Junshi Biosciences begins late-stage lymphoma drug trial
A biopharmaceutical company has completed the first patient dosing in a late-stage trial of a new treatment for a common and aggressive form of blood cancer. Junshi Biosciences announced the milestone in its Phase 3 study of JS203, a bispecific antibody designed to combine with chemotherapy for patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). The trial, the first registrational study for JS203, will compare its efficacy against the standard treatment of rituximab plus chemotherapy.
Lymphoma’s rising toll in China
Diffuse large B-cell lymphoma accounts for roughly 40% of adult non-Hodgkin lymphoma cases in China, with about 45,000 new cases diagnosed annually, according to GLOBOCAN 2022 statistics, and the disease’s incidence rate shows a slow but steady increase. The disease is known for its rapid progression, and even after treatment, patients with relapsed or resistant forms have a median overall survival of over one year and a five-year survival rate of around 30%, according to Asian population data. These figures highlight the urgent need for more effective therapies.
JS203 works by targeting two proteins: CD20, found on lymphoma cells, and CD3, found on T cells. By binding to both, the antibody recruits T cells to attack and destroy cancer cells. Early results from a Phase 1 trial showed promising outcomes when JS203 was used alone at the recommended dose.
Among patients with CD20-positive relapsed or refractory B-cell lymphoma, the objective response rate (ORR) reached 72.4%, with a complete response rate (CRR) of 39.4% in those with DLBCL, and persistent relief was observed. Among all DLBCL patients in the Phase 1 study, the ORR was 69.7%, reinforcing the consistency of response across different patient subgroups. Safety data also indicated a manageable profile, with cytokine release syndrome (CRS) occurring in 27.3% of cases and no reports of immune effector cell-associated neurotoxicity syndrome (ICANS).
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The JS203-003-III-DLBCL Study is a randomized, open-label, multicenter trial led by Professor Yuqin Song of Beijing Cancer Hospital. The study team has emphasized that early clinical studies have shown encouraging efficacy and a favorable safety profile for JS203 in combination with chemotherapy in patients with R/R DLBCL. It will enroll 282 patients and measure overall survival (OS) as its primary endpoint. The study’s design reflects the need for rigorous comparison against the current standard of care—rituximab plus chemotherapy—to determine whether JS203 offers meaningful improvements in survival and tolerability.
Junshi’s expanding pipeline beyond JS203
Junshi Biosciences has positioned JS203 as part of a broader pipeline of innovative therapies, including toripalimab, an anti-PD-1 monoclonal antibody approved in over 50 countries, including China, the U.S., and Europe. The company, founded in 2012, employs over 3,000 people globally and focuses on developing treatments for cancer, autoimmune, metabolic, and infectious diseases using modalities such as antibody-drug conjugates (ADCs), bispecific antibodies (bsAbs), fusion proteins, monoclonal antibodies (mAbs), small-molecule drugs, nucleic acid drugs, and vaccines. Five of its products have received marketing authorizations in China and international markets, with toripalimab representing its first domestically developed anti-PD-1 therapy to gain global approval.
For more information, please visit: Junshi Biosciences. Junshi Biosciences Contact Information: IR Team: [email protected], +86 021-6105 8800; PR Team: [email protected], +86 021-6105 8800.
