Hanmi Pharm's Rolontis FDA Approval Delayed

"Domestic Outlook Within the Year"

[Asia Economy Reporter Cho Hyun-ui] Hanmi Pharmaceutical's new drug for neutropenia treatment, 'Rolontis,' which was licensed out to the U.S. pharmaceutical company Spectrum, has had its U.S. Food and Drug Administration (FDA) approval temporarily delayed. This is due to the FDA being unable to conduct an on-site inspection of the Pyeongtaek bioplant in Gyeonggi Province amid the spread of the novel coronavirus (COVID-19).

According to Hanmi Pharmaceutical on the 27th, Spectrum announced the previous day (local time) that "We received notification from the FDA that the approval of Rolontis will be postponed until the inspection in Korea is completed," and added, "We are working with the FDA to find a way to expedite the inspection."

Aside from the Pyeongtaek bioplant inspection, FDA inspections of the Rolontis finished product manufacturing site, finished product packaging site in the U.S., and Spectrum headquarters have all been completed. All related documents requested by the FDA for approval review have also been submitted.

Hanmi Pharmaceutical explained, "This is not a case where approval was denied or cannot be granted due to a serious disqualification," and added, "The notification of approval delay means that all other procedures necessary for approval, except for the Pyeongtaek plant inspection, have been completed."

However, it is expected that the domestic approval process for Rolontis could be completed within this year. Hanmi Pharmaceutical stated, "The Ministry of Food and Drug Safety recently completed the inspection of the Pyeongtaek bioplant, and the domestic approval process is progressing smoothly."

Rolontis is a neutropenia treatment developed by Hanmi Pharmaceutical and was licensed out to Spectrum in 2012. Spectrum completed global Phase 3 clinical trials and applied for FDA marketing approval in October last year.