Johnson & Johnson (JNJ.US) files for market approval for EGFR/cMET dual antibody "erlotinib monoclonal antibody subcutaneous injection."

On September 25th, the official website of the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) showed that the market application for Johnson & Johnson's (JNJ.US) Evinacumab monoclonal antibody injection (subcutaneous injection) has been accepted. This is the first time that the subcutaneous injection formulation of Evinacumab monoclonal antibody has been submitted for market approval in China. Evinacumab monoclonal antibody is a fully human bispecific antibody targeting EGFR and MET with immune cell-directed activity. The FDA has approved intravenous Evinacumab monoclonal antibody in combination with chemotherapy (carboplatin+paclitaxel) as first-line treatment for locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, in combination with the third-generation EGFR inhibitor Lazertinib as first-line treatment for locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations, and in combination with chemotherapy (carboplatin+paclitaxel) as second-line treatment for locally advanced or metastatic NSCLC with EGFR exon 19 deletion (ex19del) or L858R substitution mutations among other indications.