Skip to main content
SpringerLink
Log in

Toripalimab: First Global Approval

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

Abstract

Toripalimab, a recombinant, humanized programmed death receptor-1 (PD-1) monoclonal antibody that binds to PD-1 and prevents binding of PD-1 with programmed death ligands 1 (PD-L1) and 2 (PD-L2), is being developed by Shanghai Junshi Bioscience Co., Ltd in China for the treatment of various cancers. In December 2018, based on positive efficacy results of a phase 2 trial and safety data from several clinical studies, toripalimab received conditional approval in China for the treatment of unresectable or metastatic melanoma that has failed previous systemic therapy. This article summarizes the milestones in the development of toripalimab leading to this first global approval for the treatment of unresectable or metastatic melanoma.

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

References

  1. National Medical Products Administration. The first domestic PD-1 antibody drug, treipril monoclonal antibody injection, was approved for marketing [media release]. 17 Dec 2018.

  2. Shanghai Junshi Biosciences Co. Ltd. China’s first self-developed PD-1 monoclonal antibody, Treripril monoclonal antibody, was approved for marketing, and Junshi Biotechnology promoted China’s accelerated entry into a new era of tumor immunotherapy [media release]. 17 Dec 2018. http://junshipharma.com/News.html.

  3. Fu J, Wang F, Dong LH, et al. Preclinical evaluation of the efficacy, pharmacokinetics and immunogenicity of JS-001, a programmed cell death protein-1 (PD-1) monoclonal antibody. Acta Pharmacol Sin. 2017;38(5):710–8.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  4. Shanghai Junshi Biosciences Co. Ltd. Therapeutic areas: immuno-oncology: JS001 (toripalimab, anti-PD-1 mAb); 2019. http://www.junshipharma.com/en/Treatment.html. Accessed 9 Jan 2019.

  5. Shanghai Junshi Bioscience Co. Ltd. Toripalimab monoclonal antibody injection: Chinese prescribing information; 2019.

  6. 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.

  7. Chi Z, Tang B, Sheng X, et al. A phase II study of JS001, a humanized PD-1 mAb, in patients with advanced melanoma in China [abstract no. 9539]. J Clin Oncol. 2018;36(15 Suppl.).

  8. Si L, Kong Y, Xu X, et al. Prevalence of BRAF V600E mutation in Chinese melanoma patients: large scale analysis of BRAF and NRAS mutations in a 432-case cohort. Eur J Cancer. 2012;48(1):94–100.

    Article  CAS  PubMed  Google Scholar 

  9. Hutchison China MediTech Ltd. Chi-Med enters into multiple collaborations to evaluate combinations of surufatinib and fruquintinib with PD-1 checkpoint inhibitors [media release]. 29 Nov 2018.

  10. CSPC Pharmaceutical Group Ltd. Product co-development and strategic collaboration agreement [media release]. 10 Jul 2018.

  11. Shanghai Junshi Biosciences. Shanghai Junshi Biosciences Co., Ltd global offering; 2018. http://www.junshipharma.com/en/Investor-314.html. Accessed 21 Jan 2019.

  12. Tang B, Yan X, Sheng X, et al. Safety and clinical activity with an anti-PD-1 antibody JS001 in advanced melanoma or urologic cancer patients. J Hematol Oncol. 2019;12(1):7.

    Article  PubMed  PubMed Central  Google Scholar 

  13. Wang FH, Ren C, Zhang Y, et al. Phase Ia study of a humanized anti-PD-1 monoclonal antibody (JS001) in Chinese patients with refractory solid tumors [abstract no. 1186P]. Ann Oncol. 2017;28(Suppl. 5):v420–1.

    Google Scholar 

  14. Guo J, Sheng X, Si L, et al. A phase Ib study of JS001, a humanized IgG4 mAb against programmed death-1 (PD-1) combination with axitinib in patients with metastatic mucosal melanoma [abstract no. 9528]. J Clin Oncol. 2018;36(15 Suppl.).

  15. Xu R, Wang FH, Feng FJ, et al. Recombinant humanized anti-PD-1 monoclonal antibody (JS001) in patients with refractory/metastatic nasopharyngeal carcinoma: preliminary results of an open-label phase II clinical study [abstract no. 1150P]. Ann Oncol. 2018;29(Suppl. 8):viii409.

    Google Scholar 

  16. Sheng X, Chi Z, Cui C, et al. Preliminary results from patients with metastatic urothelial carcinoma (UC) in a phase 2 study of JS001, an anti-PD-1 monoclonal antibody [abstract no. e16505]. J Clin Oncol. 2018;36(15 Suppl.).

  17. Xu RH, Wang F, Shi J, et al. Recombinant humanized anti-PD-1 monoclonal antibody (JS001) as salvage treatment for advanced esophageal squamous cell carcinoma: preliminary results of an open-label, multi-cohort, phase Ib/II clinical study [abstract no. 116]. J Clin Oncol. 2018;36(4 Suppl.).

  18. Xu RH, Wang F, Xu N, et al. Recombinant humanized anti-PD-1 monoclonal antibody (JS001) as salvage treatment for advanced gastric adenocarcinoma: preliminary results of an open-label, multi-cohort, phase Ib/II clinical study [abstract no. 108]. J Clin Oncol. 2018;36(4 Suppl.).

  19. Bian L, Zhang H, Wang T, et al. A phase I study of JS001, a humanized PD-1mAb in patients with advanced triple negative breast cancer [abstract no. e15093]. J Clin Oncol. 2018;36(15 Suppl.).

  20. Yang S, Yang J, Han X, et al. Effect of JS001, a monoclonal antibody targeting programed death-1 (PD-1), on responses and disease control in patients with advanced or refractory alveolar soft part sarcoma: results from a phase 1 trial [abstract no. 11572]. J Clin Oncol. 2018;36(15 Suppl.).

  21. Zhang P, Lu M, Li J. Efficacy and safety of PD-1 blockade with JS001 in patients with advanced neuroendocrine neoplasms: a non-randomized, open-label, phase Ib trial [abstract no. 1309O]. Ann Oncol. 2018;29(Suppl. 8):viii468.

    Google Scholar 

Download references

Author information

Authors and Affiliations

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

    Susan J. Keam

Authors
  1. Susan J. Keam
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Susan J. Keam.

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 provide information for the article. Changes resulting from any information or comments received were made by the authors on the basis of scientific completeness and accuracy. Susan Keam is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

Additional information

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

Keam, S.J. Toripalimab: First Global Approval. Drugs 79, 573–578 (2019). https://doi.org/10.1007/s40265-019-01076-2

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40265-019-01076-2

Search

Navigation