HUTCHMED (Nasdaq: HCM) launches registrational Phase III HMPL-760 lymphoma trial in China
Rhea-AI Filing Summary
HUTCHMED (China) Limited has started a registrational Phase III trial of its investigational BTK inhibitor HMPL-760 in combination with R-GemOx for patients in China with relapsed or refractory diffuse large B‑cell lymphoma (DLBCL) who are ineligible for transplantation. The first patient was dosed on March 20, 2026.
The randomized, double-blind study will enroll approximately 240 patients and compare HMPL-760 plus R-GemOx with placebo plus R-GemOx. Primary goals are progression-free survival and overall survival, with additional measures including response rates, duration of response, safety and pharmacokinetics.
HMPL-760 is a third generation, non-covalent BTK inhibitor targeting both wild-type and C481S‑mutated BTK. Earlier Phase II data in the same setting showed encouraging improvements in response and survival measures with a manageable safety profile, supporting advancement to this Phase III trial. HUTCHMED retains all global rights to HMPL-760.
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Insights
HUTCHMED advances BTK inhibitor HMPL-760 into a 240-patient registrational Phase III DLBCL trial in China.
HUTCHMED is moving HMPL-760, a third generation non‑covalent BTK inhibitor, into a randomized, double-blind Phase III study in relapsed/refractory DLBCL patients ineligible for transplant. The regimen combines HMPL-760 with R-GemOx and uses progression-free and overall survival as primary endpoints.
The decision is supported by a prior Phase II study that showed encouraging improvements in objective and complete response rates, progression-free survival and overall survival versus R-GemOx alone, with a manageable safety profile and no unexpected safety signals. This positions the Phase III as a potential registration-enabling trial in China.
The trial plans to enroll approximately 240 patients under principal investigator Professor Weili Zhao, with details listed under identifier NCT07409428. Actual impact will depend on final efficacy, safety and regulatory outcomes, and HUTCHMED currently retains all rights to HMPL-760 worldwide.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE
SECURITIES EXCHANGE ACT OF 1934
For the Month of March 2026
Commission File Number: 001-37710
HUTCHMED (CHINA) LIMITED
(Translation of registrant’s name into English)
48th Floor, Cheung Kong Center, 2 Queen’s Road Central, Hong Kong
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ⌧ Form 40-F ◻
HUTCHMED (CHINA) LIMITED
Form 6-K
EXHIBIT INDEX
Exhibit No. | | Description |
| | |
Exhibit 99.1 | | Press release relating to initiation of phase III trial of HMPL-760 in patients with relapsed/refractory diffuse large B-cell lymphoma in China |
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2
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| HUTCHMED (CHINA) LIMITED | |
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| | |
| By: | /s/ Johnny Cheng |
| Name: | Johnny Cheng |
| Title: | Chief Financial Officer |
Date: March 23, 2026
3
Exhibit 99.1
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”) (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 |
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REFERENCES
| 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. BTKC481S-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 did HUTCHMED (HCM) announce about HMPL-760 in this 6-K filing?
How many patients will HUTCHMED enroll in the HMPL-760 Phase III DLBCL trial?
What are the primary endpoints of HUTCHMED’s HMPL-760 Phase III trial in DLBCL?
What prior data supported moving HMPL-760 into Phase III for HUTCHMED?
What type of drug is HMPL-760 in HUTCHMED’s pipeline?
Does HUTCHMED retain global rights to HMPL-760 mentioned in the 6-K?
Filing Exhibits & Attachments
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