Anruixi (zuberitamab) / BioRay Biopharmaceutical - LARVOL DELTA

Real-World Efficacy and Safety of Zuberitamab-Based Regimens in Previously Untreated Diffuse Large B-Cell Lymphoma: A Retrospective Single-Center Study (ESMO 2026) - No abstract available

Real-world • Real-world effectiveness • Real-world evidence • Retrospective data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Evaluation of the Efficacy of Zuberitamab Injection in Patients With Primary Membranous Nephropathy (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: BioRay Pharmaceutical Co., Ltd.

New P3 trial • Glomerulonephritis • Renal Disease

Zuberitamab in the First Episode of Paediatric Nephrotic Syndrome (clinicaltrials.gov) - P3 | N=120 | Not yet recruiting | Sponsor: Children's Hospital of Fudan University

New P3 trial • Glomerulonephritis • Nephrology • Pediatrics • Renal Disease • CD20

Orelabrutinib Combined With Induction Therapy Followed by Sequential Monotherapy Maintenance in MCD Subtype Diffuse Large B-cell Lymphoma (clinicaltrials.gov) - P2 | N=66 | Not yet recruiting | Sponsor: Ou Bai, MD/PHD

Monotherapy • New P2 trial • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

PROSPECTIVE EXPLORATION OF ZUBERITAMAB, LENALIDOMIDE COMBINED WITH ORELABRUTINIB (HRO) IN THE TREATMENT OF NEWLY DIAGNOSED MARGINAL ZONE LYMPHOMA. (EHA 2026) - "No atrial fibrillation or bleeding related to BTK inhibitors occurred. Summary/Conclusion The HRO regimen as first-line treatment for MZL, especially in elderly patients with high-risk features, is a safe and effective treatment strategy, and future research updates will include more follow-up data."

Clinical • Atrial Fibrillation • B Cell Non-Hodgkin Lymphoma • Cardiovascular • Extranodal Marginal Zone Lymphoma • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma

MRD-DRIVEN TRIPLET THERAPY WITH ORELABRUTINIB, POMALIDOMIDE, AND ZUBERITAMAB FOR NEWLY DIAGNOSED INTERMEDIATE/HIGH-RISK MANTLE CELL LYMPHOMA (EHA 2026) - P=N/A | "The OASIS2 trial demonstrated that adding venetoclax to ibrutinib and rituximab yields superior complete response (CR) and undetectable minimal residual disease (uMRD) rates, supporting the potential of BTKi + CD20 monoclonal antibody (mAb) + X regimens, particularly for high-risk MCL. Continued follow-up is warranted to assess the primary endpoint of uMRD and long-term durability of response. ."

Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukopenia • Lymphoma • Mantle Cell Lymphoma • Neutropenia • Pruritus • Respiratory Diseases • TP53

Primary thyroid lymphoma with Hashimoto's thyroiditis: A case report and literature review. (PubMed, Oncol Lett) - "The patient received four cycles of zuberitamab (a novel anti-CD20 monoclonal antibody) plus mini-CHOP therapy, with CT imaging demonstrating notable tracheal re-expansion after the first cycle...In conclusion, the present case exemplifies that elderly patients with rapidly enlarging neck masses require urgent evaluation to distinguish between thyroid lymphoma and carcinoma. While individual case results cannot be generalized to all clinical scenarios, prompt diagnosis followed by appropriate treatment remains critical for favorable outcomes."

Journal • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Endocrine Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • Thyroid Gland Carcinoma

Case Report: A case of type II cryoglobulinemia secondary to diffuse large B-cell lymphoma. (PubMed, Front Oncol) - "The patient received chemotherapy with the zuberitamab plus CHOP regimen...This case illustrates the diagnostic and therapeutic management of type II cryoglobulinemia secondary to DLBCL. It highlights the importance of closely monitoring clinical manifestations and implementing early intervention for related complications during the treatment of B-cell lymphoproliferative disorders, aiming to reduce the high mortality rate and improve patient outcomes."

Journal • Acute Kidney Injury • B Cell Lymphoma • Complement-mediated Rare Disorders • Cough • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Hepatitis C • Hepatology • Immunology • Infectious Disease • Liver Failure • Lymphoma • Musculoskeletal Pain • Nephrology • Non-Hodgkin’s Lymphoma • Oncology • Renal Disease • Respiratory Diseases

EFFECTIVENESS AND SAFETY OF ZUBERITAMAB IN MEMBRANOUS NEPHROPATHY PATIENTS : A MULTICENTER RETROSPECTIVE STUDY (ISN-WCN 2026) - "Baseline eGFR was significantly higher in patients who achieved CR or PR (100.90 [87.94, 115.62] ml/min/1.73 m2) at 6 months compared with those who did not (88.00 [60.59, 101.57] ml/min/1.73 m2, P=0.002); baseline serum albumin levels were also higher in patients who achieved CR or PR (P =0.026). No serious adverse events were detected.Conclusion Zuberitamab demonstrated favorable real-world effectiveness and safety in MN patients, with significantly reduced urinary protein levels, particularly in individuals with normal or mildly impaired renal function."

Retrospective data • Glomerulonephritis • Renal Disease

Treatment of BTKi+Hi-CVP Regimen for Previously Untreated MZL (clinicaltrials.gov) - P2 | N=65 | Active, not recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

New P2 trial • Hematological Malignancies • Marginal Zone Lymphoma • Oncology • CD20

Efficacy and safety of zuberitamab in the treatment of primary membranous nephropathy: an observational study. (PubMed, Front Immunol) - "Using 1:1 propensity score matching, we selected a comparable control cohort of 25 PMN patients who received rituximab during the same period (RTX group). Zuberitamab may be a promising treatment option for PMN, demonstrating a high complete remission rate and sustained proteinuria reduction in this study. Large-scale prospective studies are warranted to confirm these findings."

Journal • Observational data • Glomerulonephritis • Renal Disease

Bendamustine combined with Zuberitamab (BZ) followed by Orelabrutinib combined with Zuberitamab (OZ) in the treatment of newly diagnosed marginal zone lymphoma:A Phase II prospective clinical study (ChiCTR) - P=N/A | N=74 | Not yet recruiting | Sponsor: The First Affiliated Hospital of the Air Force Medical University; The First Affiliated Hospital of the Air Force Medical University

New trial • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Oncology • CD20

First-line and Second-line Therapy of Zuberitamab in Idiopathic Membranous Nephropathy: A Single-center Retrospective Study. (PubMed, Kidney Med) - "Zuberitamab was associated with favorable clinical and immunologic responses in patients with IMN, including those previously treated with rituximab. These findings support its potential role as a therapeutic option, warranting further validation in prospective studies."

Journal • Retrospective data • Glomerulonephritis • Nephrology • Renal Disease

Trium study: Exploring MRD-guided triplet therapy with sonrotoclax, zanubrutinib, and CD20mab in Untreated Mantle Cell Lymphoma: A prospective, multicenter, Phase II Study (ASH 2025) - P2 | "Sonrotoclax (BGB-11417), a next-generation BCL-2 inhibitor, exhibits higher selectivity andpharmacological potency than venetoclax, with a shorter half-life and no drug accumulation.Zanubrutinib, a next-generation BTK inhibitor, has shown favorable safety and efficacy profiles intreatment-naïve (TN) MCL patients.ObjectiveTo evaluate the efficacy and safety of sonrotoclax-containing, chemotherapy-free triplet inductiontherapy in TN MCL.MethodsThis open-label, single-arm, multicenter trial (NCT06463691) enrolled treatment-naïve MCL patients.Patients received zanubrutinib (160 mg BID) plus zuberitamab, a novel CD20mab with enhancedantibody-dependent cellulal cytotoxicity, for 2 cycles as lead-in treatment. ConclusionsThe preliminary results indicate sonrotoclax combined with zanubrutinb and zuberitamab showedpromising efficacy, with manageable toxicity and tolerability. The study is ongoing, and further resultsand details will be updated."

Clinical • P2 data • Atrial Fibrillation • Cardiovascular • Hematological Disorders • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Thrombocytopenia • TP53

Effectiveness and safety of polatuzumab vedotin combined with zuberitamab plus cyclophosphamide, doxorubicin and prednisone in untreated diffuse large B-cell lymphoma: A real-world study from China (ASH 2025) - "Introduction Polatuzumab vedotin (pola) plus rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP)demonstrated superior progression-free survival versus R-CHOP in untreated diffuse large B-celllymphoma (DLBCL) with comparable safety. Safety profiles aligned with established expectations for polatuzumab-based or zuberitamab-based regimens, with no new signals identified. These findings provide preliminary evidence supportingfurther evaluation of this novel combination in randomized controlled trials, particularly in subgroupsdefined by cell-of-origin and double-expression status."

Clinical • IO biomarker • Real-world • Real-world evidence • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • BCL2 • MYC

Zuberitamab for EBV Infection Post-Allo-HSCT (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China

New P2 trial • Bone Marrow Transplantation • Epstein-Barr Virus Infections • Infectious Disease • Transplantation

Pomalidomide Plus Orelabrutinib and Zuberitamab in Untreated Mantle Cell Lymphoma (clinicaltrials.gov) - P=N/A | N=34 | Recruiting | Sponsor: Peking University Third Hospital

New trial • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology

Cost-Effectiveness of First-Line Zuberitamab-CHOP versus Rituximab-CHOP Regimens in Untreated CD20+ Diffuse Large B-Cell Lymphoma in China. (PubMed, Risk Manag Healthc Policy) - "To conduct a cost-effectiveness analysis comparing zuberitamab combined with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone; Hi-CHOP) versus rituximab combined with CHOP (R-CHOP) as first-line therapy for previously untreated CD20-positive diffuse large B-cell lymphoma (DLBCL) patients in China. The cost-effectiveness acceptability curve (CEAC) demonstrated R-CHOP's superior cost-effectiveness probability relative to Hi-CHOP across a WTP range from $0 to $150,000. Given that Hi-CHOP is not cost-effective at conventional WTP thresholds, a substantial price reduction or unnecessary procedures, and optimizing clinical workflows for Hi-CHOP would be necessary to make it an economically viable first-line option for DLBCL compared to R-CHOP."

HEOR • Journal • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

A Phase II Study of Zuberitamab Injection in Patients With Primary Membranous Nephropathy (clinicaltrials.gov) - P2 | N=135 | Active, not recruiting | Sponsor: BioRay Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Dec 2027 ➔ May 2027 | Trial primary completion date: Dec 2027 ➔ Mar 2027

Enrollment closed • Trial completion date • Trial primary completion date • Glomerulonephritis • Renal Disease

Glofitamab Plus Polatuzumab Vedotin and Zuberitamab in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Li Zhiming

New P2 trial • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Preliminary Results of a Retrospective Study on a Regimen Based on Orelabrutinib Combined with Anti-CD20 Monoclonal Antibody in Patients with Marginal Zone Lymphoma (ASH 2024) - "The treatment protocol involved initial therapy with anti-CD20 monoclonal antibodies (rituximab, obinutuzumab, and zuberitamab), with or without bendamustine to control the tumor load. No significant adverse events (AEs) led to drug discontinuation or dose reduction, with AEs including bone marrow suppression, herpes zoster, sleep disturbances, gastrointestinal disorders, and fever.Conclusion : The combination of Orelabrutinib with anti-CD20 monoclonal antibodies, with or without bendamustine, has demonstrated promising efficacy and safety in the treatment of MZL. The follow-up time of this study is short, and the dynamic changes of MRD will be updated later, and the timing of drug withdrawal will be monitored by uMRD and CR."

Retrospective data • CNS Disorders • Extranodal Marginal Zone Lymphoma • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Herpes Zoster • Indolent Lymphoma • Lymphoma • Marginal Zone Lymphoma • Nodal Marginal Zone Lymphoma • Oncology • Sleep Disorder • Splenic Marginal Zone Lymphoma • Varicella Zoster

ZSDT for the treatment of recurrent refractory mantle cell lymphoma after BTK inhibitor failure: a multi-center prospective clinical trial (ChiCTR) - P4 | N=30 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University

New P4 trial • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology

A prospective, single-arm, phase II clinical study of RCHOP (zuberitamab, cyclophosphamide, vincristine, doxorubicin, prednisone) combined with chidamide in the treatment of newly diagnosed angioimmunoblastic T-cell lymphoma with positive Ig rearrangement (ChiCTR) - P2 | N=46 | Not yet recruiting | Sponsor: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital

New P2 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

A PHASE II TRIAL OF ORELABRUTINIB COMBINED WITH ZUBERITAMAB IN PREVIOUSLY UNTREATED MARGINAL ZONE LYMPHOMA: A MULTICENTER, SINGLE-ARM STUDY (ZOOM TRIAL) (ICML 2025) - "Interim analysis occurs after 17evaluable patients. Current Status: 5 patients enrolled; recruitment ongoing"

Clinical • P2 data • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Marginal Zone Lymphoma • Oncology

A PROSPECTIVE, TWO-ARM, PHASE II STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORELABRUTINIB PLUS ZUBERITAMAB WITH OR WITHOUT LENALIDOMIDE (HILO) IN PATIENTS WITH TREATMENT-NAÏVE MARGINAL ZONE LYMPHOMA (EHA 2025) - "The applications of rituximab (R)-based regimens for MZL first-line treatment were restricted by an unfavorable risk-benefit balance, highlighting the need for novel strategies to enhance efficacy and reduce toxicity. None. Trial in progress."

Clinical • P2 data • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology