On November 11, 2022 J INTS BIO reported on November 9th that it had received approval from the US FDA for its Phase 1/2 clinical trial of its Novel Oral 4th Generation EGFR TKI ‘JIN-A02’ in patients with advanced non-small cell lung cancer (NSCLC) (Press release, J INTS BIO, NOV 11, 2022, View Source;phase-12-ind-approved-by-us-fda-301675174.html [SID1234623858]).

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IND submission is currently ongoing sequentially in territories outside of USA.

‘JIN-A02’ is a Novel Orally administered 4th Generation EGFR TKI, which is highly selective and potent against NSCLC harboring C797S double or triple mutations, presenting in either cis or trans forms. Cis isomer is the most common and currently untreatable. ‘JIN-A02’ also has high blood-brain barrier penetrance with demonstrated in-vivo efficacy.

J INTS BIO is expecting the first patient to be recruited in the US before the end of the year.