[그린포스트코리아 이민선 기자] The Ministry of Food and Drug Safety licensed the new bio-drug’Rolontis’ developed by Hanmi Pharmaceutical as the new domestic drug No. 33.
An official from Hanmi Pharm said, “As the US marketing approval process of Rollontis is in progress along with the partner Spectrum, the US FDA’s’pre-approval due diligence’ will be conducted in May for the Hanmi Pharm’s Pyeongtaek bioplant, a manufacturing facility of Rollontis. “The domestic market for neutropenia treatments is estimated at 80 billion won, and the global market is estimated at 3 trillion won,” he said.
‘Rolontis Freefield Syringe’ is a biopharmaceutical to which Hanmi Pharm’s proprietary platform technology’Labs Coverage’ is applied, and is a long-acting biologic administered for the treatment or prevention of neutropenia occurring in cancer patients receiving chemotherapy. It is a new drug. It is used in the treatment of neutropenia, which can be seen by chemotherapy, and promotes neutrophil production by binding to the granulocyte colony stimulating factor (G-CSF) receptor. This drug is a product that increases drug persistence by linking a specific protein to a human G-CSF analog manufactured using recombinant technology.
In two clinical trials involving 643 early breast cancer patients with neutropenia, Rolontis was non-inferior to competing drugs (Duration of Severe Neutropenia) compared to competing drugs and excellent relative risk reduction rate, etc. This has been proven.
“Rolontis is the first meaningful product to be approved among new bio drugs to which Labscovery, Hanmi Pharmaceutical’s proprietary platform technology,” said Hanmi Pharmaceutical President Kwon Se-Chang. “Starting with the world’s first license in Korea, it has also acquired licenses in the United States and the global market. We will do our best to become Korea’s first new biopharmaceutical that succeeds in the world.
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