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Serplulimab: First Approval

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posted on 05.07.2022, 05:39 authored by Arnold Lee


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 about this Adis Drug Review can be found here



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.

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