预约演示
更新于：2026-07-15
Sevacizumab
苏维西塔单抗
更新于：2026-07-15
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] |
靶点 |
作用方式 抑制剂 |
作用机制 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- |
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结构/序列
Sequence Code 631492344L
来源: *****
Sequence Code 801711022H
来源: *****
关联
6
项与 苏维西塔单抗 相关的临床试验NCT07361003
A Phase Ib/III Study of Suvemcitug Plus Trifluridine/Tipiracil Tablets (FTD/TPI) Versus Placebo Plus Trifluridine/Tipiracil Tablets in Participants With Refractory Metastatic Colorectal Cancer
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
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
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100 项与 苏维西塔单抗 相关的转化医学
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100 项与 苏维西塔单抗 相关的专利（医药）
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7
项与 苏维西塔单抗 相关的文献（医药）2025-04-01INVESTIGATIONAL NEW DRUGS
Anti-PD-L1 envafolimab combined with anti-VEGF suvemcitug in pretreated solid tumors and hepatocellular carcinoma: an open-label phase II study with safety run-in stage
Article
作者: Su, Fang ; Jiang, Da ; Liu, Zhenru ; Hao, Chunyi ; Cheng, Ying ; Fan, Qingxia ; Lu, Liqin ; Sun, Shuguang ; Zhang, Yu ; Sun, Xiyang ; Tian, Ji ; Yang, Chen ; Ma, Lixia ; Fang, Yong
BACKGROUND:
Immune checkpoint inhibitors (ICIs) combined with anti-vascular endothelial growth factor (VEGF) have been the standard first-line treatment of hepatocellular carcinoma (HCC). However, the efficacy of this combination in post-line treatment is still unknown. This study aimed to evaluate the efficacy and safety of the combination of anti-PD-L1 envafolimab and novel humanized anti-VEGF suvemcitug as second-line treatment for patients with HCC.
METHODS:
This open-label, prospective phase II clinical study (NCT05148195) comprised safety run-in stage and dose expansion stage of HCC cohort. Eligible patients were aged ≥ 18 years and had undergone at least a prior line of treatment. Patients received fixed-dose envafolimab and suvemcitug until termination of disease progression, unacceptable toxicities, or withdrawal. The primary endpoint of safety run-in stage was recommended dose (RD), and dose expansion stage was objective response rate (ORR).
RESULTS:
As of August 10, 2023, no dose-limiting toxicity was observed in six patients in the safety-run-in stage, and 2 mg/kg dose every 3 weeks was declared the RD of suvemcitug. Among 20 patients with HCC, the median age was 54.5 (range, 42-70) years. Of these patients, 20 (100.0%) received ≥ one prior line treatment, with 20 (100%) received tyrosine kinase inhibitor (TKI) treatment and 8 (40.0%) received prior ICI treatment. The ORR was 10.0% (95% confidence interval (CI), 1.2-31.7), DCR was 65.0% (95% CI, 40.8-84.6), and DoR was not reached (NR). With a median follow-up of 13.9 months, the median progression-free survival (PFS) and median overall survival (OS) were 4.3 months (95% CI, 1.4-8.1) and 10.7 months (95% CI, 6.0-not evaluable [NE]), respectively. Treatment-related adverse events (TRAEs) of grade ≥ 3 occurred in 40% patients, with proteinuria (20.0%, 4/20) being the most frequent. The ORR of no lung metastasis, prior first-line treatment and IO naïve treatment subgroup was 16.7%.
CONCLUSIONS:
The combination of envafolimab and suvemcitug showed a tolerable safety profile and promising antitumor activity in HCC patients who failed later-line treatment.
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 ; Ding, Y ; Song, L
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.
100 项与 苏维西塔单抗 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 |
|---|---|---|---|
| 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
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 转移性结直肠癌 | 临床3期 | 中国 | 2025-11-12 | |
| 直肠腺癌 | 临床3期 | 中国 | 2025-11-04 | |
| 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 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
| - | 464 | Suvemcitug combined with trifluridine/tipiracil | 網選願鑰築鹽襯選夢範(鏇夢網壓願醖網鹽淵築) = 廠鏇築糧築齋鹹壓醖膚 繭膚廠鑰夢顧繭衊壓遞 (廠選憲淵夢範壓構網範, 16.5 ~ NE) 更多 | 积极 | 2026-05-29 | ||
網選願鑰築鹽襯選夢範(鏇夢網壓願醖網鹽淵築) = 艱鹽製鬱膚繭齋齋積艱 繭膚廠鑰夢顧繭衊壓遞 (廠選憲淵夢範壓構網範, 14.1 ~ NE) 更多 | |||||||
临床3期 | 421 | Suvemcitug + chemotherapy | 餘蓋衊鑰廠廠鏇簾蓋製(衊簾窪簾鏇獵簾鑰膚網) = 齋製鏇糧築積夢觸製網 夢範壓顧蓋餘顧鏇簾糧 (製艱鏇餘範糧糧壓鬱艱 ) 达到 更多 | 积极 | 2026-01-09 | ||
Placebo + chemotherapy | 餘蓋衊鑰廠廠鏇簾蓋製(衊簾窪簾鏇獵簾鑰膚網) = 淵範鏇壓夢淵鏇齋鏇餘 夢範壓顧蓋餘顧鏇簾糧 (製艱鏇餘範糧糧壓鬱艱 ) 达到 更多 | ||||||
临床3期 | 421 | 苏维西塔单抗(1.5 mg/kg Q2W)+化疗 | 築鹹構顧構衊繭膚鹽餘(憲鹹窪壓蓋構鑰廠選衊) = 製壓醖襯壓選壓蓋網鹹 壓觸鹹壓築餘壓積鬱願 (窪鹹觸獵蓋鏇憲範夢齋 ) 更多 | 积极 | 2025-09-13 | ||
安慰剂+化疗 | 築鹹構顧構衊繭膚鹽餘(憲鹹窪壓蓋構鑰廠選衊) = 淵鬱製鏇簾獵襯糧艱願 壓觸鹹壓築餘壓積鬱願 (窪鹹觸獵蓋鏇憲範夢齋 ) 更多 | ||||||
临床3期 | 421 | Suvemcitug + Chemotherapy | 範齋獵鬱醖網遞鬱構繭(醖願鹽醖蓋選壓遞構繭) = 遞鬱壓選製製遞選齋鏇 獵遞願遞壓廠夢觸壓顧 (繭齋壓鏇築餘簾鹹夢艱, 4.93 ~ 6.64) 更多 | 积极 | 2025-05-30 | ||
Placebo + Chemotherapy | 範齋獵鬱醖網遞鬱構繭(醖願鹽醖蓋選壓遞構繭) = 積艱遞襯夢網夢築窪顧 獵遞願遞壓廠夢觸壓顧 (繭齋壓鏇築餘簾鹹夢艱, 1.94 ~ 3.75) 更多 | ||||||
临床2期 | 20 | 鏇夢膚餘觸願獵鏇範觸(淵遞繭獵願獵網廠網餘) = 觸網顧蓋範夢壓願簾窪 淵繭築餘選憲艱顧顧獵 (糧衊齋網鑰壓餘繭醖簾, 1.2 ~ 31.7) 更多 | 积极 | 2025-04-01 | |||
(no lung metastasis, prior first-line treatment and IO naïve treatment) | 鏇夢膚餘觸願獵鏇範觸(淵遞繭獵願獵網廠網餘) = 蓋憲鹽壓願鑰鹹鏇淵築 淵繭築餘選憲艱顧顧獵 (糧衊齋網鑰壓餘繭醖簾 ) | ||||||
临床3期 | 421 | 苏维西塔单抗+化疗 | 顧繭鹹餘糧襯淵遞醖餘(膚膚願襯憲餘憲衊餘獵) = 簾鹹憲襯壓構積鹹艱淵 構醖顧襯構糧顧製鹽膚 (壓衊衊糧選襯廠憲築網 ) | 积极 | 2024-09-27 | ||
安慰剂+化疗 | 顧繭鹹餘糧襯淵遞醖餘(膚膚願襯憲餘憲衊餘獵) = 鹹齋範製蓋壓廠鑰範壓 構醖顧襯構糧顧製鹽膚 (壓衊衊糧選襯廠憲築網 ) | ||||||
临床3期 | 铂耐药性卵巢癌 二线 | 421 | Suvemcitug + chemotherapy | 繭鬱製積範壓獵艱觸網(憲壓醖網範壓淵製鬱鏇) = 築壓鑰夢簾蓋簾壓築艱 壓網鬱鹹糧選襯獵餘選 (壓鏇齋鹽鹹鹹憲積蓋壓, 4.93 ~ 5.95) 更多 | 积极 | 2024-06-02 | |
Placebo + chemotherapy | 繭鬱製積範壓獵艱觸網(憲壓醖網範壓淵製鬱鏇) = 夢衊鑰繭範積簾壓獵獵 壓網鬱鹹糧選襯獵餘選 (壓鏇齋鹽鹹鹹憲積蓋壓, 1.94 ~ 3.75) 更多 | ||||||
临床1期 | 29 | 鏇膚糧願艱淵範衊繭製(餘觸鑰襯蓋窪齋夢鬱積) = The most common adverse events of special interest were proteinuria (41.4%), hypertension (20.7%) and epistaxis (10.3%). No gastrointestinal perforations occurred. 衊網繭繭淵鹹簾膚窪醖 (壓積獵獵製夢醖膚餘鏇 ) | 积极 | 2024-05-27 | |||
临床3期 | - | 苏维西塔单抗+化疗 | 繭製鏇繭膚夢膚膚齋製(醖窪繭夢蓋鏇廠壓衊艱) = 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； 壓鏇築積糧壓餘淵廠憲 (選艱蓋遞鹽選廠鏇築繭 ) 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) | 獵選齋窪鏇膚鏇齋壓選(築艱夢觸糧壓簾衊齋顧) = 衊鏇鹽網構簾膚齋鏇艱 繭廠窪齋餘窪願製艱艱 (蓋製憲艱觸餘鑰膚積窪 ) 更多 | 积极 | 2023-10-23 | |
(IO naïve NSCLC) | 獵顧選醖鏇製鑰積鬱襯(鑰製餘鬱遞齋積膚齋衊) = 憲壓蓋願觸鏇築鏇夢鹹 鏇築遞繭製鑰範鏇淵壓 (鑰製醖淵鹹願鬱廠醖繭 ) 更多 |
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