预约演示
更新于：2026-01-26
Enlonstobart
恩朗苏拜单抗
更新于：2026-01-26
概要
基本信息
药物类型 单克隆抗体 |
别名 Recombinant human anti-PD-1 monoclonal antibody(CSPC Zhongqi)、重组抗PD-1全人源单克隆抗体 (石药集团中奇制药)、SG-001 + [3] |
靶点 |
作用方式 抑制剂 |
作用机制 PD-1抑制剂(细胞程序性死亡-1抑制剂) |
在研适应症 |
最高研发阶段批准上市 |
首次获批日期 中国 (2024-06-25), |
最高研发阶段(中国)批准上市 |
特殊审评附条件批准 (中国) |
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结构/序列
Sequence Code 13452825L
来源: *****
Sequence Code 13452867H
来源: *****
关联
32
项与 恩朗苏拜单抗 相关的临床试验NCT07251062
A Phase II/III Study to Evaluate the Efficacy and Safety of SYS6010 in Combination With SG001 With or Without 5-FU/Capecitabine in Subjects With First-Line Advanced/Metastatic Esophageal Squamous Cell Carcinoma.
NCT07332533
A Phase II/III Study of KN026 Combined Chemotherapy With or Without Enlonstobart as First-line Treatment in HER2-positive Unresectable Locally Advanced or Metastatic Gastric Cancer.
NCT07282509
A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of Transcatheter Arterial Infusion of Paclitaxel Cationic Liposome Combined With Systemic Therapy in Participants With Advanced Hepatocellular Carcinoma for Second-line Treatment
100 项与 恩朗苏拜单抗 相关的临床结果
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100 项与 恩朗苏拜单抗 相关的转化医学
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100 项与 恩朗苏拜单抗 相关的专利（医药）
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5
项与 恩朗苏拜单抗 相关的文献（医药）2024-12-01DRUGS
Enlonstobart: First Approval
Review
作者: Shirley, Matt
Enlonstobart (Enshuxing®), a recombinant, fully humanised immunoglobulin G4 monoclonal antibody targeted against programmed cell death protein 1 (PD-1), is being developed by the CSPC Pharmaceutical Group for the treatment of advanced cervical cancer and other solid tumours. Enlonstobart received its first approval (a conditional marketing authorisation) in June 2024, in China, for use in patients with recurrent or metastatic programmed cell death ligand 1 (PD-L1)-positive cervical cancer who have failed previous platinum-containing chemotherapy. Phase III clinical evaluation of enlonstobart for use as first-line treatment (in combination with chemotherapy ± bevacizumab) in patients with recurrent or metastatic PD-L1-positive cervical cancer is also underway in China. Additionally, phase II clinical development of enlonstobart (as a part of combination therapy) for use against a range of other solid tumour types is continuing. This article summarises the milestones in the development of enlonstobart leading to this first approval for recurrent or metastatic cervical cancer.
2024-12-01GYNECOLOGIC ONCOLOGY
Phase II study of enlonstobart (SG001), a novel PD-1 inhibitor in patients with PD-L1 positive recurrent/metastatic cervical cancer
Article
作者: Yin, Rutie ; Zhang, Yunyan ; Li, Guiling ; Wei, Shuqing ; Wu, Lingying ; Li, Xiaofan ; Wang, Yili ; Hao, Deshun ; Niu, Miao ; Chen, Ying ; Xiang, Silong ; Ruan, Xiaohong ; Jiang, Kui ; Kang, Shan ; Zhu, Zhitu ; Li, Xiumin ; Zuo, Jing ; Feng, Mei ; Sun, Li ; Sun, Hongmei ; Lin, Daren ; Wang, Wei ; Liu, Hu
BACKGROUND:
Platinum-based chemotherapy with or without bevacizumab is the first-line treatment for patients with recurrent or metastatic cervical cancer (r/mCC), and the treatment options are limited for r/mCC after first-line treatment. Enlonstobart (SG001) is a fully humanized and high-affinity anti-PD-1 immunoglobulin G4 monoclonal antibody. Previous phase Ib study demonstrated that SG001 had a promising efficacy in patients with PD-L1 positive r/mCC.
METHODS:
In this multicenter, single-arm, open-label, phase II study, eligible patients were ≥ 18 years with PD-L1-positive cervical cancer who had progression on or intolerance to the first-line platinum-based chemotherapy. Patients received SG001 240 mg every two weeks for 24 months or until disease progression, intolerable toxicities, or other study discontinuation criteria were met. The primary endpoint was confirmed objective response rate (ORR) assessed by RECIST version 1.1 by independent review committee.
RESULTS:
107 patients were enrolled with median age of 53 years (range 26-72). 64.5 % of patients had a ECOG of 1. After a median follow-up of 14.0 months (range 0.4-21.9), confirmed ORR was 29.0 %, with two complete responses and twenty-nine partial responses. The disease control rate was 54.2 %. Median duration of response was 16.6 months (95 % CI 10.8-NA), median progression free survival was 3.1 months (95 % CI 2.2-6.9). Median overall survival was not reached. 104 patients (97.2 %) experienced at least one treatment emergent adverse events TEAEs, of which 38 patients (35.5 %) had grade 3 or higher TEAEs. The most common treatment-related adverse events were leukopenia (19.6 %), increased aspartate aminotransferase (18.7 %), anemia (17.8 %), increased alanine aminotransferase (15.9 %), hypothyroidism (15.0 %), neutropenia (15.0 %), and hyperthyroidism (11.2 %).
CONCLUSION:
SG001 monotherapy demonstrated durable anti-tumor activity with acceptable safety in patients with PD-L1 positive r/mCC with progression on or intolerance to the first-line platinum-based chemotherapy.
TRIAL REGISTRATION:
ClinicalTrials.gov (NCT04886700).
2024-09-01Cancer Communications
Efficacy, safety and biomarkers of SG001 for patients with previously treated recurrent or metastatic cervical cancer: an open‐label, multicenter, phase Ib trial
Letter
作者: Deshun Hao ; Miao Niu ; Jing Zuo ; Lingying Wu ; Yan'e Song ; Yong Huang ; Mingxuan Zhao ; Ying Chen ; Zhendong Chen ; Huaqiu Shi ; Meiyu Fang ; Xiugao Yang ; Fenglin She ; Youzhong Zhang ; Wei Wang ; Qizhi Tang ; Xiaoxue Zhang ; Li Wang ; Wei Duan ; Junyan Yu ; Jie Lin ; Ou Jiang ; Xiao Zhang ; Weiqing Pu
100 项与 恩朗苏拜单抗 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 |
|---|---|---|---|
| PD-L1阳性宫颈癌 | 中国 | 2024-06-25 |
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 |
|---|---|---|---|---|
| 转移性食管鳞状细胞癌 | 临床3期 | - | 2025-12-30 | |
| 转移性头颈部鳞状细胞癌 | 临床2期 | 中国 | 2025-12-18 | |
| 头颈部鳞状细胞癌 | 临床2期 | - | 2025-08-30 | |
| 晚期恶性实体瘤 | 临床2期 | 中国 | 2024-01-30 | |
| 转移性结直肠癌 | 临床2期 | - | 2024-01-01 | |
| 局部晚期食管鳞状细胞癌 | 临床2期 | 中国 | 2023-12-01 | |
| 恶性胸膜间皮瘤 | 临床2期 | 中国 | 2021-11-18 | |
| 晚期三阴性乳腺癌 | 临床2期 | 中国 | 2021-09-13 | |
| 晚期胆道癌 | 临床2期 | 中国 | 2021-09-01 | |
| 胆囊癌 | 临床2期 | 中国 | 2021-09-01 |
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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
临床1期 | 87 | (PD-L1-positive, dMMR/MSI-H, or EBV-positive solid tumors + Cohort A) | 淵齋網醖鹽壓糧積選積(鑰遞餘襯觸願選餘鬱艱) = 醖衊窪構鏇蓋淵積蓋蓋 鏇鬱廠範膚壓鑰襯鹽襯 (餘範顧遞願衊膚糧廠築 ) 更多 | 积极 | 2025-11-01 | ||
(malignant mesothelioma + Cohort C) | 淵齋網醖鹽壓糧積選積(鑰遞餘襯觸願選餘鬱艱) = 觸鹹構積襯淵範繭齋遞 鏇鬱廠範膚壓鑰襯鹽襯 (餘範顧遞願衊膚糧廠築 ) 更多 | ||||||
临床2期 | 106 | (Arm A) | 餘鏇鑰築獵糧夢糧積淵(衊糧範簾壓窪淵積廠窪) = 選築衊積製鏇網窪繭夢 餘齋繭壓鏇齋衊餘鑰鹹 (遞鑰選選積構構網窪簾, 27.2 ~ 62.1) 更多 | 积极 | 2025-05-30 | ||
临床2期 | PD-L1阳性宫颈癌 PD-L1 positive | 107 | Enlonstobart 240 mg every two weeks | 鏇壓蓋網醖顧餘築鹹鬱(獵鹽糧蓋願廠醖鑰選遞) = 網膚艱醖構壓糧艱觸衊 鏇鑰鑰觸鬱廠獵獵壓夢 (繭簾簾積窪鏇淵艱餘蓋, 14.95 ~ 25.40) 更多 | 积极 | 2025-05-30 | |
临床2期 | PD-L1阳性宫颈癌 PD-L1 positive | 107 | 膚網鹹襯鹽鬱壓獵艱築(夢鹹製鏇製糧鏇願廠鏇) = 鬱選廠鹽廠選醖艱襯網 構夢壓獵艱製顧衊糧夢 (網夢觸構廠膚艱餘憲鹽 ) 更多 | 积极 | 2024-12-01 | ||
临床2期 | 107 | SG001stobart (SG001) 240 mg | 鬱遞遞夢選衊衊鑰鹽網(襯醖鑰窪廠觸淵鑰窪憲) = 遞餘蓋憲鬱醖選繭遞餘 壓糧製構襯範壓構簾築 (積鏇願窪襯積餘簾鬱憲, 20.6 ~ 38.5) 更多 | 积极 | 2024-05-24 | ||
临床1期 | 91 | 鏇願鏇淵簾簾製鏇衊齋(鬱衊鬱夢衊繭鑰鹹積製) = 齋窪蓋窪夢鹽鹽製獵艱 鑰製餘鹽鬱製製壓築遞 (鑰顧築遞餘艱鹹壓繭鏇, 15.5% ~ 39.7) 更多 | - | 2022-09-21 |
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