Hanmi Pharm's 'Rolontis' Manufacturing Facility to Undergo FDA Inspection in May

Hanmi Pharmaceutical's New Drug 'Rolontis' (Provided by Hanmi Pharmaceutical)

[Asia Economy Reporter Lee Chun-hee] In May, the U.S. Food and Drug Administration (FDA) will conduct an inspection of Hanmi Pharmaceutical's Rolontis biopharmaceutical manufacturing facility.

Hanmi Pharmaceutical announced on the 17th that it received notification from the FDA that a "pre-approval inspection" of the Pyeongtaek Bio Plant in Gyeonggi, where Rolontis active pharmaceutical ingredient is produced, will take place in May. Hanmi's partner, Spectrum, also announced this in a press release late last night (Korean time).

Currently, Rolontis completed all Phase 3 clinical trials and was submitted for FDA approval in October 2019. The inspection was originally scheduled for March last year but was repeatedly postponed due to the global COVID-19 outbreak and the U.S. government's restrictions on overseas travel for officials.

Rolontis is a biopharmaceutical developed using Hanmi Pharmaceutical's proprietary platform technology, "Lapscovery." It is a long-acting drug administered for the treatment or prevention of neutropenia occurring in cancer patients undergoing chemotherapy.

Kwon Se-chang, CEO of Hanmi Pharmaceutical, said, "We are pleased that the FDA inspection schedule for the Rolontis manufacturing plant, which was delayed due to COVID-19, has been confirmed. We will make every effort to prepare thoroughly for the inspection to quickly obtain marketing approval in the U.S. and become Korea's first successful biopharmaceutical in the global market." Joe Turgeon, President of Spectrum, also said, "We are very pleased that the inspection schedule has been confirmed,” adding, “This FDA inspection will be the final step for Rolontis' marketing approval in the U.S.”

This content was produced with the assistance of AI translation services.