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New Indications For Mercetuximab Are Declared And Listed

On November 3, the official website of China's CDE showed that Merck's cetuximab (trade name: Erbitux) was declared for the market.


Cetuximab is a human-mouse chimeric IgG1 monoclonal antibody targeting epidermal growth factor receptor (EGFR), and it is also the first anti-EGFR monoclonal antibody approved for marketing in the world. It can specifically bind to the EGFR domain expressed on the surface of cancer cells, competitively inhibit the corresponding ligands, block intracellular signal transduction pathways, and thus exert anti-tumor effects; through antibody-dependent cell-mediated cytotoxicity (ADCC) effects Kill tumor cells; down-regulate hypoxia factor 1-α and Bcl2 proto-oncogenes, activate autophagy genes, thereby inducing autophagy by tumor cells.


In February 2004, Cetuximab was first launched in the United States, and subsequently launched in the European Union, China, and Japan. At present, cetuximab has been approved for marketing in more than 100 countries around the world, mainly for the treatment of colorectal cancer and squamous cell carcinoma of the head and neck (SCCHN).


In September 2021, cetuximab expanded its new indications in the United States, specifically combining encorfenib in the treatment of previously treated BRAF V600E mutation-positive metastatic colorectal cancer (CRC) patients. Cetuximab was originally developed by ImClone, and Merck, BMS and Eli Lilly jointly own the rights.