Hanmi’s Rolontis receives US FDA marketing approval

Will be released in the US within the year

Hanmi’s partner Spectrum receives approval of marketing authorization notice from the FDA

Hanmi Pharmaceutical’s neutropenia treatment ‘Rolontis (US product name: Rolvedon)' received approval from the US FDA.

 

Hanmi Pharmaceutical and its partner Spectrum Pharmaceuticals announced on the 9th (local time) that it had received written notice of approval allowing for the marketing authorization of Rolontis from the FDA.

 

This is the first new drug developed by Hanmi Pharmaceutical to be granted marketing authorization by the FDA.

 

In terms of achievements made by the domestic biopharmaceutical industry, Hanmi Pharmaceutical’s approval this time marks the 6th new homegrown drug MA granted by the FDA and is the first among new anticancer drugs Hanmi Pharmaceutical and Spectrum Pharmaceuticals explained that they are ready to launch Rolontis in the US market.

 

The companies expect to have the product available within the year based on the nationwide sales and marketing network they have established in the US.

 

Se-Chang Kwon, President & CEO of Hanmi Pharmaceutical, said, “The approval holds significance as it is Hanmi’s first new drug to be granted approval and the first demonstration of the potential held by the company’s proprietary platform technology, LAPSCOVERY, The approval will be a decisive opportunity for the commercial success of Rolontis and the rise in the future value of new biologics based on LAPSCOVERY.