Skip to main content
Log in

Hetrombopag: First Approval

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

Abstract

Hetrombopag (Hengqu®), an oral nonpeptide thrombopoietin receptor agonist, is being developed by Jiangsu Hengrui Pharmaceutical for the treatment of thrombocytopenia and aplastic anaemia. On 16 June 2021, hetrombopag received its first approval in China as a second-line treatment for primary immune thrombocytopenia (ITP) and severe aplastic anaemia (SAA) in adults. The drug is also undergoing phase III development in China for the treatment of chemotherapy-induced thrombocytopenia. This article summarizes the milestones in the development of hetrombopag leading to this first approval for ITP and SAA.

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

Access this article

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

Instant access to the full article PDF.

Similar content being viewed by others

References

  1. Audia S, Mahevas M, Samson M, et al. Pathogenesis of immune thrombocytopenia. Autoimmun Rev. 2017;16(6):620–32.

    Article  CAS  Google Scholar 

  2. Mei H, Liu X, Li Y, et al. A multicenter, randomized phase III trial of hetrombopag: a novel thrombopoietin receptor agonist for the treatment of immune thrombocytopenia. J Hematol Oncol. 2021;14(1):37.

    Article  CAS  Google Scholar 

  3. Killick SB, Bown N, Cavenagh J, et al. Guidelines for the diagnosis and management of adult aplastic anaemia. Br J Haematol. 2016;172(2):187–207.

    Article  Google Scholar 

  4. Xie C, Zhao H, Bao X, et al. Pharmacological characterization of hetrombopag, a novel orally active human thrombopoietin receptor agonist. J Cell Mol Med. 2018;22(11):5367–77.

    Article  CAS  Google Scholar 

  5. Hengrui JS. Hetrombopag olamine tablets: Chinese prescribing information. 2021

  6. National Medical Products Administration. 2021. https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20210621084907105.html. Accessed 19 Jul 2021

  7. Zheng L, Liang MZ, Zeng XL, et al. Safety, pharmacokinetics and pharmacodynamics of hetrombopag olamine, a novel TPO-R agonist, in healthy individuals. Basic Clin Pharmacol Toxicol. 2017;121(5):414–22.

    Article  CAS  Google Scholar 

  8. Wang Z, Chen X, Li A, et al. Effect of food on the pharmacokinetic and pharmacodynamic profiles of hetrombopag in healthy volunteers. Clin Ther. 2020;42(12):2280–8.

    Article  CAS  Google Scholar 

  9. Yang G, Huang R, Yang S, et al. Effect of postdose fasting duration on hetrombopag olamine pharmacokinetics and pharmacodynamics in healthy volunteers. Br J Clin Pharmacol. 2020;86(8):1528–36.

    Article  CAS  Google Scholar 

  10. Wang Z, Chen L, Zhang F, et al. First-in-patient study of hetrombopag in patients with chronic idiopathic thrombocytopenic purpura. J Thromb Haemost. 2020;18(11):3053–60.

    Article  CAS  Google Scholar 

  11. Zhang F, Peng G, He G, et al. A multicenter, open-label, single-arm, phase 2 study to evaluate the efficacy and safety of hetrombopag in patients with severe aplastic anemia (SAA) [abstract no. 2751]. Blood. 2020;136(Suppl. 1):3–4.

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Yahiya Y. Syed.

Ethics declarations

Funding

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

Authorship and 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. Yahiya Y. Syed is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability

Not applicable.

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.

Supplementary Information

Below is the link to the electronic supplementary material.

Supplementary file1 (PPTX 503 KB)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Syed, Y.Y. Hetrombopag: First Approval. Drugs 81, 1581–1585 (2021). https://doi.org/10.1007/s40265-021-01575-1

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40265-021-01575-1

Navigation