Biopharmaceutical company HUTCHMED (China) Limited (Nasdaq: HCM) (AIM: HCM) (HKEX: 13) announced on Monday that it has initiated a registrational Phase III clinical trial of HMPL-760 in combination with R-GemOx in patients with relapsed or refractory diffuse large B-cell lymphoma in China, with the first patient dosed on 20 March 2026.

The randomised, double-blind, positive-controlled study will assess the efficacy, safety and pharmacokinetics of HMPL-760 versus placebo, both in combination with R-GemOx, in patients who have failed prior systemic treatments and are ineligible for transplantation. The trial will enrol approximately 240 patients, with primary endpoints of progression-free survival and overall survival, alongside multiple secondary efficacy and safety measures.

Diffuse large B-cell lymphoma is the most common aggressive form of non-Hodgkin lymphoma, representing around 40% of cases in China, where an estimated 81,000 new non-Hodgkin lymphoma diagnoses were recorded in 2022. HMPL-760 is an investigational, non-covalent third-generation Bruton's tyrosine kinase inhibitor designed to target both wild-type and mutation-driven resistance pathways.

The Phase III programme follows positive Phase II data, which demonstrated improved response rates and survival outcomes versus R-GemOx alone with a manageable safety profile. The study is led by Professor Weili Zhao of Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine.

HUTCHMED retains global rights to HMPL-760 and continues to advance its pipeline of targeted therapies and immunotherapies for oncology and immunological diseases.