Johnson & Johnson Submits NDA in China for Subcutaneous Amivantamab, a 5-Minute Injection for EGFR-Mutated NSCLC

Today (September 25), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has just announced,Johnson & Johnson's submissionAmivantamab Injection (Subcutaneous Injection)The listing application has been accepted.

Public information shows that this was developed by Johnson & Johnson.EGFR/MET Bispecific AntibodyAmivantamab and recombinant human hyaluronidase fixed combination for subcutaneous administration. In June this year, Johnson & Johnson has submitted this subcutaneous injection to the U.S. FDA.AmivantamabBiologics License Application,For all currently approved or submittedAmivantamabIndications for intravenous formulations, covering different types of non-small cell lung cancer (NSCLC).According to a previous press release from Johnson & Johnson, patients are able to complete the injection of this subcutaneous formulation within 5 minutes.

Screenshot source:CDE Official Website

AmivantamabIt is a humanized EGFR/MET bispecific antibody.It has multiple mechanisms of anticancer action, not only blocking EGFR and MET-mediated signal transduction but also guiding immune cells to target those with activating and drug-resistant mutations.EGFR/METTumors with mutations and amplifications.The intravenous formulation of this product was earliestReceived FDA approval in May 2021Accelerated Approval, which has subsequently been approved for multiple indications, including:

• EGFRAdult patients with locally advanced or metastatic NSCLC who have exon 20 insertion mutations and whose disease has progressed during or after platinum-based chemotherapy;

• Combined with third-generation EGFR-TKI oral medicationLanreotide Tablets (lazertinib）First-line treatment confirmed by FDA-approved testing to haveEGFRExon 19 deletion or exon 21L858RAdult patients with locally advanced or metastatic NSCLC harboring substitution mutations;

• Combined with standard chemotherapy (carboplatin and pemetrexed) for the treatment ofEGFRExon 19 deletion or exon 21L858RSubstitution MutationAdult patients with locally advanced or metastatic NSCLC.

In China,Amivantamab Intravenous InjectionThree marketing applications have been approved by the NMPA.Acceptance, includingAndLangetinib Mesylate TabletsThe combination therapy has also been submitted to the CDE.‍Listed‍Application。

Evanmab Injection (Subcutaneous Injection) is a fixed combination of Evanmab and recombinant human hyaluronidase for subcutaneous administration. According to a previous press release from Johnson & Johnson, in the PALOMA-3 study, regardingEGFRExon 19 deletion orL858RPatients with mutated NSCLC,AmivantamabSubcutaneous formulation has a similar overall response rate as intravenous formulation. The subcutaneous formulation also demonstrated significantly shorter administration time, with infusion-related reactions reduced by 5 times, along with longer overall survival, progression-free survival, and duration of response.. The detailed experimental results of the study were published inJournal of Clinical Oncologyjournal. In addition, the data from Phase 2 trial PALOMA-2 also supportsAmivantamab Injection(Subcutaneous injection) withDosing frequency of every two weeks and every three weeks.

According to the official website of China Drug Clinical Trial and Information Disclosure Platform, Johnson & Johnson is conducting clinical trials in China.Amivantamab (Subcutaneous Injection)Two international multicenter clinical studies, including a Phase 2 study, targetingAdvanced or metastatic solid tumors (includingEGFRPatients with mutant non-small cell lung cancer; and a Phase 3 study targetingDisease progression after receiving osimertinib and chemotherapyEGFRPatients with mutant advanced or metastatic non-small cell lung cancer, evaluate the combination of this productEfficacy and Safety of Lanreotide Tablets.

The submission of this subcutaneous injection formulation of the bispecific antibody product for marketing approval in China marks a significant advancement in its development process within the country.