YH-42946

JIN-A04 will slot into a pipeline led by the EGFR tyrosine kinase inhibitor lazertinib. Yuhan Corporation has bought its way into a cancer space targeted by Boehringer Ingelheim and Takeda, wagering up to $325 million to get its hands on a preclinical HER2 tyrosine kinase inhibitor (TKI). The oral drug candidate, which Korea’s Yuhan is licensing from its compatriot J INTS BIO, is designed for use in non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations. Around 3% of NSCLC patients have HER2 mutations, and around 90% of those mutations are exon 20 insertions. The potential to improve outcomes in that subset of patients has attracted a clutch of drug developers.  Spectrum Pharmaceuticals sought FDA approval for poziotinib in NSCLC harboring HER2 exon 20 insertion mutations late in 2021 but deprioritized the program after receiving a rejection notice last year. Rival drug candidates remain in active clinical development, with Boehringer studying BI 1810631 in a phase 1 trial and Takeda securing approval two years ago for mobocertinib, a TKI that targets EGFR and HER2 insertions.  Flanked by deep-pocketed rivals with more advanced programs, J INTS BIO has pitched its TKI candidate as a potential best-in-class molecule. The claim, which is backed by in vitro and in vivo models showing it is potent against HER2 exon 20 insertions, has helped the Korean biotech land a deal for the therapy. Yuhan has taken the other side of the agreement. The Korean drugmaker, which owns a 15% stake in J INTS BIO, is paying $1.9 million upfront as part of a deal worth up to $325 million to secure rights to the JIN-A04 drug candidate.    At Yuhan, JIN-A04 will slot into a pipeline led by the EGFR TKI lazertinib. Johnson & Johnson paid Yuhan $50 million upfront and committed to $1.2 billion in milestones for rights to the small molecule outside of Korea in 2018. Yuhan went on to launch the drug in Korea, under the Leclaza name, as a second-line treatment for NSCLC while continuing to study the molecule in other settings. 

SEOUL, South Korea, May 31, 2023 /PRNewswire/ -- Yuhan Corporation (CEO, Wook-Je Cho) announced on the 30th of May that it has signed an in-license agreement with J INTS BIO (CEO, Anna Jo) for a Tyrosine Kinase Inhibitor (TKI) targeting HER2, 'JIN-A04'. The total contract size is 325 million dollars, and it includes an upfront payment of 1.9 million dollars and milestone payments according to future development, permits, and sales. JIN-A04 is an oral TKI targeting non-small cell lung cancer carrying HER2 mutations, and there is currently no approved oral drug approved to date. Preclinical data of JIN-A04 was recently presented at the 2023 edition of the American Cancer Research Association (AACR) annual meeting in April at Orlando, USA showing strong efficacy in both In-vitro and In-vivo studies. Yuhan Corporation CEO, Wook-Je Cho said, "We have taken a step forward in the development of the 2nd and 3rd LECLAZA by securing an additional anti-cancer drug pipeline with this contract. We plan to further strengthen our anticancer drug pipeline in the future." Anna Jo, CEO of J INTS BIO, said, "JIN-A04 is expected to be a hope for NSCLC patients with 'HER2 Exon20 insertion' mutations." And it can become the most promising Best-in-Class TKI therapy in this field." Meanwhile, Yuhan invested 1.5 million dollars in J INTS BIO in 2021 and 2022, respectively, and holds a 14.8% stake in the company. View original content to download multimedia: SOURCE J INTS BIO Company Codes: Korea:000100