预约演示
更新于：2025-09-28
Sevacizumab
苏维西塔单抗
更新于：2025-09-28
概要
基本信息
药物类型 单克隆抗体 |
别名 Suvemcitug、赛伐珠单抗、APX-003 + [4] |
作用方式 抑制剂 |
作用机制 VEGF抑制剂(血管内皮生长因子抑制剂)、VEGF-A抑制剂(血管内皮生长因子A抑制剂) |
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 (2025-06-30), |
最高研发阶段(中国)批准上市 |
特殊审评- |
登录后查看时间轴
结构/序列
Sequence Code 631492344L
来源: *****
Sequence Code 801711022H
来源: *****
关联
8
项与 苏维西塔单抗 相关的临床试验NCT05148195
An Open Label, Multi-cohort, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Envofolimab in Combination With BD0801 Injection With/Without Chemotherapy in Patients With Advanced Solid Tumors
CTR20212879
恩沃利单抗联合注射用BD0801联合/不联合化疗在晚期实体瘤患者中的有效性和安全性的开放、多队列、多中心II期临床研究
NCT04908787
A Randomized, Double-blind, Phase III Study of BD0801 Injection Combined With Chemotherapy Versus Placebo Combined With Chemotherapy in Patients With Recurrent, Platinum-resistant Epithelial Ovarian, Fallopian Tube , or Primary Peritoneal Cancer.
100 项与 苏维西塔单抗 相关的临床结果
登录后查看更多信息
100 项与 苏维西塔单抗 相关的转化医学
登录后查看更多信息
100 项与 苏维西塔单抗 相关的专利（医药）
登录后查看更多信息
3
项与 苏维西塔单抗 相关的文献（医药）2024-08-01GYNECOLOGIC ONCOLOGY
Suvemcitug plus chemotherapy for platinum-resistant epithelial ovarian, fallopian tube and primary peritoneal cancer: A phase 1b dose-escalation trial
Article
作者: Zheng, Hong ; Wu, Yan ; Sun, Haolin ; Zhang, Keqiang ; Yuan, Guangwen ; Zhang, Jiajing ; Sun, Xiyang ; Wu, Lingying
OBJECTIVE:
The use of bevacizumab has been hampered by safety concerns despite demonstrable progression-free survival (PFS) benefit in subjects with platinum-resistant ovarian cancer, highlighting the need for novel effective and safe antiangiogenic agents. This study aimed to characterize the tolerability, safety, and antitumor activities of escalating doses of anti-VEGF antibody suvemcitug plus chemotherapy in platinum-resistant ovarian cancer patients.
METHODS:
This open-label, dose-escalation trial enrolled adult patients (≥18 years) with platinum-resistant histologically or cytologically-confirmed epithelial ovarian, fallopian tube and primary peritoneal cancer. Eligible patients received paclitaxel or topotecan plus escalating doses of suvemcitug 0.5, 1, 1.5, or 2 mg/kg once every two weeks. The primary endpoints were safety and tolerability, and antitumor activities of suvemcitug.
RESULTS:
Twenty-nine subjects received paclitaxel (n = 11) or topotecan (n = 18). No dose-limiting toxicities occurred. The most common adverse events of special interest were proteinuria (41.4%), hypertension (20.7%) and epistaxis (10.3%). No gastrointestinal perforations occurred. Nine subjects (31.0%, 95% CI 15.3-50.8) demonstrated investigators-confirmed objective response, including complete response in 1 and partial response in 8. The median PFS was 5.4 months (95% CI 2.2-7.4).
CONCLUSIONS:
Suvemcitug demonstrated an acceptable safety profile and promising antitumor activities in platinum-resistant ovarian cancer patients, supporting its further clinical development.
2023-06-01ESMO open
Suvemcitug as second-line treatment of advanced or metastatic solid tumors and with FOLFIRI for pretreated metastatic colorectal cancer: phase Ia/Ib open label, dose-escalation trials
Article
作者: Zhang, Y ; Feng, X ; Ji, D ; Zhang, J ; Cao, J ; Xu, N ; Wu, Y ; Mao, C ; Liu, L ; Song, W ; Song, L ; Ding, Y
BACKGROUND:
Suvemcitug (BD0801), a novel humanized rabbit monoclonal antibody against vascular endothelial growth factor, has demonstrated promising antitumor activities in preclinical studies.
PATIENTS AND METHODS:
The phase Ia/b trials investigated the safety and tolerability and antitumor activities of suvemcitug for pretreated advanced solid tumors and in combination with FOLFIRI (leucovorin and fluorouracil plus irinotecan) in second-line treatment of metastatic colorectal cancer using a 3 + 3 dose-escalation design. Patients received escalating doses of suvemcitug (phase Ia: 2, 4, 5, 6, and 7.5 mg/kg; phase Ib: 1, 2, 3, 4, and 5 mg/kg plus FOLFIRI). The primary endpoint was safety and tolerability in both trials.
RESULTS:
All patients in the phase Ia trial had at least one adverse event (AE). Dose-limiting toxicities included grade 3 hyperbilirubinemia (one patient), hypertension and proteinuria (one patient), and proteinuria (one patient). The maximum tolerated dose was 5 mg/kg. The most common grade 3 and above AEs were proteinuria (9/25, 36%) and hypertension (8/25, 32%). Forty-eight patients (85.7%) in phase Ib had grade 3 and above AEs, including neutropenia (25/56, 44.6%), reduced leucocyte count (12/56, 21.4%), proteinuria (10/56, 17.9%), and elevated blood pressure (9/56, 16.1%). Only 1 patient in the phase Ia trial showed partial response, [objective response rate 4.0%, 95% confidence interval (CI) 0.1% to 20.4%] whereas 18/53 patients in the phase Ib trial exhibited partial response (objective response rate 34.0%, 95% CI 21.5% to 48.3%). The median progression-free survival was 7.2 months (95% CI 5.1-8.7 months).
CONCLUSIONS:
Suvemcitug has an acceptable toxicity profile and exhibits antitumor activities in pretreated patients with advanced solid tumors or metastatic colorectal cancer.
INTERNATIONAL JOURNAL OF COLORECTAL DISEASE
The efficacy and safety of suvemcitug, envafolimab, and FOLFIRI in microsatellite-stable or mismatch repair–proficient colorectal cancer: preliminary results of a phase 2 study
Article
作者: Gu, Kangsheng ; Zhang, Yu ; Liu, Zhenru ; Cheng, Ying ; Fan, Qingxia ; Wang, Jufeng ; Sun, Shuguang ; Sun, Xiyang ; Tian, Ji ; Liu, Ying ; Yang, Chen ; Deng, Yanhong ; Fang, Yong ; Hu, Changlu
PURPOSE:
This phase II study is designed to evaluate the combination therapy involving suvemcitug and envafolimab with FOLFIRI in microsatellite-stable or mismatch repair-proficient (MSS/pMMR) colorectal cancer (CRC) in the second-line treatment setting.
METHODS:
This study is a non-randomized, open-label prospective study comprising multiple cohorts (NCT05148195). Here, we only report the data from the CRC cohort. Participants received envafolimab, suvemcitug, and FOLFIRI until disease progression, unacceptable toxicity, or voluntary withdrawal. The recommended dose (RD) and objective response rate (ORR) by investigator assessment were primary endpoints. Secondary endpoints comprised progression-free survival (PFS) and duration of response (DoR). Disease control rate (DCR), overall survival (OS), and safety were also analyzed.
RESULTS:
At the data cutoff, no dose-limiting toxicity event was observed in the safety run-in stage, and 2 mg/kg Q2W was declared as RD for suvemcitug combined with envafolimab and FORFIRI. Among 20 patients, 50.0% and 10.0% had been treated with prior antiangiogenic agents and anti-EGFR agents, respectively. ORR and DCR were 25.0% (95% CI 8.7-49.1%) and 90.0% (95% CI 68.3-98.8%), and DoR was 4.1 months (95% CI 3.02, NE). The median PFS and median OS were 5.6 months (95% CI 4.0-8.3) and not reached (95% CI 8.5, NE) by the time of study closure. Neutrophil count decreased, white blood cell count decreased, and hypertension were the most common grade ≥3 treatment-related adverse events (TRAE).
CONCLUSIONS:
The safety profile was manageable and the preliminary anti-tumor efficacy was observed in patients with MSS/pMMR CRC in this study, who had failed prior to one line of therapy.
86
项与 苏维西塔单抗 相关的新闻（医药）2025-09-27
·先声药业
抗体药物偶联物临床申请临床研究
2025-09-21
·信狐药迅
疫苗信使RNA临床申请临床1期申请上市
2025-09-09
·先声药业
抗体药物偶联物临床申请突破性疗法
100 项与 苏维西塔单抗 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 复发性铂耐药性输卵管癌 | 中国 | 2025-06-30 | |
| 复发性铂耐药性卵巢癌 | 中国 | 2025-06-30 | |
| 复发性铂耐药性原发性腹膜癌 | 中国 | 2025-06-30 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 铂耐药上皮性卵巢癌 | 临床3期 | 中国 | 2021-06-05 | |
| 铂耐药性输卵管癌 | 临床3期 | 中国 | 2021-06-05 | |
| 铂类耐药性原发性腹膜癌 | 临床3期 | 中国 | 2021-06-05 | |
| 晚期恶性实体瘤 | 临床2期 | 中国 | 2021-12-13 | |
| 铂耐药性卵巢癌 | 临床1期 | 中国 | 2018-04-24 | |
| 输卵管癌 | 临床1期 | 中国 | 2018-04-04 | |
| 卵巢上皮癌 | 临床1期 | 中国 | 2018-04-04 | |
| 原发性腹膜癌 | 临床1期 | 中国 | 2018-04-04 | |
| 复发性卵巢癌 | 临床1期 | 中国 | 2018-04-04 | |
| 转移性结直肠癌 | 临床1期 | 中国 | 2015-10-13 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 421 | Suvemcitug + Chemotherapy | 襯窪鬱壓壓簾積顧選遞(夢鑰構鏇獵膚觸鏇網網) = 淵鹹襯壓範蓋製遞齋網 築構鹹夢壓蓋顧齋淵窪 (憲糧壓糧積遞網憲艱糧, 4.93 ~ 6.64) 更多 | 积极 | 2025-05-30 | ||
Placebo + Chemotherapy | 襯窪鬱壓壓簾積顧選遞(夢鑰構鏇獵膚觸鏇網網) = 醖築艱願顧窪艱窪壓簾 築構鹹夢壓蓋顧齋淵窪 (憲糧壓糧積遞網憲艱糧, 1.94 ~ 3.75) 更多 | ||||||
临床3期 | 421 | 苏维西塔单抗+化疗 | 鏇願夢憲憲網鹹鏇餘壓(憲鏇鏇繭鏇蓋衊鹹製艱) = 製製鑰簾壓觸糧淵鏇鹽 顧選簾簾餘糧鹽鹽鬱鑰 (蓋願夢鏇積願夢顧觸壓 ) | 积极 | 2024-09-27 | ||
安慰剂+化疗 | 鏇願夢憲憲網鹹鏇餘壓(憲鏇鏇繭鏇蓋衊鹹製艱) = 鏇簾積鑰繭獵範簾獵鑰 顧選簾簾餘糧鹽鹽鬱鑰 (蓋願夢鏇積願夢顧觸壓 ) | ||||||
临床3期 | 铂耐药性卵巢癌 二线 | 421 | Suvemcitug + chemotherapy | 築積製鑰鏇顧積蓋齋夢(鹽鹹願醖願蓋築範範鑰) = 蓋鬱選選膚襯廠淵壓顧 鹹鹽醖艱製夢醖窪製積 (鹹醖構願鹹鑰餘選壓觸, 4.93 ~ 5.95) 更多 | 积极 | 2024-06-02 | |
Placebo + chemotherapy | 築積製鑰鏇顧積蓋齋夢(鹽鹹願醖願蓋築範範鑰) = 襯觸餘遞餘繭廠壓製選 鹹鹽醖艱製夢醖窪製積 (鹹醖構願鹹鑰餘選壓觸, 1.94 ~ 3.75) 更多 | ||||||
临床1期 | 29 | 遞鑰夢艱淵艱築觸淵夢(壓鏇淵鏇壓築醖鬱製觸) = The most common adverse events of special interest were proteinuria (41.4%), hypertension (20.7%) and epistaxis (10.3%). No gastrointestinal perforations occurred. 願襯醖蓋遞襯膚餘餘獵 (淵壓餘鹹襯選艱獵積構 ) | 积极 | 2024-05-27 | |||
临床3期 | - | 苏维西塔单抗+化疗 | 夢壓餘憲簾夢製範觸糧(壓夢鏇廠鏇夢鏇鬱糧壓) = SCORES研究达到基于盲态独立影像评估委员会(BIRC)依据RECIST 1.1 标准评估的PFS研究主要终点。对比安慰剂联合化疗组，苏维西塔单抗组PFS显示出具有统计学意义和临床意义的改善。苏维西塔单抗在所有亚组均显示出PFS临床获益的一致性。研究者评估的试验组PFS获益与BIRC评估获益相当； 蓋觸選積範艱餘遞醖鏇 (繭觸窪獵襯夢選顧壓壓 ) 更多 | 积极 | 2024-01-04 | ||
安慰剂+化疗 | |||||||
临床2期 | 非小细胞肺癌 二线 | 40 | (IO treated NSCLC) | 築範壓製衊顧鏇鹽鏇構(獵襯構膚積觸遞鏇廠餘) = 齋鑰窪願廠鬱鏇艱獵鏇 願淵齋繭製鑰範餘夢積 (繭窪顧鏇鹹製觸廠衊鏇 ) 更多 | 积极 | 2023-10-23 | |
(IO naïve NSCLC) | 餘範鏇夢鑰積構觸繭網(糧膚獵構夢鹽構襯觸艱) = 淵衊憲鏇鏇繭齋壓壓願 鹹窪網醖鑰積壓觸願簾 (鑰選繭鏇蓋憲製製觸壓 ) 更多 | ||||||
临床2期 | 肝细胞癌 二线 | 20 | Suvemcitug+envafolimab | 遞窪願衊遞鑰顧選選艱(窪願鑰膚觸齋網願鹹顧) = 鬱夢夢衊選構膚鬱觸鏇 壓繭糧選範鏇壓憲衊製 (築範觸衊簾衊繭衊鑰餘 ) 更多 | 积极 | 2023-10-23 | |
临床2期 | 20 | 積鏇淵觸網鑰積膚艱淵(願壓選願鬱齋餘繭膚廠) = 廠繭築鑰鏇鬱範廠鏇夢 衊憲鹹夢鑰簾鬱壓構繭 (選鏇觸壓範壓膚構構淵, 8.7 ~ 49.1) 更多 | 积极 | 2023-10-22 | |||
临床1期 | 29 | 網鑰餘繭遞鹽夢觸齋鑰(壓憲鬱構願醖簾觸範製) = 選選願願觸顧網餘醖壓 鬱夢糧憲衊顧遞鏇膚範 (壓製衊夢獵築淵襯餘鏇, 49.2 ~ 84.7) 更多 | - | 2021-09-25 | |||
临床1期 | 转移性结直肠癌 二线 | 49 | 膚鬱願齋窪選齋鹹遞鹹(顧廠齋顧壓構積齋願餘) = neutropenia (41%), proteinuria (24.4%), leukopenia (22.4%), hypertension (20.4%) and diarrhea (16%) 鏇網網夢繭顧蓋窪糧齋 (淵積夢遞鏇構簾廠選鹹 ) 更多 | 积极 | 2018-06-01 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
生物类似药
生物类似药在不同国家/地区的竞争态势。请注意临床1/2期并入临床2期，临床2/3期并入临床3期
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
Eureka LS:
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用