HUTCHMED Advances Cancer Drug to Pivotal Phase III Trial
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) has advanced its oncology pipeline by initiating a registrational Phase III clinical trial for HMPL-760 in China. The biopharmaceutical company announced that the first patient received a dose on March 20, 2026, officially launching the study for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This trial is a critical step toward seeking regulatory approval for the drug.
The randomized, double-blind study will enroll approximately 240 patients to evaluate the efficacy and safety of HMPL-760 when combined with a standard chemotherapy regimen (R-GemOx). The primary goals are to measure improvements in progression-free survival and overall survival, building on encouraging results from an earlier Phase II study. Success in this late-stage trial would significantly de-risk the asset and pave the way for commercialization.
Drug Targets 40% of China's Most Common Lymphoma
HMPL-760 targets a significant market opportunity within China's healthcare landscape. DLBCL is the most common aggressive non-Hodgkin lymphoma, accounting for approximately 40% of all such cases in the country. With an estimated 81,000 new non-Hodgkin lymphoma cases diagnosed in China in 2022, a successful treatment could capture a substantial patient population. HUTCHMED's strategic focus on this indication positions it to address a clear unmet medical need.
The drug's design provides a key competitive advantage. HMPL-760 is a third-generation Bruton’s tyrosine kinase (BTK) inhibitor, a validated target for hematological cancers. Crucially, it is engineered to be effective against both wild-type BTK and the C481S-mutated variant, which is a known cause of resistance to earlier-generation BTK inhibitors. By retaining full worldwide rights to HMPL-760, HUTCHMED stands to realize the full financial upside from its development and potential commercial success.
