Janssen's EGFR×c-Met Bispecific Antibody Amivantamab Approved in China for New NSCLC Indication

April 25,Johnson & JohnsonAnnounced that its innovative therapeutic drugsCarestream^®(Amivantamab Injection)Approved by the National Medical Products Administration (NMPA)) approved, administered in combination with carboplatin and pemetrexed, applicable for the treatment of patients carrying epidermal growth factor receptor（EGFR）Exon 19 deletion or Exon 21L858R Substitution mutations with disease progression during or after EGFR tyrosine kinase inhibitor treatmentLocally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer（NSCLC）Adult Patients。

This approval marks the Evomela monoclonal antibodyHas received its second lung cancer indication in China this year. Previously, the drugWas approved in February this year for the treatment ofFirst-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer carrying EGFR exon 20 insertion mutations。

Lung cancer ranks first in both incidence and mortality among all malignant tumors in China. According to statistics, there are over 1 million new cases of lung cancer annually in China, accounting for more than one-third of the total number of lung cancer patients worldwide.EGFR Gene mutations are the most common driver genes in non-small cell lung cancer, and about 40% of patients in China carry this type of mutation.

EGFR There are various types of sensitive mutations, among which deletions in exon 19 and exon 21L858R Point mutations are the most common type of EGFR mutation.According to statistics, patients receiving EGFR tyrosine kinase inhibitors（TKI）TreatmentEGFR Patients with advanced non-small cell lung cancer due to mutations have a 5-year survival rate of less than 20%.

The acquired resistance mechanisms that emerge after previous treatment with EGFR TKI monotherapy are diverse and polyclonal. This makes targeted therapy more challenging after disease progression, thereby limiting the efficacy of targeted treatments. Additionally, combining immunotherapy with chemotherapy has not demonstrated clinically meaningful improvements.

This timeThe approval and market launch of amivantamab for its new indication is based on the robust efficacy and safety data from the MARIPOSA-2 Phase III study. The study results demonstrate:

Based on the results of the MARIPOSA-2 clinical trial, the NCCN Clinical Practice Guidelines issued by the National Comprehensive Cancer Network recommend amivantamab in combination with chemotherapy as a standard treatment.EGFR The only Class 1 preferred treatment option for mutant advanced NSCLC patients after progression on osimertinib.

Amivantamab is a fully humanized bispecific antibody targeting EGFR and MET., it can not only block EGFR and MET-mediated signal transduction, but also guide immune cells to target those with activating and resistant mutations.EGFR/MET Tumors with mutations and amplifications. According to Johnson & Johnson's Q1 financial report forecast this year,Amivantamab + Lazertinib CombinationSales are estimated to reach at least 3.6 billion US dollars in the 2027/2028 market, indicating solid potential.BlockbusterMedicine。

1.https://mp.weixin.qq.com/s/QHohk-zge-1vFjMlrfvjXA

2. Other Public Information on the Internet

Exciting Live Broadcast Preview

Press and hold to scan the QR code to participate immediately ↓

Swipe up to view

Recommendation 1

April 28th, 19:00-20:00

Industry-Research Dialogue: Innovation and Translation of CAR-NK Therapy for Solid Tumors

Recommendation 2

April 29, 15:00-16:00

Development and Safety Testing of "Universal" Technology in Cell Therapy

In Partnership with 医麦客 IBI EXPO 2026

Statement and Copyright Notice

Disclaimer: This article aims to convey industry development information and explore the frontier progress of biomedicine. The content of the article represents the author's viewpoint and does not represent the position of EBC, nor does it constitute any value judgment, investment advice, or medical guidance. If necessary, please consult a professional for investment or visit a regular hospital for medical advice.

Copyright Statement:Welcome to share the article on your personal Moments. Unauthorized media or institutions are prohibited from reprinting the article in any form to other platforms. If you need to reprint, please leave a message under the article to obtain authorization.

Dian Dian "Share”、“Like" and "In Progress", give me a little recharge~"