Rolontis, the 33rd New Drug Developed in Korea, Obtains Approval


The 33rd new drug developed in Korea has been revealed: It is Rolontis, a therapeutic agent for neutropenia from Hanmi Pharmaceutical.

Rolontis, which garnered a great deal of attention as the first biological new drug from Hanmi Pharmaceutical, is the third new drug to be introduced in Korea this year, and this recent news has raised expectations about the future performance of Korea’s pharmaceutical and bio industry.

On the 18th of this month, the Ministry of Food and Drug Safety of Korea announced that it approved Rolontis, Hanmi Pharmaceutical’s biological new drug for treatment of neutropenia, as the 33rd new drug.

Rolontis is a biological drug incorporated with LAPscovery, a platform technology independently developed by Hanmi Pharmaceutical. That is, using genetic engineering technology, specific proteins are linked to granulocyte colony-stimulating factor (G-CSF) analogs to enhance the sustainability of the drug efficacy.

Neutropenia, which usually occurs in cancer patients receiving chemotherapy, refers to an abnormally low concentration of neutrophils, which normally account for 40 to 70% of all white blood cells, in the blood, and it leaves the affected individual vulnerable to infection. Rolontis is a biological new drug with sustained efficacy that is designed to treat or prevent this condition.

Rolontis was found to exhibit noninferiority in terms of the duration of severe neutropenia and reduced risk in relation to a comparison drug during four treatment cycles in two clinical trials carried out with 643 early-stage breast cancer patients with neutropenia.

Hanmi Pharmaceutical, along with its American partner, Spectrum Pharmaceuticals, has begun the procedure to obtain FDA approval for market release of Rolontis. The US FDA’s pre-approval inspection of the Pyeongtaek Bio Plant, the manufacturing plant for the new drug, is scheduled for May.

The domestic market for therapeutic agents for neutropenia is estimated to be KRW 80.0 billion in size, and the global market KRW 3 trillion.

“Rolontis is the first biological new drug developed using Hanmi Pharmceutical’s platform technology, LAPscovery, to obtain approval, which is meaningful,” said Kwon Se-chang, the President and Co-CEO of Hanmi Pharmaceutical, who also added, “Now that it has been approved for the first time in Korea, we will do our best to obtain approval in the United States and other countries so that it becomes Korea’s first biological new drug to succeed in the global market.”

Meanwhile, Leclaza, a therapeutic agent for non-small cell lung cancer developed by Yuhan Corporation, and Regdanvimab for Injection for treatment of COVID-19 from Celltrion received approval from the Ministry of Food and Drug Safety as the 31st and 32nd new drugs in January and February this year, respectively.

Source: Doctors Times