Anruixi (zuberitamab) / Zhejiang Hisun - LARVOL DELTA

A Phase II Trial of Orelabrutinib Combined with Zuberitamab in Previously Untreated Marginal Zone Lymphoma: A Multicenter, Single-Arm Study (ZOOM Trial) (ICML 2025) - No abstract available

Clinical • P2 data • 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

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

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

A Phase II Study of Zuberitamab Injection in Patients With Primary Membranous Nephropathy (clinicaltrials.gov) - P2 | N=135 | Not yet recruiting | Sponsor: BioRay Pharmaceutical Co., Ltd.

New P2 trial • Glomerulonephritis • Renal Disease

Antibodies to watch in 2024. (PubMed, MAbs) - "In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi))...These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa)...Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates..."

Journal • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases

LYMPHOPE: A real-world study of Zuberitamab Injection in Chinese patients with diffuse large B-cell lymphoma (ChiCTR) - P=N/A | N=500 | Not yet recruiting | Sponsor: HARBIN THE FIRST HOSPITAL; HARBIN THE FIRST HOSPITAL

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

COMPARISON OF ZUBERITAMAB PLUS CHOP WITH RITUXIMAB PLUS CHOP FOR THE TREATMENT OF DRUG-NAÏVE PATIENTS DIAGNOSED WITH CD20-POSITIVE DIFFUSE LARGE B-CELL LYMPHOMA: A PHASE 3 TRIAL (EHA 2024) - "Zuberitamab (375 mg/m2) plus CHOP was non-inferior to rituximab plus CHOP regarding ORR butdemonstrated a higher CR rate, along with a tendency of lower risk of disease progression and death in CD20-positive, previously untreated Chinese DLBCL patients, especially in GCB subtype. Besides it was well-tolerated."

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

Zuberitamab, an innovative anti-CD20 monoclonal antibody, for patients with primary immune thrombocytopenia in China: a randomized, double-blind, placebo-controlled, phase 2 study. (PubMed, Lancet Reg Health West Pac) - "Primary immune thrombocytopenia (ITP) is an autoimmune disease, and rituximab (RTX) induces long-term effect as second-line treatments. National Natural Science Foundation of China and Zhejiang Bioray Biopharmaceutical Co. Ltd."

Clinical • Journal • P2 data • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Lymphoma • Oncology • Thrombocytopenia • Thrombocytopenic Purpura

Zuberitamab (Anruixi), the first domestically developed anti-CD20 antibody as a Class I innovative drug from BioRay Pharmaceutical, has been approved for marketing in China (PRNewswire) - "Recently, BioRay Pharmaceutical Co., Ltd...announced that its independently developed Class I innovative therapeutic biological product, Zuberitamab Injection (trade name: Anruixi®), indicated for the treatment of CD20-positive diffuse large B-cell lymphoma (DLBCL), was officially approved for marketing by the National Medical Products Administration (NMPA)."

Non-US regulatory • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Characterization and exploration of an artifact in the reducing capillary electrophoresis-sodium dodecyl sulfate analysis of the 'me-too' drug zuberitamab related to rituximab. (PubMed, J Pharm Biomed Anal) - "We concluded that noncovalent protein aggregation can be related to strong hydrophobicity and low electrostatic repulsion of local amino acid regions, which complicates drug quality control. These findings shed light on the relationship between protein aggregation and the local hydrophobicity region, and broaden the way to analyze the detection 'artifacts' in reducing CE-SDS studies of therapeutic proteins."

Journal • Review