Skip to main content
SpringerLink
Log in

Serplulimab: First Approval

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

Abstract

Serplulimab (汉斯状®) is an intravenously administered anti-PD-1 antibody being developed by Shanghai Henlius Biotech, Inc. for the treatment of solid tumours. Anti-PD-1 immunotherapies, such as serplulimab, can stimulate immune responses by relieving PD-1-related immunosuppression. Serplulimab received its first approval on 25 Mar 2022 in China for the treatment of adult patients with advanced unresectable or metastatic microsatellite instability-high (MSI-H) solid tumours that have failed to respond to previous standard treatments. This article summarizes the milestones in the development of serplulimab leading to this first approval in the treatment of MSI-H solid tumours in adults.

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. Shanghai Henlius Biotech, Inc. Henlius receives NMPA approval for its first innovative monoclonal antibody HANSIZHUANG [media release]. 25 Mar 2022. https://www.henlius.com/.

  2. Shanghai Henlius Biotech, Inc. The National Medical Products Administration approved Hansizhuang (serplulimab injection) for the treatment of unresectable or metastatic microsatellite instability-high (MSI-H) solid tumours that have failed to respond to the standard therapy [media release]. 25 Mar 2022. https://www1.hkexnews.hk/.

  3. Shanghai Henlius Biotech, Inc. Serplulimab injection: Chinese prescribing information [Chinese]. 2022. https://www.henlius.com/. Accessed 14 Apr 2022.

  4. Shanghai Henlius Biotech, Inc. Henlius and KG Bio announce a collaboration for Henlius novel anti-PD-1 mAb HLX10 in the Asia Pacific region [media release]. 12 Sep 2019. https://www.henlius.com.

  5. Shanghai Henlius Biotech, Inc. Henlius and KG Bio enter into exclusive license agreement for Henlius novel anti-PD-1 mAb HLX10 [media release]. 30 Sep 2019. https://www.henlius.com.

  6. Issafras H, Fan S, Tseng CL, et al. Structural basis of HLX10 PD-1 receptor recognition, a promising anti-PD-1 antibody clinical candidate for cancer immunotherapy. PLoS ONE. 2021;16(12):e0257972.

    Article  CAS  Google Scholar 

  7. Qin S, Li J, Zhong H, et al. Efficacy and safety of HLX10, a novel anti-PD-1 antibody, in patients with previously treated unresectable or metastatic microsatellite instability-high or mismatch repair-deficient solid tumors: a single-arm, multicenter, phase 2 study [abstract no. 2566]. J Clin Oncol. 2021;39(15):2566.

    Article  Google Scholar 

  8. Cheng Y, Han L, Wu L, et al. Serplulimab, a novel anti-PD-1 antibody, plus chemotherapy versus chemotherapy alone as first-line treatment for extensive-stage small-cell lung cancer: an international randomized phase 3 study [abstract no. 8505]. J Clin Oncol. 2022;40(16):8505.

    Article  Google Scholar 

  9. Shanghai Henlius Biotech, Inc. Hepatocellular carcinoma phase 2 clinical study results of a novel anti-PD-1 mAb serplulimab has been selected for the innovation session at 2021 CSCO [media release]. 28 Sep 2021. https://www.henlius.com.

  10. An J. Efficacy and safety of serplulimab (an anti-PD-1 antibody) combined with albumin-bound paclitaxel in patients with advanced cervical cancer who have progressive disease or intolerable toxicity after first-line standard chemotherapy [abstract no. 74]. In: SGO Annual Meeting. 2022.

  11. Chao TY, Ho CL, Cheng WH, et al. A novel anti-PD-1 antibody HLX10 study led to the initiation of combination mmunotherapy [abstract no. 324P]. Ann Oncol. 2019;30(Suppl. 9):9.

Download references

Author information

Authors and Affiliations

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

    Arnold Lee

Authors
  1. Arnold Lee
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Arnold Lee.

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. Arnold Lee 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 (PDF 601 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Lee, A. Serplulimab: First Approval. Drugs 82, 1137–1141 (2022). https://doi.org/10.1007/s40265-022-01740-0

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40265-022-01740-0

Search

Navigation