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THE INVESTOR
July 21, 2019
Big Reunion

Bio & Medicine

Hanmi Pharma seeks US FDA approval for Rolontis

  • PUBLISHED :December 28, 2018 - 13:48
  • UPDATED :December 28, 2018 - 14:12
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[THE INVESTOR] Hanmi Pharmaceutical said on Dec.28 it has sought approval from the US Food and Drug Administration for Rolontis, its biologic drug for management of chemotherapy-induced neutropenia.




US-based Spectrum Pharmaceuticals, which has been developing Rolontis for commercialization since in-licensing it from Hanmi in 2012, has submitted a biologics license application to the FDA.

“Rolontis is an important and significant future growth driver for our company,” Spectrum Pharmaceuticals President and CEO Joe Turgeon said in a statement.

“Today’s milestone brings us one step closer to bringing the first novel G-CSF to health care providers in over 15 years in a large market that we are familiar with.”

Originally developed by Hanmi, Rolontis is also the first-ever drug employing the Korean drug maker’s proprietary Lapscovery technology to seek commercialization in the US.

Lapscovery -- short for Long Acting Protein and Peptide Discovery -- is Hanmi’s exclusive drug delivery technology that extends the life of a peptide or protein in the body, extending the efficacy and potency.

Spectrum said it had filed a BLA for Rolontis based on data from two phase 3 clinical trials evaluating its safety and efficacy in 943 early-stage breast cancer patients for the treatment of neutropenia due to myelosuppressive cytoxic chemotherapy.

The clinical trials demonstrated that Rolontis has a similar efficacy and safety profile to pegfilgrastim, a drug marketed under the trade name Neulasta, according to Spectrum.

Hanmi’s Lapscovery’s technology is also employed in other drugs that have been licensed out to global pharma companies. They include efpeglenatide, in-licensed by Sanofi, and HM12525A which was in-licensed by Janssen.

By Sohn Ji-young/The Korea Herald (jys@heraldcorp.com)

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