Skip to main content
SpringerLink
Log in

Camrelizumab: First Global Approval

  • AdisInsight Report
  • Published:
Drugs Aims and scope Submit manuscript

A Correction to this article was published on 24 August 2019

This article has been updated

Abstract

Camrelizumab (AiRuiKa™), a programmed cell death 1 (PD-1) inhibitor being developed by Jiangsu Hengrui Medicine Co. Ltd, recently received conditional approval in China for the treatment of relapsed or refractory classical Hodgkin lymphoma. The drug is also being investigated as a treatment for various other malignancies, including B cell lymphoma, oesophageal squamous cell carcinoma, gastric/gastroesophageal junction cancer, hepatocellular carcinoma, nasopharyngeal cancer and non-squamous, non-small cell lung cancer. This article summarizes the milestones in the development of camrelizumab leading to this first approval for classical Hodgkin lymphoma.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

Change history

  • 24 August 2019

    Page 1355, Abstract, Inline table ‘Camrelizumab (AiRuiKa™): Key Points’, and Introduction.

References

  1. Mo H, Huang J, Xu J, et al. Safety, anti-tumour activity, and pharmacokinetics of fixed-dose SHR-1210, an anti-PD-1 antibody in advanced solid tumours: a dose-escalation, phase 1 study. Br J Cancer. 2018;119(5):538–45.

    Article  CAS  Google Scholar 

  2. Jiangsu Hengrui Medicine. Announcement on obtaining new drug certificate and drug registration approval [media release]. 31 May 2019. http://cfi.cn/p20190531000358.html.

  3. Alsaab HO, Sau S, Alzhrani R, et al. PD-1 and PD-L1 checkpoint signaling inhibition for cancer immunotherapy: mechanism, combinations, and clinical outcome. Front Pharmacol. 2017;8:561.

    Article  Google Scholar 

  4. Jiangsu Hengrui Medicine Co. Ltd. Camrelizumab: Chinese prescribing information. Lianyungang: Jiangsu Hengrui Medicine Co. Ltd; 2019.

  5. Hogan Lovells. The China Food and Drug Administration pushes forward on conditional approval and compassionate use of new drugs [media release]. 17 Jan 2018. https://www.lexology.com/library/detail.aspx?g=73ce9342-8178-4b42-9c31-389edf0278c1.

  6. Incyte Corporation. Incyte announces global license agreement with Jiangsu Hengrui Medicine for SHR-1210, an investigational anti-PD-1 monoclonal antibody [media release]. 2 Sep 2015. http://www.incyte.com.

  7. Incyte Corporation. Form 10-Q quarterly report for the quarterly period ended 31 March 2018. 2018. https://investor.incyte.com/static-files/9a5c18d8-681c-4212-9bf3-c82405b7754b. Accessed 21 June 2019.

  8. LSK Biopharma, Jiangsu Hengrui Medicine. LSK BioPharma and Jiangsu Hengrui Medicine announce global clinical collaboration to evaluate the combination of anti-angiogenesis and immuno-oncology therapy for patients with advanced hepatocellular carcinoma (HCC) [media release]. 21 Oct 2018. http://www.lskbiopharma.com.

  9. Nie J, Wang C, Liu Y, et al. Addition of low-dose decitabine to anti-PD-1 antibody camrelizumab in relapsed/refractory classical Hodgkin Lymphoma. J Clin Oncol. 2019. http://doi.org/10.1200/jco.18.02151.

    Article  CAS  Google Scholar 

  10. Zhu J, Feng J, Chen X, et al. A phase II study of SHR-1210, an antipd-1 antibody, in Chinese patients with relapsed/refractory classic Hodgkin Lymphoma [abstract no. T026 (0025)]. HemaSphere. 2018;2(Suppl. 3):41.

  11. Zhang W, Liu Y, Mei Q, et al. Safety and efficacy of GVD and anti-PD-1 (SHR-1210) regimen with or without low-dose decitabine priming for refractory bulky and aggressive primary mediastinal large B-cell lymphoma [abstract no. 7556]. J Clin Oncol. 2018;36(15 Suppl.).

    Article  Google Scholar 

  12. Pang Q, Li X, Zhang W, et al. Safety and effect of radiation therapy combined with anti-PD-1 antibody SHR-1210 as first-line treatment on patients with intolerable concurrent chemoradiotherapy esophageal cancer: a phase 1b clinical trial [abstract no. SU_9_2089]. Int J Radiat Oncol Biol Phys. 2018;102(3 Suppl.):e39.

    Article  Google Scholar 

  13. Jing Z, Du D, Zhang N, et al. Combination of radiation therapy and anti-PD-1 antibody SHR-1210 in treating patients with Esophageal Squamous Cell Cancer [abstract no. SU_8_2071]. Int J Radiat Oncol Biol Phys. 2018;102(3 Suppl.):e31.

    Article  Google Scholar 

  14. Huang J, Xu B, Mo H, et al. Safety, activity, and biomarkers of SHR-1210, an anti-PD-1 antibody, for patients with advanced esophageal carcinoma. Clin Cancer Res. 2018;24(6):1296–304.

    Article  CAS  Google Scholar 

  15. Shen L, Peng Z, Zhang YQ, et al. Camrelizumab combined with capecitabine and oxaliplatin followed by camrelizumab and apatinib as first-line therapy for advanced or metastatic gastric or gastroesophageal junction cancer: updated results from a multicenter, open label phase II trial [abstract no. 4031]. J Clin Oncol. 2019;37(15 Suppl.).

    Article  Google Scholar 

  16. Data on file, Jiangsu Hengrui Medicine, 2019.

  17. Xu J, Zhang Y, Jia R, et al. Anti-PD-1 antibody SHR-1210 combined with apatinib for advanced hepatocellular carcinoma, gastric, or esophagogastric junction cancer: an open-label, dose escalation and expansion study. Clin Cancer Res. 2019;25(2):515–23.

    Article  Google Scholar 

  18. Huang J, Mo H, Zhang W, et al. Promising efficacy of SHR-1210, a novel anti-programmed cell death 1 antibody, in patients with advanced gastric and gastroesophageal junction cancer in China. Cancer. 2019;125(5):742–9.

    Article  CAS  Google Scholar 

  19. Qin SK, Ren ZG, Meng ZQ, et al. A randomized multicentered phase II study to evaluate SHR-1210 (PD-1 antibody) in subjects with advanced hepatocellular carcinoma (HCC) who failed or intolerable to prior systemic treatment [abstract no. LBA27]. Ann Oncol. 2018;29(Suppl. 8):viii719–20.

  20. Fang W, Yang Y, Ma Y, et al. Camrelizumab (SHR-1210) alone or in combination with gemcitabine plus cisplatin for nasopharyngeal carcinoma: results from two single-arm, phase 1 trials. Lancet Oncol. 2018;19(10):1338–50.

    Article  CAS  Google Scholar 

  21. Zhou C, Gao G, Wu F, et al. A phase Ib study of SHR-1210 plus Apatinib for heavily previously treated advanced nonsquamous non-small cell lung cancer (NSCLC) patients [abstract no. e21017]. J Clin Oncol. 2018;36(15 Suppl.).

  22. Chen X, Ma L, Wang X, et al. Reactive capillary hemangiomas: a novel dermatologic toxicity following anti-PD-1 treatment with SHR-1210. Cancer Biol Med. 2019;16(1):173–81.

    Article  CAS  Google Scholar 

  23. Wu F, Gao G, Zhou C, et al. A phase III, randomized, open-label, multicenter study of SHR-1210 (anti-PD-1 antibody) in combination with pemetrexed and carboplatin as first line therapy in subjects with advanced/metastatic non-squamous non-small cell lung cancer [abstract no. 1505TiP]. Ann Oncol. 2018;29(Suppl. 8):viii545.

Download references

Author information

Authors and Affiliations

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

    Anthony Markham & Susan J. Keam

Authors
  1. Anthony Markham
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Susan J. Keam
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Anthony Markham.

Ethics declarations

Funding

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. A. Markham, a contracted employee of Adis International Ltd/Springer Nature, and Susan Keam, a salaried employees of Adis International Ltd/Springer Nature are responsible for the article content and declare no relevant conflicts of interest.

Additional information

Additional information for this AdisInsight Report can be found at https://doi.org/10.6084/m9.figshare.8636738.

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.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Markham, A., Keam, S.J. Camrelizumab: First Global Approval. Drugs 79, 1355–1361 (2019). https://doi.org/10.1007/s40265-019-01167-0

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40265-019-01167-0

Search

Navigation