On February 6, 2023 J INTS BIO announced that the preclinical results of "JIN-A04," a novel oral tyrosine kinase inhibitor (TKI) targeting HER2 Exon20 insertion mutation in NSCLC, will be presented at the upcoming 2023 American Cancer Research Association meeting in Orlando, U.S. from April 14 to 19 (Press release, J INTS BIO, FEB 6, 2023, View Source [SID1234626895]).

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HER2 Exon20 insertion mutation accounts for 2-3% of NSCLC and there is currently no approved oral targeted therapy.

"JIN-A04" showed potent efficacy against HER2 Exon20 insertion mutant NSCLC cell lines, and in-vivo mouse models using HER2 Exon20 insertion mutant cell lines significant tumor regression was demonstrated.

J INTS BIO completed the application for designation of ‘JIN-A04’ as an orphan drug with the US FDA in August last year and said that the procedure for designation as an orphan drug is in progress. As a result, the company said, "If JIN-A04 is approved for designation as an orphan drug, it will be possible for it to be used in patients after the completion of Phase 1 and Phase 2 clinical trials." To this end, the company plans to submit an IND to the US and Korea in the first half of this year, allowing us to enter Phase 1 clinical study in the US and Korea simultaneously.