• Phase Ib trial to evaluate CS5001 in combination with R-CHOP as a first-line treatment for diffuse large B-cell lymphoma (DLBCL), aiming to reshape the standard-of-care landscape.
• CS5001 is also being investigated globally in a multi-center Phase Ib clinical trial for multiple solid tumor types.

CStone Pharmaceuticals ("CStone", HKEX: 2616), a biopharmaceutical company dedicated to developing innovative cancer therapies, today announced the submission of a Phase Ib clinical trial application in Australia for CS5001, its ROR1-targeting antibody-drug conjugate (ADC), in combination with first-line standard-of-care (SoC) for DLBCL. CS5001 is also being evaluated as both a monotherapy and in combination with a PD-L1 inhibitor for advanced solid tumors in an ongoing global multi-center clinical trial.

Building on promising data from CS5001 monotherapy in later-line aggressive and indolent lymphomas, this Phase Ib trial aims to expand the therapeutic potential of CS5001 across all DLBCL stages and solid tumors. The study will explore:

• CS5001 + R-CHOP: First-line treatment for DLBCL patients who have not received prior systemic therapy.
• CS5001 + SoC: For patients with relapsed or refractory DLBCL.
• CS5001 Monotherapy: Targeting ROR1-expressing solid tumors.
• CS5001 + Sugemalimab: Combination therapy for advanced solid tumors.

Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, stated: "We are thrilled to reach another key clinical milestone for CS5001. The existing data underscore its broad potential in both lymphomas and solid tumors. Notably, a ROR1 ADC combined with R-CHP has demonstrated an impressive complete response (CR) rate in a Phase II trial for first-line DLBCL. As we advance from late-line monotherapy to frontline combination therapy, we are optimistic that CS5001 will provide significant clinical benefits to DLBCL patients and establish itself as a first-line treatment option. Meanwhile, we continue to explore CS5001's potential in solid tumors and eagerly anticipate further positive outcomes."

The global multi-center Phase Ib trial for CS5001 is actively enrolling patients across the United States, Australia, and China. Recruitment is ongoing for monotherapy cohorts targeting aggressive and indolent advanced lymphomas, which could potentially expand into a Phase II single-arm registrational study. Additional cohorts, including the first-line DLBCL combination therapy and solid tumor monotherapy and combination therapy arms, will be initiated soon.