Yuhan gets green light for phase 3 trials of LazertinibYuhan said Thursday that it has won approval from the Ministry of Food and Drug Safety on Wednesday to start Phase 3 clinical trials for its non-small cell lung cancer treatment candidate.
The Korean pharmaceutical company is planning to conduct a global scale trial for Lazertinib and has now obtained the first nod in Korea among the many countries participating in the trial.
In Korea, Yuhan plans to work with 27 local institutions including Samsung Medical Center and Severance Hospital to confirm the safety and efficacy of Lazertinib through a randomized, double-blind trial in comparison to Iressa, marketed by AstraZeneca and Teva.
The company hopes to start recruiting patients starting in the first quarter of next year.
Yuhan signed a deal worth up to $1.25 billion with Janssen Biotech to license Lazertinib in November last year, and the two companies have been collaborating in developing the treatment candidate.
By Ko Jun-tae