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 GlomerulonephritisPurpura, Thrombocytopenic, Idiopathic+ [1]

Inactive Indication

CD20 Positive B-Cell Non-Hodgkin LymphomaCD20 positive Non-Hodgkin LymphomaIndolent Non-Hodgkin Lymphoma

Originator Organization

BioRay Biopharmaceutical Co., Ltd.

Active Organization

Zhejiang Hisun Pharmaceutical Co., Ltd.

BioRay Biopharmaceutical Co., Ltd.

Beijing Mabworks Biotech Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (12 May 2023),

CD20 positive Diffuse Large B-Cell Lymphoma

Regulation-

Gene Sequence

Sequence Code 616720952H

Source: *****

Sequence Code 616720955L

Source: *****

Clinical Trials associated with Zuberitamab

NCT06642909 / Not yet recruitingPhase 2

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

This study is a multicenter, randomized, open label, cyclosporine controlled Phase II trial aimed at evaluating the efficacy, safety, pharmacokinetics, and immunogenicity of Zuberitamab in patients with primary membranous nephropathy, and exploring the Phase III dosing regimen, sample size, and endpoint evaluation time

Start Date01 Oct 2024

Sponsor / Collaborator

BioRay Biopharmaceutical Co., Ltd.

CTR20211966 / RecruitingPhase 2

泽贝妥单抗(HS006) 治疗原发免疫性血小板减少症患者安全性和有效性的 II 期多中心临床试验

[Translation] Phase II multicenter clinical trial to evaluate the safety and efficacy of zebetozumab (HS006) in the treatment of patients with primary immune thrombocytopenia

评价泽贝妥单抗在既往治疗失败的原发持续性或慢性 ITP 患者中的安全性和有效性

[Translation]

To evaluate the safety and efficacy of zabetuzumab in patients with primary persistent or chronic ITP who have failed previous treatment

Start Date28 Oct 2021

Sponsor / Collaborator

BioRay Biopharmaceutical Co., Ltd.

CTR20180855 / CompletedPhase 3

多中心、随机、双盲、阳性药比较Hi-CHOP与R-CHOP在初治DLBCL患者中的有效性和安全性的Ⅲ期临床研究

[Translation] A multicenter, randomized, double-blind, active-drug phase III clinical study comparing the efficacy and safety of Hi-CHOP and R-CHOP in patients with newly diagnosed DLBCL

要目的：以利妥昔单抗375mg/m2（美罗华®）联合CHOP作为阳性对照，评价海正抗CD20单抗（HS006，简称Hi）联合CHOP作为DLBCL一线治疗的有效性。次要目的：评价Hi-CHOP作为DLBCL一线治疗的安全性。比较HS006与利妥昔单抗（美罗华®）药代动力学及药效学特征

[Translation]

Primary objective: To evaluate the efficacy of Hi-CHOP combined with rituximab 375 mg/m2 (MabThera®) as a first-line treatment for DLBCL, using rituximab 375 mg/m2 (MabThera®) combined with CHOP as a positive control. Secondary objective: To evaluate the safety of Hi-CHOP as a first-line treatment for DLBCL. Compare the pharmacokinetic and pharmacodynamic characteristics of HS006 and rituximab (MabThera®)

Start Date25 Oct 2018

Sponsor / Collaborator

Zhejiang Hisun Pharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Zuberitamab

100 Translational Medicine associated with Zuberitamab

100 Patents (Medical) associated with Zuberitamab

Literatures (Medical) associated with Zuberitamab

31 Dec 2024·mAbs

Antibodies to watch in 2024

Article

Author: Kaplon, Hélène ; Crescioli, Silvia ; Wang, Lin ; Reichert, Janice M. ; Visweswaraiah, Jyothsna ; Chenoweth, Alicia

The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. 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)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. 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). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.

01 Oct 2024·Journal for ImmunoTherapy of Cancer

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

Article

Author: Li, Wenyu ; Song, Yuqin ; Wang, Zhao ; Jiang, Wenqi ; Zhou, Min ; Shen, Jianzhen ; Zhong, Meizuo ; Zhou, Hui ; Wang, Jishi ; Jing, Hongmei ; Lin, Lie ; Yang, Wei ; Guo, Qunyi ; Li, Zhiming ; Zhu, Jun ; Zhang, Weihua ; Lv, Fangfang ; Zhang, Xiaohong ; Zhang, Mei ; Zhao, Weili ; Gao, Sujun ; Cheng, Ying ; Liu, Huilan ; Sun, Xiuhua ; Zhang, Liling ; He, Chuan ; Zhang, Mingzhi ; Cen, Hong ; Zhu, Xiongpeng ; Feng, Ru ; Wang, Jingbo ; Liu, Lihong ; Xu, Bing ; Zhao, Hongguo ; Yang, Yu ; Yang, Haiyan ; Huang, Yunhong ; Zhang, Qingyuan ; Jin, Jie ; Yan, Feng ; Yu, Ding ; Qian, Zhengzi ; Zhang, Donghua ; Xiang, Ying

Background:

In patients with untreated CD20-positive diffuse large B-cell lymphoma (DLBCL), a phase 3 trial was carried out to evaluate the efficacy and safety of zuberitamab plus CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone; Hi-CHOP) versus rituximab plus CHOP (R-CHOP) treatment regimens.

Methods:

In a 2:1 ratio, eligible patients were assigned randomly to receive treatment of six cycles of either 375 mg/m2zuberitamab or rituximab together with conventional CHOP chemotherapy. The objective response rate (ORR) at C6D50 served as the primary endpoint, and a non-inferiority margin of 10% was established. The secondary endpoints included the complete response (CR) rate at C6D50, duration of response (DOR), progression-free survival (PFS) and event-free survival (EFS) judged by blinded-independent review committee (BIRC), overall survival (OS) and safety outcomes.

Results:

Of the 487 randomized patients, 423 patients including 287 in the Hi-CHOP and 136 in the R-CHOP groups completed the C6D50 assessment. For the full analysis set (FAS) and per-protocol set (PPS), BIRC-assessed ORR at C6D50 for the Hi-CHOP and R-CHOP groups were 83.5% versus 81.4% and 95.3% versus 93.7%, respectively. The non-inferiority was confirmed as the lower limit of the two-sided 95% CI for the intergroup differences of −5.2% and −3.3%; both were >−10% in the FAS and PPS. The BIRC-assessed CR rate of Hi-CHOP was significantly higher in PPS (85.7% vs 77.3%, p=0.038), but comparable in FAS (75.2% vs 67.9%, p=0.092). After a median follow-up of 29.6 months, patients in the Hi-CHOP group had a slight advantage with regard to the DOR (HR 0.74, p=0.173), PFS (HR 0.67, p=0.057), EFS (HR 0.90, p=0.517) and OS (HR 0.60, p=0.059). Patients with the germinal-center B cell-like subtype who received Hi-CHOP exhibited statistically significant improvements in ORR (p=0.034) and CR rate (p=0.038) at C6D50, EFS (p=0.046) and OS (p=0.014). Treatment-emergent adverse event occurrence rates were comparable across groups (all p>0.05). Infusion-related responses occurred more often in the Hi-CHOP group (32.1% vs 19.9%, p=0.006), all of grade 1–3 severity.

Conclusions:

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.

Trial registration number:

Chinese Clinical Trial Registry, ChiCTR2000040602, retrospectively registered.

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.

News (Medical) associated with Zuberitamab

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	CN	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 2	CN	BioRay Biopharmaceutical Co., Ltd.	01 Oct 2024
Purpura, Thrombocytopenic, Idiopathic	Phase 2	CN	BioRay Biopharmaceutical Co., Ltd.	28 Oct 2021
CD20 positive Non-Hodgkin Lymphoma	Phase 2	CN	Zhejiang Hisun Pharmaceutical Co., Ltd.	27 May 2016
CD20 positive Non-Hodgkin Lymphoma	Phase 2	CN	Beijing Mabworks Biotech Co., Ltd.	27 May 2016
Indolent Non-Hodgkin Lymphoma	Phase 2	CN	Zhejiang Hisun Pharmaceutical Co., Ltd.	27 May 2016
Indolent Non-Hodgkin Lymphoma	Phase 2	CN	Beijing Mabworks Biotech Co., Ltd.	27 May 2016
Diffuse Large B-Cell Lymphoma	Phase 2	-	Zhejiang Hisun Pharmaceutical Co., Ltd.	12 May 2016
CD20 Positive B-Cell Non-Hodgkin Lymphoma	Phase 1	CN	Beijing Mabworks Biotech Co., Ltd.	26 Feb 2015
CD20 Positive B-Cell Non-Hodgkin Lymphoma	Phase 1	CN	Zhejiang Hisun Pharmaceutical Co., Ltd.	26 Feb 2015
Rheumatoid Arthritis	IND Approval	CN	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


Phase 3 Trial (EHA2024)	Phase 3	CD20 positive Diffuse Large B-Cell Lymphoma CD20 positive	483	Zuberitamab plus CHOP	jrfhtlkedk(elnqnqclhk) = oyrcfhueis wtkrzmjpqc (ibqktylmtx ) View more	Positive	14 May 2024
				Rituximab plus CHOP	jrfhtlkedk(elnqnqclhk) = rznlvhiaim wtkrzmjpqc (ibqktylmtx ) View more
NEWS Manual	Phase 3	Diffuse Large B-Cell Lymphoma	483	Zebituzumab + CHOP	lazwxmopea(rqzfahengq) = nhwpvtjjbk hqkgpwiygd (oisnvhjwno ) Met View more	Superior	17 May 2023
				Rituximab + CHOP	lazwxmopea(rqzfahengq) = fpqmnbobye hqkgpwiygd (oisnvhjwno ) Met View more

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