Hanmi's 'Rolontis' Nears FDA Approval, Completes US Distribution Network

Hanmi Pharmaceutical's neutropenia treatment 'Rolontis'

[Asia Economy Reporter Lee Chun-hee] Hanmi Pharmaceutical's neutropenia treatment 'Rolontis' has completed preparations for its launch in the United States ahead of the U.S. Food and Drug Administration (FDA)'s decision on market approval.

Hanmi Pharmaceutical announced on the 30th that its U.S. partner, Spectrum, has finalized the launch product name of Rolontis as 'Rolvedon' and has completed preparations for the launch by recruiting sales and marketing personnel responsible for sales nationwide in the U.S.

The FDA operates a review deadline system under the Prescription Drug User Fee Act (PDUFA). Accordingly, the FDA must decide on the final market approval of Rolontis by the 9th of next month. Initially, Spectrum applied for a Biologics License Application (BLA) for Rolontis to the FDA, but faced a setback last August when it received a Complete Response Letter (CRL) requesting additional inspection of the active pharmaceutical ingredient manufacturing facility.

However, the BLA for Rolontis was resubmitted in March, and in June, the FDA conducted an inspection of the Pyeongtaek Bio Plant, where the active ingredient production facility is located. Hanmi Pharmaceutical explained that "the inspection was completed without major issues."

Exterior view of Hanmi Pharm Bio Plant in Pyeongtaek-si, Gyeonggi Province (Photo by Hanmi Pharm)

Since the inspection, which had been delayed due to the COVID-19 pandemic and other factors, was conducted without significant problems, approval is expected, and efforts are focused on completing the sales network. Spectrum is currently mobilizing sales personnel across various regions to increase contact with key cancer centers in each state. Hanmi Pharmaceutical is also closely involved in establishing Spectrum's marketing strategy for Rolvedon in the U.S. market. Both companies plan to actively highlight the advantages of Rolontis, which is regarded as a next-generation treatment compared to existing neutropenia therapies, aiming to receive excellent evaluations in the market as soon as possible.

A Hanmi Pharmaceutical official said, "Rolontis is significant as Hanmi Pharmaceutical's first globally launched new drug," adding, "We will concentrate the group's capabilities to ensure tangible results in the neutropenia treatment field, which forms a market worth approximately 3 trillion KRW in the U.S. alone."

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