Henlius Receives US FDA IND Clearance for HLX05-N (Biosimilar, Erbitux)
Shots:
- The US FDA has granted IND clearance to HLX05-N, a biosimilar version of Erbitux (cetuximab) for the treatment of metastatic colorectal cancer (mCRC)
- HLX05-N is developed by Henlius in accordance with biosimilar guidelines in China, the EU, & the US, and showed high similarity to reference cetuximab in analytical & non-clinical comparative studies
- Cetuximab is an anti-EGFR monoclonal antibody that binds to EGFR, blocking ligand binding & signaling to inhibit proliferation, induce apoptosis, & suppress angiogenesis, while also mediating ADCC to enable immune cells to kill tumor cells
Ref: Henlius | Image: Henlius | Press Release
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