‘Rolontis’, a new drug for neutropenia developed by Hanmi Pharmaceutical, was listed as the 33rd domestic drug.
The Ministry of Food and Drug Safety announced on the 18th that it has approved the domestic market of the new bio-drug Rollontis. Rollontis is a treatment that prevents abnormal reduction of neutrophils, which account for 40-70% of white blood cells. When a cytotoxic anticancer drug is taken, normal cells are also attacked, so the neutrophil count drops to the bottom. This makes them vulnerable to various infections. Rolontis promotes neutrophil production by binding to the granulocyte colony-stimulating factor (G-CSF) receptor, the company explained.
Rollontis is also a drug to which Hanmi Pharm’s platform technology’Labs Coverage’ is applied, which increases the duration of the drug’s efficacy in the body of biopharmaceuticals.
In a clinical trial involving 643 breast cancer patients who developed neutropenia in the early stage, Rollontis was second to the competing drugs in terms of the duration and safety of severe neutropenia, the company explained.
Hanmi Pharmaceutical plans to release Rollontis to the US through its overseas partner, Spectrum. In May, the U.S. Food and Drug Administration (FDA) plans to conduct a’before approval’ due diligence on a bioplant in Pyeongtaek, Gyeonggi, that produces Lolontis undiluted solution. Kwon Se-chang, president of Hanmi Pharm, said, “Rolontis is the first approved product among new bio drugs to which Labscovery is applied.”
Reporter Oh Sang-heon [email protected]
Ⓒ Hankyung.com prohibits unauthorized reproduction and redistribution