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On March 28, Henlius Group issued an announcement stating that the company's recombinant anti-PD-1 humanized monoclonal antibody injection HLX10 is used for unresectable or metastatic highly microsatellite instability that has failed standard treatments.
HLX10 is a recombinant anti-PD-1 humanized monoclonal antibody independently developed by Henlius.
The primary endpoint reached this time is a single-arm, open, multiple-arm, open-ended, multiple-arm, open-ended, multiple-arm, unresectable or metastatic MSI-H or dMMR solid tumor patient who has failed standard treatments to evaluate the efficacy, safety, and tolerability of HLX10.
MSI-H and dMMR are two common genetic abnormalities.
Previously, anti-tumor therapies that were differentiated not based on tumor source but based on biomarkers had been approved for marketing in the United States.
Reference materials:
[1] Voluntary announcement-HLX10 (recombinant anti-PD-1 humanized monoclonal antibody injection) is used to repair unresectable or metastatic highly microsatellite unstable or mismatch defective solid tumors that have failed standard treatments The Phase 2 clinical study reached the main research endpoint.