Hanmi Pharm: "Rolontis Shows Same Efficacy in Koreans as in Other Ethnicities"

Two Clinical Analysis Results Presented at GBCC

[Asia Economy Reporter Kim Ji-hee] Hanmi Pharmaceutical's neutropenia treatment ‘Rolontis,’ which has completed global Phase 3 clinical trials, has been shown to have the same efficacy in Koreans.

Hanmi Pharmaceutical announced that it presented two clinical analysis results, both orally and as posters, at the Global Breast Cancer Conference (GBCC) held in Seoul from the 8th to the 10th. The orally presented research results were post-analyses of two global Phase 3 clinical trials, proving that the pharmacokinetics and pharmacodynamics of Rolontis show no differences between Koreans and other ethnic groups.

Hanmi Pharmaceutical conducted a clinical trial in which 643 early breast cancer patients were randomly assigned 1:1 to receive either Rolontis or an active comparator the day after chemotherapy. Based on these results, a comparative analysis was performed between the Korean subgroup and the overall population. The non-inferiority of Rolontis in terms of duration of severe neutropenia (DSN) compared to the active comparator showed no difference in the Korean subgroup analysis.

Other key secondary endpoints, such as the nadir neutrophil count and the incidence of febrile neutropenia, also showed no significant differences. The overall safety profile was similar. This study was also nominated for the GBCC Outstanding Presentation Award.

Additionally, Hanmi Pharmaceutical presented a poster comparing the pharmacokinetics (PK) and pharmacodynamics (PD) of Rolontis by dosage between Koreans and non-Koreans based on two Phase 1 clinical studies. The analysis showed similar pharmacokinetics across all ethnicities, and pharmacodynamics analyzed by absolute neutrophil count (ANC) and hematopoietic stem cells (CD34+ cells) showed no ethnic differences. This means that the pharmacokinetic and pharmacodynamic characteristics of Rolontis proven in global clinical trials can be equally applied to Koreans.

The Ministry of Food and Drug Safety approved Rolontis last month as Hanmi Pharmaceutical’s first biopharmaceutical for market release. Currently, Hanmi Pharmaceutical is preparing for the FDA inspection of its Pyeongtaek bioplant scheduled for May to obtain U.S. marketing approval for Rolontis.

Kwon Se-chang, CEO of Hanmi Pharmaceutical, said, “We are pleased to present the various clinical advantages of Rolontis, which is useful for Koreans, at the Global Breast Cancer Conference,” and added, “We will do our best to ensure thorough preparation for the FDA inspection in May, obtain U.S. marketing approval within this year, and enter the global market.”