On October 11, the China National Medical Products Administration's (NMPA) Center for Drug Evaluation (CDE) website just announced that Johnson & Johnson's (JNJ.US) two products have been accepted for review, namely the EGFR/MET bispecific antibody therapy amivantamab injection (subcutaneous injection) and the third-generation EGFR-TKI oral drug lazertinib. From Johnson & Johnson's public information, it is speculated that this time the application for approval may be a combination therapy composed of the two, with indications possibly for the indications already approved for the intravenous formulation of amivantamab.The FDA approved this combination therapy mainly based on the positive results of the MARIPOSA clinical 3rd phase study, which showed that amivantamab and lazertinib could reduce the risk of disease progression or death by 30% compared with active control drugs, and the median PFS of the combination therapy was 23.7 months and 16.6 months in the active control drug group; the median DOR of the combination therapy was 9 months longer than that of the active control drug (25.8 months vs 16.7 months).The analysis showed that amivantamab and lazertinib had a 30% lower risk of disease progression or death than active control drugs, and the median PFS of the combination therapy was 23.7 months and 16.6 months in the active control drug group; the median DOR of the combination therapy was 9 months longer than that of the active control drug (25.8 months vs 16.7 months).The FDA approved this combination therapy mainly based on the positive results of the MARIPOSA clinical 3rd phase study, which showed that amivantamab and lazertinib could reduce the risk of disease progression or death by 30% compared with active control drugs, and the median PFS of the combination therapy was 23.7 months and 16.6 months in the active control drug group; the median DOR of the combination therapy was 9 months longer than that of the active control drug (25.8 months vs 16.7 months).The analysis showed that amivantamab and lazertinib had a 30% lower risk of disease progression or death than active control drugs, and the median PFS of the combination therapy was 23.7 months and 16.6 months in the active control drug group; the median DOR of the combination therapy was 9 months longer than that of the active control drug (25.8 months vs 16.7 months).The analysis showed that amivantamab and lazertinib had a 30% lower risk of disease progression or death than active control drugs, and the median PFS of the combination therapy was 23.7 months and 16.6 months in the active control drug group; the median DOR of the combination therapy was 9 months longer than that of the active control drug (25.8 months vs 16.7 months).The analysis showed that amivantamab and lazertinib had a 30% lower risk of disease progression or death than active control drugs, and the median PFS of the combination therapy was 23.7 months and 16.6 months in the active control drug group; the median DOR of the combination therapy was 9 months longer than that of the active control drug (25.8 months vs 16.7 months).The analysis showed that amivantamab and lazertinib had a 30% lower risk of disease progression or death than active control drugs, and the median PFS of the combination therapy was 23.7 months and 16.6 months in the active control drug group; the median DOR of the combination therapy was 9 months longer than that of the active control drug (25.8 months vs 16.7 months).The analysis showed that amivantamab and lazertinib had a 30% lower risk of disease progression or death than active control drugs, and the median PFS of the combination therapy was 23.7 months and 16.6 months in the active control drug group; the median DOR of the combination therapy was 9 months longer than that of the active control drug (25.8 months vs 16.7 months).The analysis showed that amivantamab and lazertinib had a 30% lower risk of disease progression or death than active control drugs, and the median PFS of the combination therapy was 23.7 months and 16.6 months in the active control drug group; the median DOR of the combination therapy was 9 months longer than that of the active control drug (25.8 months vs 16.7 months).The analysis showed that amivantamab and lazertinib had a 30% lower risk of disease progression or death than active control drugs, and the