Hanmi Pharmaceutical submitted a new drug approval application for Rolontis, Korea’s first biopharmaceutical product for treating neutropenia, to the Ministry of Food and Drug Safety on Monday.
|Hanmi's neutropenia treatment Rolontis|
If the ministry approves the drug, the company hopes to launch the drug in the first half of next year. The company also expects to release the drug in the United States in the second half of this year as scheduled, as the Food and Drug Administration has procedures underway to approve the drug.
Rolontis is a new bio-drug developed by Hanmi and licensed out to Spectrum, a U.S. pharmaceutical company, in 2012.
It is a biological drug with long-acting Granulocyte-Colony Stimulating Factor (G-CSF) that utilizes Hanmi’s Lapscovery, a proprietary platform technology. In 2012, Hanmi Pharmaceuticals signed a licensing agreement with Spectrum Pharmaceuticals, giving the global rights concerning Rolontis to its U.S. partner, except for Korea, China, and Japan.
The application submitted to the ministry is based on the data from two phase 3 clinical trials – ADVANCE and RECOVER – conducted by Spectrum.
“Rolontis demonstrated safety and efficacy in 643 early breast cancer patients with neutropenia following myelosuppressive chemotherapy,” the company said. “The two phase 3 clinical trials showed non-inferiority in terms of the duration of severe neutropenia compared with pegfilgrastim during the four cycles of chemotherapy.”
If it launches the drug in Korea in the first half of next year, the company expects the drug will be the most commercially available bio-drug developed and marketed by a Korean company.
“Rolontis is a meaningful product as it will become the first bio-drug that will be commercialized using our proprietary Labscovery technology,” a company official said.
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