Qilu Pharmaceutical Submits NDA for PD-1 Antibody Iparomlimab Injection

On September 17, the CDE website showed that the marketing application of Aipaloli Monoclonal Antibody Injection, a PD-1 antibody developed by Qilu Pharmaceutical, was accepted. This is Qilu's second antibody innovative drug to be submitted for marketing after QL1706.

On August 12, the marketing application for Qilu Pharmaceutical's Aipalolizumab/Tovorolizumab (QL1706) Injection was accepted ().

QL1706 is a bifunctional combination antibody developed by Qilu Pharmaceutical. It utilizes the novel combination antibody technology platform MabPair to simultaneously produce two engineered monoclonal antibodies in a single cell at a ratio of approximately 2:1 — the Programmed Death Receptor-1 (PD-1) IgG4 antibody Iparomlimab and the Cytotoxic T Lymphocyte-Associated Protein 4 (CTLA-4) IgG1 antibody Tuvonralimab.

(Source: Qilu Pharmaceutical Official Account)

Therefore, QL1706 can simultaneously inhibit PD-1 and CTLA-4, and the CTLA-4 antibody component has a shorter clearance half-life in vivo, resulting in a shorter exposure time of the CTLA-4 antibody within a dosing cycle. Thus, QL1706 has the synergistic mechanism of action of blocking both PD-1 and CTLA-4 while reducing the toxicity generated by the CTLA-4 antibody.

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