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Sintilimab: First Global Approval

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Abstract

Sintilimab (Tyvyt®) is a fully human IgG4 monoclonal antibody that binds to programmed cell death receptor-1 (PD-1), thereby blocking the interaction of PD-1 with its ligands (PD-L1 and PL-L2) and consequently helping to restore the endogenous antitumour T-cell response. It has been co-developed by Innovent Biologics and Eli Lilly and Company, and was recently approved in China for the treatment of classical Hodgkin’s lymphoma in patients who have relapsed or are refractory after ≥ 2 lines of systemic chemotherapy. Sintilimab is undergoing phase I, II and III development for use in various solid tumours, including non-small cell lung cancer and oesophageal cancer, in China. Phase I/II development of sintilimab for use in solid tumours is underway in the USA, with the US FDA accepting an Investigational New Drug application for sintilimab in January 2018. This article summarizes the milestones in the development of sintilimab leading to this first approval for the treatment of classical Hodgkin’s lymphoma in patients who have relapsed or are refractory after ≥ 2 lines of systemic chemotherapy.

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References

  1. Merryman RW, Armand P, Wright KT, et al. Checkpoint blockade in Hodgkin and non-Hodgkin lymphoma. Blood Adv. 2017;1(26):2643–54.

    CAS  PubMed  PubMed Central  Google Scholar 

  2. Marin-Acevedo JA, Dholaria B, Soyano AE, et al. Next generation of immune checkpoint therapy in cancer: new developments and challenges. J Hematol Oncol. 2018;11(1):39.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  3. Ansell SM. Hodgkin lymphoma: 2018 update on diagnosis, risk-stratification, and management. Am J Hematol. 2018;93(5):704–15.

    Article  PubMed  Google Scholar 

  4. Innovent Biologics. China’s NMPA approves Innovent’s anti-PD-1 antibody Tyvyt® (sintilimab injection) for Hodgkin’s lymphoma [media release]. 26 Dec 2018. http://innoventbio.com/en/#/news/123.

  5. Innovent Biologics. Tyvyt® (sintilimab): Chinese prescribing information. Suzhou: Innovent Biologics; 2019.

    Google Scholar 

  6. Innovent Biologics. Innovent receives an approval from the US FDA to initiate clinical trials for its anti-CD47 monoclonal antibody IBI-188 [media release]. 29 Sept 2018. http://innoventbio.com/en/#/news/111.

  7. Eli Lilly and Company. Lilly and Innovent Biologics announce a strategic alliance to bring potential oncology therapies to patients in China and around the world [media release]. 20 Mar 2015. http://lilly.mediaroom.com/.

  8. Eli Lilly and Company. Lilly and Innovent Biologics expand their strategic alliance to include immuno-oncology bispecific antibodies in China and globally [media release]. 11 Oct 2015. http://lilly.mediaroom.com/.

  9. Innovent Biologics. Innovent announces global collaboration with Hutchison MediPharma to evaluate combination of sintilimab and fruquintinib in solid tumors [media release]. 29 Nov 2018. http://innoventbio.com/en/#/news/119.

  10. Zhang S, Zhang M, Wu W, et al. Preclinical characterization of sintilimab, a fully human anti-PD-1 therapeutic monoclonal antibody for cancer. Antibody Ther. 2018;1(2):65–73.

    Google Scholar 

  11. Shi Y, Su H, Song Y, et al. Safety and activity of sintilimab in patients with relapsed or refractory classical Hodgkin lymphoma (ORIENT-1): a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2019;6(1):e12–9.

    Article  PubMed  Google Scholar 

  12. Xu JM, Jia R, Wang Y, et al. A first-in-human phase 1a trial of sintilimab (IBI308), a monoclonal antibody targeting programmed death-1 (PD-1), in Chinese patients with advanced solid tumors [abstract no. e15125]. J Clin Oncol. 2018;36(15 Suppl).

  13. Jia R, Li YL, Jin YS, et al. Efficacy and safety of anti-PD-1 antibody (IBI308) in treating advanced neuroendocrine neoplams [abstract no. 2143]. Neuroendocrinology. 2018;106(Suppl 1):230.

  14. Ying K, Xu N, Jiang H, et al. Efficacy and safety of sintilimab combined with 1st line chemotherapy in advanced squamous cell non-small cell lung cancer [abstract no. OA08]. J Thorac Oncol. 2018;13 (12 Suppl):S1047.

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Authors and Affiliations

  1. Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand

    Sheridan M. Hoy

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  1. Sheridan M. Hoy
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Correspondence to Sheridan M. Hoy.

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The preparation of this review was not supported by any external funding.

Conflict of interest

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Sheridan Hoy is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

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This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Hoy, S.M. Sintilimab: First Global Approval. Drugs 79, 341–346 (2019). https://doi.org/10.1007/s40265-019-1066-z

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