Henlius Receives NMPA IND Clearance for HLX05-N (Biosimilar, Erbitux)
Shots:
- The NMPA has granted IND clearance to Henlius’ HLX05-N, a biosimilar version of Erbitux (cetuximab), for the treatment of metastatic colorectal cancer (mCRC)
- HLX05-N showed high similarity to reference cetuximab in analytical & non-clinical studies, with Henlius planning to initiate an international multi-center P-I trial upon meeting required conditions
- 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
Related News: Henlius Receives NMPA IND Clearance for HLX18 (Biosimilar, Opdivo)
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