CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Complement dependent cytotoxicity (CDC) effects

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [3]

Active Indication

CD20 positive Diffuse Large B-Cell LymphomaIdiopathic Membranous GlomerulonephritisRheumatoid Arthritis

Inactive Indication

CD20 Positive B-Cell Non-Hodgkin LymphomaCD20 positive Large B-cell lymphomaCD20 positive Non-Hodgkin Lymphoma+ [2]

Originator Organization

BioRay Biopharmaceutical Co., Ltd.

Active Organization

BioRay Biopharmaceutical Co., Ltd.

Inactive Organization

Beijing Mabworks Biotech Co., Ltd.

Zhejiang Hisun Pharmaceutical Co., Ltd.

License Organization

Wuzhou Drug International Trading Co., Ltd.

Zhejiang Hisun Pharmaceutical Co., Ltd.

BioRay Biopharmaceutical Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

China (12 May 2023),

CD20 positive Diffuse Large B-Cell Lymphoma

Regulation-

Structure/Sequence

Sequence Code 616720952H

Source: *****

Sequence Code 616720955L

Source: *****

Clinical Trials associated with Zuberitamab

NCT07830433

/ Not yet recruitingPhase 3

Evaluation of the Efficacy of Zuberitamab Injection in Patients With Primary Membranous Nephropathy

This is a randomized, open-label, cyclosporine-controlled, multicenter Phase III study. It aims to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of zuberitamab versus cyclosporine in patients with primary membranous nephropathy, and provide evidence to support the expansion of zuberitamab's indication for primary membranous nephropathy. Approximately 150 study participants are expected to be enrolled in this trial and randomized in a 1:1 ratio to the HS006 1000 mg group (treatment group) and the cyclosporine group (control group), with 75 participants in each arm.

Start Date01 Oct 2026

Sponsor / Collaborator

BioRay Biopharmaceutical Co., Ltd.

NCT07765914

/ Not yet recruitingPhase 3IIT

Efficacy and Safety of Single-dose Zuberitamab in the Initial Episode of Paediatric Steroid-sensitive Nephrotic Syndrome: A Multicenter Randomized Controlled Trial

The goal of this clinical trial is to learn whether adding Zuberitamab to standard corticosteroid therapy can help prevent relapse in children and adolescents aged 1 to 18 years with newly diagnosed steroid-sensitive nephrotic syndrome (SSNS). It will also learn about the safety of Zuberitamab.
The main questions it aims to answer are:
* Does Zuberitamab plus standard corticosteroid therapy prolong the time to first relapse compared with standard corticosteroid therapy alone?
* What medical problems do participants experience during treatment?
Researchers will compare Zuberitamab plus standard corticosteroid therapy to standard corticosteroid therapy alone to see whether adding Zuberitamab improves disease control.
Participants will:
* Receive standard corticosteroid treatment for approximately 12 weeks, with or without a single intravenous infusion of Zuberitamab after achieving remission
* Take preventive antibiotics if they are in the Zuberitamab group
* Test their urine daily at home using dipsticks and record results in a diary
* Visit the clinic for regular checkups and blood and urine tests during follow-up for up to 12 months

Start Date20 Aug 2026

Sponsor / Collaborator

Paediatrics Hospital Affiliated To Fudan University

[+5]

ChiCTR2600134003

/ SuspendedPhase 2IIT

Efficacy and Safety of Ultra-Low-Dose Radiotherapy Combined with Zuberitamab in the Treatment of Localized Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma: A Prospective, Single-Arm, Phase II Clinical Study

Start Date01 Jul 2026

Sponsor / Collaborator-

100 Clinical Results associated with Zuberitamab

100 Translational Medicine associated with Zuberitamab

100 Patents (Medical) associated with Zuberitamab

Literatures (Medical) associated with Zuberitamab

01 Jan 2026·Kidney Medicine

First-line and Second-line Therapy of Zuberitamab in Idiopathic Membranous Nephropathy: A Single-center Retrospective Study

Article

Author: Wang, Linna ; Yang, Miaomiao ; Shao, Fengmin ; Yan, Lei

Rationale & Objective:

Idiopathic membranous nephropathy (IMN) is a major cause of nephrotic syndrome. Although rituximab has improved outcomes, resistance or intolerance occurs in a subset of patients. Zuberitamab, a chimeric anti-CD20 immunoglobulin G1 monoclonal antibody, may offer an alternative therapeutic option. This study aimed to evaluate the effectiveness and safety of zuberitamab in patients with phospholipase A2 receptor (PLA2R)-associated IMN.

Study Design:

Single-center, retrospective observational cohort study.

Setting & Participants:

Sixty patients with biopsy-proven or serologically diagnosed PLA2R-associated IMN were treated with zuberitamab at Henan Provincial People's Hospital between July 2023 and June 2024. Thirty-five received zuberitamab as first-line therapy; 25 received it as second-line therapy following prior immunosuppressive treatment.

Interventions:

Zuberitamab infusions administered in 2-3 doses over several months, guided by B-cell kinetics.

Outcomes:

The primary outcome was complete or partial remission of proteinuria at 3 and 6 months. Secondary outcomes included changes in serum albumin, serum creatinine, estimated glomerular filtration rate, CD19+ B cells, and anti-PLA2R antibody titers.

Results:

At month 3, 80% (48/60) of patients achieved remission (5 complete and 43 partial). By month 6, 13 patients achieved complete remission (11 first line and 2 second line; P = 0.03), and 35 achieved partial remission. Serum albumin levels improved, whereas proteinuria and creatinine levels declined in both groups. At 6 months, PLA2R antibody < 2 RU/mL was seen in 90.9% (30/33) of first-line and 81.0% (17/21) of second-line patients (P = 0.29). No serious adverse events were observed.

Limitations:

Single-center, retrospective design; short follow-up; no direct comparator group; incomplete biomarker data owing to testing limitations.

Conclusions:

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.

01 Jun 2024·Lancet Regional Health-Western Pacific

Zuberitamab, an innovative anti-CD20 monoclonal antibody, for patients with primary immune thrombocytopenia in China: a randomized, double-blind, placebo-controlled, phase 2 study

Article

Author: Yuan, Guolin ; Qian, Shenxian ; Shu, Jinhui ; Song, Yanping ; Zhou, Hu ; Xu, Min ; Wang, Shuye ; Lin, Li-E ; Mei, Heng ; Liu, Qingchi ; Huang, Meijuan ; Hu, Yu ; Gong, Yuping ; Zhou, Zeping ; Lou, Shifeng ; Huang, Ruibin ; Guo, Jingming

Background:

Primary immune thrombocytopenia (ITP) is an autoimmune disease, and rituximab (RTX) induces long-term effect as second-line treatments. Zuberitamab is an innovative anti-CD20 monoclonal antibody, which was first developed in China and launched in diffuse large B lymphoma. This study aimed to investigate the safety, efficacy, and anticipated therapeutic dose of zuberitamab in Chinese ITP patients.

Methods:

This randomised, double-blind, placebo-controlled, phase 2 study was conducted at 26 hospitals in China. Eligible patients were aged 18-70 years, had primary immune thrombocytopenia for more than 6 months, and did not respond or relapsed after previous treatment and had a pre-treatment platelet count of <30 × 10⁹/L. Patients randomly received zuberitamab in a dose escalation (100/300/600 mg) or placebo once-weekly for 4 weeks and followed up to 24 weeks. The primary endpoint is the proportion of patients with a platelet count ≥50 × 10⁹/L at week 8. Secondary endpoints include the proportion of patients with platelet counts ≥50 × 10⁹/L or ≥100 × 10⁹/L at least once within week 12/24, the proportion of patients experiencing platelets increased twice more than baseline as well as ≥30 × 10⁹/L at least once during the treatment. Adverse events, pharmacokinetic, B cell depletion and immunogenicity were also assessed. This study is registered with https://www.chictr.org.cn/as ChiCTR2100050513.

Findings:

From October 2021 to March 2023, 50 patients were screened for eligibility, of whom 32 patients were enrolled and randomly assigned to placebo (n = 4), zuberitamab 100 mg (n = 10), 300 mg (n = 8) and 600 mg (n = 10) groups. The primary endpoint (PLT ≥50 × 10⁹/L at week 8) was achieved by 40% of patients in the 100 mg group, while none in the other groups. Within 12 weeks, the proportions of patients in each treatment group achieving at least one instance of platelet count ≥50 × 10⁹/L or ≥100 × 10⁹/L or an increase twice more than baseline as well as ≥30 × 10⁹/L were (70%, 38%, 50%), (60%, 13%, 30%), and (80%, 50%, 70%) in zuberitamab 100/300/600 mg groups, respectively. By week 24, the proportions of patients achieving these secondary endpoints remained relatively stable or showed a mild increase of around 10%. The anticipated therapeutic dose of zuberitamab was 100 mg. The plasma concentration of zuberitamab showed an increasing trend with dose (100 mg-600 mg) and linear pharmacokinetic behavior. CD19+ B cells and CD20+ B lymphocytes rapidly declined to 0% within one week and consistently maintained reduced levels throughout the entire treatment phase in three groups. Adverse events occurred in all patients with most of them were mild to moderate, no severe infections occurred. A slight decrease in immunoglobulins was observed in the 600 mg group, but gradually recovered at week 20. Three patients (2 in 100 mg and 1 in 600 mg group) were tested positive for anti-zuberitamab antibodies. We also observed that women, disease duration <12 months, and MAIPA + patients may have higher response rates.

Interpretation:

This study preliminarily confirmed that 100 mg zuberitamab was safe and effective in treating ITP and was recommended to support further investigation.

Funding:

National Natural Science Foundation of China and Zhejiang Bioray Biopharmaceutical Co. Ltd.

03 Oct 2018·Journal of biomolecular structure & dynamics

The role of the oximes HI-6 and HS-6 inside human acetylcholinesterase inhibited with nerve agents: a computational study

Article

Author: Kuca, Kamil ; Gonçalves, Arlan da Silva ; da Silva, Jorge Alberto Valle ; Ramalho, Teodorico C. ; C.C. França, Tanos ; Cuya, Teobaldo

The oximes 4-carbamoyl-1-[({2-[(E)-(hydroxyimino) methyl] pyridinium-1-yl} methoxy) methyl] pyridinium (known as HI-6) and 3-carbamoyl-1-[({2-[(E)-(hydroxyimino) methyl] pyridinium-1-yl} methoxy) methyl] pyridinium (known as HS-6) are isomers differing from each other only by the position of the carbamoyl group on the pyridine ring. However, this slight difference was verified to be responsible for big differences in the percentual of reactivation of acetylcholinesterase (AChE) inhibited by the nerve agents tabun, sarin, cyclosarin, and VX. In order to try to find out the reason for this, a computational study involving molecular docking, molecular dynamics, and binding energies calculations, was performed on the binding modes of HI-6 and HS-6 on human AChE (HssAChE) inhibited by those nerve agents.

News (Medical) associated with Zuberitamab

19 Oct 2026

·www.biospace.com

Three Orelabrutinib Studies Presented in Oral Sessions at the 88th Annual Meeting of the Japanese Society of Hematology

BEIJING, Oct. 16, 2026 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that three studies of orelabrutinib, its novel BTK inhibitor, have been selected for oral presentations at the 88th Annual Meeting of the Japanese Society of Hematology (JSH 2026). The studies focused on real-world data of orelabrutinib monotherapy for chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL), preliminary Phase II results of an orelabrutinib regimen as first-line treatment for marginal zone lymphoma (MZL), as well as Phase II results of an orelabrutinib regimen as first-line treatment for diffuse large B cell lymphoma (DLBCL). Professor Huayuan Zhu from Jiangsu Provincial Hospital, and professor Wenyu Shi from Affiliated Hospital of Nantong Hospital, delivered the oral presentations at the meeting. Key highlights are summarized below: 1. Orelabrutinib Monotherapy in Chinese Patients with CLL/SLL: A Multicenter Real-world Study (Presentation No.: O3-18D-2) Real-world data support orelabrutinib monotherapy in both first-line and relapsed/refractory (R/R) CLL/SLL. The retrospective study included 211 patients. At a median follow-up of 33.5 months, median progression free survival (PFS) and median overall survival (OS) were not reached, with 36-month PFS 80.0% and OS 91.3%, demonstrating durable survival benefits of orelabrutinib monotherapy in real-world Chinese patients with CLL/SLL. The first- and second-line pooled patient group exhibited significantly better PFS than the patients initiated orelabrutinib ≥3rd-line, with 36-month PFS rate of 81.8% vs. 70.3% respectively, suggesting that earlier initiation of orelabrutinib may yield superior progression-free survival benefits. The study also showed that the safety pro manageable. 2. Orelabrutinib+Zebetuzumab+Lenalidomide (OZL) in Newly Diagnosed MZL: Phase 2 Preliminary Results (Presentation No.: O3-18D-3) The chemo-free orelabrutinib+zebetuzumab+lenalidomide regimen demonstrated high response rates with deep remissions and a manageable safety pro newly diagnosed MZL. Of evaluable patients, all (100%) achieved overall response (OR) after 6 cycles of induction, including 62.5% complete responses (CRs). Among patients who were Minimal Residual Disease (MRD)-positivity at baseline, 70% achieved MRD negativity at the end of induction. The safety pro manageable, with no new safety signals identified. The study’s primary endpoint is 3-year progression free survival. Recruitment is currently ongoing. 3. PRO Regimen (Polatuzumab, Orelabrutinib, Rituximab) in Frail DLBCL Frontline Setting (Presentation No.: O2-6C-5) The chemo free orelabrutinib, polatuzumab and rituximab regimen showed high efficacy and manageable safety and is a promising frontline option for elderly and frail DLBCL patients including those over 80 years. The median age of patients was 78, with 43.6% over 80 and 74.3% with comorbidities. Among patients who completed 6 cycles of efficacy assessment, the complete response (CR) rate was 91.7%, and the overall response rate (ORR) was 95.8%. At a median follow up of 7.0 months, median PFS and OS were not reached and the estimated 9-month PFS rate was 92.8%. Outcomes were similar in patients over 80. The safety pro manageable. The 88th Annual Meeting of the JSH 2026 is hosted by the Japanese Society of Hematology, which was held from Oct. 9-11 at Kyoto, Japan. More information can be found at JSH official website. About InnoCare Pharma InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing innovative drugs for the treatment of cancers and autoimmune diseases, two therapeutic areas with unmet medical needs worldwide. InnoCare has established comprehensive innovation platforms for drug discovery. To date, the Company has developed a robust product pipeline comprising three approved drugs (orelabrutinib, tafasitamab and zurletrectinib), more than ten innovative drug candidates in clinical development, and multiple programs in preclinical stages. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. For more information about InnoCare, please visit and follow us on LinkedIn. Contact Media Investors Chunhua Lu 86-10-66609879 86-10-66609999 chunhua.lu@innocarepharma.com ir@innocarepharma.com

Clinical ResultPhase 2ASH

13 Sep 2023

·www.prnewswire.com

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

SHANGHAI, Sept. 13, 2023 /PRNewswire/ -- Recently, BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as "Bioray") 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). In preclinical studies, Anruixi® showed stronger antibody-dependent cell-mediated cytotoxicity (ADCC), a larger volume of distribution at steady state, and more sustained clearance of B cells, demonstrating better efficacy compared to other products. Positive results were observed in a randomized, double-blind, active-controlled phase III clinical trial of Anruixi®, conducted in 43 study sites nationwide with 487 subjects enrolled. In the head-to-head study with Rituximab, the overall response rate of Anruixi® + CHOP was not inferior to that of R-CHOP in patients with early-stage DLBCL, and it had a significantly higher complete response rate vs. R-CHOP. In terms of long-term survival benefits, the Anruixi® group achieved better 1-year, 2-year, and 3-year PFS and OS rates compared with the Rituximab group. As the first domestically developed Class I anti-CD20 drug in China, Anruixi® will become BioRay's next major product following Anruize®. Additionally, clinical research is being conducted to explore the use of Anruixi® in the field of autoimmune diseases, such as primary immune thrombocytopenia (ITP). "As the company's sixth product on the market and its first new drug in the field of tumor immunology，we are particularly grateful for the tremendous efforts made by the clinical researchers who participated in the product's clinical study, our partners, and our colleagues at Bioray." said Dr. Haibin Wang, CEO of Bioray. "In the future, Bioray will continue to focus on the field of immunology and the unmet medical needs, providing more clinical treatment options, and bringing more medical solutions to patients." About BioRay BioRay is a pioneer in China's biopharmaceutical industry focusing on immune-mediated diseases. Its extensive autoimmune and oncology portfolio includes six marketed products and over 10 clinical-stage drug candidates. Operating a fully integrated platform with end-to-end capabilities across drug discovery, clinical development, manufacturing, and commercialization, BioRay has over 1,700 employees globally, with main sites in Taizhou, Hangzhou, Shanghai, and San Diego. For more information about BioRay, please visit the company website: SOURCE BioRay Pharmaceutical Co., Ltd

Clinical ResultDrug ApprovalImmunotherapyPhase 3Phase 1

07 Jan 2022

·endpts.com

Planting another flag on Pfizer and Alnylam's turf, AstraZeneca grabs amyloidosis drug from the biotech that invented Aduhelm

AstraZeneca — or, more specifically, its rare disease subsidiary Alexion — is serious about getting into ATTR amyloidosis. Just weeks after licensing a late-stage antisense candidate from Ionis, AstraZeneca has struck another deal to pick up a Phase Ib antibody hitting the same target, this time from Swiss biotech Neurimmune. The upfront from Alexion comes in at $30 million, with the potential to add up to $730 million in milestones. Alexion is hoping the program would tackle transthyretin amyloid cardiomyopathy, or ATTR-CM, which is characterized by cardiac buildup of toxic amyloid fibrils. As ATTR-CM can lead to progressive heart failure and be fatal, the deal fits into AstraZeneca’s broader ambitions to become the leader in heart failure, integrating into a portfolio that also features the SGLT2 inhibitor Farxiga. Eplontersen, the antisense compound it scored from Ionis weeks ago for $200 million in cash, is also being tested in ATTR cardiomyopathy (in addition to ATTR polyneuropathy). “With 30 years of experience in developing medicines for people with rare diseases, Alexion is uniquely positioned to advance innovative science for small patient populations who are frequently underdiagnosed,” CEO Marc Dunoyer said. Dubbed NI006, the Neurimmune drug specifically targets misfolded transthyretin and is designed to spur the removal of amyloid fibril deposits in the heart. Neurimmune is known for its other amyloid-clearing antibody, the FDA-approved Alzheimer’s drug Aduhelm, which was still known as aducanumab when it was licensed to Biogen. It will be responsible for completing the current Phase Ib trial, with Alexion shouldering part of the costs before taking over clinical development, manufacturing and commercialization. But Alexion will have plenty of catching up to do. Pfizer’s Vyndaqel and Vyndamax (two formulations of the same transthyretin-stabilizer, tafamidis) were approved two and a half years ago for ATTR-CM, and together they brought in more than $1 billion in sales just over the first nine months of 2021. Alnylam is also far ahead in testing its suite of RNAi therapies for the indication. In a statement, Alexion noted that “multiple mechanisms of action” will likely be required to address the needs of patients with various types and levels of severity of amyloidosis.

CollaborateAntibody

100 Deals associated with Zuberitamab

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
CD20 positive Diffuse Large B-Cell Lymphoma	China	BioRay Biopharmaceutical Co., Ltd.	12 May 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Idiopathic Membranous Glomerulonephritis	Phase 3	China	BioRay Biopharmaceutical Co., Ltd.	20 Sep 2026
Purpura, Thrombocytopenic, Idiopathic	Phase 2	China	BioRay Biopharmaceutical Co., Ltd.	28 Oct 2021
CD20 positive Non-Hodgkin Lymphoma	Phase 2	China	Zhejiang Hisun Pharmaceutical Co., Ltd.	27 May 2016
CD20 positive Non-Hodgkin Lymphoma	Phase 2	China	Beijing Mabworks Biotech Co., Ltd.	27 May 2016
Indolent Non-Hodgkin Lymphoma	Phase 2	China	Beijing Mabworks Biotech Co., Ltd.	27 May 2016
Indolent Non-Hodgkin Lymphoma	Phase 2	China	Zhejiang Hisun Pharmaceutical Co., Ltd.	27 May 2016
CD20 positive Large B-cell lymphoma	Phase 2	-	Zhejiang Hisun Pharmaceutical Co., Ltd.	12 May 2016
CD20 Positive B-Cell Non-Hodgkin Lymphoma	Phase 1	China	Beijing Mabworks Biotech Co., Ltd.	26 Feb 2015
CD20 Positive B-Cell Non-Hodgkin Lymphoma	Phase 1	China	Zhejiang Hisun Pharmaceutical Co., Ltd.	26 Feb 2015
Rheumatoid Arthritis	IND Approval	China	BioRay Biopharmaceutical Co., Ltd.	07 Nov 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO2026	Not Applicable	Diffuse Large B-Cell Lymphoma First line CD20-positive	71	Zuberitamab-based regimens	wrsyazvasl(duurocejvd) = rrqeukipbr udhutexrsg (rdiklkupjn, 94.9 - 100.0) View more	Positive	23 Oct 2026
NCT07257510 (OASIS2, EHA2026)	Phase 1	Mantle-Cell Lymphoma First line	10	Orelabrutinib+Pomalidomide+Zuberitamab	flqqhyctiz(komsencdsf) = grade 2 pulmonary infection (n=1) alelhygrgl (yfdmovilfb ) View more	Positive	12 May 2026
CTR20180855 (EHA2024)	Phase 3	CD20 positive Diffuse Large B-Cell Lymphoma CD20 positive	483	Zuberitamab plus CHOP	fjtxzjpjfc(rxzajxnkuk) = hnhgehjlhi mkxwlndvtf (ljatqepofb ) View more	Positive	14 May 2024
CTR20180855 (EHA2024)	Phase 3	CD20 positive Diffuse Large B-Cell Lymphoma CD20 positive	483	Rituximab plus CHOP	fjtxzjpjfc(rxzajxnkuk) = wanklujvzu mkxwlndvtf (ljatqepofb ) View more	Positive	14 May 2024
CTR20180855 (NEWS) Manual	Phase 3	Diffuse Large B-Cell Lymphoma	483	Zebituzumab + CHOP	ehldatdqdz(vwfpasrdhx) = camqkdewit jxrgreyqek (opqxqphkkf ) Met View more	Superior	17 May 2023
CTR20180855 (NEWS) Manual	Phase 3	Diffuse Large B-Cell Lymphoma	483	Rituximab + CHOP	ehldatdqdz(vwfpasrdhx) = hspxypvyao jxrgreyqek (opqxqphkkf ) Met View more	Superior	17 May 2023

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