Hanmi Pharmaceutical said Thursday that it has received sales approval for Rolontis (ingredient: eflapegrastim), a novel long-acting neutropenia drug, as Korea's 33rd novel drug from the Ministry of Food and Drug Safety.

The Ministry of Food and Drug Safety has approved Hanmi's neutropenia treatment, Rolontis, as Korea's 33rd novel drug. (Hanmi)
The Ministry of Food and Drug Safety has approved Hanmi's neutropenia treatment, Rolontis, as Korea's 33rd novel drug. (Hanmi)

The ministry based its approval on two clinical trials involving 643 early breast cancer patients with neutropenia. The test showed that Rolontis' bioequivalence to competing drugs for a total of four treatment cycles, including the non-inferiority of DSN (Duration of Severe Neutropenia) and relative risk reduction rate.

Rolontis is a biological drug with a 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.

"Rolontis is meaningful as it is the first new bio drug approved by the ministry that applies Hanmi's Hanmi Pharmaceutical's proprietary Labscovery platform technology," Hanmi Pharmaceutical CEO Kwon Se-chang said. "Starting with the world's first license in Korea, we will do our best so that Rolontis can become Korea's first new bio-drug that succeeds in the global market by acquiring licenses in the U.S. as well."

Spectrum, Hanmi's U.S. partner, is also in the process of obtaining marketing approval for Rolontis with the U.S. Food and Drug Administration. The FDA is scheduled to conduct a pre-approval due diligence for Hanmi Pharmaceutical's Pyeongtaek plant, a manufacturing facility of Rolontis, in May.

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