrational trial plans to enroll approximately 240 patients. According to the company, the first patient received the first dose on March 20, 2026.

What are the primary endpoints for HUTCHMED's HMPL-760 Phase III study (HCM)?

Primary outcome measures are investigator-assessed progression-free survival (PFS) and overall survival (OS). According to the company, these will drive the registrational assessment of benefit.

Which patients are eligible for HMPL-760 Phase III trial (HCM) in China?

The trial enrolls relapsed or refractory DLBCL patients ineligible for transplantation after prior systemic chemotherapy, immunotherapy, or immunochemotherapy. According to the company, eligibility excludes transplant candidates.

What secondary outcomes will HUTCHMED measure in the HMPL-760 Phase III trial (HCM)?

Secondary measures include IRC-assessed PFS, objective response rate (ORR), complete response rate (CRR), duration of response, clinical benefit rate, time to response, safety and PK. According to the company, these support benefit and safety assessment.

Where can investors find the HMPL-760 Phase III trial registration details for HCM?

Trial details are registered at clinicaltrials.gov under identifier NCT07409428. According to the company, the listing provides protocol and enrollment information for the study.