信迪利單抗

信迪利單抗
單克隆抗體
種類	完整抗體
目標	PD-1
臨床資料
商品名（英語：Drug nomenclature）	達伯舒
其他名稱	IBI308
法律規範狀態
法律規範	中：處方藥 ;
識別資訊
CAS號	2072873-06-2
UNII	8FU7FQ8UPK;

信迪利單抗（Sintilimab，商品名達伯舒）是一種用於治療霍奇金淋巴瘤的PD-1抑制劑，^[2]並已在中國獲得NMPA批准上市，^[3]它是一種完全人源化IgG4 單克隆抗體 ^[4]，可與程序性死亡蛋白1（PD-1）結合。^[5]該藥由蘇州信達生物^[6]和禮來聯合開發。^[7]

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臨床應用

信迪利單抗用於治療二線全身化療失敗後復發或難治性霍奇金淋巴瘤。^[5]^[8]

副作用

常見的副作用包括發熱、甲狀腺功能障礙、肝轉氨酶升高和自體免疫性肺病。^[9]

臨床研究

目前，該藥正在進行20多項有關於其他適應症的臨床試驗，以評估信迪利單抗在單藥或與其他藥物聯合應用治療各種實體腫瘤的臨床療效^[10]。2019年1月，信迪利單抗的有關治療復發性霍奇金淋巴瘤的臨床試驗結果發表。^[8]

參考文獻

[1]
anti-PDCD1 monoclonal antibody IBI308 - National Cancer Institute. National Cancer Institute. [2019-09-08]. （原始內容存檔於2020-10-14）.
[2]
Antibody Drug Conjugates Market Growth Forecast Analysis by Manufacturers, Regions, Type and Application to 2026. Reuters. October 24, 2018. （原始內容存檔於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]. （原始內容存檔於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. （原始內容存檔於2019-04-24）.
[7]
Sintilimab - Eli Lilly/Innovent Biologics - AdisInsight - Springer. Springer. 28 Mar 2019. （原始內容存檔於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. （原始內容存檔於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]. （原始內容存檔於2019-03-07）.

[1] [1]
anti-PDCD1 monoclonal antibody IBI308 - National Cancer Institute. National Cancer Institute. [2019-09-08]. （原始內容存檔於2020-10-14）.

[2] [2]
Antibody Drug Conjugates Market Growth Forecast Analysis by Manufacturers, Regions, Type and Application to 2026. Reuters. October 24, 2018. （原始內容存檔於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]. （原始內容存檔於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. （原始內容存檔於2019-04-24）.

[7] [7]
Sintilimab - Eli Lilly/Innovent Biologics - AdisInsight - Springer. Springer. 28 Mar 2019. （原始內容存檔於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. （原始內容存檔於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]. （原始內容存檔於2019-03-07）.

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