Hanmi Pharm's Biopharmaceutical 'Rolontis' Wins Korea New Drug Development Award

Application of Reader Platform Technology 'Labscovery'
Hanmi's First Biopharmaceutical
FDA Approval Application in the US Scheduled for Q1
US Approval Expected Within the Year

[Asia Economy Reporter Lee Gwan-joo] Rolontis, the next-generation long-acting neutropenia treatment and Hanmi Pharmaceutical’s first approved biopharmaceutical, has been awarded the Grand Prize at the Korea New Drug Development Awards.

Hanmi Pharmaceutical announced on the 21st that Rolontis was selected as the Grand Prize winner in the new drug development category at the 23rd Korea New Drug Development Awards, hosted by the Korea New Drug Development Association with support from the Ministry of Health and Welfare and the Ministry of Science and ICT.

This marks Hanmi Pharmaceutical’s fourth time receiving the Korea New Drug Development Award. Previously, in 2005, the hypertension treatment Amodipine won an excellence award, followed by Amozaltan in 2010, and in 2021, Epinofepegdutide, which was licensed out to MSD in the U.S., received the technology export award.

Rolontis, which received marketing approval from the Ministry of Food and Drug Safety in March last year as Korea’s 33rd new drug, is used for the treatment or prevention of severe neutropenia occurring in cancer patients undergoing chemotherapy. Rolontis is the first product among more than ten new drugs developed using Hanmi Pharmaceutical’s proprietary platform technology ‘Lapscovery,’ which enhances the efficacy of biopharmaceuticals, to receive domestic marketing approval.

Rolontis was licensed out at the clinical stage to the U.S. pharmaceutical biotech company Spectrum in 2012, and Spectrum plans to submit a Biologics License Application (BLA) to the U.S. FDA in the first quarter of this year. If the FDA inspections of Hanmi Pharmaceutical’s Pyeongtaek Bio Plant, which produces the active pharmaceutical ingredient of Rolontis, and the finished product manufacturing sites in the U.S. proceed smoothly, marketing approval in the U.S. is expected as early as this year.

In two clinical trials involving 643 early breast cancer patients who developed neutropenia, Rolontis demonstrated non-inferiority in Duration of Severe Neutropenia (DSN) and superior relative risk reduction compared to competing drugs over four chemotherapy cycles.

Notably, Rolontis specifically distributes to the bone marrow, the main target organ, and acts continuously due to the pharmacological mechanism of the Lapscovery platform technology, showing superior hematopoietic stem cell differentiation and proliferation efficacy compared to existing products. Based on this, unlike existing products that can only be administered 24 hours after chemotherapy, Rolontis has the advantage of being co-administered with chemotherapy, which has been confirmed through additional research, and further clinical studies are underway. Hanmi Pharmaceutical plans to expand the dosing regimen through ongoing additional clinical trials to allow administration of Rolontis immediately or within a few hours after chemotherapy, thereby securing advantages in dosing convenience compared to existing treatments.

Kwon Se-chang, CEO of Hanmi Pharmaceutical, said, “We are very honored that Rolontis has received the Grand Prize at the Korea New Drug Development Awards ahead of its entry into the global market worth 4 trillion won,” and added, “We will work closely with our partner Spectrum to develop Rolontis into the most successful global new drug from Korea.”

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