HUTCHMED Initiates Phase III Trial of HMPL-760

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 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.

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.

[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.