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FDA Approves Shanghai Henlius Biotech IND for Cetuximab Biosimilar
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FDA Approves Shanghai Henlius Biotech IND for Cetuximab Biosimilar
On May 10, 2026, Shanghai Henlius Biotech announced that the FDA has approved its IND for a proposed biosimilar, HLX05-N, to Eli Lilly’s ERBITUX (cetuximab) product for the treatment of metastatic colorectal cancer (mCRC). ERBITUX is approved in the United States for the treatment of KRAS wild-type, epidermal growth factor receptor (EGFR)-expressing mCRC, among other indications.Henlius indicated that it plans to advance the program through cli…
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