Iparomlimab and Tuvonralimab: First Approval

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. Susan J. Keam is a contracted employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its 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.

Abstract

Iparomlimab and tuvonralimab (齐倍安®) is a bifunctional combination of anti-programmed death receptor-1 (PD-1)/anti-cytotoxic T lymphocyte-associated protein-4 (CTLA-4) monoclonal antibodies (mAbs) being developed by Qilu Pharmaceutical Co., Ltd for the treatment of advanced, solid, malignant tumours. In September 2024, iparomlimab and tuvonralimab was granted conditional approval (based on surrogate endpoints) for the treatment of patients with recurrent or metastatic cervical cancer who have failed previous platinum-based chemotherapy. This article summarizes the milestones in the development of iparomlimab and tuvonralimab leading to this first approval for the treatment of patients with recurrent or metastatic cervical cancer who have failed previous platinum-based chemotherapy.  

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