HUTCHMED (China) Limited (HCM), a commercial-stage, biopharmaceutical company, on Friday announced that it has initiated a registrational Phase III clinical trial of it's investigational candidate HMPL-760 in combination with R-GemOx in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in China. The first patient was dosed on March 20, 2026.
HMPL-760 is an investigational BTK inhibitor and the eleventh potential oncology drug candidate in clinical development for HUTCHMED.
The initiation of this Phase III clinical trial was supported by encouraging results from a Phase II study evaluating HMPL-760 in combination with R-GemOx(Rituximab, Gemcitabine and Oxaliplatin) in patients with relapsed/refractory DLBCL.
In the Phase II trial, HMPL-760 has demonstrated improvements in objective response rate, complete response rate, progression-free survival, and overall survival compared with R-GemOx alone, with a manageable safety profile and no unexpected safety signals, according to the firm.
The initiated Phase III clinical trial is a randomised, double-blind, positive-controlled study to evaluate the efficacy, safety, and pharmacokinetics of HMPL-760 in combination with R-GemOx versus placebo in combination with R-GemOx.
The trial plans to enrol 240 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).
DLBCL is the most common form of aggressive non-Hodgkin lymphoma (NHL), a type of cancer of the lymphatic system, which is part of the body's immune system. According to the firm, this accounts for approximately 40% of all NHL cases in China.
Earlier this month, the firm reported its full-year 2025 financial results. The firm's net income attributable to HUTCHMED for 2025 increased to $456.91 million, or $0.52 per share, from $37.73 million, or $0.04 per share, in the prior year.
Meanwhile, total revenue slipped to $548.51 million from $630.20 million in the prior year.
Total consolidated revenue for oncology products decreased 21% to $214.35 million from $271.53 million in the prior year. The company's oncology products that generate revenue include FRUZAQLA, ELUNATE, SULANDA, ORPATHYS, and TAZVERIK.
Looking ahead to 2026,HUTCHMED expects oncology/immunology consolidated revenue in the range of $330 million to $450 million.
As of December 31, 2025 HUTCHMED had cash, cash equivalents and short-term investments of $1,367.3 million.
HCM has traded between $11.51 and $19.50 in the last year. The stock closed Friday's trade at $13.94, up 0.87.
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