信迪利单抗

信迪利单抗
单克隆抗体
种类	完整抗体
目标	PD-1
临床资料
商品名（英语：Drug nomenclature）	达伯舒
其他名称	IBI308
法律规范状态
法律规范	中：处方药 ;
识别信息
CAS号	2072873-06-2
UNII	8FU7FQ8UPK;

信迪利单抗（Sintilimab，商品名达伯舒）是一种用于治疗霍奇金淋巴瘤的PD-1抑制剂，^[2]并已在中国获得NMPA批准上市，^[3]它是一种完全人源化IgG4 单克隆抗体 ^[4]，可与程序性死亡蛋白1（PD-1）结合。^[5]该药由苏州信达生物^[6]和礼来联合开发。^[7]

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信迪利单抗用于治疗二线全身化疗失败后复发或难治性霍奇金淋巴瘤。^[5]^[8]

常见的副作用包括发热、甲状腺功能障碍、肝转氨酶升高和自体免疫性肺病。^[9]

目前，该药正在进行20多项有关于其他适应症的临床试验，以评估信迪利单抗在单药或与其他药物联合应用治疗各种实体肿瘤的临床疗效^[10]。2019年1月，信迪利单抗的有关治疗复发性霍奇金淋巴瘤的临床试验结果发表。^[8]

[1]
anti-PDCD1 monoclonal antibody IBI308 - National Cancer Institute. National Cancer Institute. [2019-09-08]. （原始内容存档于2020-10-14）.
[2]
Antibody Drug Conjugates Market Growth Forecast Analysis by Manufacturers, Regions, Type and Application to 2026. Reuters. October 24, 2018. （原始内容存档于2019-11-29）.
[3]
NMPA Approves Tyvyt For Hodgkin's lymphoma Read more from Asian Scientist Magazine. Asian Scientist Magazine. January 9, 2019 [2019-09-08]. （原始内容存档于2020-08-20）.
[4]
OA08 Efficacy and Safety of Sintilimab Combined with 1st Line Chemotherapy in Advanced Squamous Cell Non-small Cell Lung Cancer. Journal of Thoracic Oncology. [Dec 1, 2018].
[5]
SM Hoy. Sintilimab: First Global Approval. - NCBI. Drugs (National Center for Biotechnology Information). 11 February 2019, 79 (3): 341–346. PMID 30742278. doi:10.1007/s40265-019-1066-z.
[6]
Chi-Med Announces Amendment to the 2013 License & Collaboration Agreement on Fruquintinib with Eli Lilly and Company. SEC.gov. December 20, 2018. （原始内容存档于2019-04-24）.
[7]
Sintilimab - Eli Lilly/Innovent Biologics - AdisInsight - Springer. Springer. 28 Mar 2019. （原始内容存档于2019-04-24）.
[8]
Stephen M. Ansell. Sintilimab: another effective immune checkpoint inhibitor in classical Hodgkin lymphoma. The Lancet. Jan 1, 2019.
[9]
A first-in-human phase 1a trial of sintilimab (IBI308). American Society of Clinical Oncology. 12 October 2019. （原始内容存档于2019-04-24）.
[10]
Innovent Organized a Forum Discussing the Pending Launch of its Anti PD-1 Tyvyt® (Sintilimab injection). The New York Times. [Feb 22, 2019]. （原始内容存档于2019-03-07）.

[1] [1]
anti-PDCD1 monoclonal antibody IBI308 - National Cancer Institute. National Cancer Institute. [2019-09-08]. （原始内容存档于2020-10-14）.

[2] [2]
Antibody Drug Conjugates Market Growth Forecast Analysis by Manufacturers, Regions, Type and Application to 2026. Reuters. October 24, 2018. （原始内容存档于2019-11-29）.

[3] [3]
NMPA Approves Tyvyt For Hodgkin's lymphoma Read more from Asian Scientist Magazine. Asian Scientist Magazine. January 9, 2019 [2019-09-08]. （原始内容存档于2020-08-20）.

[4] [4]
OA08 Efficacy and Safety of Sintilimab Combined with 1st Line Chemotherapy in Advanced Squamous Cell Non-small Cell Lung Cancer. Journal of Thoracic Oncology. [Dec 1, 2018].

[nlm.nih.gov-5] [5]
SM Hoy. Sintilimab: First Global Approval. - NCBI. Drugs (National Center for Biotechnology Information). 11 February 2019, 79 (3): 341–346. PMID 30742278. doi:10.1007/s40265-019-1066-z.

[6] [6]
Chi-Med Announces Amendment to the 2013 License & Collaboration Agreement on Fruquintinib with Eli Lilly and Company. SEC.gov. December 20, 2018. （原始内容存档于2019-04-24）.

[7] [7]
Sintilimab - Eli Lilly/Innovent Biologics - AdisInsight - Springer. Springer. 28 Mar 2019. （原始内容存档于2019-04-24）.

[The_Lancet-8] [8]
Stephen M. Ansell. Sintilimab: another effective immune checkpoint inhibitor in classical Hodgkin lymphoma. The Lancet. Jan 1, 2019.

[9] [9]
A first-in-human phase 1a trial of sintilimab (IBI308). American Society of Clinical Oncology. 12 October 2019. （原始内容存档于2019-04-24）.

[10] [10]
Innovent Organized a Forum Discussing the Pending Launch of its Anti PD-1 Tyvyt® (Sintilimab injection). The New York Times. [Feb 22, 2019]. （原始内容存档于2019-03-07）.

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信迪利单抗

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临床应用

副作用

临床研究

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