更新于：2024-11-04
Zuberitamab
泽贝妥单抗
更新于：2024-11-04
概要
基本信息
药物类型 单克隆抗体 |
别名 Zebituzumab、Zuberitamab、重组人-鼠嵌合抗CD20单克隆抗体 (海正药业) + [4] |
靶点 |
作用机制 CD20抑制剂(B淋巴细胞抗原CD20抑制剂)、ADCC(抗体依赖的细胞毒作用)、补体依赖的细胞毒性作用 |
在研适应症 |
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2023-05-12), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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序列信息
Sequence Code 616720952H
来源: *****
Sequence Code 616720955L
来源: *****
关联
8
项与 泽贝妥单抗 相关的临床试验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
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
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
100 项与 泽贝妥单抗 相关的临床结果
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100 项与 泽贝妥单抗 相关的转化医学
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100 项与 泽贝妥单抗 相关的专利（医药）
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38
项与 泽贝妥单抗 相关的文献（医药）2024-12-31mAbs
Antibodies to watch in 2024
Article
作者: Crescioli, Silvia ; Kaplon, Hélène ; 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.
2024-10-01Journal 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
作者: Li, Wenyu ; Wang, Zhao ; Song, Yuqin ; Jiang, Wenqi ; Zhou, Min ; Shen, Jianzhen ; Zhong, Meizuo ; Zhou, Hui ; Jing, Hongmei ; Wang, Jishi ; Lin, Lie ; Yang, Wei ; Li, Zhiming ; Guo, Qunyi ; Zhu, Jun ; Zhang, Weihua ; Lv, Fangfang ; Zhang, Xiaohong ; Zhao, Weili ; Zhang, Mei ; Gao, Sujun ; Cheng, Ying ; Sun, Xiuhua ; Liu, Huilan ; He, Chuan ; Zhang, Liling ; Zhang, Mingzhi ; Cen, Hong ; Feng, Ru ; Zhu, Xiongpeng ; Liu, Lihong ; Wang, Jingbo ; Zhao, Hongguo ; Xu, Bing ; Yang, Yu ; Yang, Haiyan ; Huang, Yunhong ; Zhang, Qingyuan ; Yan, Feng ; Jin, Jie ; Yu, Ding ; Qian, Zhengzi ; Xiang, Ying ; Zhang, Donghua
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.
2024-06-01Lancet 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
作者: Yuan, Guolin ; Qian, Shenxian ; Shu, Jinhui ; Song, Yanping ; Zhou, Hu ; Xu, Min ; Lin, Li-E ; Wang, Shuye ; 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.
107
项与 泽贝妥单抗 相关的新闻（医药）2024-07-22
·信狐药迅
细胞疗法免疫疗法申请上市临床申请ASH会议
2024-07-05
·药智网
抗体药物偶联物引进/卖出蛋白降解靶向嵌合体上市批准
2024-06-28
·医药地理
上市批准生物类似药
100 项与 泽贝妥单抗 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| CD20阳性弥漫性大B细胞淋巴瘤 | 中国 | 2023-05-12 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 特发性膜性肾病 | 临床2期 | 中国 | 2024-10-01 | |
| 免疫性血小板减少症 | 临床2期 | 中国 | 2021-10-28 | |
| CD20阳性非霍奇金淋巴瘤 | 临床2期 | 中国 | 2016-05-27 | |
| CD20阳性非霍奇金淋巴瘤 | 临床2期 | 中国 | 2016-05-27 | |
| 惰性非霍奇金淋巴瘤 | 临床2期 | 中国 | 2016-05-27 | |
| 惰性非霍奇金淋巴瘤 | 临床2期 | 中国 | 2016-05-27 | |
| 弥漫性大B细胞淋巴瘤 | 临床2期 | - | 2016-05-12 | |
| CD20阳性的B细胞非霍奇金淋巴瘤 | 临床1期 | 中国 | 2015-02-26 | |
| CD20阳性的B细胞非霍奇金淋巴瘤 | 临床1期 | 中国 | 2015-02-26 | |
| 类风湿关节炎 | 临床申请批准 | 中国 | 2023-11-07 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | CD20阳性弥漫性大B细胞淋巴瘤 CD20 positive | 483 | Zuberitamab plus CHOP | 糧範鬱鹹鏇糧蓋顧淵襯(製壓願顧壓夢醖鏇餘膚) = 獵廠構構遞觸憲糧壓膚 鑰鑰鏇餘繭憲壓齋網夢 (衊顧蓋齋鬱積鬱選鹹顧 ) 更多 | 积极 | 2024-05-14 | |
Rituximab plus CHOP | 糧範鬱鹹鏇糧蓋顧淵襯(製壓願顧壓夢醖鏇餘膚) = 積糧築製夢顧範構遞鹹 鑰鑰鏇餘繭憲壓齋網夢 (衊顧蓋齋鬱積鬱選鹹顧 ) 更多 | ||||||
NEWS 人工标引  | 临床3期 | 483 | Zebituzumab + CHOP | 願簾獵窪鹹壓醖襯衊遞(襯鬱顧製顧網艱鑰壓願) = 製鏇範選積廠選觸餘範 醖範簾製淵網繭選衊遞 (範膚憲選鑰範積艱選糧 ) 达到 更多 | 优效 | 2023-05-17 | |
Rituximab + CHOP | 願簾獵窪鹹壓醖襯衊遞(襯鬱顧製顧網艱鑰壓願) = 鹹顧夢鏇簾顧糧繭蓋製 醖範簾製淵網繭選衊遞 (範膚憲選鑰範積艱選糧 ) 达到 更多 |
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