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THE INVESTOR
November 21, 2018
Big Reunion

Bio & Medicine

Hanmi’s neutropenia therapy to file for US marketing approval in Q4

  • PUBLISHED :February 07, 2018 - 15:35
  • UPDATED :February 07, 2018 - 15:35
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[THE INVESTOR] Hanmi Pharmaceutical said on Feb. 6 it would seek US marketing approval for its neutropenia drug Rolontis in the fourth quarter based on positive clinical data.

“As the drug showed positive results in the final round of clinical trials, we expect it will be entitled to target the multibillion dollar market,” said Hanmi Pharmaceutical CEO Kwon Se-chang. 




Rolontis is being co-developed by Hanmi and Spectrum Pharmaceuticals to treat chemotherapy-induced neutropenia.

On Feb. 5, Spectrum Pharmaceuticals said that the drug candidate met its primary endpoint of non-inferiority in duration of severe eutropenia in comparison to Amgen’s Neulasta, affirming the efficacy and safety that Rolontis demonstrated in previous trials.

“The completion of enrollment of our second phase 3 keeps us on track to file a Biologics License Application in the fourth quarter of 2018,” Spectrum Pharmaceuticals CEO Joe Turgeon said.

Rolontis gained global rights for Rolontis from Hanmi Pharmaceutical, except Korea, China, and Japan, in 2012.

If approved by the US, Rolontis is expected to hit the market in 2019 and will be the first to reach the commercialization stage among out-licensed treatments by Hanmi Pharmaceutical.

By Park Han-na (hnpark@heraldcorp.com)

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