Anruixi (zuberitamab) / Zhejiang Hisun Pharmaceutical - LARVOL DELTA

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

BR Combined With OR in Treatment-naïve Marginal Zone Lymphoma (clinicaltrials.gov) - P2 | N=37 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

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

Efficacy and safety of Zuberitamb combined with bendamustine alternating Zuberitamab combined with high-dose cytarabine first-line induction therapy for mantle cell lymphoma: a prospective, multicenter, single-arm clinical study (ChiCTR) - P=N/A | N=50 | Not yet recruiting | Sponsor: Second Affliated Hospital of Army Medical University, PLA; Second Affliated Hospital of Army Medical University, PLA

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

A prospective, multicenter, single-arm study of the OZB regimen (Orelabrutinib combined with zuberitamab and Bendamustine) in patients with indolent lymphoma (ChiCTR) - P=N/A | N=48 | Not yet recruiting | Sponsor: Taizhou Central Hospital (Affiliated Hospital of Taizhou University); Taizhou Central Hospital (Affiliated Hospital of Taizhou University)

New trial • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Oncology • CCND1 • CD20

Clinical Study on Zuberitamab for treating lupus nephritis (ChiCTR) - P4 | N=60 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Wenzhou Medical University; The First Affiliated Hospital of Wenzhou Medical University

New P4 trial • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

FIRST-AND SECOND-LINE THERAPY OF ZUBERITAMAB IN IDIOPATHIC MEMBRANOUS NEPHROPATHY: A SINGLE-CENTER RETROSPECTIVE STUDY (ISN-WCN 2025) - "While rituximab has significantly improved outcomes for patients with IMN, its efficacy is not universal, and resistance is common. Download: Download high-res image (78KB) Download: Download full-size image Download: Download high-res image (166KB) Download: Download full-size image Conclusions Zuberitamab shows significant effectiveness and favorable safety in the clinical treatment of IMN. It represents a promising therapeutic option for Chinese patients with IMN."

Retrospective data • Glomerulonephritis • Renal Disease

A multicenter, randomized, open label, cyclosporine controlled phase II clinical study evaluating the efficacy and safety of Zuberitamab Injection (HS006) in patients with primary membranous nephropathy (ChiCTR) - P2 | N=135 | Sponsor: Zhongshan Hospital, Fudan University; BioRay Pharmaceutical Co.,Ltd.

New P2 trial • Glomerulonephritis • Renal Disease

Efficacy and Safety of Zuberitamab Combined with Bendamustine, Followed by Monotherapy Maintenance, in Treatment-naïve Follicular Lymphoma (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Sun Yat-sen University

Monotherapy • New P2 trial • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

Comparison of zuberitamab plus CHOP versus rituximab plus CHOP for the treatment of drug-naïve patients diagnosed with CD20-positive diffuse large B-cell lymphoma: a phase 3 trial. (PubMed, J Immunother Cancer) - "Zuberitamab (375 mg/m2) plus CHOP was non-inferior to R-CHOP regarding ORR but exhibited a higher CR rate and was well tolerated in CD20-positive, previously untreated Chinese patients with DLBCL."

Clinical • Journal • P3 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20