HUTCHMED (00013) has announced the initiation in China of a registrational Phase III clinical trial for HMPL-760. The trial will evaluate HMPL-760 in combination with the R-GemOx regimen (rituximab, gemcitabine, and oxaliplatin) for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The first patient received their initial dose on March 20, 2026. Diffuse large B-cell lymphoma is the most common aggressive form of non-Hodgkin lymphoma (NHL) globally, accounting for approximately 40% of all NHL cases in China. It is estimated that there were about 81,000 new cases of non-Hodgkin lymphoma in China in 2022. Bruton's tyrosine kinase (BTK) is a validated drug target for the treatment of certain blood cancers. HMPL-760 is a potent, selective, and reversible inhibitor of BTK, including both wild-type and C481S mutant forms, designed to bind its target for an extended duration. This study is a randomized, double-blind, active-controlled Phase III clinical trial. It aims to assess the efficacy, safety, and pharmacokinetics of HMPL-760 combined with R-GemOx compared to a placebo combined with R-GemOx. The trial will enroll patients with relapsed or refractory DLBCL who are ineligible for transplantation and have previously received at least one line of systemic chemotherapy, immunotherapy, or immunochemotherapy. The primary endpoints of the study are investigator-assessed progression-free survival (PFS) and overall survival (OS). Secondary endpoints include PFS as assessed by an Independent Review Committee (IRC), objective response rate (ORR), complete response rate (CRR), duration of response (DoR), clinical benefit rate (CBR), time to response (TTR), safety, and pharmacokinetic profile, as evaluated by both the IRC and investigators. The registrational clinical trial plans to enroll approximately 240 patients. The principal investigator is Professor Zhao Weili, Vice President of Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine and Director of the Shanghai Institute of Hematology.