‘Poziotinib,’ a drug licensed out by Hanmi Pharmaceuticals, is entering its last phase for authorization in the US.

The variables that remain to approval are the US FDA’s interpretation of the clinical trial results and the on-site investigations on the company’s production and manufacturing facilities. If these progress as planned, Hanmi Pharmaceuticals will be able to achieve its first global commercialization landmark with the new drug technology export earlier next year.

On the 6th (local time), the US company Spectrum Pharmaceuticals submitted a new drug application (NDA) for poziotinib. It is indicated for the treatment of locally advanced and metastatic HER2 Exon20 mutant-posi